Entity Study Site Oversight Status

DescriptionThe state of a study at a particular facility as assigned by an oversight committee.

For example:
Request not submitted
Submitted, pending
Submitted, approved
Submitted, exempt
Submitted, denied
Submission not required

Attributes
Review Board Approval Number TxtReview Board Approval Number Txt
Review Board ProcessReview Board Process
Review Board Process Date and TimeReview Board Process Date and Time

Relationship
assignedStudySiteOversightStatusassignedStudySiteOversightStatus

Dependencies
 NONE

Reverse Dependencies
 

Attribute Details

 Review Board Approval Number Txt
DescriptionA character string that is assigned by the review board upon approval of the protocol.
Data TypeStandards - Data Domains.ddm/Data Domains/Text Small [VARCHAR(50)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Review Board Process
DescriptionSpecifies the phase in the lifecycle of the review board process.

For example:
Request not submitted
Submitted, pending
Submitted, approved
Submitted, exempt
Submitted, denied
Submission not required
Data TypeStandards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse



 Review Board Process Date and Time
DescriptionThe date and time on which the Institutional Review Board (IRB) determine the status of the study for execution at the site.
Data TypeStandards - Data Domains.ddm/Data Domains/Date Time [TIMESTAMP]
Is Part Of PrimaryKeyfalse
Is Requiredfalse
Is Derivedfalse
Is Surrogate Keyfalse

Relationship Details

 assignedStudySiteOversightStatus
Description
Is Identifying Relationshipfalse
Child TableStudy Site Oversight Status
Child Role NameassigningOversightCommittee
Child MultiplicityZERO_TO_MANY
Child Referential Integrity: On DeleteSET_NULL
Child Referential Integrity: On InsertNONE
Child Referential Integrity: On UpdateSET_NULL
Parent TableOversight Committee
Parent Role NameassignedStudySiteOversightStatus
Parent MultiplicityZERO_TO_ONE
Parent Referential Integrity: On DeleteNONE
Parent Referential Integrity: On InsertSET_NULL
Parent Referential Integrity: On UpdateSET_NULL