Electronic submission standards, as established byFDA, CDISC, and ICH, require that an individual subject’scomplete Case Report Form (CRF)be submitted as aPortable Document Format (.pdf)file. ThePDF formatis universally recognized and accepted because it ensures that the structure, format, and visual fidelity of the CRF are preserved exactly as originally designed, regardless of software or hardware environment.

According to theFDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format (2006)andCDISC SDTM standards, sponsors must include asubject-level CRFin PDF form for each participant in the submission dataset. This requirement ensures that reviewers can trace data points from analysis datasets back to their source entries in the CRF, fulfilling the principles ofdata traceability and transparency.

TheGood Clinical Data Management Practices (GCDMP)also support this requirement, emphasizing that CRF archiving should maintain readability and regulatory accessibility. Formats like RTF, DOCX, or SAS datasets are not acceptable substitutes for regulatory CRF submission because they may alter formatting, structure, or introduce modifiable content, violating FDA data integrity principles.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Archiving and Submission

FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format, April 2006

CDISC SDTM Implementation Guide, Section 5.3 – CRF Representation and Traceability