76s Abstracts

A65 PROCEDURES FOR HANDLING CRITICISM AND

COMMENTS FROM STUDY INVESTIGATORS

Mae Gordon, Donald Everett, Karla Zadnik, Joseph Barr and Timothy Edrington Wmhington University School of Medicine, St. Lou& Miwouri

National Eye Institute, RockviUe, Maryland University of California, Berkeley, California

University of Calvomia, Davis, California The Ohio State University, Columbus, Ohio

Southern California College of Optometry, Fullerton, California

The CLEK study is the first multi-center optometric study funded by the National Eye Institute. The Executive Committee wanted a simple procedure for receiving, tracking and responding to large volumes of communications on study issues including forms, protocol and organization. The Executive Committee requested investigators to describe the problem on a “Feedback Report” form. Investigators typically faxed the Feedback Report to a member of the Executive Committee; and when necessary, the report was discussed by the entire committee. Seventy-nine Feedback Reports were received in the first six months of the study. Forty-two percent of the reports identified a need to change the protocol. Sixty-three percent of the problems involved clinical tests, 37% involved forms, 34% involved the examination protocol. Mean response time from the date of the Feedback Report was nine days until discussion by the entire Executive Committee (n=41), 14 days until a major protocol change or clarification notification (n=5), and seventeen days until a routine protocol clarification (n =12). We conclude that our procedures for handling Feedback Report forms are an efficient and responsive method for receiving and tracking the resolution of study issues. Supported by NIH grants EY10419, EY10069, EY10077, and EY02687.

A66 PERSONNEL CERTIFICATION AND TURNOVER

IN THE COLLABORATIVE OCULAR MELANOMA STUDY RenCe Y. Church, Jonathan S. Kerman, Barbara S. Hawkins

and Claudia S. Moy for the COMS Group The Johns Hopkins University

Baltimore, Maryland

Training of clinical center personnel is an important component of multicenter clinical trials. Some trials require that personnel meet additional criteria to be “certified” to perform their study roles. The objective of a certification program is to enhance protocol compliance and standardization acrossclinical centers. This aspect of quality assuranceis usually the responsibility of the coordinating center and other resourcecenters and presents demands on personnel time that are likely to vary during different stages of the trial.

Certification patterns in the Collaborative Ocular Melanoma Study (COMS) illustrate the magnitude of and temporal :ariation in personnel certifications. The COMS consists of two multicenter randomized clinical trials to evaluate radio-therapy for choroidal melanoma. Many clinical centers are required to enroll, treat, and follow a large number (3400) of patients who have a rare cancer. Because of the long enrollment period and length of follow-up (10 years), the COMS will take about 20 years to complete. Each active clinical center is required to have one or more individuals certified to perform each of 9 roles. The number of individuals that have been certified ranges from 109 ophthalmic ultrasonographers to 189 visual acuity examiners. Certifications during the first 2 years of the study accounted for 407 (32%) of the 1268 certifications granted to date. During subsequently years, “peaks” in numbers of certifications