1. MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS
ACCORD SOP CR010 v3.0
(Effective 30 May 2016)
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. WHAT HAS CHANGED? Responsibilities ACCORD e-mail Deviation Log
Violation Form
Trending
Retention of records
New responsibilities in ACCORD only
New ACCORD for reporting
Updates to Log and Form
Review of data by ACCORD
Where are records retained?

4. 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
s to Research Governance will forward to this
All communication now with ACCORD QA team

5. PROTOCOL DEVIATION LOG
(CR010-T01 v2.0)
REC No.
Event No.
Code
Sign/Date
PI informed
Actions complete
Review/receipt of log
REPORTING TIMELINES HAVE NOT CHANGED
(Every 3 months or as per protocol)
Replaces R&D No.
Allows ACCORD to track deviations (not applicable for studies already started)
ACCORD internal use only
To evidence timely PI awareness
To evidence actions complete
To evidence oversight from PI/ACCORD

6. VIOLATION FORM (CR010-F01 v2.0) 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

7. 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)

8. 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;

9. CONTACTS & REFERENCES Please address any questions to;
(QA Manager)
(QA Coordinator)
SOP CR010 and examples of completed Deviation Logs/Violations Forms are available on the ACCORD website