Clinical Trial Standards Applied During Audit Proceedings
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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 - Outdated consent used -Failure to comply with Institutional Review Board (IRB) approval and reapproval guidelines, including lapsed or expired annual continuing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 ...
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Clinical Trial Standards Applied During Audit ProceedingsMajor 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 VIOLATIONSMINOR VIOLATIONSA. IRB/ConsentA. IRB/Consent Failure to document properly obtained patient consentConsents 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 understoodon each page bythe patient. Outdated consent used Failure to complywith Institutional Review Board (IRB) approval andreapproval guidelines, including lapsed or expired annual continuing reviews, inappropriate use of less than fullboard review and approval and improper review of appropriate amendments or revisions (i.e. patient entered prior to IRB approval.) B. EligibilityB. Eligibility Doesnot meet eligibility criteria Small variations of criteria with reasonable explanation/approval (Phase II and III only) C. PretherapyC. Pretherapy Missing a small number of minor testsPretherapy tests of major importance were not done or notdone priorto therapy Unacceptablefrequency of minor violations D. Registration/Randomization/StratificationD. Registration/Randomization/Stratification Patientnot registered prior to treatment Date of birth/date of diagnosis inconsistent Informationgiven at registration is inconsistent with actual data in medical records chart (wrong stage, diagnosis, cell type, etc..) E. Forms/DataSubmission/Special RequirementsE. Forms/DataSubmission/Special Req. Submissionof data outside of protocol guidelines Incorrect data (sporadic pieces of data are Incorrectdata (substantial amounts of data areincomplete or inaccurate) incompleteor inaccurate for 1 or more forms)
F. TreatmentF. Treatment Inappropriateadministration of nonprotocolWrong antiemetic given as per protocol anticancer treatment(additional drugs, radiation, etc.)Wrong doses (<25% deviation without explanation forone dose; or 25% deviation from dose reduction indicated) Failureto modify doses according to protocol, (especiallyWrong timing (<2 week delaywith acceptable wheredoses are expected to have a major impact on outcome)explanation (i.e. holiday, bad weather, flu sx) Failureto dose reduce in the face of severe toxicity Failureto dose escalate on a doseintensification study Inappropriatedose reduction on a dose intensity study Repetitiveor systemic errors in dosing Repetitiveor serious errors in dosing, timing or schedule Wrongroute in administration Failureto document drug administration Errorin Concomitant Medications Failureto administer an important medication or the administrationof a prohibited medication ortreatment G. ToxicityG. Toxicity Failureto obtain the required protocol baselineNot reporting occasional grade 3 toxicities studiesrequired to effectively assess toxicityFrequent nonreporting of grade 1 & 2 toxicities Failureto get necessary followup studies to assess toxicityas required by protocol Unreportedmajor toxicity (Grade 4) Repetitivefailure to report Grade 2 & 3 toxicities Seriousor repetitive failure to properly characterize toxicityor grade Failureto file required NCI Adverse Reaction Reports accordingto protocol when applicable H. RequiredEvaluationEvaluationH. Required Unacceptablefrequency of required evaluationMissing a small number of minor required violationsevaluations or tests I. Response/FollowUpI. Response/FollowUp Failure to assess disease status according to theMissing minor measurements requiredprotocol guidelines either pretherapyMissing one of several measurements used orin response to treatmentto assess response and scans unavailable for review Failureto obtain baseline CT scan to document pretherapytumor size Failureto obtain the required followup CT scan todocument persistent reduction in tumor size to definea response as specified in the protocol Inaccurateassessment of tumor response Substantialinaccuracy in the detection of cancer (as in aprevention study) or determination of cancer progression J. DataQuality J.Data Quality Unacceptablelevel of missing documentation Acceptable level of missing documentation with explanation Missingcharts Minor and sporadic missing tests Repetitivefailure to obtain protocol specified Infrequent errors in submitted data laboratorytests or diagnostic studies Frequent inaccuracies or errors in submitted data
