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 Frequently Asked Questions
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Oncology Patient Enrollment Network (OPEN)
1. Social Security Numbers (SSN) cannot be given by our site, is this question mandatory in the demography screen?
  The Lead Organization for the study will determine which fields in the demographic screen are mandatory. Those fields that are not mandatory will not be required to process an enrollment. Required fields in OPEN are marked with a red asterisk ( * ).
 
CTSU Membership
2. Who can become a member of the CTSU?
  CTSU membership is open to all persons participating in the NCI supported National Clinical Trials Network (NCTN) Program, the Experimental Therapeutics Clinical Trials Network (ETCTN) Program, and on a limited basis, to other networks collaborating on CTEP and DCP-supported trials. In addition, staff at the organizations sponsoring protocols, CTEP staff, and their contractors are included on the CTSU roster.
 
3. How do I become a member of the CTSU?
  All persons on the CTSU roster must register with CTEP. Investigators (any physician involved with an aspect of clinical research) must register through the Pharmaceutical Management Branch (PMB) Investigator Registration process, and are strongly encouraged to obtain a CTEP-Identity and Account Management (IAM) user name and password. Associates (persons other than physicians involved in the conduct of research) must obtain a CTEP-IAM account. Instructions on obtaining an account are available on the CTSU Public website at https://www.ctsu.org/public/RegProced_ir-ar.aspx.

Please note that obtaining a CTEP-IAM account and being added to the CTSU roster is a two-step process. The initial authorization for your user name and password is completed by CTEP. Credentialing to verify your affiliation is completed by the CTSU. Access to the CTSU Members' website is not allowed until you have received the "Welcome to CTSU" e-mail.
 
CTSU Members Website
4. Why do I have to update my IAM password so often and follow so many rules?
  The requirements to maintain a CTEP-IAM password are developed in accordance with NIH policies. With the implementation of the Oncology Patient Enrollment Network (OPEN) and the Clinical Data Tab more sensitive information is available to users on the members' website and it is critical to provide a safe and secure environment to our users and the public we serve.
PLEASE - NEVER SHARE YOUR PASSWORDS!!!!
 
CTSU Membership
5. What privileges are granted with CTSU membership?
  Persons with an active status on the CTSU roster and who maintain an active CTEP-IAM account are allowed to access the CTSU Members' website including the Oncology Patient Enrollment Network (OPEN) tab and are included on routine communications from CTSU.
 
6. Who needs to be assigned roles on the CTSU roster?
  Sites that have enrolled subjects through the CTSU or participate on studies where CTSU is responsible for data management must maintain two primary site contacts on the CTSU roster. The CTSU Site Administrator (AD) and Site Data Administrator (DA) receive general targeted communications from the CTSU, have access to restricted areas of the website under the Clinical Data Tab, and may assign roles to other individuals at their site, or withdraw persons from their site via the Site Roles Tab on the CTSU members' website. The CTSU DA is the primary data management contact for the institution for the CTSU and the Network Groups. Sites that fail to maintain these primary roles will be suspended from further CTSU enrollments until the roles are assigned.
 
7. Do I need to assign other staff roles on the CTSU roster?
  The Site Roles Tab is a tool provided to the site to better manage their CTSU roster and to assign person roles for all NCTN Network Groups. Persons designated by each NCTN Group and the CTSU to maintain site roles should use the site roles screens to maintain Rave access roles (Rave CRA, Read Only, and Site Investigator), the OPEN Registrar role, and other roles as required for contact and access purposes by their affiliated Network Group.

The Rave-related and the CTSU DM or Data Management roles, can be assigned by protocol or lead organization to accomodate centralized or de-centralized data management assignments at the site. It should be noted that only one person can be assigned the DM role per protocol. The DM role also allows the user access to restricted areas of the Clinical Data Tab on the CTSU website.

The Registrar role must be assigned at the institution level to allow site staff to enroll patients using the Oncology Patient Enrollment Network (OPEN) to protocols for which their site is not affiliated to the lead protocol Group.
 
8. How do I assign the Site Administrator and Data Administrator or add people to my site roster?
  To assign or change the Site Administrator or Data Administrator the CTSU Roster Update Form must be submitted and signed by the person assuming the role. In addition, to link a person to a site the Roster Update Form must be submitted.
 
9. How do I use the Site Roles Tab?
  The Site Roles tab is located at https://www.ctsu.org/rss/. The Site Roles table outlines for each NCTN Group the avaialble roles and which roles can be managed through the Site Roles screen. In addition, a training video and a Help document located on the tool bar for the Site Roles screen that explain the how to withdraw persons or add/change person roles.
 
Protocols
10. I recently received notification of an SAE on an open study at my site. We have another study sponsored by a different Lead Protocol Organization (LPO) that uses the same drug. Why haven't I received notification of the SAE with regards to this other study?
  The CTSU posts SAEs upon receipt from the sponsoring/lead Cooperative Group. An SAE occurring on one Cooperative Group trial may possibly affect other CTSU menu trials being sponsored by other Cooperative Groups. However, we can only post SAEs once we receive notification from the Lead Group sponsoring the trial.
 
11. Our site is interested in a study that is currently active on the CTSU menu but it is a limited participation trial. How can we be considered for participation in these trials?
  There are several reasons why participation in certain trials on the CTSU menu may be restricted. These include membership requirements, technical capabilities of the clinical site, accrual history on other related protocols, and funding status for the clinical trial. Interested sites should contact the CTSU helpdesk for assistance. In some cases, a request for consideration will be honored, however in other cases it may not be possible for every site to participate on certain CTSU web-posted trials.
 
12. Where can I find information about additional funding for a protocol?
  The CTSU will post any additional funding information for a study in the Funding tab of the protocol. In this tab, you will find specific funding information listed for this protocol, as well as any supporting funding documents that CTEP has approved.
 
Oncology Patient Enrollment Network (OPEN)
13. What do I need to be able to enroll a patient in OPEN?
  In order to access OPEN you need to have a CTEP-IAM account. If you do not have one you can log into their website at https://eappsctep.nci.nih.gov/iam and request an account. Please allow three business days for processing. If this is an urgent matter please contact the CTSU Help Desk.

You will need the ‘registrar’ role on a Network Group or POs (Participating Organization) roster in order to enroll patients via OPEN. A link to the OPEN Portal is available under the OPEN tab of the CTSU members’ website. Or you may log in using the OPEN url: https://OPEN.ctsu.org.
 
14. How can I check if I am on my Group roster as a registrar?
  If your institution is a member of one or more Network Group, you will need to contact each Network Group to be sure you are listed on their roster as a ‘registrar’ in order to enroll patients via OPEN. You may also view your role on the Lead Protocol Organization (LPO) or Participating Organizations (POs) rosters via the RSS Site Roles Maintenance Screen in the CTSU members’ website: https://www.ctsu.org
 
15. What training is available for OPEN?
  OPEN is user-friendly and intuitive, however, a number of training tools have been developed to assist users in navigating through the system. On all of the OPEN screens, users will have access to a training module and the site user guide.

OPEN also has a ‘practice mode’ feature, where users can perform practice enrollments to familiarize themselves with the application and enrollment forms prior to actually enrolling patients. The training module and OPEN user guide are also available in the OPEN tab of the CTSU members’ website.
 
16. How do I know whether to use OPEN to enroll patients on a particular study?
  All NCTN protocols will use OPEN for patient enrollment. To determine which studies are active in OPEN, log onto the CTSU Members’ web site and click on the OPEN tab. You will find the list of studies that are active in OPEN. In addition, if a given study is active in OPEN, the protocol page will display the OPEN logo indicating that enrollments to the study must go through OPEN. You must use OPEN to enroll patients on the specified studies.
 
17. How do I access OPEN to enroll patients?
  A link to the OPEN Portal is available under the OPEN tab on the CTSU members website.
 
18. Can you complete a registration that was initiated by another user?
  Yes, all individuals with enrollment privileges for their site may complete any enrollments that are "in progress" for their site.
 
