Study Documentation
2. What Are Source Documents?
Source documents contain source data. They are original documents, data and records in which these original (source) data are noted. Examples include:- Hospital records and clinical charts.
- Lab result sheets.
- Memos.
- Patients’ diaries or evaluation checklists.
- Medication dispensing records.
- Recorded data from automated instruments, ECG, X-ray.
- Informed consent form.
Copies are only recognised as ‘source documents’ if they are certified after verification as being accurate.