The OPEN portal provides a centralized system which allows patient registrars to register patients to various clinical trials using a uniform web-based interface.

The OPEN portal application system:

· Enables patient registrars to enter eligibility checklist data and determine patient eligibility for inclusion on a given clinical trial.

· Communicates eligibility checklist and related regulatory data to Group randomization system(s) using industry standards: XML and CDISC schema.

· Communicates Group registration output data such as treatment assignment, patient ID, and registration notes back to the OPEN portal user.

The OPEN Portal application is used to register patients on NCI-sponsored clinical trials that have been activated within the system.

1.1 System Requirements

Minimum System Requirements
Operating System	Windows 2000 and up
Memory	2 GB of RAM minimum
Display	Super VGA (1024 x 768) or higher-resolution monitor

1.2 URLs

Application	URL
OPEN Portal	https://open.ctsu.org/open
CTSU members website	http://www.ctsu.org

Application

URL

OPEN Portal

https://open.ctsu.org/open

CTSU members website

http://www.ctsu.org

2. OPEN Portal

2.1 Business Process

The OPEN Portal business process is shown in the following diagram:

Figure 1: OPEN Portal Business Process

3. OPEN Portal Screens

All persons accessing OPEN must have an active CTEP-IAM account, and maintain the account via the policies outlined by CTEP. Please see the Guidelines for OPEN Access and Crediting for more information.

There are two ways to access the OPEN Application: by using the OPEN URL, or by going through the CTSU Members’ web site.

Both methods are described below.

3.1 Logging into the OPEN Application Using the OPEN URL

To log into the OPEN Portal application directly:

1) Launch a new internet window.

2) Type in the URL for OPEN Portal located in the URLs section.

3) The Log-in screen will be displayed and the User ID and password is requested.

Figure 2: Log On Screen

4) Enter your CTEP-IAM username in the IAM User field and your associated password in the password field (these are the same username and password you use to enter the CTSU members’ web site).

5) Press the “Log on” button to enter the system

6) Press the “Reset” button to clear the entered fields.

The Log on button will validate the entered IAM ID and password and allow you to enter the OPEN portal application. The welcome screen will be displayed, as shown in Figure 3 or Figure 4 below.

If the IAM ID and password entered is invalid OPEN will return the message “Invalid username or password”. The user is able to re-enter the IAM username and password.

If you have additional problems logging into the OPEN application please contact the CTSU Help desk for assistance at 1-888-823-5923.

Figure 3: Welcome Tab

Figure 4: Welcome Tab – Multiple Site/Role Selection

3.2 Logging into OPEN via the CTSU Members Web Site

You can also log into the OPEN Portal application via the CTSU members’ web site.

1) Open a new internet window.

2) Log into the CTSU members web site (see the URLs section).

3) Go to and click on the tab labeled “OPEN”. This tab will display information specific to OPEN and provide a link to enter the OPEN application.

4) Click the link to the OPEN system. The OPEN application will launch displaying the welcome tab as shown in Figure 3 or Figure 4 above.

3.3 Viewing Your Profile

The profile section displays information associated with the CTEP-IAM ID of the person who is logged into the OPEN system. All existing data associated with the user’s CTEP-IAM Account will be displayed, if there is no data for that listing it will be blank.

1) Login to the OPEN application.

2) Click on the Profile tab.

The following fields are displayed in the profile section:

· Last Name

· First Name

· RSS Role

· Person Type

· Account Name

· Account Status

· Status Date

· Registration Expiry Days

· Password Expiry Days

· CTEP ID

· CTEP Investigator ID

· CTEP Title

· HSP Certification

· HSP Certification Type

· HSP Certification Date

3.4 Reset Password

You are able to reset your password while logged into the OPEN application. Please note: Resetting your password in OPEN will update your password associated with your CTEP-IAM account ID, thus changing the password for all systems that use your CTEP-IAM Account ID (e.g., the CTSU members’ web site).

1) Login to the OPEN application.

2) Click on the Profile tab.

3) Click on the “Reset Password” button

4) Verify the pre-populated User Name is accurate

5) Enter your current password

6) Enter your desired password according to the password rules presented on the screen.

7) Confirm your password

8) Click on the submit Button

3.5 Creating a New Registration

The Enroll tab gives you multiple ways of controlling the registration of a patient. In this section you will be able to create a new registration. For creating ‘practice’ registrations please see the “Performing a Practice Registration” section of this document.

1) Log into the OPEN application.

2) Verify the site and role displayed.

Figure 5: Site and Role

If you are affiliated with more than one site or have multiple roles within a site, and wish to create a registration for a site or role different from what is displayed, a drop down list will be shown (Figure 6). Use the drop down list to select a new site and role type. Only sites with which you are affiliated will be included in the drop down lists.

