Data Safety Job Aids

Document For... Summary
HRDSP and System Update - One-page Intro Everyone A brief overview of the data safety review process and upcoming changes to the Harvard Research Data Security Policy.
Data Safety Submission Guide PI & Study Staff A reference guide for PIs and study teams that includes steps for submitting a new protocol, amendment, or continuing review, and responding to reviewer clarification requests.
Data Safety Reviewer/ Specialist Guide Data Safety Reviewers A reference guide for Data Safety reviewers that includes the Data Safety workflow along with steps for tracking and managing reviews.
Data Safety Viewer Guide Guests and others with View-Only Access A reference guide for individuals that have view-only access to Data Safety protocols that includes steps for accessing a submission, understanding the project workspace, and communicating with the study team or reviewers.