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CVIA Common Structure
None
Functional Documents
{Project Short Name} Clinical
Clinical Agreements
{Study Number}
Central Trial Level Documents
File Notes, Meetings and Correspondence
Clinical Study Reports
Template Subject Materials
Trial Documents
Local Laboratory Testing
Facility Documentation
File Notes, Meetings and Correspondence
Sample Documentation
Data Management
Data Capture
Data Management
Database
EDC Management Specifics
Notes, Meetings and Correspondence
Investigational Product and Trial Supplies
Notes, Meetings and Correspondence
IP Allocation Documentation
IP Documentation
IP Release Process Documentation
Storage
{Name of IRB} IRB
Correspondence not related to submission
Initial and Change Research Submission and Approvals
CVIA Common Structure
28 concepts
By @mayimbe