Data Safety Job Aids

Document	For...	Summary
Cross-Suite Mini Navigation Guide	Everyone	A bulleted list of key information presented in each application
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.

Research Administration and Compliance Suite Office Hours (ESTR-IRB, Agreements-DUA, Data Safety, OAIR)

The system support team is available during regular office hours to provide one-on-one time to demonstrate system functions, provide training, answer questions, and collect feedback. Sessions cover the entire suite (ESTR-IRB, Agreements-DUA, Data Safety, and OAIR) and are customized based on the registrant preference.

Office hours are open
• Tuesdays: 10:00am ET - 11:00am ET
• Thursdays: 3:00pm ET - 4:00pm ET

1. Visit the Bookings page (linked here)
2. Choose a time. Available times (not already booked) will display for 30-minute increments.
3. Share your name and email
4. Click "Book" at the bottom of the page.

After completing the steps through Bookings, you will receive a confirmation email/calendar invitation reserving the time.
If you have any questions or concerns, please contact us at rshelp@harvard.edu.

Tip: Preparing Data Safety submission

As you are completing a submission in the Agreements system, you will be directed as to where to attach relevant information and documentation (see the submission guide for details).
For example, it may be helpful to:

Prepare a draft Data Management Plan (if there is one-- see the DMPTool for resources and more information),
Prepare a description of the data and how you plan to use it, and
Review Data Security Level determination guidance if you intend to make a self-assessment.

Research Administration and Compliance Systems

Facilitating Research at Harvard

Data Safety Job Aids

Research Administration and Compliance Suite Office Hours (ESTR-IRB, Agreements-DUA, Data Safety, OAIR)

Accessing the System

Tip: Preparing Data Safety submission

Do you have feedback about the policy or process?