Frequently Asked Questions

Q: What kinds of clinical data are included in the Owen Clinic database?

A: The Owen Clinic database includes diagnoses, medications, laboratory tests, and quality-of-life assessments documented on patients under care at the Owen Clinic since 1995.

Q: Do I need IRB approval to obtain data from the Owen Clinic database?

A: In general, an IRB-approved research protocol is required. We can, however, provide summary data that have no patient identifiers to assist investigators in making sample size and power calculations for grant submissions.

Q: Who has to approve requests for data from the Owen Clinic database?

A: The co-directors of the Clinical Investigation Core review data requests and assign them a priority based on scientific merit, number of hours required to construct the requested dataset, and number of competing requests for Core services.

Q: Are there additional requirements for investigators receiving Core services?

A: The Core is required to document how and to what extent our services are used, and how our services are leveraged to support successful grant applications and publications. Therefore, if you would like to use core services, please use our Service Request form.

In addition, any conference presentations or publications that resulted in whole or in part from contributions of the CFAR Clinical Investigation and Biostatistics Core should acknowledge CFAR support as follows:

If any grants were awarded based in part on services provided by the Core, we request that you contact us so we can collect information about the award.

Q: What statistical services are available from the Core?

A: Core services can be provided to help plan a clinical project, provide sample size calculations, write brief analytic plans for grants and to perform concisely defined analyses. Full statistical support for major clinical research projects is beyond the scope of the Core; it is more the function of the Core to help investigators apply for grants that would then contain sufficient funding for statistical services.  All requests are prioritized based on scientific merit and number of competing requests.

Q: Can the Core help with a Safety Monitoring Plan?

A: The Core offers periodic interim safety reviews for single-site investigator-initiated clinical research projects. We can also help investigators design monitoring plans and assist in assembling a Data and Safety Monitoring Board. However, full DSMB services are beyond the scope of the Core.