Report and manage protocol deviations
Open CTMS > Quality and click Report Deviation. Describe what happened and when; the sponsor team then classifies it, records root cause and CAPA, and closes it with a signature once the investigator has reviewed it.
Where to find it
CTMS > Quality
Before you start
- The CTMS module is switched on.
Report a deviation
Open CTMS > Quality and click Report Deviation.
Choose the Site and, if it applies, the participant and visit.
Choose the Category, enter the Date of deviation and Date identified, and describe What happened.
Optionally propose a classification and severity, tick the immediate-hazard box if relevant, and add root cause, impact, CAPA and ethics committee details.
Click Report Deviation.
Classify, review and close
- Classify (sponsor team): classification, severity, rationale, whether it is a serious breach, and whether CAPA is required before closing.
- Record Investigator Review (the site's investigator) and CAPA Completed when the actions are done.
- Close and Sign: choose the outcome (resolved, duplicate or not a deviation), give the reason and sign.
Closing is blocked until the deviation is classified, the root cause is recorded, any required CAPA is complete and the investigator has reviewed it. Reopen needs a reason. The QTL Breaches tab lists quality tolerance limit breaches to acknowledge and resolve.
Was this guide helpful?
Related guides
Still need help?
Email support@capture.study or use the contact form. Tell us the study name, what you were trying to do and the exact message on screen; a screenshot helps.
Please never send participant names, contact details or health information to support.