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Case Report Forms SOP Considerations

When developing SOPs for the completion of a Case Report Form (CRF), you should keep in mind:

  • All protocol activities conducted during a site visit must be captured in the source documentation as it is completed.
  • All source documentation should be the original record and/or certified copies.
  • Source documents must be kept in a secure location throughout the trial.
  • A complete source record should be provided to the sponsor representative upon request.
  • After each research visit, the Principal Investigator designee will complete applicable CRF pages in a timely manner when all necessary information is available.  Data reported on the CRF that are derived from source documents will be consistent with source documents. The CRF will not be used as an original source document unless indicated in the protocol. 
  • Any discrepancies found between the source document and the CRF entries will be corrected on the original CRF.    
  • Sponsor guidelines will be followed for any corrections to data entries. NOTE: Sponsor of protocol may require that changes be made on data clarification forms (DCFs) or query forms. 
  • In the event that a data entry error occurs, corrections will be made by following the sponsor-provided guidelines within the CRF instructions.
  • The Principal Investigator will sign the required CRF pages only once data is reviewed as complete and accurate.
  • The Principal Investigator-designee will submit completed CRF pages as instructed by the sponsor-designee as part of the data management process.
  • Copies of all sponsor requested data edits will be retained in the subject’s file to maintain the data audit trail.
  • A legible copy of all source documentation and CRFs will be maintained at the site or appropriate designated storage facility. The long-term maintenance of the Principal Investigator’s copy of the CRF is the responsibility of that investigator.