Protocol Activation Process

Implementation:

Once the investigator has received a GCRC Advisory Committee (GAC) approval letter and is ready to begin the research project, he/she should contact the PCRC Nurse Manager or Administrator Director to set up the study activation meeting. All PCRC staff members involved in the conduct of the study will participate in this meeting. To assist the investigator with the preparation for this meeting, please find an outline of points that need to be addressed depending on the complexity of the research project.

1. Background (about 5 minutes)
   
2. Science (about 5 minutes)
   
3. Patient Schedule
   
1. Number of patients to be studied
   
2. Visit or admission schedule
   
1. Number of visits or admissions per patient
   
2. If necessary, special day or time requirements
   
3. Facilities required, i.e., treatment room, infusion room, etc.
   
4. Length of stay
   
5. Name of covering physician, if applicable
   
6. Name of service team coverage, if applicable
   
3. Person responsible for scheduling (beeper and telephone number)
   
4. Detailed explanation of the protocol: outpatient or inpatient
   
4. Nursing Responsibilities
   
1. Study team research nurse/coordinator responsibilities
   
2. PCRC research nurse responsibilities
   
1. Technical
   
2. Educational
   
3. Miscellaneous
   
5. Principal Investigator/Fellow Responsibilities
   
1. Updated contact information (beeper and telephone numbers)
   
2. Details of procedures to be performed
   
3. Delegation of duties
   
4. Miscellaneous
   
6. Bionutrition Research Responsibilities
   
1. Special dietary requirements
   
2. Data to be collected
   
3. Miscellaneous
   
7. VII. Equipment/Supplies
   
1. Those to be provided by the PCRC
   
2. Those to be provided by the investigator
   
3. Contact people (telephone and beeper numbers)
   
4. Storage arrangements: note there is very limited storage space available on the PCRC
   
8. Drugs/Biologicals
   
1. Supplier: distinguish routine support items, research items and related patient charges
   
2. Role of the research pharmacist
   
1. Details of date(s) and time(s) when research items are required
   
2. Inpatient preparation and record if applicable
   
3. Arrangements for outpatient dispensing and records
   
4. Storage
   
9. Specimens
   
1. Collection
   
1. Person responsible
   
2. Special containers
   
2. Processing instructions (please provide in writing, if not included in the protocol)
   
3. Shipping instructions, destination (note person responsible and contact information)
   
10. Informed Consent Forms
    Provide a copy of the final IRB approval letter and informed consent forms.
11. Research Subject Advocate
    Dr. Thomas Silber will contact you to go over his role and the resources available to you.
12. PCRC Core Laboratories,(Genetic, Bioanalytical, BPIC)
    
1. Review requested for core services and schedules
   
13. Orders
    There need to be written orders for all relevant aspects of staff activities such as dispensing of medication, obtaining specimens etc.
    
14. Budget
    
1. Review of requested and approved support provided by the PCRC
   
2. Other funding supporting this project and the institutional account number
   In order to ensure compliance with NIH guidelines we request documentation that no other grant funds are available to support supply and ancillary costs for your protocol. Provide a copy of the grant budget
   
3. For industry studies, please provide copy of final study budget, contract, IND etc