Updates to Required Protocol Staff Assignments

Updates to Required Protocol Staff Assignments

As of January 1, 2024, two new Protocol Staff roles are required as Minimum Footprint Guidelines for OnCore Data Entry: Primary Regulatory Coordinator and Consenting Provider.

Please see the information below regarding role descriptions, scope and location of entry in OnCore CTMS.

Primary Regulatory Coordinator

    • Role Description: Primary protocol staff member responsible for regulatory documentation and IRB submissions
    • Scope: All protocols with a ‘New’ status on or after 01/01/2024
    • Location in OnCore: PC Console > Main > Staff tab
    • Other Notes:
      • If there is only one protocol staff member managing regulatory submissions, assign them to the role of ‘Primary Regulatory Coordinator’
      • Additional staff members may be assigned the role of ‘Regulatory Coordinator’
      • Protocols active in OnCore prior to 01/01/24 are not required to add the Primary Regulatory Coordinator role, but are encouraged to do so during regulatory staff transitions.


Consenting Provider

    • Role Description: Provider who facilitated the consent process and/or signed the informed consent form
    • Scope: Oncology protocols categorized as DT4 = Interventional (PC Console > Main > Details tab) and for subjects consented on or after 01/01/2024
    • Location in OnCore: CRA Console > Subject Console > On Study tab, in the Subject Staff section
    • Other Notes:
      • Consenting Provider must be entered when Consented Status is documented in OnCore
      • Staff member performing data entry must have Subject Management edit permissions in OnCore.


For questions regarding requirements and maintenance of Protocol Staff, please refer to the Minimum Footprint Guidelines, Protocol Management Work Instructions, or contact CTMS@fredhutch.org. Please note that OnCore login is required to view documentation.