Figure 6: Site and Role

Click on the “Create New Registration” link on the welcome page or click on the Enroll tab and press the ‘Create New’ option. This will allow you to complete the preliminary steps of the registration process.

Figure 7: Create New Tab

3) The site name that is displayed or selected on the welcome page will automatically populate the institution field as shown in Figure 7. If you choose to change the site from this page, you will be redirected to the welcome screen and will need to begin the registration process again.

4) Select the protocol number that the patient will be registered to. Only the protocols approved for the institution chosen in the previous steps will be listed. This is a mandatory field and must be populated.

*** If an institution or protocol number is not listed that you believe should be listed please contact the CTSU Help desk for assistance at 1-888-823-5923.

5) Click on the “Protocol’s Missing?” link to receive details on each of the protocols that are associated with the selected institution.

6) Select the registration step from the drop down list.

7) Click on the “Steps Missing?” link to receive details on each of the steps that are associated with the selected protocol.

8) Select the person type and person name (from the drop down list) associated with the enrollment. The number of persons and person type required is designated by the Lead Organization and will depend on the protocol selected in step 4. This section will preload with the number of rows needed to accommodate all mandatory person types.

9) When a Treating Investigator or a Drug Shipment Investigator is selected the address where the drugs will be shipped will populate the Shipping Address section of this form. The address will default to the treating investigator if no drug shipment investigator is provided. However, if a drug shipment investigator is added, that individual’s address will populate the address field.

10) To add additional associated people to the registration, press the button. A new row will be displayed. Press the button to delete a row.

11) Select a Cooperative Group from the “Cooperative Group Credit” drop down list. This is the Cooperative Group that will be credited with the enrollment. This is a mandatory field and must be populated.

12) The Treating Investigator selected in step 8 will automatically populate the “Credit Investigator” field once a crediting group has been selected. If the treating investigator is not a member of the crediting group, then the treating investigator will not pre-populate and you must select a Credit Investigator from the “Credit Investigator” drop down. This is a mandatory field and must be populated.

13) The CCOP Accrual will be automatically determined.

14) Any additional details can be entered in the case notes box. This information will also be displayed in the registration summary. This field is optional for site use only. The information entered here is not submitted to the Lead Organization with the enrollment data.

15) The “Express Courier Information for Drug Shipment” section will appear as section 4 of the Create New screen if deemed Mandatory or Optional by the Lead Organization (as seen in Figure 8 below). If this section is deemed not required it will not appear on your create new screen (as seen is Figure 7 above).

Figure 8: Create New with the Express Courier section

16) Press the ‘Continue’ button to proceed to the next step. When the ‘Continue’ button is pressed you will receive a pop up message and asked to confirm the registration initialization (as seen in Figure 9).

Figure 9: Initialize Registration

17) Press ‘OK’ to initialize the first half of the registration and add a listing to the Enroll à In Progress screen (see the In Progress section for details). You will then be taken to the next step in the registration process.

Once the registration is initialized you will be supplied with the tracking number that can be used to track a registration in the OPEN Portal application and the option to:

i) Edit the Registration – clicking on the “Edit Summary” button will redirect you to the “Create New” screen and you will be able to edit the registration as desired.

ii) View the summary of the registration - clicking on the “View Summary” button will redirect you to the summary screen.

iii) Continue this registration – This option will display the next step for the selected protocol

Figure 10: Registration Initialized

The Summary, Prerequisite, Demography and Checklist Form options can also be initiated from the second row of tabs located at the top of the screen.

18) Once a registration is initiated and a tracking number is assigned, the identifying registration information will be displayed in the header, as shown in Figure 11. To get additional information click on the ‘Details’ or ‘Summary’ links.

Figure 11: Selected Registration Information

3.6 Completing the Prerequisite Screen

The Prerequisite screen is used when data needs to be entered or captured before the Prerequisite and checklist screens are completed. The Prerequisite screen will only be active for those protocols that have been assigned prerequisite modules by the protocol administrator.

1) Open the Prerequisite screen by pressing the “Prerequisite” tab. (If the first section of the registration has not been completed follow the steps in section 3.5.)

2) Once the Prerequisite screen is displayed you can enter the requested data per the requirements of the protocol.

3) The system will return a validation error if any of the data on the form is invalid or incomplete.

Examples of errors that could be included are:

· Mandatory fields that are not completed.

· Dates that are not within a required period of time.

· Fields that are inconsistent with another.

· Fields that do not match eligibility requirements.

Each protocol can have different error checks. These will be determined by the administrators of that protocol and eligibility checklist.

4) There are multiple ways to save your registration, you can:

a) Press the ‘Save’ button

You will be able to save the Prerequisite screen data at any stage. You will receive a message verifying that the data has been saved.

A registration that has not been submitted will be stored in the system for no more than 7 calendar days from the time it was last saved. After 7 calendar days the registration will be deleted and it will need to be re-entered. The system will remind the user of this time limitation at the time the data is saved.