General Regulatory
19. How can I find the NCI Institution Code?
  There are several ways to determine your NCI Institution Code. To start, it may be helpful to verify to which codes your Lead Networks are claiming you.
Here is how to verify this:
  • Log onto the CTSU members' website
  • Select the Regulatory Tab
  • In the Browser Tree on the left side, select your name

    The CTSU website will then display your active membership information, including the Site CTEP # for the locations to which your Lead Networks claim you.

    If you are unsure of which of these codes you should be utilizing, you should call your Lead Network directly to dicuss the code that best reflects your institution.
     
  • Audit
    20. How are cases selected for audit?
      At least 10% of the cases accrued since the last audit must be selected. These cases should be comprised of 10% treatment studies, 10% from protocols with advanced imaging and 10% from DCP cancer control/prevention trials. Unitl approximately 2016, 10% of the endorsed and non-enorsed legacy cases credited to the Group must also be included.
     
    Oncology Patient Enrollment Network (OPEN)
    21. Why is the protocol I want to enroll a patient on not in the drop down list for my site?
      Your site may not have regulatory approval to participate on the protocol. To check your approval status, click on the ‘Site Status List’ on the ‘Create New Screen ‘in OPEN to view details on each of the protocols that are associated with your institution. Alternately, detailed site registration status is available by clicking on the Regulatory Tab on the CTSU members’ website https://www.ctsu.org. Your site may not be a member of a partipant on the protocol. Check the cover page of the protocol to see if your site is a member of the Lead Protocol Organization or a participating organization.
     
    22. What is the difference between the Treating Investigator and the Credit Investigator?
      The Treating Investigator is the investigator who will have contact with the patient throughout the course of the study. When the Treating Investigator is not a member of the Network Group the site would like to give credit to, the site will need to choose an investigator who affiliated with the site and is a member of the Lead Organization.
    The Credit Investigator will receive payment and will have the ultimate responsibility for the patient and audit activities for the study.
     
    23. Do I have to choose a Drug Shipment Investigator?
      No, the Drug Shipment Investigator is an optional field; however, it may be required for some protocols. Section 2 on the 'Create New' Screen will include protocol specific instructions regarding the requirements for persons associated with the enrollment.
     
    24. Can I fix an error on a completed enrollment?
      Errors to completed enrollments cannot be made in OPEN at this time. For errors on the credentialing screen, you must contact the CTSU Help Desk to make changes to the enrollment. For errors to Demography or Eligibility Checklist data you must contact the lead Group and the CTSU Help Desk to make the changes.
     
    25. How long will the OPEN screen remain idle before it times out?
      The OPEN screen will time out after 30 minutes with no activity. You will then have to log in with your username and password.
     
    Audit
    26. Where can I find information on audit guidelines?
      The NCI CTMB Audit Guidelines are available on the CTSU Member's website at the following location:
  • Click on the Education and Resources tab
  • Select Audit Resources from the left side browser tree
  • Select NCI Clinical Trials Monitoring Branch (CTMB) Links and Materials

    You may also access the guidelines directly via the following link: http://ctep.cancer.gov/branches/ctmb/clinicalTrials/monitoring_coop_ccop_ctsu.htm
     
  • 27. Who is responsible for conducting the audit?
      The Network Group or CCOP/NCORP or Research Base credited with the accrual is responsible for the audit.
     
    Protocols
    28. Can our site edit the model informed consent form?
      Yes, sites are allowed to update the consent according to their institution’s needs, however the main scientific content must remain unchanged.
     
    Awareness, Education & Training
    29. Does the CTSU website have any educational materials or tools for individual studies?
      The CTSU makes a number of educational materials and tools available on our members website. Under the Education and Resources tab there is a folder entitled Protocol Specific Materials. By clicking on that folder you will see a description of the various items we produce and/or make available for many trials listed on the website, and you can then find these items by going to the appropriate study's sub-folder (these items can also be found on a given study's page under the Protocols tab). These tools can help you screen patients, set up study calendars, promote a study among healthcare providers at your site, etc.
     
    30. I am part of a study team or Cooperative Group. How can the CTSU help with study promotion?
      The CTSU can do several things to assist with the promotion of a study or group of studies. For more information on this see the CTSU Road Map: Promoting Clinical Trials under the Education and Resources tab, CTSU Operations Information/CTSU Processes.
     
    31. Does the CTSU website have any information about the audit process?
      For information about NCI site audits, go to the Education and Resources and click on the Audit Resources folder. Here you will find links that will assist you in preparing for and succeeding in site audits. Take special note of the Protocol-Specific Audit Worksheets, which are used by actual NCI auditors, and are tools that can help you to prepare for audits. Additionally, you can look in the Educational Presentations and Webcasts folder for a number of presentations that will help you prepare for an audit at your site.
     
    CTSU Members Website
    32. My password always seems to expire, how many days does it last?
      Your password is good for 60 days and passwords must follow NIH password rules.
     
    33. Are passwords for the CTSU Members website case sensitive?
      Yes, the passwords ARE case sensitive. For more information about passwords for the CTSU Members' website, please visit the CTEP-IAM registration system and click on "Reset Password".
     
    Protocols
    34. Why are some protocols posted under the Lead Protocol Organization (LPO)'s folder but with no protocol documents posted?
      These protocols are available on the website to display funding information only. These studies are not open for cross-network participation. The protocol and supporting documents for this study are available on the lead protocol organization’s (LPO) website.
     
    CTSU Membership
    35. Can I use the Site Roles screen to maintain my roster for other Groups?
      You can view all the NCTN and other network rosters to which you are affiliated from the Site Roles tab. The NCTN Groups allow the addition and removal of selected person roles through the Site Roles screen by persons with the appropriate privileges to maintain roster information using the Site Roles tab.
     
    Audit
    36. Will the CTSU perform an independent audit of our site?
      The CTSU will not independently audit any site that is an enrolling member of a Network Group, CCOP/NCORP or Research Base, unless requested by CTMB. Periodically, the organization that has scheduled the audit will request assistance with auditing the CTSU and/or DCP enrolled cases. This is typically due to a high volume of auditable cases or the accrual type is not part of their scientific agenda. As of 8/01/13, CTSU will supplement the lead audit team at a limited number of visits to assist with the auditing of non-endorsed legacy accrual until 2016.
     
    37. Will CTMB accompany the auditors on each visit?
      CTMB may join any group audit at their discretion but they are not typically a member of any of the audit teams.
     
    38. What documentation are we required to provide during an audit?
      You will be responsible for ensuring that all relevant materials are available for review. These materials could include:
  • Patient and outpatient medical records
  • Study flow sheet and other research records
  • Protocol or study roadmaps
  • Enrollment tracking sheets
  • Subject diaries / calendars
  • NCI Drug Accountability Record Forms (DARFs)
  • Informed consents and IRB documents
    For more information, please review the CTMB Audit Guidelines Section 5.
     
  • 39. Are there any available resources that would assist in providing further education for our site?
      Yes, CTSU members may access the Education and Resources tab on the member's website. Under this tab, you will find educational materials such as audit related presentations and webcasts developed for training, study specific audit worksheets that are used by the auditors, protocol specific materials and links to the NCI Clinical Trials Monitoring Branch audit guidelines and other useful materials.
     
    40. How will our site be evaluated during an audit?
      Per CTMB Audit Guidelines, there are three audit categories that comprise a complete audit evaluation: IRB and Informed Consent review, Patient case review and Pharmacy review. Each of these components is reviewed unless otherwise specified prior to the audit and is assessed an Acceptable, Acceptable Needs Follow Up or Unacceptable rating based upon the findings during the audit. You may review these criteria and find further details in the CTMB audit guidelines under Audit Resources on the CTSU website.
     
    41. I have noticed that the date protocol material is posted on the CTSU website sometimes differs from the date the material is posted on the Group website. Which posting do I utilize?
      The CTSU and the lead protocol organization websites should display the same protocol information with the exception of protocol information specific to the lead organization or to CTSU members, and minor posting delays. Please contact the CTSU Help Desk regarding discrepancies between the lead group and the CTSU website.
     
