When will an NCCIH interim visit be scheduled?
NCCIH interim visit(s) may be conducted multiple times during the life of a study. Typically, the first interim visit occurs 1 year after the initiation visit or once 50 percent of the expected accrual is reached, whichever occurs first. Subsequent visits will occur on an annual basis. Interim visits may be conducted sooner and/or more frequently as determined by NCCIH.
Who will schedule the interim visit?
With NCCIH approval, a monitor will contact the PI or study coordinator by phone or e-mail to begin scheduling a visit. The monitor will inquire about availability and scheduling preferences months in advance, providing as much notice as possible.
Once a mutually agreeable date is determined, the monitor will e-mail a confirmation letter to the PI confirming the date and outlining the visit objectives. NCCIH staff will receive copies of this correspondence. The confirmation letter will be e-mailed to the PI at least 21 calendar days in advance of the visit.
How long will the interim visit typically last?
The monitor is usually on site for 2 to 3 days to conduct an interim visit.
What arrangements need to be made for the monitor?
The monitor will ask in advance for campus directions and any visitor requirements specific to the site, such as visitor sign-in, parking tag, or a visitor badge.
The monitor will need an appropriate work space each day of the site visit. For studies utilizing an electronic medical record (EMR) or electronic data capture (EDC), a computer terminal and password access may be necessary. Please see the FAQ below on the use of EMR and EDC for more information.
The monitor will need access to all study records outlined in the confirmation letter. These study records will need to be readily available throughout the site visit.
Which study staff will need to meet with the monitor, and when?
The monitor will ask to meet briefly with the study coordinator on arrival the first day for an informal introduction and a brief orientation to the facilities, location of study records, and organization of research charts. The study coordinator will be asked to check in with the monitor once or twice each day to answer any questions that may arise during the review.
The monitor may ask to meet briefly with study representatives from data management or other staff as applicable to the visit objectives. If the study includes a study agent, the monitor will ask for an appointment with the pharmacy.
On the final day of the visit, the monitor will ask the PI and all relevant study staff to meet for an exit summary meeting to discuss any findings and recommendations. This exit meeting will be scheduled in advance at a mutually agreeable time.
What will the monitor review during the interim visit?
The monitor will perform a detailed review of the following items as they pertain to each NCCIH study:
- Informed consent forms obtained from all participants to verify:
- Consent form is complete with valid signatures and dates.
- Correct version of the consent form, with appropriate IRB approval, was used.
- Consent was obtained prior to any study-related intervention.
- Consent process is documented in the study record.
- Regulatory documents to be verified:
- Appropriate program director and Office of Clinical and Regulatory Affairs approval of the protocol and all amendments. (All amendments with substantive changes must be approved prior to implementation.)
- IRB approval of the protocol and all amendments prior to implementation.
- Any additional IRB and sponsor-required documentation (must be complete, current, and maintained on site).
- Compliance with NCCIH-approved DSMP to be verified:
- All Adverse Events must be reported to the safety monitor/monitoring board, NCCAM and the local IRB per the DSMP.
- All Serious Adverse Events must be reported properly to these entities (and the FDA if applicable) per the DSMP.
- Pharmacy records (if applicable) to be verified:
- Proper receipt, storage, security, dispensation, and accountability of study agent. This review usually involves a visit to the site pharmacy.
- Site operations to be verified:
- Adequate staffing and resources to support the conduct of the study.
- Sample of participant records (also known as chart review) to be verified:
- Source documentation must support each entry on the CRF.
- All relevant information in the source documentation must be reported on the CRF.
- Sufficient source documentation must exist to re-create the study activities.
- Entries on the CRF must be complete and legible.
- Any forms used as both source documentation and the CRF must be listed in the protocol or other study records, and must be signed and dated in real time.
- All enrolled participants must meet the eligibility criteria.
- Compliance with the approved protocol for all study visits, assessments, and interventions must be met.
- Adverse Events must be properly documented and reported.
How will the monitor review documentation in an EMR and/or EDC?
In cases when the study process involves an EMR system for source documents and/or an EDC system for data capture, the study staff is responsible for providing one of the following for the monitor during the site visit:
- Proper system access for direct monitoring of electronic records (preferred)
- Printed documents from EMR system and EDC system
How and when will the monitor’s findings be communicated to the site and to NCCIH?
The monitor will provide a verbal summary of the findings during the exit meeting at the conclusion of the site visit.
In addition, the monitor will prepare a written report using an NCCIH-approved template specific for an interim visit. The written report will describe the items reviewed during the visit, monitoring findings, and any Action Items for the site. The monitor will distribute the final report, reviewed by NCCIH, to the PI and relevant site staff 2 to 3 weeks after the visit.
Will any followup be required after the interim visit?
The monitor’s written report will outline any Action Items that require followup, and the Action Items will also be listed in an Action Item Site Response Form. The monitor will provide an additional form for response if a Corrective Action Plan (CAP) is also required. The site will have 30 days after receipt of the monitoring report to respond to the Action Items identified in the report. The response to the Action Items (and CAP) as applicable should be submitted in writing to the monitor.