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 conducts internal sync reviews for non-clinical research billing (non-CRB) studies involving human subjects with an executable agreement and IRB-approved informed consent, ensuring accuracy, consistency, and compliance with all applicable regulations, laws, and policies.
For non-CRB studies without an agreement, the team releases the calendar in OnCore.
Additionally, the team reviews executable Data Use Agreements (DUAs) before execution to ensure alignment with regulatory and institutional standards.
Note: Study agreements cannot be executed until the ORA review is complete.
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.