Figure 12: Save Alert Message

b) Press the ‘Save & Validate’ button

The Save & Validate button will save the Prerequisite screen data at any stage but it will also review the data for any validation errors; however your data will still be saved even if there are validation errors.

Errors will be presented in the module where the error occurred. To quickly view any errors you can expand and collapse all modules by clicking on the “Expand/Collapse all Modules” link. This will bring you directly to the module in the checklist that contains the error.

Figure 13: Save & Validate Messages

Once the Prerequisite screen is completed press the “Continue” button to proceed to the demography screen.

3.7 Completing the Demography Screen

The Demography screen will display the demography form that is associated with the study you selected in the first section of the registration process. Completing the demography form is mandatory, and will advance you to the eligibility checklist form which will complete the registration process.

5) Open the demography screen by pressing the “Demography” tab. (If the first section of the registration has not been completed follow the steps in section 3.5.)

6) Once the demography screen is displayed you can enter the patient demography data per the requirements of the protocol.

7) If you have an existing patient ID you can enter the patient ID in the “Existing Patient ID” field and press the associated “Populate Data” button, the demography screen will automatically populate. This will be available only in protocols where the associated Lead Organization support pre-filling the demography data.

8) For multi-step protocols, when demographic data is available from the previous registration step, the data will auto populate the demographic screen when enrolling to the subsequent step. If all the required responses in the demographic screen are complete, OPEN will automatically hide the “Populate Demography” button.

A message appears on the demography screen “All matching patient demographic data from the previous step has been populated! Click [Save & Validate] in the demography screen to validate data.”

Figure 14: Demographic Data Pre-populated

9) The system will return a validation error if any of the data on the form is invalid or incomplete.

Examples of errors that could be included are:

· Mandatory fields that are not completed.

· Dates that are not within a required period of time.

· Fields that are inconsistent with another.

· Fields that do not match eligibility requirements.

Each protocol can have different error checks. These will be determined by the administrators of that protocol and eligibility checklist.

10) There are multiple ways to save your registration, you can:

c) Press the ‘Save’ button

You will be able to save the demography screen data at any stage. You will receive a message verifying that the data has been saved.

Figure 15: Save Alert Message

d) Press the ‘Save & Validate’ button

The Save & Validate button will save the demography screen data at any stage but it will also review the data for any validation errors; however your data will still be saved even if there are validation errors.

Figure 16: Save & Validate Messages

11) Once the demography screen is completed press the “Continue” button to proceed to the eligibility checklist.

3.8 Completing the Eligibility Checklist

The Checklist tab will display the eligibility checklist form that is associated with the study you selected in the first section of the registration process. Completing and submitting the Checklist Form will complete the final section in the registration process.

1) Open the eligibility checklist. (If the first two sections of the registration have not been completed follow the steps in section 3.5 and section 3.6.)

2) Once the checklist form is displayed you are responsible for entering the patient data per the requirements of the protocol.

3) The system will return a validation error if any of the data on the form is invalid or incomplete.

Examples of errors that could be included are:

· Mandatory fields that are not completed.

· Dates that are not within a required period of time.

· Fields that contains data which are inconsistent with the data in another field.

· Fields that do not match eligibility requirements.

Each protocol can have different error checks. These will be determined by the administrators of that protocol and eligibility checklist.

4) There are multiple ways to save your registration, you can:

a) Press the ‘Save’ button

You will be able to save the eligibility checklist at any stage. You will receive a message verifying that the data has been saved. The checklist will be retrievable from the Enroll -> In Progress tab.

A registration that is not submitted and registered will be stored in the system for no more than 7 calendar days from the time it is last saved. After 7 calendar days the registration will be deleted and it will need to be re-entered. The system will remind the user of this time limitation at the time the data is saved.

Figure 17: Save Alert Message

b) Press the ‘Save & Validate’ button

The Save & Validate button will save the eligibility checklist at any stage but it will also review the eligibility checklist for any validation errors; however your data will still be saved even if there are validation errors.

Errors will be presented in the module that the error occurred. To quickly view any errors you can expand and collapse all modules by clicking on the “Expand/Collapse all Modules” link. This will bring you directly to the module in the checklist that contains the error.

Figure 18: Save & Validate Messages

The checklist will be retrievable from the Enroll -> In Progress tab by selecting the desired registration and clicking on the “Eligibility Checklist” button.

3.9 Ability to Show a Custom Message when Lookup Widget Returns No Rows

The lookup widget in OPEN displays a list of values when the user clicks on the “Select” link associated with the question, as shown in Figure 19. If the group Lookup widget did not return any values it will return a custom message that can be customized for each form. In the earlier versions of OPEN the system displayed a generic message saying “No records found”.

