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KMID : 0391020070150020091
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2007 Volume.15 No. 2 p.91 ~ p.98
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Analysis of Q & A Records in a Clinical Research Center
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Lee Kyu-Sun
La Hyen-O
Choi Sun
Jeong Sook-Hyun
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Abstract
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Background: Since early 2000’s Korean government introduced the INDA(Investigational New Drug Application) system and has operated clinical trial infrastructure conducting support program. In Korea the Clinical trials have shown rapid growth based on such active policy of Korean government. Additionally each institution does many efforts to provide high-quality clinical trials; establishment of the clinical trial center. Not only clinical trials are conducted by multi-disciplinary, but also need multistep to successful conduct. Catholic Medical Center (CMC) need to centralized system to provide 8 affiliated hospitals with high-quality clinical trials related service. For this, CMC CRCC (Catholic medical center clinical research coordinating center) was established at 2004. The administrative support division of CRCC has taken charge of main administrative affairs including consultation, research budget accounting, and computerized central trial management system(CTMS) operation. To provide better service weevaluated administrative work of CRCC by analyzing Q&A data since its opening.
Method: Q&A records (from November 2004 to August 2007) of administrative support division of CRCC were analyzed. The records included requester information (affiliation, occupation), request and response method (verbal answer, letter or e-mail, others), required time for response, and classification of request. Since all variables were categorical, the results were only analyzed by descriptive methods.
Result: Total 439 days’ records were analyzed except the records omitted periods. Total Q&A cases were 22,748. Among these 63% were external and 36% were internal questions. As for affiliation and occupation of requester, the sponsor (55%), researchers (20%), nurses (11%), members of IRB (6%), and the others (7%). Over 85% request and response were used phone call as a method and over 10% used e-mail. The most frequent question was about research budget (30%), and then administrative affairs (26%), CTMS use (24%).
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KEYWORD
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Q&As, Clinical research, Clinical trial, Catholic clinical research coordinating center, Clinical trial center, IRB
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