Frequently Asked Questions About NCCIH Closeout Visits
1) When will an NCCIH closeout visit be scheduled?
An on-site or remote a National Center for Complementary and Integrative Health (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, but the site should be prepared to discuss plans for completion.
2) How long will the closeout visit typically last?
For both on-site and remote monitoring, the site monitor usually reviews records for 1 day, or less, to conduct the closeout visit.
3) Can the closeout visit be combined with an interim visit?
Yes, the site monitor may conduct a combined interim/closeout visit and complete the objectives for both visit types during one visit. The site monitor usually reviews records for 2 to 3 days during a combined interim/closeout visit. See the FAQ about interim visits, including more information about remote monitoring of research records.
4) Who will schedule the closeout visit?
With NCCIH approval, a site monitor will contact the principal investigator (PI) or study coordinator by phone or email to inform them an on-site or remote monitoring visit is planned and begin the scheduling process. The site monitor will inquire about availability and scheduling preferences 4 to 6 weeks in advance, providing as much notice as possible.
Once a mutually agreeable date is determined, the site monitor will email 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 emailed to the PI at least 21 calendar days in advance of the visit or soon after confirmation of visit dates if less than 21 calendar days in advance of the visit.
5) What arrangements will need to be made for the site monitor?
For on-site monitoring, the site monitor will ask in advance for campus directions and any visitor requirements specific to the site, such as visitor sign-in, a parking tag, or a visitor badge. The site monitor will need an appropriate workspace with internet access 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 question below on the use of EMR and EDC for more information.
For remote monitoring, site staff will receive information and guidance on remote monitoring procedures and preparation. Site staff should ensure all requested research records are available in electronic format for remote review and inform the site monitor of any research records that are not available for remote review. Institutional Review Board (IRB) or privacy officer approval/acknowledgment for remote monitoring is required, and the site should develop a standard operating procedure (SOP) for remote monitoring that describes the authorized site staff responsible for accommodating the visit, as well as the approved electronic systems and institutional procedures for creating certified copies and whether Protected Health Information (PHI) is allowed to be shared remotely.
Prior to an on-site or remote visit, ensure the monitor will have access to all study records outlined in the confirmation letter on the scheduled date. These study records will need to be readily available throughout the site visit. Provide the site monitor a phone number and email address for the study staff responsible for accommodating the remote monitoring visit.
6) For a multisite study, will each site have a closeout visit?
Each site responsible for recruiting and following participants will have an closeout visit, 1 day at each site, preferably within a few weeks of one another.
7) Which study staff will need to meet with the site monitor, and when?
For both on-site and remote monitoring, the site monitor will ask to meet briefly with the study coordinator for an informal introduction and a brief orientation to the site’s standard procedures, final status update, location/access to research records, and organization of participant charts/records. The site monitor may ask to meet briefly with study representatives from data management or other staff as applicable to the visit objectives.
For remote monitoring, site staff may be asked to be present and engaged for longer periods than at on-site visits due to the limitations of approved electronic systems. For example, screen-sharing systems are a common approved method and require that a designated trained staff member attend the session with the site monitor for the entire remote visit.
If the study includes a study agent, the site monitor will request documentation for final disposition and a brief meeting with the pharmacist.
The site 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.
8) What will the site monitor review during the closeout visit, and is it the same for on-site and remote visits?
For both on-site and remote monitoring visits, the site monitor will request the same set of research records with the understanding that some may not be available for remote review. The site 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 informed consent form (ICF) is on file for each study participant. This may include review of PHI.
- Confirm that the local IRB has been informed of study closure or that the site has plans to do so in accordance with their local IRB reporting requirements.
- Assure that all case report forms (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/record indicating that the end of study participation was communicated to the participant, and associated source documents that include PHI.
- 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.
- The PI is responsible for posting a summary of the analysis and publishing to PubMed and ClinicalTrials.gov.
- If applicable, determine the disposition of any remaining study agent and assure all accountability documentation is in order. For remote visits, there are limitations for reviewing final disposition (e.g., final physical inventory).
- Confirmation of file storage and/or archive location of study files, including subject records and the regulatory binder.
9) How will the site 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, study staff will be responsible for providing one of the following for the site monitor during the site visit:
- Proper system access for direct monitoring of electronic records (preferred)
- Certified, printed documents from the EMR system and EDC system. For remote monitoring, site staff should inform the site monitor if printed documents can be scanned/uploaded.
10) How and when will the site monitor’s findings be communicated to the site and to NCCIH?
The site monitor will provide a verbal summary of the findings during the exit meeting at the conclusion of the site visit.
In addition, the site 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 site monitor will distribute the final report, reviewed by NCCIH, to the PI and relevant site staff 2 to 3 weeks after the visit.
11) Will any follow-up be required after the closeout visit?
The site monitor’s written report will outline any action items that require follow-up, and the action items will be listed in an Action Item – Site Response Form. The site will have 30 calendar 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 site monitor via email.
In the event that the study coordinators and research assistants resign or transition to other projects after the closeout visit, it is the PI's responsibility to address pending action items or designate a trained co-investigator to respond. It is recommended that at least one trained study coordinator be delegated to remain part of the team until final closeout action items are addressed.