A site visit may be conducted at the Board’s discretion.
Rationale for a Board-requested site visit may include a study that targets a vulnerable population such as nursing home residents (learn about Safeguards for Vulnerable Subjects) or an investigator who has demonstrated noncompliance.
Additionally, a site visit by a Board representative is required annually for all FDA regulated studies involving investigational drugs or biologics that are being conducted within the state of Massachusetts. A site visit is not required for studies involving investigational devices. All Massachusetts investigators should be familiar with the Massachusetts Department of Public Health regulations for conducting clinical research, as well as FDA regulations. You may contact the Massachusetts Department of Public Health to receive information about conducting clinical research in Massachusetts.