Trial Participant

Type: Information Object

Status: Planned
Industry Sector: Pharmaceuticals & Life Sciences
Sensitivity Level: Confidential
Personal Information: Sensitive PII

Description:
Individual enrolled in a clinical study under an approved protocol.

Accessed by Application(s):

• Clinical Trial Management System
• Electronic Data Capture Application

 Yes

Attributes

Order	Name	Description	Type	Cardinality	Example value
1	Participant ID	Unique identifier for the trial participant	GUID	Mandatory
2	Study ID	Reference to the clinical study	Reference	Mandatory
3	Site ID	Reference to the investigational site	Reference	Mandatory
4	Consent Status	Current informed consent status	Enumeration	Mandatory
5	Enrollment Date	Date when the participant was enrolled	Date	Mandatory
6	Randomization Arm	Assigned treatment or control arm	String	Optional
7	Participant Status	Current participation status	Enumeration	Mandatory
8	Withdrawal Date	Date when the participant withdrew or was withdrawn	Date	Optional

 Yes
 
 Planned
 Sensitive PII
 Confidential
 Pharmaceuticals & Life Sciences
 Individual enrolled in a clinical study under an approved protocol.

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