New Business Rules in RUMS

RUMS will enforce several RCR-related business rules including:

  • Investigators (IVRs) and Non-Physician Investigators (NPIVRs) must list the practice site (i.e., site at which they enroll or treat patients) on the Form FDA 1572 in RCR to allow a rostering request to that site through RUMS;
  • Individuals must hold the appropriate registration type to allow assignment of system-wide roles including:
    • OPEN Registrar Role = Associate Plus (AP), NPIVR or IVR
    • Rave CRA Role = AP, NPIVR or IVR
    • Rave SLA (Senior Lab Admin) = Associate (A), AP, NPIVR, or IVR
    • CRA Lab Admin = AP, NPIVR, or IVR
    • Rave Site Investigator = NPIVR or IVR
    • Site and Data Administrator = AP, NPIVR or IVR
    • TRIAD Site User Role = AP, NPIVR, or IVR 
  • Individuals holding an Associate Basic role cannot be added or assigned roles through RUMS.

Important Note: The above business rules are not applied until the individual has re-registered in RCR. Prior to re-registration the current business rules will apply.

 

Changes to the RUMS Application

The Person Roster Browser will display the new Registration Types.

Under Add Persons feature, the available sites to add IVRs and NPIVRs will appear first in the list. If applicable, the next list will display sites that the user can request changes, but are not on the IVR or NPRIVR’s Form FDA 1572. Finally, if applicable, the third list will display sites on which the IVR or NPIVR are already claimed. 

 

 

 

 

 

Figure 1: Add IVR/NPIVR

If an IVR or NPIVR cannot be added to a site a warning will display, “Investigators cannot be added to the following treatment sites (REASON: Not listed as a practice site on their Form FDA 1572.)”

Under the Add Role icon, only roles allowed for the registration type of the individual will be available for selection. For example, when adding roles for an individual with the Associate registration type, the Rave and OPEN Registrar roles cannot be selected, but the Rave Read Only role is available.

Figure 2: Add Restricted Role

 Buttons, the At-A-Glance feature enhancements include:

  • NCI Registration Expiry Date field for all registration types
  • Links to RCR registration documents as available (i.e., Biosketch, Form FDA 1572, HSP/GCP training certificates)
  • Information as applicable on Degrees, Training, and Licensure

Please note that the expanded information is only available for individuals at sites to which the user is associated. An abbreviated view is available on individuals that are not at the user’s site(s). The abbreviated view includes the individual’s name, CTEP ID, Status, Expiration Date, City, State, and Zip Code.

A summary of the registration types, required documentation, and business rules for RCR is provided in the table below. Links for RCR registration and information include:

Table 1: RCR Registration Summary

Registration Type

Abb. 

Registration Requirements

Business Rules

Investigator

IVR

Electronic annual registration using RCR

       FDA Form 1572

       Financial Disclosure Form

       NCI Biosketch

       Agent Shipment Form (if applicable)

       Human Subjects Protection*

       Good Clinical Practice*

       Optional CV*

       Practice Site must be on the 1572 to be claimed on a roster

       IRB number on the site registration must be on the Site - Protocol PI’s 1572

       IRB number covering the treating, consenting, credit, drug shipment, receiving (transfer to) investigator must be listed on their 1572

Non-Physician Investigator

NPIVR

Electronic annual registration using RCR

       FDA Form 1572

       Financial Disclosure Form

       NCI Biosketch

       Human Subjects Protection*

       Good Clinical Practice*

       Optional CV*

       Practice Site must be on the 1572 to be claimed on a roster

       IRB number on the site registration must be on the Site - Protocol PI’s 1572

       IRB number covering the treating, consenting, credit, receiving (transfer to) non-physician investigator must be listed on their 1572

Associate Plus

AP

Electronic annual registration using RCR

       Financial Disclosure Form

       NCI Biosketch

       Human Subjects Protection*

       Good Clinical Practice*

       Optional CV*

Must have an AP, NPIVR, or IVR registration status to hold the OPEN Registrar role, RAVE CRA role, primary site roles, or the CTMB-AIS Auditor role.

Associate

A

Electronic annual registration using IAM

May access CTSU website and systems including view access to OPEN and RAVE

Associate Basic

AB

Electronic annual registration using IAM

Cannot access CTEP, DCP, CIRB, or CTSU systems