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SOP on Case Report Form (CRF) Data Entry Procedure for Clinical Trials

 Title: Case Report Form (CRF) Data Entry Procedure for Clinical Trials


Introduction and Purpose:

Case Report Forms (CRFs) are essential documents, whether in paper or electronic format, designed to systematically record all protocol-required information and results for each participant in a clinical trial. Accurate and timely data entry into the CRF is critical for ensuring the trial's proper conduct, evaluating safety and efficacy endpoints, and forming the basis for trial-related reports and publications. This Standard Operating Procedure (SOP) establishes standards for the accurate and timely entry of data into CRFs for clinical trials, following International Council on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. These standards should be adhered to, unless the study contract or Clinical Trial Agreement (CTA) specifies more specific requirements.


Definitions and Acronyms:

  • Clinical Research: Encompasses all research involving human participants, excluding secondary studies using existing biological specimens or data collected without identifiers or publicly available data.
  • Clinical Trial: Refers to clinical research studies involving human participants assigned to an intervention designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.
  • CFR: Code of Federal Regulations
  • CRO: Contract Research Organization
  • CTA: Clinical Trial Agreement
  • GCP: Good Clinical Practice
  • OSP: Office of Sponsored Projects
  • PI: Principal Investigator
  • SOP: Standard Operating Procedure


Procedure:

Case Report Form Data Entry:

  • Delegated research staff, such as study coordinators, are responsible for identifying, collecting, recording, maintaining, and making available all necessary clinical trial data in the CRF.
  • All data entered into the CRF must have available source documentation, except when source data is directly transmitted into the CRF.
  • Data entry begins after the initiation of the study and the enrollment of participants and should be completed prospectively thereafter.
  • Source documentation (clinic notes, procedure reports, test results, source forms, etc.) should be created contemporaneously with the study visit or available within 2–3 business days in the Electronic Health Record system.
  • All available data should be entered into the CRF within 10 business days of the study visit that generated the data.
  • If data availability is delayed, the PI and study personnel should make efforts to acquire and enter it into the CRF as soon as possible.
  • If the study contract or CTA specifies different data entry requirements, those should be followed instead of this SOP.
  • The PI is responsible for ensuring the accuracy, completeness, legibility, and timeliness of data collected in the CRF to ensure it aligns with the protocol.
  • Every field in the CRF should be completed, and blanks should be avoided. If CRFs are in paper format, blue or black ink should be used, and pencil should never be used.

Queries and Corrections:

  • Queries and requests for changes to CRF entries are common, often following sponsor or Contract Research Organization (CRO) monitoring visits or from data management or pharmacovigilance teams.
  • Any change or correction to a CRF should be dated, initialed, and explained if necessary, and it should not obscure the original entry to maintain an audit trail. This applies to both paper and electronic CRFs.
  • Each query should be addressed, corrected, or appropriately responded to within 10 business days of notification or issuance.

Contracts and Clinical Trial Agreements:

  • During the feasibility and contract negotiation phase for new clinical trials, the study coordinator or appropriate team member should inform the Office of Sponsored Projects (OSP) program officer of the 10 business day data entry requirement outlined in this SOP. This is to prevent shorter data entry requirements from being included in the contract or CTA.

Materials Required:

  • Access to the study's paper or electronic CRF database (may require user training and logon credentials)
  • IRB-approved clinical trial protocol
  • Access to the study contract or CTA, or contact information for the responsible OSP program officer
  • Access to the Electronic Health Record and all other study source data

References:

  • 21 CFR Part 312.62: Investigator Recordkeeping and Record Retention
  • 21 CFR Part 312.68 Inspection of investigator's records and reports
  • ICH Guidance for Industry E6(R2): Good Clinical Practice 4.9

Document Approval:

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