    42. Are the audit worksheets revised when protocol amendments or revisions are released?
      Currently, the CTSU revises the posted audit worksheets for every revision or amendment, when appropriate. During the revision period, these audit worksheets will be removed from the website. Since these services will discontinue post 2016, lead organizations are welcome to use these worksheets as templates for any studies that to not have a posted worksheet.
     
    Data Submission
    43. Where can I find information about data submission expectations, how to complete CRFs, and where to submit data?
      Protocol-specific CRF completion guidelines and data submission instructions are located on the CTSU members' website. Go to the Protocol tab to find the study. Expand the tree on the left side of your screen for the desired protocol. Click on 'LPO Documents.' Click on "Case Report Forms" in the expandable tree on the left side of your screen OR scroll down to the Case Report Forms section on the protocol page. As an alternative, you can use the Document Search capability on the Home page by entering the protocol and selecting Document Type.
     
    44. I received a delinquency notice on CRFs that I already faxed to the CTSU. How can I find out if the CTSU received my submission?
      Go to the Clinical Data tab on the CTSU Members' website. Click on the Received Forms tab and perform a search for your site, protocol, and patient. All data that has been entered into the database will appear on this page.

    Data faxed to the CTSU are typically keyed into the database within four business days of receipt. When data cannot be processed (e.g., missing patient ID number), the CTSU will notify the site of the issue and request a corrective action to be managed by the site. Common errors include unsuccessful fax transmissions, incorrectly completed transmittal forms and missing patient identifiers. If you have a concern about a data submission and are unable to locate it under the Received Forms tab, you may contact the CTSU help desk at 1-888-823-5923.
     
    45. How do I find a list of patients enrolled at my site?
      Go to the Clinical Data tab on the CTSU members website. Click on the Patients tab and perform a search for your site and protocol.
     
    46. How do I find what forms the CTSU has received for a protocol?
      Go to the Clinical Data tab on the CTSU Members' website. Click on the Received Forms tab and perform a search for your site, protocol, and patient. All data that has been entered into the database will appear on this page.

    Data faxed to the CTSU are typically keyed into the database within four business days of receipt. When data cannot be processed (e.g., missing patient ID number), the CTSU will notify the site of the issue and request a corrective action to be managed by the site. Common errors include unsuccessful fax transmissions, incorrectly completed transmittal forms and missing patient identifiers. If you have a concern about a data submission and are unable to locate it under the Received Forms tab, you may contact the CTSU help desk at 1-888-823-5923.
     
    47. How am I notified of data clarification forms (DCFs) or RDC discrepancies that require resolution?
      Go to the Clinical Data tab on the CTSU Members' website. Click on the Outstanding DCFs tab or the RDC Discrepancies tab, as applicable. You can search by site, protocol, and patient. We suggest that you check this page daily for new entries.

    RDC discrepancies can also be found via the Search function within the RDC application.
     
    48. How can I get access to the Clinical Data tab on the CTSU Members' website?
      To have access to all the information under the Clinical Data tab you must be assigned a role (as determined by your site administrator). Authorized individuals at your site (i.e., your site administrator) can authorize access for you. Contact your site administrator regarding role changes or access. Instructions are posted under the Regulatory tab on the CTSU members' website: click on the Site Roles subtab and select the "Site Roles Slide Set" document.
     
    49. I received an email indicating my site had outstanding data clarification forms (DCFs). How can I find out what protocol(s) the DCFs are for?
      Go to the Clinical Data tab on the CTSU Members' website. A 'Summary of Your Account' table will display at the bottom of the page. Click on '+' in the Protocol column of the table; the table will expand to display DCFs and RDC discrepancies by protocol.
     
    50. I recently discovered an error was made on a previously submitted case report form (CRF). How do I correct this error?
      Follow the instructions in the protocol-specific data submission instructions. To find the instructions, go to the Protocol tab on the CTSU members website. Expand the tree on the left side of your screen for the desired protocol. Click on 'LPO Documents.' Click on "Case Report Forms" in the expandable tree on the left side of your screen OR scroll down to the Case Report Forms section on the protocol page. As an alternative, you can use the Document Search capability on the Home page by entering the protocol and selecting Document Type.

    Note: updates to data originally submitted via a paper CRF are made using a data update/modification form or an amended CRF while updates to data managed via RDC are made directly by the site user in RDC.
     
    Awareness, Education & Training
    51. Where can new staff at my site go to learn about the CTSU?
      Prior to obtaining access to the CTSU member website, refer to the resource: Instructions for Getting Started with the CTSU. After a new staff member has obtained usernames and passwords to access the CTSU members website they should go to the Education and Resources Tab. The CTSU Operations Information folder contains the best resources for those new to the CTSU, especially within the Basic Information Materials sub-folder. The NCTN webpage and ETCTN webpage will provide additional valuable information regarding those programs.
     
    Protocols
    52. My center is interested in offering symptom management trials to patients currently enrolled on treatment trials. Can this be done through the CTSU?
      Yes, the CTSU is offering a growing number of supportive care and symptom management trials sponsored by the NCI Division of Cancer Prevention. Many of these trials allow co-enrollment on a cancer treatment trial; read the eligibility criteria carefully. To locate these trials, go to the Protocol tab of the CTSU members' website, click on the Reports tab, select list by Study Type, and view the output for Cancer Control trials.
     
    53. I heard about a study that may be of interest to our site but it is not yet active; how do I know if this study will be offered on the CTSU website for cross-network participation?
      The CTSU Protocols and Accrual Report provides easy access to this information. On the members' side of the CTSU website, click on the Protocol tab, and then click on the Reports tab. This section will help you find a list of all active, in-development, and closed studies that are, will be, or have been offered through the CTSU, respectively. You will be able to sort by Study Type, Cancer Type, Lead Organization, or Study Number.
     
    54. How do I get protocol revisions or safety reports from previous Bi-monthly Broadcasts?
      Older Bi-monthly broadcasts are available on the CTSU members' website. On the CTSU home page, click on the Broadcast/Newsletter tab then click View All. This contains an archive of previous Bi-monthly Broadcasts.
     
    RAVE
    55. Why can't I update information in the Enrollment forms for a subject?
      Information in the Subject Enrollment, Demography, Step Information and Treatment Assignment forms are loaded directly from the OPEN system. Please contact the CTSU Helpdesk if it is necessary to update data in any of these forms. The CTSU Helpdesk will direct you to the appropriate LPO contact.
     
    CTSU Membership
    56. What is the CTSU?
      The National Cancer Institute (NCI) developed the Cancer Trials Support Unit (CTSU) aas an integral support system for NCI's cancer clinical trials.

    The CTSU objectives are as follows:
  • Enhance the integration of information technology services supporting NCI's national cancer clinical trial program
  • To streamline and standardize processes, including patient enrollment and data collection services
  • To reduce regulatory/administrative burden on investigators participating in NCI-sponsoredclinical trials Faciliate physician and patient access to NCI-sponsored clinical trials
     
  • Awareness, Education & Training
    57. What is an NCI-sponsored Clinical Trials Cooperative Group?
      An NCI-sponsored Clinical Trials Cooperative Group is a large network of health care professionals, from both academic institutions and community-based cancer treatment centers throughout the United States, Canada, and internationally that develop and conduct large-scale cancer treatment trials (research studies) as well as smaller, developmental trials. Cooperative Groups enroll approximately 20,000 new participants per year into cancer treatment trials. Each is a separate organization with different leadership and research goals.

    The nine Adult Cooperative Groups sponsored by NCI are as follows:
  • American College of Surgeons Oncology Group (ACOSOG)
  • Cancer and Leukemia Group B (CALGB)
  • Eastern Cooperative Oncology Group (ECOG)
  • Gynecology Oncology Group (GOG)
  • National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
  • National Surgical Adjuvant Breast and Bowel Project (NSABP)
  • North Central Cancer Treatment Group (NCCTG)
  • Radiation Therapy Oncology Group (RTOG)
  • SWOG (SWOG)
     
  • 58. How does CTSU support Clinical Trials Cooperative Groups?
      CTSU supports the Cooperative Groups in the following manner:
  • Facilitates the enrollment of patients on clinical trials
  • Facilitates collection of research data on selected protocols
  • Produces education and training materials and makes these available online
  • Provides centralized auditing, regulatory, and fiscal management support
     
  • Patient Enrollment
    59. How do I know what group to credit for my enrollment?
      You may credit any group with which your site and your physician are both affiliated. See the OPEN Guidelines document for more information about the crediting rules.
     
