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

Thinking of joining PhUSE?

Already a member but not sure how you can benefit?

PhUSE is an expanding, global society with a membership of more than 9,500 clinical data scientists. It requires a large pool of resources to help with its running, and so there are many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly online newsletter, we are always keen to hear from volunteers.

Find Out More