Clinical Trial Standards Applied During Audit Proceedings

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• Publié par: Lomif
• Nombre de lectures: 32
• Langue: English

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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 VIOLATIONSMINOR VIOLATIONS A. IRB/ConsentA. 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 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   Outdated consent used Failure to complywith Institutional Review Board (IRB) approval andreapproval guidelines, including lapsed or expired annual continuing reviews,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 fullboard 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. PretherapyC. Pretherapy  Missing a small number of minor testsPretherapy 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 nonprotocolWrong 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, (especiallyWrong 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 doseintensification 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 baselineNot reporting occasional grade 3 toxicities  studiesrequired to effectively assess toxicityFrequent nonreporting of grade 1 & 2 toxicities  Failureto get necessary followup 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 evaluationMissing a small number of minor required  violationsevaluations or tests I. Response/FollowUpI. Response/FollowU p  Failure to assess disease status according to theMissing minor measurements  requiredprotocol guidelines either pretherapyMissing one of several measurements used  orin response to treatmentto assess response and scans unavailable for review  Failureto obtain baseline CT scan to document  pretherapytumor size  Failureto obtain the required followup 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