    60. What documents do I need to submit for the registration and where can I find them?
      The forms required for your enrollment are located on the CTSU member's website. Log on to CTSU member's website and click on the Protocols tab. On the left side of the screen, click on By Lead Organization and choose your protocol. Select the Documents folder and then the Patient Enrollment folder. The right side of the screen will have the current registration documents posted. You can also refer to the CTSU Appendix of the protocol for complete instructions in order to know what you should submit for your enrollment.
     
    61. When asked for IRB approval date, what date do I put on the registration forms?
      The date in question refers to the latest annual IRB approval date for the protocol. This date is not to be confused with the protocol amendment or protocol meeting dates. If you are unsure and would like to verify your IRB approval date contact the CTSU helpdesk at 1-888-823-5923.
     
    62. Who do I contact about drug shipment process?
      For questions concerning drug shipment, refer to the protocol for study specific information on who to contact for drug shipment information.
     
    63. Who do I contact get an exception for a protocol?
      Study exceptions can only be granted by the protocol Lead group. CTSU Registrars cannot grant exceptions.
     
    64. Can I change my crediting group in between steps?
      Yes , sites are allowed to change credited groups within 7 claendar days of the enrollment.
     
    65. How can I check to see if my site status is pending and why?
      To check your site's status for a protocol, log onto the CTSU Members website:
  • Go to the Regulatory tab
  • The sites you are affiliated with will be listed on the left side of the screen
  • On the right side of the screen, click on the Site Registration tab
  • Enter the Site Number and you may choose to view a specific registration status (all, approved, disapproved, pending, closed)
  • Click 'Go'

    The list of protocols, registration status (depending on which was selected above), missing requirements and comments will be displayed for the site selected.
     
  • General Regulatory
    66. How can I see what my approval status is?
      You can check your site's registration status for all studies maintained in RSS by following these steps:
  • Log on to the CTSU Members' Website
  • Select the Regulatory tab
  • Select the Site Registration tab
  • Enter your Institution's NCI code into the Site Number field.
  • If desired, modify your search by Registration Status and Protocol number
  • Click Go

    The CTSU Website will display all of the protocols with records in RSS that meet the parameters identified. The second column titled Registration Status will indicate current status of the study (ex. Approved, Pending, etc.) in the CTSU's database. The last column called Missing Requirements will list any outstanding requirements (Active trials only) that need to be submitted to the CTSU prior to patient enrollment.
     
  • Regulatory - for sites using their local IRB
    67. Do I need to send IRB continuing review approvals for trials that are closed to accrual?
      At the time of closure, the Lead Protocol Organization (LPO) will dictate to the CTSU whether annual IRB renewals of the trial need to continue to be submitted to the CTSU Regulatory Office. To verify if the LPO is requiring you to submit renewals for a closed study, you may follow these steps:
  • Log onto the CTSU members' website
  • Click on the Regulatory Tab
  • Enter your Institution's NCI code into the Site Number field.
  • Enter the protocol code in the Protocol field (or use the Pick button)
  • Click Go

    For your trials that are closed to accrual by the LPO, the Registration Status column will display one of two statues: Closed or Closed, Cont Rvw. If the protocol is Closed, then no further continuing reviews are being collected at the CTSU Regulatory Office. If the protocol is Closed, Cont Rvw, IRB continuing review is being collected in RSS.
     
  • CTSU Membership
    68. What are the CTSU business rules for Associates and Investigators to be approved for membership?
      1) Investigators - must be active on a NCTN, ETCTN, or other NCI-supported network roster and active in PMB.

    2) Associates - must be active on a NCTN, ETCTN, or other NCI-supported network roster. In addition, NCTN and ETCTN staff persons, CTEP staff, and CTEP contractors are added to the CTSU roster.
     
    69. What is the CTSU site business rule?
      A site must be active on a Cooperative Group treatment roster to be added to the CTSU site roster.
     
    70. What does it mean when a person's NCI status is suspended?
      The CTEP-IAM requires an annual re-registration. This process is separate from the password update process which occurs every 60 days and does NOT impact CTEP or CTSU roster status. Persons that do not re-register with CTEP are automatically set to suspended at CTEP and on the CTSU roster. If an associate remains suspended for greater than 6 months their CTSU roster status is set to "withdrawn", and for investigators, if their CTEP IR status remains suspended for greater than 1 year their CTSU roster status is "withdrawn".
     
    71. How can I remove myself from a roster?
      For an individual to remove themselves from a NCTN Network Group roster they must contact the Group directly. CCOP members must contact their CCOP Administrative to be removed through CCOPSYS.
     
    72. What are the roster status definitions for CTSU?
      All rosters managed in the Regulatory Support System now use standard member role terminology.

    For Sites:
    Active - member in good standing and may participate via CTSU on CTEP-supported trials.

    Suspended - temporary suspension of accrual previldges generally associated with with data quality or audit issues.

    Withdrawn - site that has completed all patient followup and is no longer particpating on NCI-supported trials. All persons at an institution with a status of withdrawn will also have a withdrawn status.

    Follow up - site that is no longer able to accrue subjects, but continues to follow patients on study. All persons at a site in follow up will also have a follow up status.

    For Persons:
    Active - member in good standing and may participate via CTSU on CTEP-supported trials.

    Suspended - temporary status generally due to failure to re-register through IR for investiagors and IAM for associates.

    Withdrawn - person that is no longer participating in NCI-supported trials.

    Follow up - used only for investigators to designate an investigator that is still following patients, but no longer accrues new subjects.
     
    73. The CTEP status terms are different than the CTSU roster terms, what are the CTEP statuses and what do they mean?
      Associate Statuses:
  • Active
  • Suspended (failure to re-register)
  • Approved (failure to reset temporary password)

    Investigator Statuses:
  • Active
  • Suspended (failure to re-register)
  • Inactive (suspended for more than five consecutive years)
  • Withdrawn (provided written notification to PMB that they are no longer involved in clinical research)
  • Deceased
  • Disqualified (on the FDA disqualified list)
  • Pending registration (Preliminary investigator record created for an investigator to be abstracted by PIO on a new LOI / Concept / Protocol. The investigator is sent a registration packet at the time the "pending registration" record is created with the intent that they will complete and submit the packet and become "active" … which happens most of the time; but, not all of the time.)
  • Registration not required - Investigator record created for a non-MD to be abstracted by PIO on a new LOI / Concept / Protocol for a non-treatment ancillary study.

    There is currently no way to tell from an investigator status alone if an investigator has an IAM account or if that IAM account status is currently active.
     
  • 74. I was looking at my site registration and it indicated I was missing the Site_RTF number. What is that?
      Sites and persons can be linked to attributes on the CTSU roster and on their affiliated Cooperative Group rosters. Attributes are often linked to Protocol Specific Requirements as it allows the site to comply once to a requirement to cover multiple studies with the same requirement. The Site_RTF is a site attribute linking the radiation facility to the clinical site.
     
    Protocols
    75. I am submitting two protocols that require the Radiation Therapy (RT) Facilities Inventory Form. Do I need a separate inventory for each protocol?
      No, the CTSU keeps a copy of the RT Facilities Inventory on file, which can be used for each protocol. However, you do need to complete and submit a new RT Facilities Inventory for each separate facility that is being used for treatment.
     
    Awareness, Education & Training
    76. What is meant by "Institution/Practice Name"?
      The Institution refers to the name of the location, covered under the IRB, with which treating physicians are affiliated. Some medical centers have separate practices within the center that would have different names. (e.g. Major University Hospital, Oncology Research Center).
     
