MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS

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Presentation transcript:

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

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

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

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

VIOLATION FORM (CR010-F01 v4.0) REC No. and PI Code Conclusion Sign/Date Assessment Actions complete 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

To Senior Management Team/Senior Clinical Trials Monitor (ACCORD) 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)

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;

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