Frequently Asked Questions About NCCIH Initiation Visits
1) When is a National Center for Complementary and Integrative Health (NCCIH) initiation visit scheduled?
An NCCIH initiation visit occurs once the final protocol, case report forms (CRFs), informed consent form (ICF), and Data and Safety Monitoring Plan (DSMP) are approved by NCCIH and the local Institutional Review Board (IRB) and site staff training is completed (including training for collaborating sites), and before any participants are enrolled in the study.
2) Who schedules the initiation visit?
With NCCIH approval, a site monitor (sometimes referred to as a clinical research associate or CRA) will contact the principal investigator (PI) or study coordinator by phone or e-mail to inform that an on-site or remote monitoring visit is being planned and begin the scheduling process. The site monitor will inquire about availability and scheduling preferences, providing as much notice as possible.
Once a mutually agreeable date is determined, the site 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 or soon after confirmation of visit dates if less than 21 calendar days in advance of the visit.
3) How long does the initiation visit last?
The length of an initiation visit may vary according to the complexity of each study, but a typical initiation visit lasts about 7 hours. Not all parts of the visit require attendance by all staff.
4) What arrangements need to be made for the initiation visit?
For on-site visits, the site monitor will ask the site staff to reserve an appropriate meeting space for the visit. This request may also include equipment, such as a projector, screen, and/or conference phone line.
- 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.
For a remote monitoring visit, the site monitor will request information about available video conferencing and web-based portals (for regulatory documents).
5) For a multisite study, will each site have an initiation visit?
The initiation visit is only conducted once with the grant PI, site investigators, and key site staff from all collaborating sites.
For on-site visits, staff can attend in-person or remotely (per site capability).
For remote visits, everyone will attend from a remote location (e.g., home or office).
6) Which study staff will attend the initiation visit and when?
All study staff responsible for the implementation of the study will attend the initiation visit, including staff from collaborating sites. This typically includes the PI, co-investigator(s), study coordinator(s), research nurses, research assistant(s), and/or other study staff who will interact with participants (e.g., laboratory/magnetic resonance imaging technicians), as well as data management staff. If the study randomization scheme is of particular interest, the study statistician may be asked to attend while that topic is discussed. If a study agent is involved, the pharmacist may be asked to attend. Questions about staff attendance for individual studies can be discussed with the site monitor as part of visit planning. Prior to the initiation visit, it is the PI’s responsibility to train all staff based on their delegated responsibilities. It is the PI’s responsibility to train any other staff delegated to study activities who are not in attendance at the site initiation visit, including ongoing or refresher training for all staff after the initiation visit.
7) What study documents will the site monitor review during the initiation visit?
The site monitor will review the following NCCIH- and IRB- approved documents, as applicable to the study:
- Most recent protocol version ICF, DSMP, CRFs
- In addition to reviewing the documents listed above, the site monitor will review the correspondence from NCCIH indicating approval of the protocol, as well as any correspondence between the PI and the IRB.
- Please refer to the Guidance for Maintaining Regulatory Documents [1MB Word file] for a complete list of regulatory documents that will be reviewed during the visit.
8) What topics will be discussed during the initiation visit?
The site monitor will provide the site with a draft initiation visit agenda in advance of the visit, and will work with the PI, study coordinator, or other designee to finalize the agenda prior to the visit.
The initiation visit agenda will include the following items, with modifications to reflect the specifics of each protocol and study team:
- Detailed discussion about the study procedures and NCCIH expectations for study staff
- Review of the protocol to ensure each member of the study team is familiar with the details of the study plan
- Verification that each member of the study team has been trained and is clear about his/her role and responsibilities
- Verification that all documents and systems necessary to begin study implementation are ready, such as required regulatory documents, standard operating procedures, quality control (QC) plan, CRFs, and checklists for source data documentation
- Verification that the study database is ready for implementation
- Verification that the necessary study supplies are ready for use
- Verification per brief staff-guided tour that the facilities are adequate for study implementation
- NCCIH representatives may elect to participate in the initiation visit in person or remotely.
9) Who will lead the discussion and will the site monitor provide training?
The PI is required to provide protocol-specific training to site staff, specific to their delegated responsibilities, prior to the initiation visit.
The PI and other key staff will be presenters during the initiation visit.
- The PI may provide an overview of the study plan
- The study coordinator may review the CRFs that will be used for data capture
- All key staff should be prepared to lead the protocol discussion according to the visit agenda.
The site monitor will provide general training on PI responsibilities and compliance with Good Clinical Practice (GCP), NCCIH standards, and applicable regulations.
An initiation visit agenda will be provided for the study staff to review prior to the scheduled date for the initiation visit.
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 discussions and findings 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 initiation visit. The written report will describe the topics discussed, items reviewed, 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 initiation 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 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.
12) Is there a difference between a remote initiation and on-site initiation?
Remote initiation visits limit the site monitor’s ability to make some assessments (e.g.,
tour of facilities or visual verification of site resources and security measures), but both follow the same procedures to ensure the objectives are met.
Site monitoring may be conducted in-person or remotely depending on the study design, the research environment, and the availability of in-person monitors. There may also be local restrictions (e.g., COVID-19 pandemic) that would also require a remote initiation visit to be prioritized over an on-site visit.
13) Will on-site or remote monitoring be conducted after enrollment begins?
Site monitoring may be conducted in-person or remotely depending on the study design, the research environment, and the availability of in-person monitors and will be dependent on NCCIH monitoring program procedures, site institutional requirements and other factors.
The objective for both on-site and remote interim visits will be the same (i.e., ensure subject safety and verify compliance with protocol, GCP, and applicable regulations.)
14) How will I know when the study may open to enrollment?
The study may open to enrollment upon receipt of written approval from the NCCIH program director.
Before NCCIH approval is granted, the site must show that all action items from the initiation visit have been resolved or there is an adequate plan for resolution in place.