    77. What is meant by "Investigative Site/Performance Site"?
      This refers to the location where most of the trials will be conducted, consent obtained, and treatment given. This is usually an outpatient clinic or a physician practice site.
     
    78. What is a CCOP?
      CCOP stands for Community Clinical Oncology Program. The program was initiated in 1988 by the National Cancer Institute (NCI) in an effort to bring state of the art treatment for cancer to patients in their own communities. The CCOP program allows physicians or groups of physicians who are interested in participating in clinical research to join together to apply for NCI funding which will support an infrastructure for them to conduct research in their community or private practice setting. Typically, a CCOP will consist of several oncologists (medical, surgical and radiation) as well as physicians with an interest in clinical research in cancer treatment and/or cancer prevention. An individual CCOP may be one institution with a few associated physician practices located in one relatively small geographic area, or 50-60 individual practices with several institutions covering several hundred square miles. In either case the goal is the same, to support and participate in the accrual of patients to NCI sponsored clinical trials. For the most part, the CCOPs accrue patients onto clinical trials that the Cooperative Groups and other CCOP Research Bases develop. These trials involve cancer treatment regimens, symptom management, quality of life, and cancer prevention.

    To learn more about the CCOP program please visit their web site at: http://prevention.cancer.gov/programs-resources/programs/ccop.
     
    Patient Enrollment
    79. How are payments made for patient enrollments conducted through the CTSU?
      Payments will be made by the Network Group designated to receive the accrual credit on the patient enrollment form. For information about protocol funding, see the funding information tab for the protocol on the CTSU website.

    If you are part of a Community Clinical Oncology Program (CCOP) you will be reimbursed in the form of a treatment credit reported to the Division of Cancer Prevention (DCP), which will fund you through your established mechanism.

  • Per patient case reimbursement is 1.0 credit.
  • An additional per patient case reimbursement of 0.5 credit will be given if the protocol includes a cancer control component.
     
  • Audit
    80. How do we ensure the quality of the data? Is there an audit function?
      Audits are conducted by the Groups at least once every three years. Regardless of membership type, the initial audit is performed 18 months after entry of the first patient. A percentage of CTSU enrollments are audited during the regularly scheduled Group audit.

    The on site audit consists of reviewing and evaluating three components independently with compliance to the Clinical Trials Monitoring Branch (CTMB) and National Institutes of Health (NIH) guidelines for the conduct of clinical trials. The three components are as follows:
  • IRB and Informed Consent
  • Pharmacy and Drug Accountability
  • Patient cases
     
  • Regulatory - for sites using their local IRB
    81. My IRB approved a new site to participate on an open study to which they already have an existing approval. What do I need to send to the CTSU Regulatory Office to notify them of the new site?
      A protocol-specific IRB approval is needed indicating the date the new site was added as a participating site to your IRB's current approval for the protocol. If your IRB's approval of the new site is not protocol-specific or applies to all open studies, then a list of the applicable protocols must be provided as an attachment.

    The CTSU Site Addition Form can be utilized when an IRB has added a new site to an existing IRB approval. Should the CTSU Site Addition Form be submitted alone, not in conjunction with IRB documentation, it must be signed by an IRB signatory.

    Any additional requirements established by the Lead Protocol Organization for each trial will also need to be submitted for the new site.
     
    General Regulatory
    82. Does the CTSU accept electronic regulatory submissions?
      Yes. In additon to accepting regulatory submissions via fax and mail, the CTSU Regulatory Office also accepts site registration, person, and institution documents via email at CTSURegulatory@ctsu.coccg.org.
     
    Regulatory - for sites using their local IRB
    83. What regulatory documents require an IRB signature?
      Documentation for all local IRB approvals must contain a valid IRB signature.

    If your IRB's approval letters are maintained electronically and do not have a signature, please ensure the CTSU Regulatory Office has either a copy of your IRB's signature policy on file or a Note to File from your IRB indicating they do not sign their approval letters.

    The exception to this rule is in regards to local protocol terminations. If your IRB has permanently closed a study, local site research personnel can complete and sign the CTSU's Optional Form 1: Withdrawal from Protocol Participation located on the CTSU website. This form does not require an IRB signature.
     
    84. Can I request expedited processing of my regulatory submission if I have a patient waiting?
      Yes. A regulatory submission is considered urgent if an institution has a patient they need to enroll within the next three days and their site registration status in RSS is ‘Pending’. If the documentation for the pending regulatory requirement has not yet been submitted, the submission’s fax cover sheet or the body of the email should contain a message indicating the submission is “URGENT”.

    If the CTSU has already received your submission, the Regulatory Help Desk should be notified immediately and your regulatory submission will be pulled from the queue and reviewed in an expedited manner.
     
    General Regulatory
    85. How do I determine what regulatory requirements are required by a Lead Protocol Organization (LPO) for participation in a study?
      You can verify the protocol-specific requirements necessary for a study by following these steps:
  • Log onto the CTSU members' website
  • Select the Regulatory Tab
  • Select the Protocol Req Tab
  • Enter the protocol code in the Protocol field (or use the Pick button)
  • Click Go

    All of the protocol-specific requirements (PSR) for the study will be displayed. If the Affiliation Type is CTSU it means the requirement is only applicable to institutions that are not a member of the LPO and are cross-network participants. Should a requirement only apply to a specific country or region of the world, the Applicable To column will indicate this information. PSR Types that are Collect will not effect your ability to enroll.
     
  • Regulatory - for sites using their local IRB
    86. My site permanently closed a study locally, what do I need to send to the CTSU Regulatory Office?
      To withdraw a trial from your institution, the CTSU requires documentation that states the study has been permanently closed and provides the current status of any patients that were on the study. Acceptable forms of documentation are local IRB closure approval or the CTSU's Optional Form 1: Withdrawal from Protocol Participation. This form may be sent in lieu of a memo from the site and does not require an IRB signature. Should your IRB's local closure approval not indicate the status of patients enrolled to the study at your institution, the CTSU recommends sending the CTSU Optional Form 1 in conjunction with your local closure document.

    If the study has simply been closed to new accrual by the sponsor and your site is still following patients, you are not required to submit an update to the CTSU.
     
    87. How can I determine if an amendment approval should be submitted to the CTSU?
      When a Lead Protocol Organization (LPO) releases an amendment to a protocol, they will dictate to the CTSU whether or not to collect IRB approval of the amendment from sites participating in the study. This information is included in the amendment notification from the LPO.

    You can also verify this information via the CTSU Website, by following the steps below:
  • Log onto the CTSU members' website
  • Select the Regulatory tab
  • Select the Protocol Req Tab
  • Enter the protocol code in the Protocol field (or use the Pick button)
  • Click Go

    The CTSU website will display all regulatory requirements for the trial indicated, as specified by the LPO. Amendments requiring collection in RSS are listed here. If the amendment in question is not listed on this screen, your IRB's approval does not need to be submitted to the CTSU.
     
  • Protocols
    88. How does the CTSU treat Data Safety Monitoring Committee Reports for the various protocols?
      The CTSU policy for posting Data Safety Monitoring Committee (DSMC) reports is as follows: if a Lead Protocol Organization (LPO) sends a Data Safety Monitoring report or if one is included in their monthly broadcast, the CTSU will post that report on the home page of the CTSU members' website under "Latest Protocol Updates". In addition, the DSMC report will be included in the next CTSU Bi-monthly Broadcast under the "Amendments, Revisions, and Memoranda" section.
     
    89. Where does the CTSU post Drug Safety Notifications?
      Drug safety notifications can be found in the Protocol section of the CTSU Registered Members' Website. Click on the Drug Safety Notification link in the sub-folders for any specific protocol. From this page you can view or search for notifications by protocol and then by drug name.
     
    Awareness, Education & Training
    90. How does the Help Desk handle inquiries regarding eligibility, treatment, dose, etc?
      First, if the inquiry is received via telephone, Help Desk staff will ask that the site send the question via e-mail (if possible) to CTSUContact@westat.com to serve as source documentation. If e-mail is not possible, CTSU staff will submit the client’s question verbatim to the appropriate contact at the lead protocol organization.

