Preparation of a Study Data Reviewer’s Guide (SDRG) is recommended as an integral part of a CDISC standards-compliant study data submission. The challenge is to operationalize this new documentation requirement efficiently and effectively.
The SDRG package has been developed to comply with the FDA Technical Conformance Guide
SDRG - Study Data Reviewers Guide version 1.1 Dated 17.03.17
SDRG - Study Data Reviewers Guide version 1.1 Template