Figure 19: Lookup Feature

The enhancement in Lookup Widget allows displaying a custom message if the Lookup widget returns no values, as shown in Figure 20

Figure 20: Custom Lookup Message

3.10 Save Enrollment Data on Forced Logout

During patient enrollment if the user is on any of the Prerequisite, Demography or Eligibility Checklist screens, a session timeout alert will pop-up on the 24^th minute starting from the time when the form was last saved. Figure 21 displays the alert. If the user responds to the alert by clicking the OK button, then the session time will be updated on the server and the session will remain active. Otherwise, on the 28^th minute the data entered will be saved and on the 30^th minute the system will enforce a forced logout.

Figure 21: Session Timeout Alert

In Google Chrome browser the pop up blocker is enabled by default. In such cases the alert will pop up only if the pop up blocker is disabled manually. You can disable the pop up blocker by following these steps.

· Click the wrench icon on the browser toolbar.

· Select Options

· Click the Under the Hood Tab.

· Click Content settings in the “Privacy Section.

· In the “Pop-ups” section, select “Allow all sites to show pop-ups.”

Once the settings are changed to allow pop-ups in the Chrome browser, this feature will work similar to Internet Explorer.

The steps to be followed for disabling the pop up blocker in Google Chrome Browser are detailed in the following screenshots.

Figure 22: Select Options

Figure 23: Allow Pop-ups

3.11 Submitting the Eligibility Checklist

The user is able to submit the eligibility checklist to the Lead Group for approval.

1) Complete the eligibility checklist.

2) Press the Continue button on the eligibility checklist.

Figure 24: EC Submit

3) The eligibility checklist is checked for any validation errors. If validation errors are found you must fix the errors or request and receive an override in order to continue (for more details see the “Request an Override” section). You may also receive alert messages. Alert messages are only used to convey information to the user; therefore the Eligibility Checklist can be submitted with alert messages present.

4) If no validation errors are found you will be given a synopsis of the data entered into the eligibility checklist and asked to confirm the submission.

5) If changes are necessary hit the Demography sub-tab or the Checklist sub-tab to return to the desired form, this will allow you to update entered data as desired.

6) If no changes are needed press the “Submit” button on this screen.

7) Click on the “OK” button to submit the form to the Lead Organization.

8) The Eligibility Checklist is then submitted to the Lead Organization. A confirmation of the registration and details will be displayed. This will include the Patient ID, Treatment Arm and Site Instructions, if any.

Figure 25: Confirmation

9) The completed registration can now be selected and viewed on the History screen.

3.12 Resubmitting a Registration

The resubmit option gives you the means to resubmit a previously submitted registration.

When a registration is completed in OPEN the registration is then sent to the associated Lead Organization. If the Lead Organization’s system is not active or for some reason is not available to process the registration it will come back to OPEN in the status “Submitted”. The resubmit option gives you the means to resubmit the registration as necessary. Only registrations that are in “Submitted” status can be resubmitted.

Figure 26: Resubmit a Registration

To resubmit a registration,

1) Select the “Submitted” registration from the In Progress screen

2) Go to the checklist form.

3) On the checklist form you will find the entered checklist for that registration and a “Resubmit” button (as shown in Figure 26).

4) Click on the Resubmit button.

5) Review the registration and confirm the submission by pressing the “Resubmit” button on the review page

6) Click “Ok” on the confirmation pop-up

7) If the resubmit is successful you will be given the Lead Organization’s response.

Figure 27: Successful Resubmit

3.13 Completing a Multiple Step Registration

There are two options available to complete a multiple step registration.

3.13.1 Multiple Step Registration - Option 1

For Protocols that require multiple steps:

1) Follow the steps in section 3.5 of this User Guide to create the initial registration step.

2) Follow the steps in section 3.6 of this User Guide to create the initial Demography form.

3) Follow the steps in section 3.8 of this User Guide to create the initial EC.

4) Follow the steps in section 3.11 of this User Guide to submit the initial EC.

5) Click on the History tab.

6) Select the registration you would like to continue.

7) In the Summary screen select the “Create Step _” button. The next valid step will be displayed.

Figure 28: Create Next Step

8) Click “OK” to copy over the registration details from the previous registration step (see Figure 29).

Figure 29: Copy Details Confirmation

9) Review the pre-populated data.

10) If desired make updates to the registration. Only the associated persons section, the specify credits section, the express courier sections (if applicable), and the case notes can be updated.

11) Press the “Continue” button.

12) Press the OK button on the pop up window.

13) A new tracking number will be assigned to the next registration step.

14) Press the “Continue” button.

15) Once the demography screen is displayed you can enter the patient demography data per the requirements of the protocol.

1) In the Demography form (if applicable), validate that the pre-populated patient ID number from the previous step is correct. Then click the “Populate Demography” button. This will retrieve and populate the demographic data for that patient ID. This will be available only in protocols where the associated Lead Organization support pre-filling the demography data.