    Sites with eligibility or drug treatment questions have the option of bypassing the CTSU Helpdesk and contacting the study chair directly, using the contact information provided in each protocol. If opting to use the Help Desk, staff will forward the e-mail to the appropriate lead Cooperative Group contact (e.g. Study Chair and/or Protocol Editor) and copy the inquirer. We will ask the Study Chair/protocol editor to respond to CTSU and the site. The site may contact the CTSU if they have any additional questions.
     
    CTSU Members Website
    91. I am trying to find information on a cancer clinical trial, but I can't find it on the CTSU menu of trials. Who should I contact for this information?
      If the protocol is not available on the CTSU menu of studies, use the National Cancer Institute's (NCI) Clinical Trials Search Service -Physician Data Query (PDQ) to locate the clinical trial in which you are interested. PDQ has a database of over 1,800 active cancer clinical trials and 10,100 closed clinical trials. You may search the PDQ database located on NCI's website.
     
    92. Do I need to re-register for my CTEP-IAM account?
      Yes, CTEP-IAM requires annual re-registration for associates and investigators. This process IS SEPARATE from updating your IAM password. You will receive an email notification prior to re-registration.
     
    Regulatory - for sites using their local IRB
    93. When submitting annual IRB renewals, are consent form documents required as well?
      Consent form requirements vary per protocol. Informed consents are only required when designated by the Lead Protocol Organization (LPO). If an informed consent is not an established protocol-specific requirement, it should not be submitted to the CTSU. If required, informed consents only need to be submitted once at the time of initial activation and do not need to be submitted again with each annual IRB renewal.
     
    94. Where can I find the CTSU IRB Transmittal Form and the CTSU IRB Certification Form on the CTSU website?
      The CTSU IRB Transmittal Form and CTSU IRB Certification Form are located in multiple sections throughout the CTSU website. These forms can be found in the Site Registration Documents section for each study in the Protocol Tab. They are also available at the bottom of the Regulatory Tab as well as in the RSS Browser Tree in the Regulatory and Roster Forms and Resources section, in the Printable CTSU Forms folder.
     
    General Regulatory
    95. How can I find an Investigator's NCI number?
      You can look up the NCI number of an Investigator or Associate by following these steps:
  • Log onto the CTSU members' website
  • Select the Regulatory tab
  • Select the CTEP ID Search
  • Enter the first and last name of the individual to which you are interested
  • Click Go

    The CTSU website will then display all individuals registered with CTEP with the first and last name identified. Their CTEP IDs are provided along with the individuals' CTEP registration statuses and expiration dates.
     
  • Remote Data Capture (RDC)
    96. What is Oracle Clinical - Remote Data Capture (OC-RDC)?
      OC-RDC makes it possible for sites to enter patient-level data into an Oracle Clinical database over the Internet. OC-RDC is also used to notify the sites of discrepant data and provides tools for data correction online at the point of entry.
     
    97. Which studies use Remote Data Capture?
      The protocols currently using RDC are:
  • MAYO Phase II Consortium 8233
  • NYCC Phase II Consortium 8376
     
  • 98. Is OC-RDC training required?
      Before being granted access to the OC-RDC database for data entry or data management, all users are required to complete training.
     
    99. How do I request training for Remote Data Capture?
      OC-RDC Training for CTSU studies using RDC is administered through Westat's Learning Management System (LMS). To request RDC training log in to the CTSU members website. Click on the Clinical Data tab, select the Remote Data Capture link, then click on the Training sub tab. Click the button labeled Request a Training Account and choose either the Fast Track training (for user with some previous experience with an electronic data collection system) or Full training for those users who need some practice before entering data. Once that selection is made all required training elements will be added to your To Do list in the learning management system. From there, simply follow the directions to complete each training item and to record your progress.
     
    100. How do I get an RDC production account?
      After completing the training requirements, follow the directions for providing notification. Upon receipt of a training completion notice, the CTSU Help Desk will immediately begin processing your request for a production account. You can also initiate the process by contacting the CTSU Help Desk at ctsucontact@westat.com and request a production account.
     
    101. How do I get RDC access to another study or investigator?
      Contact the CTSU Help Desk at ctsucontact@westat.com and request that your RDC production account be modified to add access to the investigator.
     
    102. RDC fails to launch when I click the "RDC Production Application" button. What should I do?
      RDC may require a special plugin or upgrade in order to run. Please view the ‘Important Notices’ banner at the top of the Production tab after logging into RDC for any special instructions.
     
    103. Are Windows 7 and Windows Vista Operating Systems compatible with RDC?
      RDC does not work on the Windows 7 and Windows Vista Operating Systems. However, users working on computers running these operating systems can still access RDC through a "virtual computer" system.
     
    104. How do I access RDC on a computer that uses the Windows 7 or Windows Vista operating system?
      If you are trying to access RDC on a computer running either a Windows 7 or Windows Vista Operating system, contact the CTSU Help Desk at ctsucontact@westat.com for instructions on how to request "virtual" access to RDC.
     
    105. What are my RDC login credentials (username and password)?
      Your RDC username is the same as your CTSU website username. Your RDC password is also the same as your CTSU website password. The CTSU website keeps your RDC password in synch with your CTSU password. So, when you update your CTSU password your RDC password is automatically updated to match.
     
    Patient Enrollment
    106. Where is the patient transfer documentation located on the website?
      On the CTSU Members website, click on the Education & Resources tab and then click to expand the CTSU Operations Information folder. Under the CTSU Operations Information folder, click on Generic Forms. This will cause a list of links to appear on the right side of the screen which will contain the link to the CTSU Transfer Form and Checklist. Double click on the link to open the checklist and form.
     
    CTSU Members Website
    107. Why are there two options when I dial the 888-823-5923 number?
      Option #1 is the Main Help Desk in Rockville, MD that manages the protocols on the CTSU menu and the documents listed for those protocols. Option #2 transfers you to the Regulatory Help Desk in Philadelphia, PA where IRB and protocol approval documents are submitted.
     
    Oncology Patient Enrollment Network (OPEN)
    108. What is the difference between "New" and "Incomplete" statuses for a registration?
      A registration has the status of "New" when the registration is saved for the first time (the demography or eligibility checklist has not been started). A status of "Incomplete" is assigned after the corresponding checklist form has been started but has not been submitted for registration or has validation errors.
     
    109. How do I view the enrollments for my site?
      From the OPEN Home Page, click on the History Tab. All completed enrollments for your site can be viewed. Click on the Select button next to the enrollment you wish to view.
     
    110. Will I be able to view data from our affiliate sites?
      Yes, you will be able to view the enrollments for all of the sites with which you are affiliated and listed on the roster.
     
    111. Can other staff at my site see the enrollments for our site if they do not enroll patients?
      Yes, all site staff with an active CTEP-IAM account may log into OPEN and see all of the completed enrollments for the sites with which they are affiliated. However, they will not be able to view enrollments that are incomplete if they do not have a 'registrar' role.
     
    112. Is the time on the enrollment in Eastern Standard Time?
      Yes, the time stamp for enrollments in OPEN will be Estern Standard Time.
     
    RAVE
    113. I am activating my account and notice that some of the information in my Profile Data Screen is out of date. Should I update it here?
      You should not change any of the information in this screen except in special circumstances, as it will not sync up with your CTEP-IAM account. Any changes to your CTEP-IAM account information should be made directly in CTEP-IAM at https://eapps-ctep.nci.nih.gov/iam/index.jsp.
     
    114. I just changed my e-mail address directly with CTEP-IAM as instructed, but now I can't log into iMedidata. What happened?
      It can take up to 20 minutes for data updates in CTEP-IAM to move into RSS and then into iMedidata. You should let some time pass and try again. If it still doesn’t work, contact the CTSU Help Desk at 1-888-823-5923 or via email at ctsucontact@westat.com
     
    115. If we are supposed to be able to use our CTEP-IAM credentials to access, why do I get an error message about my pre-filled CTEP-IAM user name when I try to activate my iMedidata account? What should I do?
      If your user name already exists in iMedidata, you will need to change it. The username for your iMedidata account will be required when updating your iMedidata password (see next question).
     
