CLINICAL RESEARCH ORIENTATION PROGRAM

The Clinical Research Orientation Program is a comprehensive series of lectures that cover clinical, administrative, legal, and financial aspects of conducting human subject clinical research at MetroHealth. The purpose of this required program is to provide to the research staff the current regulatory agency requirements (highlighting areas that regulatory agencies are targeting in audits), the requirements of our IRB as well as the requirements for submitting contracts and budgets to the Research Administration Business Office.

All non-physician research staff who meet one or more of the following criteria are required to attend this program within 90 days of hire.

1. If you have direct subject contact whether in person or by phone;
2. If you consent subjects to research studies;
3. If you review medical records and or maintain databases for potential study subjects;
4. Prepare IRB submissions. This may include, but not limited to, initial request for approval to conduct a study and/or amendments, SAE(s) (serious adverse event) reporting.

Should you have questions as to whether you or a member of your research staff needs to attend the program or to register for the program, please contact Kelly Robertson, Assistant Director, Clinical Research.



RESEARCH EDUCATION,
TRAINING & COMPLIANCE