Figure 30: Populate Data

16) Click “OK” on the Confirmation pop-up screen to retrieve the data.

17) Click the “Continue” button to proceed to the next screen.

18) Complete the Eligibility Checklist form.

19) Press the “Continue” button.

20) Press the “Submit” button on this page.

21) Press the “OK” button on the pop up window.

22) View the registration result.

3.13.2 Multiple Step Registration – Option 2

2) Follow the steps in section 3.5 of this User Guide to create the initial registration step.

3) Follow the steps in section 3.6 of this User Guide to create the initial Demography form

4) Follow the steps in section 3.8 of this User Guide to create the initial EC.

5) Follow the steps in section 3.11 of this User Guide to submit the initial EC.

6) Go to the Create New screen to begin the next step registration.

7) Select the desired protocol number

8) Select the appropriate next step in the registration.

9) A new screen will appear requesting the patient ID from the previous step. Enter the patient ID in the “Patient ID” box.

10) Hit the Search button

11) Registrations matching the entered data will be returned. Press the “Select” button to select the record that matches the registration you would like to continue.

12) You will be returned to the “Create New” screen.

13) Review the pre-populated data.

14) If desired make updates to the registration. Only the associated persons section, the specify credits section, the express courier section (if applicable), and the case notes can be updated.

15) Press the “Continue” button.

16) Press the OK button on the pop up window.

17) A new tracking number will be assigned to the next registration step.

18) Press the “Continue” button. The registration form that is next in sequence will be presented.

19) Once the demography screen is displayed you can enter the patient demography data per the requirements of the protocol.

20) In the Demography form (if applicable), validate that the pre-populated patient ID number from the previous step is correct. Then click the “Populate Demography” button. This will retrieve and populate the demographic data for that patient ID. This will be available only in protocols where the associated Lead Organization support pre-filling the demography data.

Figure 31: Populate Data

a) Click “OK” on the Confirmation pop-up screen to retrieve the data.

b) Review the returned data and enter additional data if applicable.

21) Click the “Continue” button to proceed to the next screen.

22) Complete the Eligibility Checklist form.

23) Press the “Continue” button.

24) Press the “Submit” button on this page.

25) Press the “OK” button on the pop up window.

26) View the registration result.

3.14 Completing an Ancillary Study

Some studies contain embedded and/or stand alone ancillary studies. These ancillary studies may be mandatory at the time of registration or may be available after enrollment to the main study is completed. All associated ancillary studies will be listed in the “Create New” screen at the beginning of the registration.

1) Click on the “Create New Registration” link on the welcome page or click on the Enroll tab and press the ‘Create New’ option. This will allow you to complete the preliminary steps of the registration process.

2) Enter the Protocol Number and Registration step in the appropriate fields.

3) If the entered protocol number has embedded or stand-alone ancillary studies associated with it, a new section will appear (Figure 32). This new section the “Ancillary protocol selection” section will display the associated ancillary protocols. Registrations that have required ancillary embedded or stand-alone protocols will automatically be selected and not editable. You must enter the information for these protocols at the same time the main study is completed. If a protocol has an optional ancillary study then the check box will be blank. Checking on the check box will allow that optional protocol to be included in the current registration. As shown in Figure 32.

Figure 32: Ancillary Create New Tab

4) The Patient ID field is optional for any initial first step registration. However this information will be necessary when performing a delayed registration. Please see section 3.15 of this document for more details.

5) Complete the “Create New” screen and continue to the demography screen. Please see section 3.5 of this document for more detailed information.

6) Complete the Demography screen and continue to the eligibility checklist. Please see section 3.6 of this document for more detailed information.

7) Review the eligibility checklist. All required ancillary studies and selected optional ancillary studies are included with the main study. Embedded and selected optional studies will be displayed with the name of the protocol listed in the header before the module name. As shown in Figure 33.

Figure 33: Embedded Ancillary Protocols

8) Complete the Eligibility Checklist and continue. See section 3.8 of this document for detailed information.

3.15 Creating a Delayed Registration

If the protocol is set up to have delayed registrations you will be able to register protocols up to a set number of days from the completion of the original registration as specified in the protocol set up.

1) Click on the “Create New Registration” link on the welcome page or click on the Enroll tab and press the ‘Create New’ option.

2) Enter the Institution CTEP ID and main Protocol Number to which the ancillary study is connected to. This should match the site and protocol number of the original registration.

3) Select the step you need to perform the delayed registration on.

4) Enter in the Patient ID that corresponds with this delayed registration (Figure 34) and press the “Tab” key on your keyboard.

5) A new screen will appear including the patient ID from the previous step.

6) Registrations matching the entered data will be returned. Press the “Select” button to select the record that matches the registration you would like to continue.

7) You will be returned to the “Create New” screen.

8) Select the ancillary protocol that you would like to complete by checking the corresponding box (Figure 34).

