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A Case Report Form (CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participant. All data on each participant of a clinical trial are held and/or documented in the CRF, including adverse events. The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions.
The size of a CRF can range from a handwritten one-time ‘snapshot’ of a participant’s physical condition to hundreds of pages of electronically captured data obtained over a period of weeks or months. (It can also include required check-up visits months after the participant’s treatment has stopped.) The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs.
Emtex Life Science medical writers can support the CRF process by compiling contributions from clinical and data management teams, ensuring alignment between the CRF and protocol requirements, managing review cycles, implementing comments, and verifying consistency across all data fields.
FAQ: Case Report Form
What is a Case Report Form (CRF) and what is its purpose?
A CRF is a paper or electronic questionnaire used in clinical trials to collect data from each participant. All participant data relevant to the clinical trial are documented in the CRF, including adverse events.
When is a CRF needed in a clinical trial?
A CRF is needed whenever a sponsor conducts a clinical trial and must collect data to test hypotheses or answer research questions. It is used throughout the participant’s participation, from the first assessment to check‑up visits that may occur months after treatment has ended.
How is a CRF designed and managed during a clinical trial?
The sponsor designs the CRF to reflect the protocol of the clinical trial and to ensure that all required data fields are captured. The sponsor is also responsible for producing the CRF, monitoring data collection, and auditing the completed forms to ensure accuracy and completeness.
How can Emtex Life Science support the preparation of a CRF?
Emtex Life Science can support the CRF process by coordinating input from clinical and data management teams, ensuring the CRF matches the protocol requirements, managing review cycles, implementing comments, and verifying consistency across all data fields.
Why is professional medical writing support valuable for a CRF?
Professional medical writing support is valuable because a CRF must be clear, accurate, and fully aligned with the clinical trial protocol. A medical writer helps ensure precise wording, logical structure, and correct data fields, which supports reliable data collection and reduces the risk of errors during monitoring and auditing.