Frequently Asked Questions About NCCIH Interim Visits
1. When will a National Center for Complementary and Integrative Health (NCCIH) interim visit be scheduled?
NCCIH interim visits may be conducted multiple times during the life of a study and usually include a combination of on-site and remote monitoring visits. 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.
2. Who will schedule the interim visit?
With NCCIH approval, a site monitor will contact the principal investigator (PI) or study coordinator by phone or email to inform them of the upcoming on-site or remote monitoring visit 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.
3. How long will the interim visit typically last?
For both on-site and remote monitoring visits, the site monitor usually reviews research records for 2 to 3 days. In consultation with NCCIH, the site monitor may reduce the number of days (if possible).
4. What arrangements 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. 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 explains whether Protected Health Information (PHI) is allowed to be shared remotely.
Prior to an on-site or remote visit, ensure the site monitor will have access to all study records outlined in the confirmation letter on the scheduled dates. 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 accommodating the remote monitoring visit.
5. For a multisite study, will each site have an interim visit?
Each site responsible for recruiting and following participants will have an interim visit, 2 to 3 days at each site. The visits will preferably occur within a few weeks of one another.
6. 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 on the first day for an informal introduction and a brief orientation to the site’s standard procedures and enrollment status, location/access to research records, and organization of participant charts/records. The study coordinator will be asked to check in with the site monitor once or twice each day to answer any questions that may arise during the review.
For remote monitoring, site staff may be asked to be present and engaged for longer periods than for 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.
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 site monitor will ask for an appointment with the pharmacy.
On the final day of the visit, the site 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.
7. What will the site monitor review during the interim 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 perform a detailed review of the following items as they pertain to each NCCIH study:
- Informed consent forms (ICFs) obtained from all participants to verify:
Please refer to the Informed Consent Checklist [34KB Word file] and Informed Consent Template [69KB Word file] for required and additional elements of the ICF.
- Regulatory documents to be verified:
Please refer to the Guidance for Maintaining Regulatory Documents for a complete list of regulatory documents that will be reviewed during the visit.
- Compliance with NCCIH-approved Data and Safety Monitoring Plan (DSMP) to be verified:
- Pharmacy records (if applicable) to be verified:
*For remote pharmacy monitoring visits, it is understood that there are limitations to verifying physical inventory and adequate storage.
- Site operations to be verified:
- Sample of participant records (also known as chart review) to be verified:
8. 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, the study staff is 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).
- Printed documents from the EMR system and EDC system. For remote monitoring, the site staff should inform the site monitor if printed documents can be scanned/uploaded.
9. For remote monitoring: What if my institution does not allow sharing PHI remotely?
If a signed Health Insurance Portability and Accountability Act (HIPAA) authorization by participants does not apply to remote monitoring and/or the IRB does not grant a waiver of HIPAA authorization, the investigator should review the institutional procedures for providing certified copies of source documents with redacted PHI and consult the site monitor about methods for providing a sample of participant records for remote review.
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 an interim 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 interim visit?
The site monitor’s written report will outline any action items that require follow-up, and the action items will also be listed in an action item site response form. The site monitor will provide an additional form for response if a corrective action plan (CAP) is also required. 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 (and CAP) as applicable should be submitted in writing to the site monitor.