Figure 34: Delayed Ancillary Study

9) Press the “Continue” button to proceed.

10) The Checklist screen appears and the delayed ancillary study checklist form is displayed.

Figure 35: Delayed Ancillary Study Checklist

11) Complete the checklist

12) If desired, press the “Full Checklist” button to review the original registration entry for the main study.

13) Press the Continue button and submit the registration.

3.16 Existing Patient

If a patient is entered in the Demography screen that closely resembles a patient that has been previously registered, the system will flag this registration and alert the user that this is “possibly” a duplicate patient. You are then able to (a) state that this is not a duplicate patient and go on with the registration or (b) confirm that this is a duplicate patient and the registration in progress will be Voided.

If a patient is entered in the Demography screen that exactly matches a patient that has been previously registered, the system will flag this registration and alert the user that this is a duplicate patient. You are then able to confirm that this is a duplicate patient and the in progress registration will be Voided or you can place the registration currently in progress on hold for further investigation. The on hold registration will go to the status of Incomplete (see section In Progress Registration Status).

3.17 History Tab

Using this tab, the user will be able to view the details of registrations that have been completed (i.e., the patients have been registered/randomized and patient IDs have been received). The various sub-tabs under the history tab are discussed below.

3.18 Browse Registrations

In this section the user is given the means to view the history of all registrations that have been completed at any institution with which they are associated.

OPEN will display the:

· Track #

· Protocol

· Site CTEP#

· Crediting Group

· Registration Step

· PID (Patient ID number)

· Arm (Treatment Arm)

· Eligibility Status

· Status of the registration

· Date and time the registration was randomized

· User who created the registration

Figure 36: History Registrations

To view the registration history of a registered patient:

1) Click on the History tab.

2) Click on the “Registration History” link.

3) You will be in the “Browse” sub-tab by default.

4) Press the ‘Select’ button of the registration you wish to view.

5) If the desired registration is not listed click on the arrow keys to navigate to the next range of records. You can also display more records to a single search page by specifying whether the results should list 25, 50 or 75 records per page (For additional information on querying registrations please see the “Query Registration Information” section).

6) Pressing the “Select” button will display the Summary screen of the selected record. You can use the “Demography” or “Checklist” sub-tabs to access the corresponding forms. This will allow you to view the details of the registration.

3.18.1 History Registration Status

Registration Statuses will be assigned to the registration when it meets certain criteria. The registration statuses are shown throughout the registration process. Data for completed registrations cannot be updated or changed.

3.18.1.1 REGISTERED

This status is assigned after a registration is submitted to the Lead Organization and a patient ID and treatment arm is returned and received by OPEN.

3.18.1.2 INELIGIBLE

The registration was deemed ineligible by the associated Lead Organization.

3.18.1.3 CANCELLED

This status is assigned when a completed registration is withdrawn. Only administrators will be able to cancel a completed registration.

3.19 In Progress Registrations

In this section you are able to view the registrations that are in progress at any of the institutions with which you are associated. You will be able to retrieve a previously started registration from this area.

OPEN will display the:

· Track #

· Protocol

· Site CTEP#

· Crediting Group

· Registration Step

· Status of the registration

· Date and time the registration was Initialized

· Date and time the registration was Modified

· User who created the registration

Figure 37: In Progress RegistrationsBottom of Form

7) Click on the Enroll tab. The In Progress screen is shown as default.

8) Press the ‘Select’ button on the line of the registration you wish to view.

9) If the desired registration is not listed click on the arrow keys to navigate to the next range of records. You can also add more records to a single search by specifying whether the results should list 25, 50 or 75 records per page (For additional information on querying registrations please see the “Query Registration Information” section).

10) The record is selected and the Summary screen is displayed showing the information related to the selected record. You can then continue the registration as desired using the “Continue” button or the appropriate sub-tabs to access the corresponding forms that will be viewed, filled out, or edited.

3.19.1 In Progress Registration Status

Registration Statuses will be assigned to the registration when it meets certain criteria. The registration statuses are shown throughout the registration process.

3.19.1.1 NEW

A registration is given the status of NEW when the registration is saved for the first time (the demography or eligibility checklist has not yet been started).

3.19.1.2 INCOMPLETE

This status is assigned after the corresponding checklist form has been started but has not been submitted or has validation

3.19.1.3 REGISTERED^A

This status is assigned when a delayed ancillary registration is in progress and the main registration has already been completed.

3.19.1.4 READY

A registration is given the status of READY when the eligibility checklist has been successfully validated and saved, and is ready for submission.

3.19.1.5 SUBMITTED

A registration is given the status of SUBMITTED when the registration has been forwarded to the Lead Organization but the accepting system is not able to receive the data.

3.19.1.6 VOID

When a registration has been saved but never submitted the registration will automatically change to VOID status after 7 calendar days. The user must then start the registration again.

