I recently find the book edited by Parexel is extremely useful.
Good Clinical Practice: A Question & Answer Reference Guide
Edited by Mark P. Mathieu, Parexel Internationl Corporation
Due to the fact that I work side by side with study managers and medical directors and due to my responsibility of overseeing the data management activities (outside of my responsibilities for biostatistics), I am involved in a lot of discussions the data collection, data quality. In a lot of situations, the decision has to be made on whether or not an event should be collected as an adverse events or how an event should be collected, ......
The Good Clinical Practice is just like the law. A lot of guidances really depends on how to interpret. The book of "A Question & Answer Reference Guide" is the one attempting to provide the interpretation of the GCPs with practical questions.
Here are two exmamples extracted from this book:
Q. Assuming that it is a study exclusion criterion, is a pregnancy while on study considered an AE? Is it considered an SAE?
A. In and of itself, a pregnancy is not considered an AE or SAE. However, abortion, whether accidental, therapeutic, or spontaneous, should always be classified as a SAE and expeditiously reported to the sponsor. Similarly, any congenital anomaly/birth defect in a child born to a female subject exposed to the investigational product should be recorded and reported as an SAE.
Q. should expected clinical outcomes of the disease under study, which are efficacy endpoints, be reported as AEs/SAEs?
A. Some protocols instruct investigators to record and report all untoward events that occur during a study as AEs/SAEs, which could include common symptoms of the disease under study and/or other expected clinical outcomes. This approach enables frequency comparisons of all events between treatment groups, but can make event recording in the CRF burdensome, result in more expedited reports from investigators to sponsors, and fill safety database with many untoward events that most likely have no relationship to study treatment and that could obscure signal identification.
In some clinical trials, disease symptoms and/or other expected clinical outcomes associated with the disease under study, which might technically meet the ICH definition of an AE or SAE, are collected and assessed as efficacy parameters rather than safety parameters.
Recently, We have a study where several subjects had elective procedures (breast augmentation, mole removal,...). To show the diligence, we might be tempted to consider them as adverse events (even though they are not drug related), however, the elective procedures should not be considered as adverse events. These elective procedures can be collected on a separate CRF page, but should not be reported in AE page.
The best way is to specify the detail either in the study protocol or in the initial training provided to the investigational sites prior to the study start so that the same criteria are followed and all investigators are clear what should be reported and what should not be reported.