CSR

Clinical Study Registration

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2.6Sep2007

2.7Jan2011

2.7.1Jul2012

...

The CSR segment will contain fundamental administrative and regulatory information required to document a patient's enrollment on a clinical trial. This segment is all that is required if one needs to message another system that an enrollment has taken place, i.e., from clinical trials to pharmacy, accounting, or order entry systems. The CSR segment may also be used to identify that OBR, OBX, RXA, and RXR segments that follow represent data applicable to the identified study.

RRequiredOOptionalCConditionalWWithdrawn|#Date/Time*Backward compat.+Filler

		C.Len						Element		v2.6
1	-	-	EI	R	1	-	01011	CSR-1	Sponsor Study ID	Length
2	-	-	EI	O	1	-	01036	CSR-2	Alternate Study ID	Length
3	-	-	CWE	O	1	9999	01037	CSR-3	Institution Registering the Patient	Length
4	-	-	CX	R	1	-	01038	CSR-4	Sponsor Patient ID	Length
5	-	-	CX	O	1	-	01039	CSR-5	Alternate Patient ID - CSR	Length
6	-	-	DTM	R	1	-	01040	CSR-6	Date/Time of Patient Study Registration	Length
7	-	-	XCN	O	*	-	01041	CSR-7	Person Performing Study Registration	Length
8	-	-	XCN	R	*	-	01042	CSR-8	Study Authorizing Provider	Length
9	-	-	DTM	C	1	-	01043	CSR-9	Date/Time Patient Study Consent Signed	2
10	-	-	CWE	C	1	9999	01044	CSR-10	Patient Study Eligibility Status	Length
11	-	-	DTM	O	3	-	01045	CSR-11	Study Randomization Date/time	Length
12	-	-	CWE	O	3	9999	01046	CSR-12	Randomized Study Arm	Length
13	-	-	CWE	O	3	9999	01047	CSR-13	Stratum for Study Randomization	Length
14	-	-	CWE	C	1	9999	01048	CSR-14	Patient Evaluability Status	Length
15	-	-	DTM	C	1	-	01049	CSR-15	Date/Time Ended Study	2
16	-	-	CWE	C	1	9999	01050	CSR-16	Reason Ended Study	Length