3.20 Delete Registrations

You are given the option of deleting records that have not been completed by pressing the icon in the column labeled ‘X’.

1) Click on the Enroll à In Progress tab.

2) Locate the record you would like to delete.

3) Press the trash can icon.

4) Verify you want to delete the record by saying OK at the confirmation pop-up.

Completed registrations in the History à Browse screen and Submitted registrations cannot be deleted. These registrations will not have the trash can icon available.

3.21 View Item Information

Information about a specific item can be displayed by pressing the icon associated with that item. This icon appears on multiple screens in OPEN. The information will be displayed as seen in Figure 38.

1) Locate the item about which you need information

2) Press the icon.

Figure 38: Information

3.22 Query Registration Information

You will be able to narrow down the registrations displayed in the In Progress or History screens by querying on a single field or on multiple fields. The In Progress tab will display all in progress registrations. The History tab will display all registrations that have been completed.

1) Click on the In Progress tab

2) Click on the History tab

3) Locate the field you want to sort by, you are able to query on any or all of the following fields:

· Tracking Number

· Study

· Site CTEP ID

· Crediting Group

· Registration Step

· Patient ID Number (History Tab only)

· Registration Status

· Status Date

· Modified Date (In Progress Tab only)

· Registrar

Figure 39: In Progress Registration Search Screen

4) Enter the corresponding field information into the appropriate field(s) as seen in Figure 39. The % (percent sign) can be used to perform searches on items that are not completely entered, for example entering “ga0%” in the Site field, will bring back all registrations done at sites that start with the characters “GA0”. Adding multiple search criteria will further reduce registrations returned.

5) Press the “search” button.

6) The filtered information will be returned where a match is found. You will receive a message if no match is found.

7) If the desired registration is not listed click on the arrow keys to navigate to the next range of records. You can also add more records to a single search by specifying whether the results should list 25, 50 or 75 records per page.

8) You can also query by using the “Filter by:” option on select screens (option available on the In Progress and the Browse screens). You can choose to filter a registration by selecting the value you would like to filter by as shown in Figure 40. Using this option you can search on fields which are not displayed on the screen – such as “Case Notes”. Once you find a result, you can use the “Select” button or “View Registration Details” icon to see the details of the corresponding registration.

Figure 40: Filter By Option

3.23 Editing a Registration

You can edit a registration as needed however; this screen will only be active if the record is not in the status of ‘Submitted’ or ‘Registered’. Once the record is registered or in submitted status no updates will be allowed.

1) After initializing a new registration click on the “Edit Summary” button.

2) From the summary screen click on the “Edit Summary” button.

3) Update the displayed information as necessary. All sections of the “Create New” screen can be updated after the registration is initiated except for section 1 (Select Institution/Protocol combinations).

4) Make desired changes.

5) Press the “Continue” button.

6) Press the “OK’” button on the pop-up confirmation box.

7) Proceed with the registration.

3.24 Request an Override

Overrides to protocol requirements may be available on certain studies per Lead Organization guidelines. A “Request Override” button will be displayed next to only those validation errors which allow overrides. To request an override you may click on the “Request Override” button that will appear in the checklist forms as shown in Figure 41.

Figure 41: Validation Errors on Eligibility Checklist

An override indicator is also available at the question level.

Located to the left of the field title, the override indicator is presented. Placing the mouse cursor over the indicator will provide override status information.

– indicates a question is eligible for an override.

– indicates an override request has been initiated.

– indicates a question has multiple overrides associated with it.

– indicates an override has been approved.

– indicates an override has been denied.

– indicates an override is on hold or is pending.

To request an override for an eligibility question:

1) Complete the demography and/or eligibility checklist forms.

2) Press the save & validate button or the continue button.

3) Review the validation errors (as seen in Figure 41).

4) Press the green button that says “Request Override.” Once an override is requested the button will change from green to orange in color and the message “Override Requested” will show.

5) A new window will appear.

6) If you already have an override code, enter the override code in the Override Code field. (Optional)

Figure 42: Override Request

7) Enter the reason for the override request (see Figure 42) in the ‘Request Reason’ field.

8) Press ‘Submit’. The override request will be available to the protocol administrator at the Lead Organization for review and approval/denial.

9) You and the protocol administrator will receive an email signifying that an override was requested.

10) Once the protocol administrator reviews the override and assigns a status (e.g., approved, denied) you will receive another email alerting you that the override is ready for further action.

11) You can also click on the “Override Requested” button in the eligibility checklist. You will be able to see the override status for that specific validation error.

Figure 43: Override Approved

12) Once the Override is approved return to the eligibility checklist and press the “submit” button. If no other validation errors are present the registration will go through.

If the override is denied the “override requested” button will turn red and the verbiage will change to say “Override Denied” as shown in Figure 41. You will not be able to submit the registration without correcting the error.

Other status possibilities are:

· On Hold – An override is pending or holding.

