model
Details

Studienzentrale

1 forms

StudyEvent: SE
1. Studienzentrale

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Organisatorische Daten

Item Group

Kodierung für Analyse

Item

Code for analysis

integer

Code für Analyse

Code List

Code for analysis

CL Item

PP (1)

CL Item

ITT (2)

CL Item

still not determined (3)

Safety

Item

Safety

integer

[CodeList.39]

Code List

Safety

CL Item

no (2)

CL Item

yes (1)

Vollständigkeit der Dokumentation

Item

Completeness documentation

integer

Dokumentation der CWS Studie

Code List

Completeness documentation

CL Item

incomplete (0)

CL Item

complete until end of therapy (1)

CL Item

complete and min. of 1 FUP (2)

CL Item

complete with min. of 2 FUP (3)

CL Item

complete with min. 3 FUP (4)

CL Item

complete with min. 4 FUP (5)

CL Item

complete with min. 5 FUP (6)

CL Item

complete with all FUP (7)

CL Item

other (8)

Dokumentationspauschale bezahlt

Item

Documentation fee paid

integer

Bezahlstatus Studiendokumentation

Code List

Documentation fee paid

CL Item

Study doc + FUP paid (2)

CL Item

not paid (3)

CL Item

other (4)

Bemerkungen zur Bezahlung

Item

Remarks concerning paiment

text

Allgemeines Bemerkungsfeld

Item

Allgemeines Bemerkungsfeld

text

Abweichungen vom Protokoll

Item Group

Kodierung für Abweichung

Item

Code for deviation

integer

Bemerkungen

Item

Bemerkungen

text

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