What is a Protocol Manager?
A CRU RN will be assigned as your principal and co-Protocol Manager (PM). The PM and co-PM will be your team's primary contacts to initiate and conduct the study as designed. The PMs can be reached at 801-581-2224.
The Purpose of the PM/Co-PM
As a vital role in successfully executing your protocol, the protocol manager will serve as the primary contact for your protocol, starting with arranging and directing the Protocol Activation Meeting (PAM). The PM will help develop documents and plans, monitor progress, and address/manage possible obstacles. The PM will provide support and leadership to additional CRU nurses assigned to your protocol. Finally, the PM will be the primary contact for protocol issues and/or changes.
Protocol Manager Roles and Responsibilities
- Coordinate initial Protocol Activation Meeting (PAM)
- Coordinate with interdisciplinary teams as needed: ARUP, Investigational Drug Services, etc.
- Monitor protocol progress and address/manage obstacles
- Serve as primary contact for the protocol
- Coordinate the development of nursing-specific documents and plans
- Provide mentoring role to study coordinator regarding necessary paperwork, billing, scheduling, and appropriate resources
- Ensure availability of proper equipment for specific protocol requirements
Protocol Activation Meeting (PAM) is required before scheduling participants
This crucial meeting is the forum to introduce your research team to the CRU nursing staff and to review your protocol in detail. The meeting will be the time to address any trouble-shooting activities or follow-up action plans to facilitate the scheduling of participants for the study. The protocol activation meeting may cover:
- CTSI resources
- Overview of the study
- Admission process
- Funding information and billing processes
- Dietary needs
- Investigational Drugs
- Laboratory needs
- IVs & blood draws
- Testing procedures
- Equipment
- CTSI and/or hospital policies
- Daily operational considerations
- Documentation requirements
How to Prepare for the Protocol Activation Meeting
Review the PAM documents
- Welcome Letter
- Workflow - How to Access CRU
- Protocol Activation Meeting Agenda
- CTSI CRU Contacts and Resources
- Scheduling on CTSI Q & A
- CTSI Scheduling Template
- Finding the CTSI Scheduling Calendar
- Sending Consent Forms to CTSI
- CTSI Pre-Visit Participant Screening
- CTSI Participant Arrival Screening Form
- Protocol Contact Information for Study Team
- Maps & Directions
Collaborate with your PM on the appropriate resources to invite to the meeting.
- For example, a pharmacist from Investigational Drug Pharmacy (IDS) may need to attend regarding an investigational drug component.
- Before the PAM, please send all relevant materials (pharmacy manual, CRFs, etc.) not available in ERICA electronically to the PM and co-PM.
What to bring to the PAM
- Contact information of the research team members
- Details of what is needed from the nursing staff on the CRU
- Be prepared to discuss the protocol in detail