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MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS

MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS. ACCORD SOP CR010 v5.0 (Effective 01 October 2018) TRAINING SLIDES. DEFINITIONS

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MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS

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  1. MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS ACCORD SOP CR010 v5.0 (Effective 01 October 2018) TRAINING SLIDES

  2. DEFINITIONS • DEVIATION: Any change, divergence, or departure from the study design, procedures defined in the protocol or GCP that does not significantly affect a subjects rights, safety, or well-being, or study outcomes • VIOLATION: A deviation that may potentially significantly impact the completeness, accuracy, and/or reliability of the study data or that may significantly affect a subject’s rights, safety, or well-being

  3. RESPONSIBILITIES • PI/research team responsibilities not changed • ACCORD QA; • Reviewing, logging, tracking and trending deviations/violations • ACCORD Senior Clinical Trials Monitor; • Awareness of study specific trends and/or significant findings • Discuss/address with Investigator

  4. PROTOCOL DEVIATION LOG (CR010-T01 v3.0) • Event No. • Code • Sign/Date • Actions complete • Review/receipt of log REPORTING TIMELINES HAVE NOT CHANGED (Every 3 months or as per protocol) Allows ACCORD to track deviations ACCORD internal use only To evidence actions complete To evidence oversight from PI/ACCORD

  5. VIOLATION FORM (CR010-F01 v4.0) • REC No. and PI • Code • Conclusion • Sign/Date • Assessment • Actions complete • Conclusion • Receipt of form • Violation No. REPORTING TIMELINES HAVE NOT CHANGED (within 3 days of becoming aware) In line with Deviation Log ACCORD internal use only Justify why participant to remain/withdraw (e.g. why no actual impact) To evidence who is making assessment To evidence actions complete To evidence who is making conclusion ACCORD internal use only

  6. TRENDING • ACCORD QA will review/report on deviations/violations • Quarterly • Study trends • Global trends • ACCORD Senior Clinical Trials Monitor will address study specific trends and/or significant findings with research team To Senior Management Team/Senior Clinical Trials Monitor (ACCORD)

  7. RETENTION OF LOG/FORMS • Original records (essential documents) stored in the Investigator Site File (ISF) by the PI, with; • Any communication regarding resolution of corrective/preventative action • Copies retained in the Trial Master File (TMF) or Sponsor File, with; • Any communication regarding resolution of corrective/preventative action

  8. CONTACTS & REFERENCES • Please address any questions to; • QA@accord.scot • Lorn.Mackenzie@nhslothian.scot.nhs.uk (QA Manager) • Gavin.Robertson@nhslothian.scot.nhs.uk (QA Coordinator) • SOP CR010 and examples of completed Deviation Logs/Violations Forms are available on the ACCORD website • www.accord.scot

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