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Regulatory Documents
The document library for regulatory docs. Here we describe the document types, business rules around the various types (e.g. expiration policies), and access rules.
Document MetaData
Documents will have the following metadata:
Title Created Date Modified Date Modified By Expiry Date Document Type
Document Types
Protocol
Protocol Acceptance page
1572
CVs
A CV is required whenever an primary investigator is added to a 1572
Expire
1 cv per primary investigator
med licenses
FDs
IRB
Is required if the site does not use a central IRB
Expire
1
IBC
ICD
IB
Ads
IND (Safety Letters)
SAEs
Correspondence
Drug Supply
LAB ranges
Are required if the site does not use a central lab
1..n
LAB certificates
Are required if the site does not use a central lab
Expire
1..n