CSR

Clinical Study Registration

...

2.2Nov1994

2.3Apr1997

2.3.1May1999

...

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.

Figure 7-14. CSR attributes

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

		C.Len						Element		v2.2
1	..60	-	EI	R	1	-	01011	CSR-1	Sponsor Study ID	NEW
2	..60	-	EI	O	1	-	01036	CSR-2	Alternate Study ID	NEW
3	..60	-	CE	O	1	-	01037	CSR-3	Institution Registering the Patient	NEW
4	..30	-	CX	R	1	-	01038	CSR-4	Sponsor Patient ID	NEW
5	..30	-	CX	O	1	-	01039	CSR-5	Alternate Patient ID	NEW
6	..26	-	TS	O	1	-	01040	CSR-6	Date/Time of Patient Study Registration	NEW
7	..60	-	XCN	O	1	-	01041	CSR-7	Person Performing Study Registration	NEW
8	..60	-	XCN	R	1	-	01042	CSR-8	Study Authorizing Provider	NEW
9	..26	-	TS	C	1	-	01043	CSR-9	Date/time Patient Study Consent Signed	NEW
10	..60	-	CE	C	1	-	01044	CSR-10	Patient Study Eligibility Status	NEW
11	..26	-	TS	O	3	-	01045	CSR-11	Study Randomization Date/time	NEW
12	..200	-	CE	O	3	-	01046	CSR-12	Study Randomized Arm	NEW
13	..200	-	CE	O	3	-	01047	CSR-13	Stratum for Study Randomization	NEW
14	..60	-	CE	C	1	-	01048	CSR-14	Patient Evaluability Status	NEW
15	..26	-	TS	C	1	-	01049	CSR-15	Date/time Ended Study	NEW
16	..60	-	CE	C	1	-	01050	CSR-16	Reason Ended Study	NEW