· Inactive – The edit check was inactivated after the override request and the override is no longer required. Resubmit the eligibility checklist.

3.25 Print Registration Detail Options

You can also print the confirmation page and the full completed checklist from the summary screen.

1. Press the history tab and select the desired registration. This will bring you to the summary screen.

2. Scroll down to the Registration/Randomization section and click on the “Print Confirmation” button.

3. Go to the Registration/Randomization section and click on the “Print Full Form” button to print the completed full registration form. This includes the demography screen data along with all checklist forms completed so far.

4. When the page displays press the print icon in the upper right corner to print the registration confirmation page.

Figure 44: Print Detail

3.26 Perform a Person Search (RSS)

On the Persons tab (under the RSS tab or the Person Search Link) you are able to search on one specific field or any combination of fields.

The searchable fields include:

· CTEP ID

· Last Name

· First Name

· Status

· Type

Figure 45: Persons Browser

1) Click on the ‘Person Search’ link

2) Click on the RSS main tab

3) Click on the ‘Persons’ sub-tab

4) Enter in the field(s) you want to search on

5) Press the ‘Search’ button.

6) If the desired person is not listed click on the arrow keys to navigate to the next range of records. You can also add more records to a single search by specifying whether the results should list 25, 50 or 75 records per page (for additional information on querying registrations please see the “Query Registration Information” section).

3.27 Site Registrations Search (RSS)

On the Site Registrations tab (under the RSS tab or the Site Registration Search Link) you are able to search on one specific field or any combination of fields. The searchable fields include:

· Site Number

· Protocol

· Status

Figure 46: Site Registrations Browser

1) Click on the ‘Site Registration Search’ link

2) Click on the RSS main tab

3) Click on the ‘Site Registrations’ sub-tab

4) Enter the criteria in the field(s) you wish to query on (see the query registration information section).

5) Press the ‘Search’ button.

6) If the desired registration is not listed click on the arrow keys to navigate to the next range of records. You can also add more records to a single search by specifying whether the results should list 25, 50 or 75 records per page.

3.28 Creating a Report

Reports can be run for a variety of subjects.

1) Click on the ‘Reports’ link from the welcome page.

2) Click on the ‘Reports’ tab.

Figure 47: General Reports

3) Locate the report you would like to run in the report list. You are able to scroll through the reports in order to locate the desired report; or you can search on the desired report by filling in one or more of the report criteria in the top row and pressing the ‘Search’ button.

4) Press the ‘Select’ button that corresponds with the desired report. You are now able to enter in criteria that will determine what is returned in your requested report.

Figure 48: Report Criteria Entry

5) Enter the parameters for the report in the appropriate fields provided.

6) Choose what format you would like the report shown in by clicking on the dropdown and choosing PDF or CSV.

7) Press the ‘Launch’ button to activate the report.

3.29 Performing a Practice Registration

Users will be able to perform a practice registration from the OPEN application. Using the current URL the user is able to switch from a normal working mode to a practice mode to create registrations without actually updating any live data.

1) From the home page select the “Start Practice” button.

Figure 49: Start Practice button

2) The screen will visibly change in color to indicate that you are in test mode, and the “Stop Practice” buttons will be presented.

Figure 50: Application in Test Mode

3) While the system is in test mode only the Enroll, History and Help screens will be active. The other tabs if pressed will return a message indicating that functionality is “Not available during practice or test mode!”

4) Registrations can be created as normal (please see section 3.5 of this document for details). All registrations created while in practice mode will have a super script ‘T’ attached to the tracking number to further indicate this is a test registration (Figure 51).

Figure 51: Test Tracking #

5) While in practice or test mode you are also able to duplicate an existing registration. This feature will only be available for step 1 studies that do not have associated ancillary studies.

a) From the In Progress or the History tab press the duplicate icon associated with the registration you want to copy.

b) Press the ‘OK’ button on the confirmation pop-up to confirm the copy.

c) You will be given a message that the registration was successfully copied.

Figure 52: Successful Registration copy message

d) Once the registration is copied from either the In Progress or the History tab the registration can be found in the In Progress screen with the status of “NEW”.

e) This copied registration can be manipulated and submitted as desired.

6) Upon final submission, a concluding alert will again remind the user that this is a practice registration.

Figure 53: Final Test Alert

TABLE OF CONTENTS

List of Figures

3.1 Logging into the OPEN Application Using the OPEN URL

3.2 Logging into OPEN via the CTSU Members Web Site

3.18.1.1 REGISTERED

3.18.1.2 INELIGIBLE

3.18.1.3 CANCELLED

3.19.1.1 NEW

3.19.1.2 INCOMPLETE

3.19.1.3 REGISTEREDA

3.19.1.4 READY

3.19.1.5 SUBMITTED

3.19.1.6 VOID

3.19.1.3 REGISTERED^A