New IRB System Information
November Implementation Calendar
December Implementation Calendar
Last year, Georgetown University and MedStar Health finalized a long-term agreement reaffirming our joint commitment to our clinical, research and educa tional partnership. This fall, a joint IRB system will go live for research at both institutions that further illustrates our expanding and deepening collaboration. The new system will replace eRIC at Georgetown, and InfoEd at MedStar.
After reviewing several options, faculty and staff from GU and MedStar recommended adoption of a system widely used by many of our peer institutions, provided by Huron, a market leader in IRB systems software.
We are working hard to make the transition process a s seamless as possible. Communication from the IRB Office via email and website posts, will provide details regarding training, system rollout and transition of existing protocols to the new Georgetown-MedStar IRB System.
We thank you for your support in this ongoing growth as we modernize our joint research infrastructure. If you have any questions, please contact the IRB office.
Deadline for the creation of new protocols, continuing reviews, amendments, and adverse events in the eRIC IRB system. After this date, the ability to create anything new in eRIC permanently goes away.
Submission deadline for ALL December full board meetings. *This will be the last day for submission of all full board items (studies, amendments, continuing reviews) in the eRIC system. Any full board item submissions after this date will need to be created and submitted in the new Georgetown-MedStar IRB System after November 29.
|November 12||Date by which PIs/study teams should complete any outstanding actions in the eRIC system. This includes the submission of new studies, amendments, and continuing reviews, as well as required actions on already approved studies (e.g., responses to contingencies, requested changes, etc.). Completion/IRB approval of these actions allows for the study to be migrated to the new Georgetown-MedStar IRB System.|
|November 22-29||The eRIC IRB system will be 'down' to facilitate migration of studies (with no outstanding actions) to the new Georgetown-MedStar IRB System.|
|November 29||New Georgetown-MedStar IRB System is live.|
|December 5||The ability to submit any created item in eRIC (studies, amendments, continuing reviews, adverse events) permanently goes away.|
Last day any actions can occur in the eRIC system. All outstanding actions must be completed by this date for the study to be migrated to the new Georgetown-MedStar IRB System. Failure to do so will result in the withdrawal of the item so the study can be migrated into the new Georgetown-MedStar IRB system. The withdrawn item will then need to be created/submitted in the new system.
- Your Protocol after November 29: Protocols in an approved state that do not have a continuing review, amendment or adverse event in process on November 29 will be migrated to the Georgetown-MedStar IRB system. All other protocols will remain in eRIC until outstanding items reach an approved state. These protocols will then be migrated in batches after November 29. Please see the table above for important information regarding timelines and items needing full board review.
- Emergency submissions and reportable new information (RNI) when eRIC is not available: Between 11/12 (nothing new can be created in eRIC) and 11/29 (Georgetown-MedStar IRB System is live), any emergent submissions (e.g., information/actions that affect subject safety, reportable events, etc.) will need to be submitted via email to the IRB Board.
- Training: Training sessions and reference materials for the Georgetown-MedStar IRB System will be available soon. Specific information on this topic will be included in a subsequent communication.