Each monitoring visit type occurs at specific timepoints during the study
Pre-Study Visit (PSV): The Pre-Study Visit, sometimes referred to as the Site Selection Visit or Pre-Study Qualification Visit is the first visit that occurs at a site/institution. The purpose of this visit is to ensure the site and research personnel have the necessary qualifications/credentials, experience, facilities/equipment, etc. to conduct a study. The visit also serves to assess if the site has the targeted patient population to be able to meet recruitment expectations.
Other topics addressed during this type of visit are typically a high-level overview of the protocol (protocol synopsis), systems/portals to be used during the study, a review of the investigational drug or device, and non-standard of care assessments, etc.
Site Initiation Visit (SIV): The Site Initiation Visit occurs before any patient recruitment/enrollment and serves to assess whether the site is ready for activation, or ready to begin the study. The purpose of the visit is to ensure site personnel are trained on the protocol and prepared to consent patients into the study.
The following topics are typically reviewed during the SIV:
- Background and purpose of the study, including study objectives and style
- Procedures of the study
- Investigator’s Brochure (IB) or Device Investigational Plan (device description section), or reference product label.
- Investigational product(s): Pharmacological or technical aspects of the product(s), management, and accountability utilizing an investigational product accountability log
- Recruitment of subject and screening, including criteria for inclusion and exclusion
- Obtaining consent
- All essential documents such as report forms (CRFs), consent forms, etc.
- Monitoring expectations
- Adverse Event/Adverse Device Effect Reporting
- Data collection and record-keeping
Routine Monitoring Visit (RMV): Routine Monitoring Visits, sometimes referred to as Interim Monitoring Visits (IMVs), are conducted at a frequency outlined in the monitoring plan. This type of visit is the first visit after the first enrollment and occurs periodically throughout the study to ensure compliance, subject safety, and audit readiness.
Close-Out Visit (COV): The Close-Out Visit occurs after the last subject at the site has completed the study, all data has been collected, and the database is locked and prepared for statistical analysis. Close-out activities ensure that the studying procedure, all regulatory documents, and data are 100% completed, and any Investigational Product (IP) or supplies are returned or destroyed with documentation of the details pertaining to the destruction. The Principal Investigator (PI) must be available to sign off all the documents required for the closeout to be completed.
The purpose of the Close-Out Visit is to make sure that everything is neat at the study site which means the documentation is well organized and is accessible in the future as required for regulatory reasons.
