#  Data Safety Job Aids 

 



SortDocumentFor...Summary[Cross-Suite Mini Navigation Guide](/resource/cross-suite-mini-navigation-guide "Cross-Suite Mini Navigation Guide")

Everyone

A bulleted list of key information presented in each application

[Data Safety Submission Guide](/resource/data-safety-submission-guide "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](/resource/safety-reviewer-guide "Safety Reviewer 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](/resource/safety-viewer-guide "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.







 

##  Accessing the System 

 Log in to the [Data Safety system](https://researchsafety.harvard.edu/) with your HarvardKey/HUID.

- [How to Get an HUID](https://harvard.service-now.com/ithelp?id=kb_article&sys_id=0a8c368bdbec0fc083a2f3f7bf9619b3)
- [How to Reactivate your HUID](https://harvard.service-now.com/ithelp?id=kb_article&sys_id=0a8c368bdbec0fc083a2f3f7bf9619b3) (for those who could once log in, and now cannot)
- [How to Request Viewer Access to Data Safety, ESTR-IRB or Agreements-DUA ](/)



 

##  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**

 **[Please schedule time with us!](https://outlook.office365.com/owa/calendar/SuiteOfficeHoursESTRIRBAgreementsDUADataSafetyOAIR@HU.onmicrosoft.com/bookings/)**

 1. [Visit the Bookings page (linked here)](https://outlook.office365.com/owa/calendar/SuiteOfficeHoursESTRIRBAgreementsDUADataSafetyOAIR@HU.onmicrosoft.com/bookings/)  
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](mailto:///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](/file_url/183)).  
For example, it may be helpful to:

- Prepare a draft Data Management Plan (if there is one-- see the [DMPTool ](https://hlrdm.library.harvard.edu/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](https://policy.security.harvard.edu/) if you intend to make a self-assessment.



 

##  Do you have feedback about the policy or process? 

Please [click here to complete our very brief survey](https://harvard.az1.qualtrics.com/jfe/form/SV_4Ubha5Q41lY60E5) to provide feedback about the Research Data Security review process or the Data Safety and Security system.

 



 

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