Choose a protocol-deviation response that prioritizes participant safety, documentation, sponsor communication, and data impact.
GCP DECISION A participant missed a protocol visit window, but safety labs and dosing decisions still matter. What should the site do first? Notify the investigator, provide medically appropriate care, document the deviation, and follow sponsor communication and data-impact procedures. Strong. This protects participant safety and keeps the protocol exception visible for sponsor, monitor, and data review. Backdate the visit in the source record because the delay was caused by weather. Unacceptable. The reason may be understandable, but backdating falsifies the source timeline and violates data integrity. Skip all assessments because the protocol window closed and no data can be…
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