Clinical Research Operations

Coordination of Audit and Monitoring Visits

Purpose: To ensure that audit/monitoring visits are coordinated and conducted in an efficient, organized, and effective manner

STEP 1: Set Date for Audit/Monitor Visit

1. Negotiate audit/monitoring dates with the auditor/monitor and ensure Principal Investigator’s availability.
2. Obtain preliminary information on availability of a conference room.
   • Clinical Center (CC) Medicolegal Dept: 301.496.3331
3. Review Clinical Center Medical Record Department’s Regulatory Audit Guide.
4. Complete Memorandum of Monitoring Audit using the Medical Record Department’s template or write memo including required data listed in the Clinical Center Medical Record Department’s Regulatory Audit Guide.
5. Submit Memorandum and applicable documentation to the Medicolegal Section (1N205).
   • At least 1 month before the first day of the audit
   • Email, fax, or hand delivery are accepted
6. Reserve room by calling Medicolegal after submitting the Memorandum.
   • 1 month prior to audit

Note: Steps 1, 2, 4, and 6 will be completed by the CCR Office of the Clinical Director for all CTEP audits.

STEP 2: Prepare for Audit/Monitor Visit

1. Request written instructions from auditor/monitor outlining what information is to be reviewed and staff with whom they will want to meet such as:
   • Protocol number
   • Subject identifiers
   • Pharmacy records
   • Regulatory Binders (including IRB-approved records - all protocol versions, amendments, and consents)
   • NCI/CCR staff with whom they will want to meet
2. Order medical records no later than 1 week prior to audit.
   Note:  For CTEP audits/monitor visits, the Office of the Clinical Director will order the medical records.
   • Clinical Center Medical Record Department:
     • Complete the Medicolegal Section Audit Record Request Form and email form if you have secure email, or deliver to room 1N205. Note: Contact the Medicolegal Section for the Excel version of this form. If the list is not provided within 48 hours of the audit, the audit space will be released.
       OR
     • Complete a NIH form 293-1 for each patient and deliver to Room 1N205.
3. Notify the PI and the Pharmacy of the visit and arrange any requested staff appointments.
4. Ensure source documents are complete and organized.
   • Tag the medical record (This applies to CTEP-sponsored studies only)
   • Locate or request any missing documents
   • Label the research record
5. Ensure the regulatory binder is complete and available. Note: See SOP # REG-12: Guidelines for Development and Maintenance of Regulatory Files/Binders.
6. Prepare roster of accrued subjects or registration list per branch/research unit guidelines on auditor/monitor request. Note: Staff may contact the CCR Central Registration Office (CRO) to obtain a registration list.
7. Ensure auditor/monitor room is prepared with medical and research records, essential documents, and any other requested items such as scans or films.

STEP 3: Provide Support During the Audit/Monitor Visit

1. Meet the auditors/monitors on their arrival and introduce them to the Medicolegal staff. Point out location of telephones, copy machine, restroom, and cafeteria. Note: For CTEP audits/monitor visits, the Office of the Clinical Director will perform this action.
2. Familiarize auditor/monitor with record systems, including the hard-copy medical record, CRIS, research record, case report forms, and chart flagging system (if applicable).
3. Discuss auditor/monitor expectations of the CCR staff. Provide contact information to auditor/monitor for these individuals.
4. Review appointment information such as meetings with the investigational pharmacists and/or principal investigators.
5. Plan and attend exit interview.
6. Check in with the Auditor/Monitor periodically to respond to data requests/queries.

STEP 4: Conclude Audit/Monitor Visit

1. Attend the Exit interview/End-of-visit meeting to discuss issues/action and answer questions.
2. Ensure Sign visit log is completed.
3. Remove all tags from the medical records.
4. Leave the medical records in Medicolegal. The Medical Record Department staff will return the records to the Medical Records Department.
5. Return research records and regulatory binders to their proper location.

STEP 5: Subsequent to Visit, Participate in Formal Written Response to Audit/Monitor Findings, As Requested