All Versions  


Contents Index Standard

HL7 - Version 2.3

  2.1 2.2 2.3 2.3.1 2.4 2.5 2.6 2.7 2.8 2.9  
  2.3 2.3 DE  

  Events Segments Msg. Types Msg. Structs Data Elements Tables Data Structs  

Segment CSR: Clinical Study Registration (Informationen über Teilnahme an einer klinischen Studie)

Seq Description German Interpretation Length C.LEN Table r/o/c Rep# Item Data Structure Section
1 Sponsor Study ID Studien-ID des Sponsors ..60

R
01011 EI
2 Alternate Study ID Alternative Studien-ID ..60

O
01036 EI 7.7.1.2
3 Institution Registering the Patient Studienzentrale ..60

O
01037 CE 7.7.1.3
4 Sponsor Patient ID Patienten-ID des Sponsors ..30

R
01038 CX 7.7.1.4
5 Alternate Patient ID Alternative Patienten-ID ..30

O
01039 CX 7.7.1.5
6 Date/Time of Patient Study Registration Meldungszeitpunkt in der Studienzentrale ..26



01040 TS 7.7.1.6
7 Person Performing Study Registration Mitarbeiter, der gemeldet hat ..60

O
01041 XCN 7.7.1.7
8 Study Authorizing Provider authorisierender Arzt ..60

R
01042 XCN 7.7.1.8
9 Date/time Patient Study Consent Signed Zeitpunkt der Patienteneinwilligung ..26

C
01043 TS 7.7.1.9
10 Patient Study Eligibility Status Eignung des Patienten ..60

C
01044 CE 7.7.1.10
11 Study Randomization Date/time Zeitpunkt der Randomisierung ..26

O Y/3 01045 TS 7.7.1.11
12 Study Randomized Arm randomisierter Studienarm ..200

O Y/3 01046 CE 7.7.1.12
13 Stratum for Study Randomization Randomisierungsschicht ..200

O Y/3 01047 CE 7.7.1.13
14 Patient Evaluability Status Auswertbarkeitsstatus bei Studienabbruch ..60

C
01048 CE 7.7.1.14
15 Date/time Ended Study Zeitpunkt des Ausscheidens aus der Studie ..26

C
01049 TS 7.7.1.15
16 Reason Ended Study Grund des Ausscheidens aus der Studie ..60

C
01050 CE 7.7.1.16

Used within the following Events:

C01 SRM - Register a patient on a clinical trial (7.6.1)
C02 SRM - Cancel a patient registration on clin.trial (for clerical mistakes only) (7.6.1)
C03 SRM - Correct/update registration information (7.6.1)
C04 SRM - Patient has gone off a clinical trial (7.6.1)
C05 SRM - Patient enters phase of clinical trial (7.6.1)
C06 SRM - Cancel patient entering a phase (clerical mistake) (7.6.1)
C07 SRM - Correct/update phase information (7.6.1)
C08 SRM - Patient has gone off phase of clinical trial (7.6.1)
C09 CSU - Automated time intervals for reporting, like monthly (7.6.2)
C10 CSU - Patient completes the clinical trial (7.6.2)
C11 CSU - Patient completes a phase of the clinical trial (7.6.2)
C12 CSU - Update/correction of patient order/result information (7.6.2)
P07 PEX - Unsolicited initial individual product experience report (7.10.1)
P08 PEX - Unsolicited update individual product experience report (7.10.1)

Links to Other/Further HL7 Information   generated: Nov 24, 2020 (FO)
Health Level Seven, Int. (HQ) HL7 Germany
HL7 Europe 		Frank Oemig's HL7 Site
(Infos about the database)
 HL7-Experts Network