Case Report Form

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A Case Report Form or CRF is a questionnaire specifically used in clinical trial research. The CRF is the primary data collection tool from the investigator site. The trial sponsor is responsible for development of a CRF that accurately represents the protocol of the clinical trial, management of CRF production, monitoring of data collection, and auditing of the content. All data, information and results on each patient, participating in a clinical trial, are held and/or documented in the CRF. So-called "unwanted events", are also logged in the CRF during a clinical trial.

[edit] See also

• Clinical trial
• Clinical trial protocol
• Patient-reported outcome
• Patient Diary
• Data clarification form
• Clinical data acquisition
• Electronic Data Capture
• Clinical research associate (CRA)
• Drug development

[edit] References

• Debbie Kennedy, CRF Designer, Canary Publications, ISBN 0-9531174-7-2

[edit] External links

• Standard Operating Procedure – Develop and Manage a Case Report Form links to CRF information