Time trends in personnel certification and turnover in the Collaborative Ocular Melanoma Study e Y MobleyClinical Trials and Biometry, The Wilmer Ophthalmological Institute, The Johns Hopkins School of Medicine, Baltimore, MD, USA; COMS Coordinating Center, Wilmer Clinical Trials and Biometry, 550 North Broadway, 9th Floor, Baltimore, MD, USA; rymobley{at}jhmi.edu
Clinical Trials and Biometry, The Wilmer Ophthalmological Institute, The Johns Hopkins School of Medicine, Baltimore, MD, USA Collaborative Ocular Melanoma Study Group Background The purpose of this analysis was to examine and quantify the coordinating center workload in regard to certification and turnover of clinical personnel who participated in the Collaborative Ocular Melanoma Study (COMS). Methods The COMS was a set of multicenter, multidisciplinary randomized clinical trials conducted to evaluate radiotherapy for initial treatment of choroidal melanoma, a primary eye cancer. Patients were screened, enrolled, treated, and followed for mortality and clinical outcomes at 43 clinical centers in the United States and Canada, beginning late in 1986. Clinical centers were added to the COMS during three calendar periods. Training and certification of clinical personnel was performed by five resource centers and coordinated at the COMS coordinating center. A personnel database was maintained at the coordinating center for tracking certification progress, recertification, transfers and resignations. Certification records were analyzed for the period 1986 through 1998 when patient accrual and treatment were completed. Results Clinical personnel (929 individuals) were certified for one or more of nine distinct roles in the COMS, resulting in 1342 certifications; 26% were certified for two or more positions. The total number certified for each role ranged from 114 to 208. Certifications per year ranged from 260 in 1987 to 35 in 1997. The certification workload at the coordinating center rose following addition of each group of new clinical centers. It also increased in 1995 as a result of recertification of current personnel mandated by the external data monitoring committee. Conclusions This analysis documented that training and certification were continuing tasks, and not limited to initiation of the study. Resignations and reassignments of certified personnel were responsible for 642 decertifications.
Clinical Trials, Vol. 1, No. 4,
377-386 (2004) |
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