I wanted to clarify what the expectation is when monitoring for the documentation of causality assessment of AE by an investigator in the medical notes. This is mainly for early phase trials. I have always expected and requested investigators to review each adverse event and document the causality in the medical notes (or AE source data worksheets where there is one). However this becomes a regular monitoring finding as is often not captured in the notes. I have several sites asking if the investigator can just sign the completed AE CRF (paper) to confirm causality assessments that have been entered on the CRF.

I note the grey guide Section 11.4.7 states 'AEs should be recorded in medical notes whether by Investigators or by the nurse. This information is transcribed onto a CRF AE form. Which will require assessment of serious and causality for each AE. If a signature of investigator is not required on the form investigators should endorse the relevant CRF page (if transcribed by a nurse) or record serious or causality in the medical notes' .

Is it therefore adequate for the AE assessment to be documented by a signature on the AE CRF only (all other aspects of the AE recorded in medical notes)? This would mean no source data for the assessment itself?