Case report form (CRF)

A case report form (CRF) is a data acquisition tool used to record protocol-required information about each participant in a clinical trial for reporting to the sponsor. A CRF may be a paper document or an electronic interface.

The CRF defines the fields used to collect study data, including clinical observations, laboratory results, treatment information, adverse events, and protocol-defined outcome assessments, as applicable to the trial. Its content and structure are determined by the study protocol and the trial’s data collection requirements.

Definitions

ICH definition

The International Council for Harmonisation (ICH) E6(R3) guideline defines a case report form as:

A data acquisition tool designed to record protocol-required information to be reported by the investigator to the sponsor on each trial participant 1.

Under ICH E6(R3), a CRF is a type of data acquisition tool (DAT). DAT is the broader category of paper or electronic tools used to collect data and associated metadata from data originators in a clinical trial and report the data to the sponsor.

Examples of DATs include, but are not limited to, CRFs, interactive response technologies (IRTs), clinical outcome assessments (COAs), including patient-reported outcomes (PROs), and wearable devices, irrespective of the media used.

FDA recordkeeping requirements

Under U.S. Food and Drug Administration (FDA) regulations, investigators conducting clinical investigations under an investigational new drug (IND) application are subject to the recordkeeping requirements specified in 21 CFR 312.62(b). This provision establishes an obligation to maintain case histories but does not provide a standalone definition of a CRF. The regulation states:

An investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation 2.

FDA definition of an electronic case report form

The FDA defines an electronic case report form (eCRF) in its guidance Electronic Source Data in Clinical Investigations: Guidance for Industry as:

An auditable electronic record of information that generally is reported to the sponsor on each trial subject, according to a clinical investigation protocol. The eCRF enables clinical investigation data to be systematically captured, reviewed, managed, stored, analyzed, and reported 3.

The guidance addresses electronic source data used to populate predefined fields in an eCRF according to the clinical investigation protocol. It discusses source data originators, audit trails, methods of data capture, investigator responsibilities for reviewing and retaining electronic data, and the use of computerized systems.

The guidance describes FDA’s recommendations and does not independently establish legally enforceable requirements. Applicable statutory and regulatory requirements remain distinct from the recommendations in the guidance.

Relationship to Source Records

Source records contain the original information or certified copies of original information documenting clinical findings, observations, and other trial-related activities.

According to the FDA guidance Electronic Source Data in Clinical Investigations whether a case report form (CRF) also constitutes a source record depends on how the data are initially captured. When data are transcribed from existing records, those records serve as the source. When data are recorded directly in an electronic system, the electronic record may itself serve as the source record.

The relationship between a CRF and source records depends on the data collection arrangements defined for the trial, including the identification of source records, methods of data capture, and applicable record retention requirements.

Related Terminology

  • Audit trail
  • Electronic data capture
  • Protocol
  • Source data

References

  1. International Council for Harmonisation. 2026. ICH E6(R3): Consolidated Guideline for Good Clinical Practice. Available at: https://database.ich.org/sites/default/files/ICH%20E6%28R3%29_Step4_FinalConsolidatedGuideline_2026_0616_.pdf ↩︎
  2. U.S. Food and Drug Administration (FDA). 21 CFR § 312.62 – Investigator Recordkeeping and Record Retention. Electronic Code of Federal Regulations. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-D/section-312.62 ↩︎
  3. U.S. Food and Drug Administration (FDA). 2013. Electronic Source Data in Clinical Investigations: Guidance for Industry. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations ↩︎