    116. If we are supposed to be able to use our CTEP-IAM credentials to access, why do I need to create a password when I activate my iMedidata account?
      iMedidata requires the creation of a password. If you are diligent about using the https://login.imedidata.com/selectlogin URL when signing into iMedidata, you will not need to use the iMedidata-specific password.
     
    117. I need to update contact information. How do I make the updates?
      Please update your contact information (phone, e-mail, address) information in the https://eapps-ctep.nci.nih.gov/iam/index.jsp. Please note: if you update your information in the iMedidata application it WILL NOT synchronize with CTEP-IAM.
     
    118. Why are there two different URLs to access iMedidata, i.e., and ?
      The select login is intended to provide easier login by allowing for single sign-on functionality (using CTEP-IAM credentials) for all CTEP Network Group studies using Rave as the CDMS.
     
    119. I can't log in using my CTEP-IAM credentials?
      There are a few possible reasons that you may not be able to log in using your CTEP-IAM credentials and the majority of them are simple to check and fix:
  • First, please verify your CTEP status is active and that your password is not expired. You can check your CTEP status by attempting to log into the CTSU website. If you can’t get in, it is a good bet your CTEP status or password is the problem.
  • The CTEP-IAM Fact Sheet provides information on updating your CTEP status and password. Another common problem is you are on the wrong URL. The current links in the iMedidata Activation e-mail and study invitations are to the iMedidata URL and require you use the iMedidata user name and password to enter. Please use the Select URL at https://login.imedidata.com/selectlogin and bookmark the link.
  • The final problem is you may have an existing account in iMedidata, which currently requires some intervention on the part of CTSU to link your existing and CTEP-IAM accounts. Please contact the CTSU Help Desk at 1-888-823-5923 or via email at ctsucontact@westat.com.
     
  • 120. What is the difference between the Account Activation Email and the Study Invitation Email?
      The Activation Email is a one-time only email that is generated when you are linked to your first study in Rave (i.e., when your site gets approval for its first Rave study). You should click on the first link in the email to begin the account activation process. The Invitation Email is generated each time your site is approved for a subsequent Rave study. You should click on the link in this email to accept the study invitation. Please see the document entitled “iMedidata Account Activation & Study Invitation Acceptance” for more information on this.
     
    121. I activated my account using the Single sign-on login but everything in iMedidata is grayed out. Did I do something wrong?
      No, if you activated your iMedidata account using the Single sign-on login and you have not received an iMedidata activation e-mail or iMedidata study invitation you will not have any active links in iMedidata. This will not cause you any difficulties in the future, but you do need to be aware that access to studies and eLearnings is controlled by your roles in RSS and your site’s site registration status for studies in Rave. Assignment of the appropriate roles in RSS and site registration approval trigger iMedidata invitations.
     
    Patient Enrollment
    122. Where do I find the CTSU Transfer Form and Checklist?
      The CTSU Transfer Form and Checklist is located under the Education & Resources tab/CTSU Operations Information folder/CTSU Generic Forms folder, and will appear in the list of documents on the right screen panel.
    You may also access this form here with this link: CTSU Transfer Form and Checklist.
     
    RAVE
    123. I have been using Medidata Rave for some pharmaceutical trials at my site. Can I use the same username and password to log into iMedidata for my CTEP trials?
      Under some circumstances your accounts can be linked but there are limitations. Rave accounts created for the NCIC-CTG MA.32 study or pharmaceutical studies that are managed in the Rave application cannot be linked to your iMedidata account. If your e-mail for a previous account and CTEP-IAM is the same, plans are underway to automatically link the two accounts, but at this time you must contact the CTSU Help Desk (1-888-823-5923 or via email at ctsucontact@westat.com) to facilitate linking of the two accounts. If you have used a different e-mail, you will need to update your CTEP-IAM e-mail address to your original iMedidata e-mail address to link the accounts. In addition, until the updates are in place you will need to contact the Help Desk to request to link the accounts.

    Please Note: if you have an existing account and change your CTEP e-mail at a later date, it will NOT automatically link to your iMedidata account and you will no longer be able to use the Select login. If you must update your CTEP e-mail address please contact the CTSU Help Desk and CTSU IT support will work to re-link your account.
     
    124. I work at Mayo and have been using Medidata Rave for some studies already. Can I use the same username and password to log into iMedidata for my CTEP trials?
      Yes, if the e-mail address on the CTEP-IAM matches with your e-mail address in iMedidata.
     
    125. I have accepted the study invitation, but cannot access the study in Rave?
      In order for the Rave EDC link to be active for a study, all required eLearnings must be completed and the user must certify completion by electronically signing. Once this has been done, the study link to Rave EDC will be activated.
     
    126. What roles do I need to access Rave and how do I get the correct role?
      There are three explicit Rave-related roles, Rave CRA (write access), Read-only (read access), and Site Investigator (write and signature). You must have one of these three Rave roles on an LPO or Participating Organization roster.
     
    127. I have the appropriate Rave roles and an active CTEP account. Why can’t I see my study in iMedidata/Rave?
      You will only see studies after your institution has received initial site registration approval in RSS.

    Please Note: changes to site registration status over the lifecycle of the protocol do not affect user access to the study in Rave with the exception of withdrawing site registration approval.
     
    Remote Data Capture (RDC)
    128. I cannot see one of our enrolled patients. What should I do?
      Access to specific data in RDC is granted based on the investigator treating the patient. If you cannot see a specific patient on the RDC spreadsheet, the most likely cause is that you do not have access to that investigator's patients. Contact the CTSU Help Desk at ctsucontact@westat.com and request that your RDC production account be modified to add access to the investigator.
     
    CTSU Membership
    129. My investigator is active at CTEP and on the group roster I was told their drug order failed because of the flag in RSS. What is this?
      RSS submits real-time transactions to the Pharmaceutical Management Branch (PMB) at CTEP for all persons associated with the clinical sites. These transactions are maintained via flags in RSS by each organization. Please contact your affiliated organization if flag needs to be set to yes.
     
    130. How can I make a patient or physician transfer?
      Complete a CTSU transfer form, and then submit to receiving (new) site for investigator signature. Upon completion they will submit to the CTSU.
     
    131. Where can I locate the patient transfer form?
      It is found on the CTSU website under the Education & Resources tab, in the CTSU Operations Information/CTSU Generic Forms folder in the tree on the left side of the screen.
     
    132. What if the transferring (old) investigator is not available to sign the patient transfer form?
      The site contact may write "not available" and sign.
     
    133. What if the receiving (new) investigator is not available to sign the patient transfer form?
      The receiving investigator is required to sign the form. We cannot process the transfer unless it is signed.
     
    134. How soon will a patient or physician transfer be processed?
      The transfer request will be reviewed within 5 business days and processed if all requirements are fulfilled.
     
    RAVE
    135. How do I gain access to iMedidata and Rave?
      Please see the document entitled "iMedidata Account Activation and Study Invitation Acceptance" workflow under the Rave tab on the CTSU members’ website.
     
    136. I lost my original activation email or it has been more than 30 days since I originally received it and the link doesn’t work. What should I do?
      You may go directly to the Select login at https://login.imedidata.com/selectlogin and enter your CTEP-IAM credentials. If you have not previously activated your account attempting to login through the Select login will automatically take you to the activation screens. If you receive an error message when trying to log in please contact the CTSU Help Desk at 1-888-823-5923 or via email at ctsucontact@westat.com.
     
    137. I have not received my iMedidata invitation but my colleagues have, what should I do?
      All users must be registered with CTEP and have a valid and active CTEP-IAM account. Verify and update your CTEP-IAM credentials by visiting https://eapps-ctep.nci.nih.gov/iam/index.jsp. Once you have updated your CTEP credentials visit https://login.imedidata.com/selectlogin and you will automatically be taken through the activation screens. If you receive an error message when trying to log in please contact the CTSU Help Desk at 1-888-823-5923 or via email at ctsucontact@westat.com.
     
