Clinical Trial Standards Applied During Audit Proceedings

Clinical Trial Standards Applied During Audit Proceedings Major and Minor Violations The guidelines below, a compilation of ECOG, CALGB and NCI definitions, were created at the DFCI in July 1994 to help define major and minor violations. An exhaustive list of examples is not given, but the examples are intended to guide the reviewers in their assessment and categorization of specific violations. A major violation is generally defined as that violation which significantly alters the clinical effectiveness of the treatment or the evaluation of its toxicity. Minor violations occur when the protocol is not followed exactly, but the data are usable and valid. MAJOR VIOLATIONS MINOR VIOLATIONS A. IRB/Consent A. IRB/Consent -Failure to document properly obtained patient consent -Consents do not have date/witness signature - Consent dated after registration/treatment of pt. -Consents do not have unique patient identifiers - Consent not obtained in a language fully understood on each page by the patient. - Outdated consent used -Failure to comply with Institutional Review Board (IRB) approval and reapproval guidelines, including lapsed or expired annual continuing reviews, inappropriate use of less than full-board review and approval and improper review of appropriate amendments or revisions (i.e. patient entered prior to IRB approval.) B. Eligibility B. Eligibility ...