What are Source Documents?
The FDA requirements for recordkeeping and record retention for clinical research are contained in 21 CFR 312.62 and 812.140, which cover
- Disposition of study drug and experimental devices
- Case histories
- Record retention
Case histories contain the information about all aspects of the investigation on the subject and must include the case report forms and supporting data.
Supporting data is commonly called "source data" and is contained in "source documents". Neither of these terms appears in the Federal regulations governing clinical research.
Because the format and content of source data and source documents are not explicitly described in the Federal regulations governing clinical research, the FDA has adopted the International Committee on Harmonization's E6 consolidation guide for GCP definitions (PDF) as a guidance document.
Additional FDA guidance on source documents can be found on the FDA webpage GCP Questions E-Mail Message at under Recordkeeping and Record Retention.
The ICH E6 document, section 1.51, defines source data as "All information in original records and certified copies of original records or clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies)."
The ICH E6 document, section 1.52, defines source documents as "Original documents, data and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries of evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial)."
CRFs as Source Documents
If allowed by the investigational plan (protocol), data may be entered directly onto the case report forms. The case report form would then be considered a source document. If this case report form is then transmitted to the sponsor, it is necessary for the study site to retain a copy to ensure that the principal investigator can provide access to the source documents to a monitor, auditor, or regulatory agency. Additional information can be found in ICH E6, section 6.4.9.
Copied CRFs as Source Documents
Photocopies of the case report forms may be used as source documents. The FDA states that the only drawback to the practice of recording information directly on the photocopied case report form is if the data is then transmitted or transcribed onto the original case report form. This introduces an additional transcription step and additional chance of error, which is also a potential source of error when using other spreadsheets or templates as source documents.
It is recommended that the photocopies are made onto colored paper so they were easy to find in the case history and will not be mistaken for case report forms. The photocopied case report forms should indicate who collected the data (sign/initial and date) as well as the subject to whom the data applies.
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