Source document
- For use of this term in accounting, see Category:Accounting source documents.
A source document is a document in which data collected for a clinical trial is first recorded. These data are usually later entered in the case report form. The ICH-GCP guidelines define source documents as "original documents, data, and records."[1] Source documents contain source data, which is defined as "all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial."[1]
The FDA does not define the term "source document."
Examples of source documents
- Receipt
- Deposite Slip
- Invoice
- Cheque
- Bank Statement
- Cash Register Roll (CRR)
- Hospital records
- Clinical and office charts
- cash receipt
- Memorandum
- Subjects' diaries or evaluation checklists
- Pharmacy dispensing records
- Recorded data from automated instruments
- Copies or transcriptions certified after verification as being accurate copies
- Microfiches
- Photographic negatives, microfilm or magnetic media
- X-rays
- Subject files
- Records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial
References
- 1 2 "Guideline for good clinical practice." (PDF). ICH-GCP. p. 7. Retrieved 12 September 2015.
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