Only relevant information please!
This challenge addresses the problem of too much information at the wrong place. Let me explain by an example of a regularly used SAE form section.
The physician is asked to provide the additional information that he/she renders important for the case (i.e. “please provide relevant medical history”). Your experience might let you agree that in the vast majority of cases this field is left untouched.
However, if all medical history is automatically “thrown” from the eCRF into the SAE report, without the physician’s assessment of its relevance for the case, the sponsor’s assessment of the case might be wrongly impacted.
For example: A site reports an SAE “gamma GT increased” within a clinical study. The patient’s medical history lists “diabetes, ongoing since 1999”, “hyperlipidemia, ongoing since 1999” and “alcohol abuse between 1980 and 1985”.
“Offer the physician a choice”
If the workflow does not explicitly ask the physician to provide the relevant medical history and, instead, all of the entries are placed in the eSAE report’s medical history field, this will make the sponsor’s causality and expectedness assessment rather difficult.
Perhaps, on a paper form the physician might have deliberately not mentioned the patient’s alcohol abuse from more than 20 years ago as it is might be completely irrelevant for the case.
Thus, I recommend technical options, where the physician is offered a choice (e.g. a drag and drop menu) if he/she considers a given entry relevant for the case or not.
Additionally, it should be clearly visible on the final output, if the information is all medical history there is, or if it is medical history selectively marked as relevant by the physician.