The original paper or electronic forms on which individual participants’ data (demographic, efficacy, safety, etc) are recorded during the clinical trial. The forms are typically the most “raw” form of detailed data available for understanding what happened in a clinical trial, and the data they contain are statistically analysed only after they have been entered into an electronic database of individual patient data. Forms can vary in length, from a few pages to hundreds of pages, and each trial can have multiple forms—for example, for different visits or for the different tests or procedures the participant undergoes.
Also called a CRF.
Example: Arthronat trial MA-CT-10-002, PDF pages 3985-4749 (source)
