Case Report Forms


Case report forms (CRFs) are arguably the most important documentation in a clinical trial since they are the last point of data entry, which ultimately influences the outcome of a study.

Research data is ultimately submitted to the sponsor and/or analyzed by the Emory Investigator by either paper case report forms (CRFs) or by electronic data capture (EDC). For the purpose of this Guidebook, the term CRF encompasses both paper CRF and EDC. CRFs must be organized, understandable, reproducible, reliable, updated, and verified for accuracy by the PI.

CRF Completion

  • The CRF must be completed by authorized site personnel, as documented on the delegation of authority log. Ensure that all CRF pages are signed and dated by the person completing the form
  • Ensure data entries are consistent with the source data (usually the subject’s medical record)
  • Always write clearly ensuring that the entries are legible to others
  • Avoid abbreviations and acronyms, unless they are standard medical abbreviations or known to be acceptable
  • Ensure that you complete the header information on each page consistently. Complete every field on each CRF page, unless otherwise indicated. If something is not done, unknown, or not applicable make a comment (ND/UK/NA) and put a strike through the field so it is obvious the item has not just been missed.
  • Do not write outside of the designated boxes. Write comments on the comments section/page.
  • Complete each box using leading zeros
  • To amend incorrect data on a CRF page:
    • Score through the error with a single line,
    • Do not obscure the original entry (do not use correction fluid),
    • Write the correct data nearby, and
    • Initial and date each amendment.
  • Do not record incomplete dates (e.g., if you know the month and year, but not the day, record- 04/NK/05).
  • Record dates in the requested format (e.g., 11/04/05; 04/11/05; 11 APR 05; 11 APR 2005)
  • Use the correct or consistent unit for weight, height, lab results, etc.
    Ensure AEs are consistent through visits, as applicable. If events are new at cycle/visit 1 but continue through cycle/visit 2, make sure it is documented at cycle/visit 2 as well. This can be best accomplished by recording AEs on an AE log which includes start date, stop date, grade of AE, attribution (relation to study drug), and action taken. Ensure that a qualified study team member, who has been given AE activity on the delegation of authority log, assesses and documents the clinical significance, grade, and attribution of the AE.
  • If a medication was given for an adverse event, document the drug, start/stop dates, and response

Verification of CRFs

The investigator should ensure the accuracy, completeness, legibility, and timeliness of the CRF data.  This can be accomplished and documented either electronically or by paper.  For electronic data capture, the sponsor may ask the PI to electronically sign each CRF page or multiple CRFs at defined periodic time points.  Some sponsors may have the PI sign an attestation page at the end of CRF completion, which will document the PI’s verification that the data is complete and accurate.  For paper CRFs, the PI may sign and date each page or sign an attestation page at the completion of all CRFs for a certain subject or entire study.  For investigator-initiated research, best practice is for the PI to sign CRFs at visit completion.

Maintenance and Storage of CRFs and Source Documentation

CRFs should be promptly completed after the data is collected.  A backlog of CRF entries compromises the data integrity.  You may not be able to recall the data later.  Once the study is complete, CRFs should be kept either via paper copy or on a CD-ROM.  Don’t ever lose sight of your CRFs and don’t rely on the sponsor to give them to you in case of an audit. 

Emory requires research records be stored for 10 years after study closure or termination.  For studies involving children, in-vitro specimens, or pregnant women, Emory requires storage of research records for 25 years.   The FDA requires that investigators and sponsors retain records for 2 years following the date a marketing application is approved for the drug/device for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.  The sponsor may have further record retention policies.  A good rule of thumb is to store the records for the longest period of time across Emory, FDA, and the sponsor.

Abbreviations for CRFs

CRF

Case report form

LE

Late entry

NK

Not known

ND

Not done

NA

Not applicable

NAD

No abnormalities detected

AE

Adverse event

SAE

Serious adverse event

UNK

Unknown

References

Emory University Records Management Policy and International Conference of Harmonization, Efficacy Guidelines, Good Clinical Practice