Research Administration & Compliance Systems - December Updates

December 12, 2019

The latest information about the Data Safety Application, ESTR-IRB, Agreements – DUA, ecrt, and GMAS.Data Safety – New Data Safety Application launches!

December 6 was the soft launch of Data Safety.

What is Data Safety? It is a new application intended to support tracking, monitoring, and compliance associated with to the data security requirements for research data sets (sensitive information collected as part of research, or obtained or shared under a Data Use Agreement or sponsored award).  
Researchers that manage data requiring Information Security review can use the system as one place to:

  • Request a security review;
  • More easily identify secure storage locations; 
  • Correspond with the reviewer;
  • Track the status of review; and
  • Manage and update information about data use (including team changes).

 

During the soft launch period, Researchers have the option to use the system to complete required reviews and provide feedback. Based on this feedback, we will continue to refine system functionality and policies to make improvements to the security review process.  When the updated Harvard Research Data Security Policy is confirmed in early 2020, system use will be required for Research Data Security reviews.

Please visit the Research Administration and Compliance Systems page for system and policy information or register for an upcoming information session.

ESTR-IRB – ESTR was recently updated!

On December 5, ESTR was updated with additional improvements to Harvard’s increasingly integrated research administration systems.

A new Data Safety and Security application has been made available in our system and it is now possible to establish and display relationships between studies and submissions in ESTR-IRB, Agreements-DUA, and the Data Safety systems. This new option to relate projects in all three systems allows researchers and administrators to quickly access related projects in other systems. Although proposed revisions to the Harvard Research Data Security Policy are still under review, the Safety system is now available to support the security review process during its soft launch. Future enhancements will support even greater improvements to the process.

Additional release highlights include:

  • Updates to Data Security Level options to accommodate the Research Data Security Policy-based process revisions;
  • Updates to notifications for both the reliance anniversary reminder and reliance expiration reminder;
  • The addition of HRP-108-SOP-HLC QIP Referral to the IRB Library; and
  • New reports to show studies involving GDPR and external IRB studies that have lapsed or been active more than three years.

Please visit the ESTR Support site to view more details regarding what was included in the release or contact the ESTR Help Desk with any questions or concerns.

Agreements-DUA – Agreements was recently updated!

On December 5, Agreements was updated with additional improvements to Harvard’s increasingly integrated research administration systems.

A new Data Safety and Security application has been made available in our system and it is now possible to establish and display relationships between studies and submissions in ESTR-IRB, Agreements-DUA, and the Data Safety systems. This new option to relate projects in all three systems allows researchers and administrators to quickly access related projects in other systems. Although proposed revisions to the Harvard Research Data Security Policy are still under review, the Safety system is now available to support the security review process during its soft launch. Future enhancements will support even greater improvements to the process.

Please visit the Agreements Support site to view more details regarding what was included in the release or contact the DUA Help Desk with any questions or concerns.

ecrt

The FY20 Q1 project statement certification period is underway. Project statements must be certified by Wednesday, December 18th.

Please reach out to ecrt@harvard.edu with any questions about the certification period.

The next ecrt Basics training sessions will be offered after the winter recess on both the Cambridge and Longwood Medical Area campuses: