Understanding the CRF: structure, completion guidelines, and common pitfalls
Identify CRF structural elements, apply completion guidelines for dates, units, and missing data, recognize common pitfalls, and understand the CRF as an investigator attestation.
Every trial speaks through its CRF
Every clinical trial, regardless of its therapeutic area, phase, or design, produces a case report form. The CRF is the document -- paper or electronic -- through which the investigator's site reports protocol-required data to the sponsor. It is the bridge between what happened at the bedside and what the sponsor, the regulatory authority, and ultimately the scientific community will see. If the source document is the original record of what was observed, the CRF is the structured translation of that record into a format the sponsor can analyze.