    Patient Enrollment
    138. How do physicians enter patients on a CTSU study?
      The first step is to obtain regulatory approval for the protocol. The CTSU has implemented the Regulatory Support System (RSS) to verify whether a physician is authorized to enroll patients on CTSU trials.

    Site staff may download protocols and related material from the CTSU Registered Members' Web Site, and submit them to the local IRB for review. Once local IRB approval is obtained, protocol-specific site registration documents should be submitted to the CTSU Regulatory Office. Institutions may access the CTSU members' web site RSS page to view the status of their regulatory documentation.

    Once regulatory approval is obtained and a patient meets the eligibility criteria for the protocol, the CTSU Registrar should be contacted to facilitate the enrollment. The CTSU Process Checklist may be used to ensure all steps are completed.
     
    Awareness, Education & Training
    139. Is there an easy reference tool containing CTSU instructions that our site can use?
      Yes, the CTSU Process Checklist is a one-page reference tool that includes CTSU information on contacts, member and protocol-specific site registration, protocol access, and patient enrollment.
     
    CTSU Membership
    140. Do the surgeons who will be participating in CTSU studies need to register with the CTSU?
      All NCTN, ETCTN, and NCI-supported network members that are participating in CTSU trials must be registered with the CTSU and the Pharmaceutical Management Branch of the NCI.
     
    Protocols
    141. I am trying to find information on a cancer clinical trial, but I'm not sure whether or not it is posted on the CTSU website for cross-network participation. Who should I contact for this information?
      Please refer to the CTSU Active Protocols List that is available on the home page of the CTSU public website, in the lower right corner of the page. If the protocol is not available on CTSU's menu of studies, use the National Cancer Institute's (NCI) Clinical Trials Search Service - Physician Data Query (PDQ) to locate the clinical trial of interest. PDQ has a database of over 1,800 active and 10,000 closed cancer clinical trials. Search the database and use the PDQ Clinical Trials User's Guide located at Cancer.gov.
     
    142. Does insurance cover costs of CTSU trials?
      Some insurance carriers cover all or part of the costs of treatment, while others do not. Often, the cost of new drugs used in the clinical trial will be covered by the sponsor of the trial. It is important that this issue be clarified with the patient's insurer before a patient enters a trial to determine which costs will and will not be covered.
     
    Patient Enrollment
    143. Where is the CTSU IRB Certification Form located?
      The CTSU IRB Certification Form can be found under the Education & Resources tab/CTSU Operations Information folder/CTSU Generic Forms folder, and will appear in the list of documents on the right screen panel. It is also found under the site registration documents for every protocol on the CTSU member's web site.
     
    CTSU Membership
    144. What if a physician or research nurse does not have an email address to register with the CTSU?
      All associate staff and investigators are strongly encouraged to register with the CTEP-IAM and there are many no cost e-mail services available to establish a unique e-mail account.
     
    145. How can I find out if my Investigator(s) are active CTSU members?
      Information on rosters is available under the Site Roles tab on the CTSU members' website or call the CTSU Help Desk at 1-888-823-5923.
     
    146. How do I know if a particular physician is approved to participate in clinical trials?
      All physicians must be active with CTEP and aligned with the lead protocol organization or a participation organization to participate on NCI-supported trials.
     
    Awareness, Education & Training
    147. How can I become a Cooperative Group Member?
      Contact the Group that you are interested in directly.

    The nine Adult Cooperative Groups sponsored by NCI are as follows:
  • American College of Surgeons Oncology Group (ACOSOG)
  • Cancer and Leukemia Group B (CALGB)
  • Eastern Cooperative Oncology Group (ECOG)
  • Gynecology Oncology Group (GOG)
  • National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)
  • National Surgical Adjuvant Breast and Bowel Project (NSABP)
  • North Central Cancer Treatment Group (NCCTG)
  • Radiation Therapy Oncology Group (RTOG)
  • SWOG (SWOG)
     
  • General Regulatory
    148. How do I notify the CTSU my Federalwide Assurance Number has been changed or the expiration date has been updated?
      To inform the CTSU Regulatory Office your Federalwide Assurance number has changed, fax or email a copy of a printout of the assurance information as displayed on OHRP's website. Be sure to indicate on your submission all NCI Institution codes to which the assurance information is applicable.

    The assurance number and expiration date on file in RSS is displayed on the CTSU website. To view this information, click on your site's name in the RSS Browser Tree.
     
    Regulatory - for sites using their local IRB
    149. I submitted my IRB's final approval letter, why is the CTSU requesting documentation of the contingent approval?
      The CTSU Regulatory Office captures 3 dates for every IRB approval collected in RSS.
    The 3 fields are:
  • The IRB Meeting Date – The date the IRB performed the review
  • The IRB Approval Date – The date the IRB approval became effective
  • The IRB Expiry Date - The date the IRB approval expires

    For contingent IRB approvals, please submit all related IRB approval letters, the IRB’s contingent approval letter and final approval letter, so the CTSU has a complete record of your IRB’s review.
     
  • General Regulatory
    150. Does the CTSU Regulatory Office have an email address for questions?
      General CTSU questions can be emailed to CTSUContact@westat.com. Regulatory specific questions will be answered faster by calling the Regulatory Help Desk at 1-866-651-CTSU. Please note the email address provided for regulatory submissions is a direct feed into the CTSU's fax servers and is not a normal functioning email address.
     
    NCTN
    151. What is required for continued access to the CTSU website?
      Clinical site staff need to be active on at least one Network Group roster and on the CTSU roster.
     
    152. Why can’t I view a study on the CTSU website?
      Access to specific protocols is limited to the Lead Protocol Organization (LPO) and the Participating Organizations (PO), you will need to be on the LPO or PO roster(s) in order to participate and access the study via the CTSU. Please refer to the lead network for information regarding that particular study.
     
    153. Why am I unable to select a credit investigator in the OPEN system?
      The site and credited investigator must be active at that site on the Network Group receiving credit.
     
    154. How do I become added to a Network Group roster?
      If your site is part of a CCOP, the CCOP administrator will add you to the Network Group roster through CCOPSYS. If your site is not part of a CCOP, the Network Group membership department may add you to the roster.
     
    155. Who has permission to edit Network Group roles through the CTSU website?
      Refer to the “Roles & Access” table posted in the Site Roles tab of the CTSU website for the role(s) on each Network Group that allow for a user to edit the roles in the Network Group roster.
     
    156. Do I need to enter in completion dates in the funding page of the OPEN system for patients enrolled before March 1, 2014?
      After March 1st, any study that has conditional or optional funding types will be required to enter additional data in OPEN for a particular patient. It is also applied to patients that were enrolled prior to March 1st. However, the completion dates must be on or after the date of enrollment. In addition, the completion date must be after the start date and prior to the end date recorded for the funding type.
     
    157. What trials may I participate in and what are the crediting rules?
      Beginning on March 1, 2014, under the NCI National Clinical Trials Network (NCTN) Program, all sites with active membership in at least one NCTN Network Group will be allowed to participate on NCI clinical trials on the CTSU website that are open to the entire network and credit any participating Network Group of which the site and investigator are active members.

    In general, new phase 3, phase 2/3, and phase 2 studies under a CTEP IND will be available for cross-network participation. New accruals to trials opened before March 1, 2014 may still be identified under the Cooperative Group nomenclature (e.g. CALGB 140503) but credit will be assigned to an NCTN Network Group.

    Crediting Rules:
  • Participating U.S. NCTN sites may credit any participating NCTN Network Group to which the site and credited investigator are affiliated and participating on the protocol
  • Canadian sites must credit the NCTN Network Group that holds the Clinical Trials Agreement (CTA) when a CTA is required
  • International sites must be a member and credit the Lead Protocol Organization (LPO) if they are a member of the LPO
  • International sites that are not members of the LPO must credit the NCTN Network Group which the site is a member of and has agreed to receive credit for the site’s participation on the protocol