Clinical Study Report

Type: Information Object

Status: Planned
Industry Sector: Pharmaceuticals & Life Sciences
Sensitivity Level: Restricted
Personal Information: No PII

Description:
Integrated summary of the methods and results of a completed clinical trial.

Accessed by Application(s):

• Electronic Data Capture Application
• Market Access Application

 Yes

Attributes

Order	Name	Description	Type	Cardinality	Example value
1	Report ID	Unique identifier for the clinical study report	GUID	Mandatory
2	Study ID	Reference to the clinical study	Reference	Mandatory
3	Protocol ID	Reference to the approved clinical trial protocol	Reference	Mandatory
4	Study Phase	Clinical development phase of the study	Enumeration	Mandatory
5	Completion Date	Date when the study was completed	Date	Optional
6	Primary Endpoint Result	Outcome for the primary endpoint	String	Optional
7	Report Status	Lifecycle status of the report	Enumeration	Mandatory
8	Submission Reference	Reference to the regulatory submission using the report	Reference	Optional

 Yes
 
 Planned
 No PII
 Restricted
 Pharmaceuticals & Life Sciences
 Integrated summary of the methods and results of a completed clinical trial.

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