Office of Human Research
SOP No.: 402 INITIATION VISIT
Author: Office of Human Research
Effective Date: October 1, 2007
Supercedes document dated: N/A
Last Reviewed on: N/A
Results of Review: N/A
This SOP pertains to: All clinical study sites participating in Thomas Jefferson University faculty-sponsored (also termed Investigator) FDA-regulated human subject research.
Responsibility for executing this SOP: Investigator and Designated Research Personnel
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR)
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR)
This procedure describes the activities and processes of the initiation visit and site training for a new clinical study site participating in Food and Drug Administration (FDA)-regulated human subject research. It also may be used when a new protocol or a new Investigator is initiated.
2. GENERAL INSTRUCTIONS
- The Investigator is responsible for ensuring that all participating Investigators understand and accept the obligations incurred in undertaking a clinical study.
- The Investigator or designee is responsible for selecting and training Monitors in the use of the investigational product and on the conduct of the clinical protocol.
- The Monitor is responsible for conducting the initiation visit and site training at the clinical site(s). The Monitor will focus on both regulatory requirements and protocol training. The objectives of an initiation visit are:
- Verify that the site's study preparation procedures are completed
- Verify that all regulatory documents are in place
- Verify that investigational product is available so that training can begin
- Review the clinical protocol, case report forms (CRF) and other worksheets
- Review all regulatory requirements
- Provide the plan for study monitoring
- Provide the site with all Investigator contact names and telephone numbers
- Confirm the Investigator's expectations on the conduct of the study
3. SPECIFIC PROCEDURES
3.1 Preparing for the Initiation Visit
- The Monitor designated to conduct the initiation visit will schedule the visit with the Investigator, making sure that other key personnel who will assist in the conduct of the study are also available, and allowing adequate time for all activities.
- Prior to the visit, the Monitor should provide the final protocol, informed consent forms, literature, video and any other appropriate training materials to the Investigator for protocol training purposes.
- Prior to the visit, the Monitor should prepare by reviewing the current protocol and associated CRF and any other relevant documents.
- The Monitor should confirm which internal and external regulatory approvals are required for the study (e.g., Institutional Biosafety Committee or IBC, Radiation Safety Committee, etc.).
3.2 Conducting the Initiation Visit
- At the meeting, the Monitor will ascertain the Investigator and team's understanding of required responsibilities through discussions and questions (See SOP Attachment 402 A, the Initiation Visit Checklist).
- Key study personnel should be provided sufficient time to discuss questions related to the study and their specific responsibilities during the initiation visit.
- The Monitor will review the following items and obligations from the Initiation Visit Checklist with the Investigator and other key personnel:
- Introduction: FDA regulations, other requirements, relevant Investigator standard operating procedures (SOP)
- Key Personnel Roles Defined: Investigator, Co/Sub-investigators, other key study personnel, Investigator, Monitor
- Study Commitment Reviewed: Study contract, study timelines, participant recruitment, participant enrollment, participant and specimen management during the study, protocol compliance
- Documents/Processes Reviewed: Study files, protocol review, CRF, participant case history records, participant coding and randomization, other worksheets, protocol-related procedures, laboratory procedures, informed consent process, recording adverse events, data management process, inventory accountability records, use of investigational device, investigational drug dosing, document retention requirements
- Monitoring: Monitoring visit schedule, monitoring procedures/expectations, access to source data and documents, access to CRF and worksheets, Investigator/Monitor meetings
- Investigational Product: Storage and dispensing, required records, inventory disposition
- Reporting Requirements: Data reporting to Investigator, protocol reporting requirements, reporting unexpected events, reporting adverse events, IRB reporting requirements, FDA reporting requirements
- The Monitor will confirm that the Investigator's study file contains the following required items and indicate on the Initiation Visit Checklist:
- Signed protocol and Investigator Statement
- Signed Investigator contract
- CVs of all participating Investigators
- Form FDA 1572 for IND studies
- IRB approval letter for the protocol
- IRB membership roster
- Final, IRB-stamped, approved informed consent form
- IBC, Radiation Safety Committee, and/or other regulatory authority approvals (as determined by OHR)
- Valid clinical/other laboratory licensure
- Laboratory normal values ranges
- Notice that indicates the study has been submitted to the FDA
- Investigator Brochure (if appropriate)
- Case report forms
- Investigational product inventory management forms
- The Monitor will review with all site personnel the use of relevant logs, e.g., SOP 402 Attachment B, Study Staff Signature Log and SOP 402 Attachment C, Site Visit Log.
- At the initiation visit, the Monitor will instruct and advise relevant site personnel on the pharmacological/ technical aspects of the investigational drug, biologic, or device (i.e., review the Investigator Brochure or device specifications and investigational plan).
- The monitor will provide the Investigator and other key personnel an opportunity to discuss, and if applicable (for medical devices), provide some hands-on practice with appropriate surrogates or training tools.
- The monitor will review procedures for obtaining informed consent, including required signatures and disposition of copies.
- The monitor will review instructions for completion of CRFs, including corrections and queries. Draft CRF may be used for training purposes during the initiation visit.
- The monitor will review procedures for investigational product accountability, storage, dispensing, reconciliation, discrepancy investigation requirements, and inventory record keeping.
- The study initiation visit may be held prior to IRB approval, arrival of investigational product and/or final approved CRF if necessary.
- Enrollment of the first participant may not occur until the Investigator has determined that all initiation visit procedures and regulatory requirements have been completed.
3.3 Documenting the Initiation Visit
- The Monitor will document the visit by signing the Site Visit Log.
- The Initiation visit discussion and status of required items is documented on the Initiation Visit Checklist.
- The Initiation Visit Checklist should be filed in the appropriate section of the Investigator's Regulatory Master File.