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.