NCCAM Site Monitoring Visits
Onsite monitoring is one element of NCCAM’s oversight of clinical research studies, which assists NCCAM and its grantees in fulfilling the mutual responsibilities for ensuring participant safety and adherence of studies to applicable regulations, and verifying data quality, completeness, and accuracy.
The NCCAM clinical research portfolio is very diverse, spanning many disciplines, conditions, and study designs. In addition to supporting studies conducted under a Food and Drug Administration (FDA) Investigational New Drug Application, NCCAM also supports clinical research that may involve other types of interventions, which may include associated risks to participants or involve vulnerable populations. These various risks, size, scope, complexity of the research, and the experience of the investigator and institution will influence the type and extent of site monitoring required by NCCAM.
For most interventional studies and large observational studies, clinical site monitors designated by NCCAM will conduct periodic onsite review of source documents, case report forms (CRFs) and other participant records, regulatory files, facilities, laboratories, and pharmacies (if applicable). For studies that will undergo site monitoring, the NCCAM program official will discuss relevant requirements with principal investigators (PIs).
Note: For studies regulated by FDA (conducted under an IND or IDE), investigators should note that NCCAM monitoring does not fulfill the sponsor monitoring requirements as specified in 21CFR312 or 21CFR812.
There are three main types of NCCAM Site Monitoring Visits:
- Initiation Visit
This type of visit occurs once the final protocol, CRFs, informed consent form (ICF), and data and safety monitoring plan (DSMP) are approved by NCCAM and the local Institutional Review Board (IRB), and before any participants are enrolled in the study.
- Interim Visit
This type of visit occurs during the time a study is open to participant enrollment. 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. However, interim visits may be conducted sooner and/or more frequently as determined by NCCAM.
- Closeout Visit
This type of visit occurs once the last participant has completed study participation.