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The Office of

Clinical Trials

Clinical Trials Links:

Address and Contact Information:

1109-A Bioinformatics Bldg.
130 Mason Farm Rd.
CB 1651
Chapel Hill, NC 27599-1651
919-843-2698 ph
919-843-2399 fax

Memo from Chancellor Moeser regarding OCT

December 18, 2001

MEMORANDUM

TO: Deans, Directors, and Department Chairs; Health Affairs Faculty

FROM: James Moeser

SUBJECT: Establishment of the Office of Clinical Trials

I am pleased to announce the formation of the Office of Clinical Trials, to begin operations in late winter or early spring, 2002. This office will be a "one-stop" processing office to perform all central administrative, budgetary, legal, and regulatory processing functions for clinical trial agreements. Initially, its primary focus will be to decrease proposal processing time and to reduce administrative burdens associated with the process. In the future, consideration will be given to providing new services if possible. The Office will be administratively responsible to the Vice Chancellor for Research and Economic Development, and is being established as a means to remedy inefficiencies and frustrations inherent in the current system of review. An implementation team is established and will communicate progress to the University community.

I wish to acknowledge the important role in the development of this Office played by a committee appointed by Vice Chancellor and Dean Jeff Houpt and chaired by Dr. Gene Orringer in the School of Medicine, consisting mostly of principal investigators who provided compelling testimony for the need for such an office. I also wish to acknowledge the important role that has been played by a committee chaired by Vice Chancellor and General Counsel Susan Ehringhaus, who developed the concept and operational framework for the Office.

Through these coordinated efforts, we have identified the key institutional functions required of a University-wide contract process. The Office of Clinical Trials aggregates those functions in a single office for efficient, effective coordination and for timely and reliable performance. From start of routing to final signature, the Office will perform the following, all of which have been identified by the committees as essential University functions:

  1. Intake (assignment of tracking number and assignment to a clinical trial agreement manager);
  2. Negotiation of contracts with outside sponsor and communication of status with UNC faculty and staff;
  3. Budget preparation assistance, if needed, and budget approval;
  4. Assurance that all necessary research compliance approvals are in place (IRB, Conflict of Interest, for example);
  5. Data collection and transmission for internal and external reporting;
  6. Final signature on behalf of the institution;
  7. Communication to the outside sponsor and to the UNC investigator/staff on contract/proposal status;
  8. Help desk (assistance with particular proposals);
  9. Training and assistance to investigators and staff in preparing documents for routing;
  10. Creation of standard operating procedures for various administrative aspects of clinical trials, especially budgetary matters; and
  11. Establishing a process for regularly soliciting investigator and staff feedback.

A location is being sought for the Office in the Health Affairs area to make it more accessible to researchers and staff.

There was consensus in both of the committees referenced earlier that the governmental, nonprofit, and industry-sponsored basic research contracting process could also be substantially improved. This has been examined, and an announcement will be made very soon that will describe a process for improving our research administration process. These are vital institutional activities, and it is essential that we assure that the processes for accomplishing our research are as sophisticated as the research itself.

Please refer any questions to Provost Shelton, Vice Chancellor Waldrop, or Vice Chancellor Ehringhaus. I hope you will find the new Office better serves your research needs. We welcome your ideas.