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During an internal compliance review, the site study team identified that a protocol-required blood sample collection was not obtained for a majority of the subjects enrolled. In accordance with the ICH GCP Guideline, the clinical investigator should:
ICH directs investigators to document and explain any deviation, with prompt reporting to IRB/IEC only when deviations are implemented to eliminate immediate hazards or as required. Exact extracts:
ICH E6(R2) 4.5.3: ''The investigator should document and explain any deviation from the approved protocol.''
ICH E6(R2) 3.3.7 & 4.5.2 (paraphrased): deviations to eliminate immediate hazards must be reported as soon as possible.
Here, absent immediate hazard, the required action is documentation and explanation (B).
ICH E6(R2) Good Clinical Practice, 4.5.3 (Compliance with protocol; deviations).
ICH E6(R2) 3.3.7; 4.5.2 (Reporting deviations implemented to eliminate immediate hazards).
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