When is an NCCIH initiation visit scheduled?
An NCCIH initiation visit occurs once the final protocol, CRFs, ICF, and DSMP are approved by NCCIH and the local IRB, and before any participants are enrolled in the study.
Who schedules the initiation visit?
With NCCIH approval, a monitor (sometimes referred to as a clinical research associate or CRA) 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, 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 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.
What arrangements need to be made for the initiation visit?
The 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 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.
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. This typically includes the PI, co-investigator(s), study coordinator, research nurses, and/or other study staff who will interact with participants, 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 monitor as part of visit planning.
What study documents will the monitor review during the initiation visit?
The monitor will review the following NCCIH- and IRB- approved documents, as applicable to the study:
- Most recent protocol version
In addition to reviewing the documents listed above, the 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 Regulatory Binder Checklist [1MB Word file] and Summary Sheet [1MB Word file] for a complete list of regulatory documents that will be reviewed during the visit.
What topics will be discussed during the initiation visit?
The 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 is clear about his/her role and responsibilities
- Verification that all documents necessary to begin study implementation are complete, such as required regulatory documents, standard procedures, quality control (QC) plan, CRFs, and checklists for source documentation if used
- 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
It is likely that the PI and other key staff will be presenters during the initiation visit. For example, the PI may provide an overview of the study plan, or 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.
NCCIH representatives may elect to participate in the initiation visit in person or by teleconference.
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 discussions and findings at the conclusion of the site visit.
In addition, the 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 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 initiation 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.
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 officer. 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.