What is an OHDSI collaborative research study?

A study in which collaborators with data in CDM format run common analytic code to generate results that are then shared with the OHDSI community.

Will any patient-level data shared?

No. OHDSI studies produce only aggregate level statistics and analysis results.

Are IRB protocols provided?

Individual study proposals may include an IRB. However, several collaborators have had success with a CDM-based research Generic IRB Protocol. For individual studies that require custom IRBs, this may serve as a starter template as well.

How are collaborative research studies proposed?

Proposals may be submitted by any named collaborator in the OHDSI consortium. The submission process involves posting a preliminary overview and protocol to the Protocols in Development page. A notification of this posting should also be made on the OHDSI Reseachers Forum. The study proposal is then reviewed by the community. This review period, typically 2-3 weeks, will determine level of interest as well as generate suggestions for modification to the study design from phenotypes to analysis method.

For a study to move from Proposed to Active status, it must have:

• At least 2 sites willing to participate
• Working code that has been tested at at least 2 sites

What are the required elements?

Is there a project approval process?

How are projects executed at local sites?

How are results returned to the OHDSI community?