Study Documentation
Completion requirements
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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.