protocol. The PI is responsible for all adverse event (AE) reporting with timely submission of reports to NIH, the Research ERB, and the Food and Drug Administration (FDA), based upon FDA guidelines. Safety monitoring for the study is provided by the GCRC through its research subject advocate (RSA) program. The DSMB/DMC has two scheduled interim reports that are forwarded to the Research ERB. Onsite monitoring is performed by MUA’s GCRC compliance officer, who limits the review to key outcomes.

E. Other Protection Considerations

Security, privacy, and confidentiality of the data are the responsibility of the PI, who will have control of the data and be responsible for preparation of all presentations and manuscripts. He will also inform the participants of the results of the study.

Both NIH and the pharmaceutical company are providing financial support for the study. NIH funding will cover patient care and travel costs as well as the cost of the investigators and their research staff to conduct the trial; the company will provide the drug and placebo free of charge. The company also is providing medical coverage for unanticipated AEs related to study conduct (indemnification). No inducements are being provided beyond the cost of conducting the study.

Training of the investigators and personnel is the responsibility of MUA.


A. Introduction

A pharmaceutical company is sponsoring a trial to evaluate the safety and efficacy of a new therapeutic agent for which it plans to submit a new drug application to FDA. This is a large, multicenter Phase 3 trial involving 100 sites throughout the United States. The investigators at all of these sites are practicing physicians in community clinics or hospitals. The pharmaceutical company has contracted with a large contract research organization (CRO), as permitted under 21 CFR 312.52: “Transfer of Obligations to a Contract Research Organization.” The duties of the CRO versus the sponsor have been delineated in the development of this contract.

The PI is a well-regarded physician with substantial expertise in caring for patients who have the medical condition of interest (e.g., coronary artery disease, rheumatoid arthritis) and who will potentially benefit from the proposed therapeutic intervention. She has a clinical faculty position with an academic institution, and her practice is 90 percent community

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