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Common Compliance Terms

Routine Monitoring Visit:  As part of the Compliance Monitoring Program, monitoring visits involve a systematic review of a selected study for regulatory compliance.  Studies are internally selected, at random, from the database of all active JHM IRB protocols.  Study selection is not based upon “for-cause” issues.

For-Cause: An event or complaint about a study that prompts an audit.

Audit: Audits are conducted for-cause and are usually directed from either the IRB of record for the protocol or the Vice Dean for Clinical Investigation.  These are only conducted when requested.

Principal Investigator: Also known as the PI, the lead investigator for a protocol.

Study Coordinator: Also referred to as the SC, the person who is usually responsible for the daily activities of the protocol.

Source Documentation: Source documentation is the original data that is collected as part of a research protocol.  This may include (but not be limited to): progress notes, laboratory results, other test results (EKG, MRI, ultrasound, etc.), and any other original documentation the site is using to verify the data that is being collected.

Case report forms (CRFs): The forms that are used to capture the data for a given protocol.