When will an NCCIH closeout visit be scheduled?
An NCCIH closeout visit will be scheduled to occur once the last participant has completed study participation. NCCIH does not expect the site to have completed all closeout activities at the time of the closeout visit.
How long will the closeout visit typically last?
The monitor is usually on site for 1 day, or less, to conduct the closeout visit.
Can the closeout visit be combined with an interim visit?
Yes, the monitor may conduct a combined interim/closeout visit and complete the objectives for both visit types during one visit. The monitor is usually on site for 2 to 3 days to conduct an interim/closeout visit.
Who will schedule the closeout 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.
What arrangements will 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 EMR or 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 for an informal introduction and a brief orientation to the facilities, location of study records, and organization of research charts.
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.
The monitor will ask the PI and all relevant study staff to meet for an exit summary meeting to discuss the status of closeout activities and discuss monitoring findings. The exit meeting will be scheduled in advance at a mutually agreeable time.
What will the monitor review during the closeout visit?
The monitor will review the following during the NCCIH closeout visit, as applicable to the particular study:
- Verify that all regulatory and other pertinent documents for the protocol are up-to-date and on file.
- Verify that a valid ICF is on file for each study participant.
- Confirm that the local IRB has been informed of the study closure, or that the site has plans to do so in accordance with their local IRB reporting requirements.
- Assure that all CRFs have been completed.
- Review the status of all outstanding data edits and data queries and the timeline for their resolution.
- Assure that a progress note or checklist entry has been included in each participant chart indicating that the end of study participation was communicated to the participant.
- Assure that the PI and other site staff understand the requirements for final Adverse Event reporting and retention of study records.
- If applicable, determine the disposition of participant specimens obtained during the study and stored on site.
- If applicable, determine the disposition of any remaining study agent and assure all accountability documentation is in order.
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 will be 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 a closeout 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 closeout 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 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 should be submitted in writing to the monitor.