What is ORA - Sync?
ORA - Sync is part of the Rush Study Activation Process whereby clinical research study documents (such as, the final coverage analysis, negotiated budget, negotiated study agreement [i.e., contract], IRB-approved study protocol, informed consent forms, and all other relevant documents) are thoroughly reviewed to ensure consistency, harmony, and accuracy throughout. The ORA - Sync process also ensures that all documents follow applicable regulations, laws, and institutional policies. Please note that study agreement cannot be executed until the ORA - Sync review process is complete.
ORA - Sync Team:
The ORA-Sync Team is a team of 8 members including the Manager, officially titled “Research Validation Specialists”. The team is divided into two sub-teams: (1) Harmonization (Sync) Team and (2) Triage Team. Both teams perform different tasks related to the harmonization of research documents.
Harmonization (Sync) Team:
The ORA - Sync “Harmonization” Team performs the ORA-Sync review as described above before contract execution.
ORA - Sync Triage Team:
The ORA - Sync “Triage” Team reviews all IRB and XIRB Amendment submissions to see if the changes from the amendment impact other study documents such as the contract and/or budget. If it does, the Triage team will inform study teams about the possible changes needed to those documents. The Triage Team also reviews and triages all Expedited, Exempt, and IRB-approved studies given a Non-Clinical Research Billing (Non-CRB) Coverage Analysis (CA) determination. In these cases, the Triage Team will also release the study calendar into OnCore (when applicable).
What services/assistance does the ORA - Sync Team offer to the research community at Rush:
Provide further clarification and guidance relating to sync findings.
Share completed harmonization checklist including the acceptance criteria checklist and face-sheet in the “Sync” workspace for transparency.
Help facilitate harmonization among all study documents for contract execution.
Collaborate with shared services in all matters relating to ORA - Sync including Sync findings.
Upon request and with advance notice, the ORA - Sync Team and/or sync member(s) can meet with the study teams, including shared services, virtually and/or over the phone for discussion on all matters relating to the ORA - Sync and Triage workflows, processes, and findings.