Protocol Implementation 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 GCRC nursing unit to set up the study activation meeting. All GCRC staff members involved in the conduct of the study will be participating in this meeting. The complexity of the research project should be addressed by the investigator in preparation for this meeting. The points to be addressed include:

  1. History (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. Day-by-day explanation of the protocol: outpatient or inpatient
  4. Nursing Responsibilities
    1. Study team research nurse/coordinator responsibilities
    2. GCRC 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 GCRC
    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 GCRC
  8. Drugs/Biologicals
    1. Supplier: distinguish among 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 dispensation 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. Destination (name person responsible and contact information)
      1. Shipping instructions
  10. Informed Consent Forms
    Provide a copy of the final IRB approval letter and informed consent forms.
  11. Research Subject Advocate
    Dr. Judith Baigis will contact you to go over her role and the resources available to you.
  12. GCRC Core Laboratories,(Genetic and Bioanalytical )
    1. Review requested for core services and schedules
  13. Orders
  14. Budget
    1. Review of requested and approved support provided by the GCRC
    2. Other funding supporting this project and the institutional account number
      3. 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.