CTSU eCourse: Manage Clinical Trials

LIST OF SOURCE DOCUMENTS

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Source documents may include but are not limited to the following items:

Institutional, research, clinic, or office patient records containing:

	Inpatient and outpatient medical records
	Progress notes
	Consults
	Nursing notes
	Pathology reports
	Radiology reports
	Signed medicine/radiation administration records
	Surgical reports
	Laboratory results
	Admission forms
	Flow sheets that are signed and dated
	Protocol or study road maps
	Appointment books
	Patient diaries/calendars

Relevant patient-specific written communication from non-study health care providers, including comments related to past medical history, entry criteria, or other referral or follow-up information

Clinical discharge summaries

Patient-specific correspondence, such as documented telephone calls, e-mail messages, and faxes

Obituaries, autopsy reports, and death certificates

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