source document definition fda
Photocopies of the case report forms may be used as source documents. The FDA states that the only drawback to the practice of recording information directly on the photocopied case report form is if the data is then transmitted or transcribed onto the original case report form.ase histories contain the information about all aspects of the investigation on the subject and must include the case report forms and supporting data. Supporting data is commonly called source data and is contained in source documents.