Raw data includes observations of the condition of the subjects, exposure to the IMP, concomitant medications administered and any indications of an adverse reaction. Raw data is the original documentation of an event that relates to the clinical trial. For Example, raw data for laboratory results would not be the recording of the results in the study records, instead it would be the report received from the laboratory. Raw data can be recorded directly into the case report form for some types of clinical data such as height, weight, blood pressure as long as that is the procedure for how this type of data is captured. There does not need to be a “source raw data” record created for this type of data and the practice of creating a “source raw data” record only allows for the possibility of transcription errors when entering it again into the case report form.
