A Study on Management and Report of Adverse Event in Clinical Trials

BACKGROUND: This research is to identify the difficulties occuring in the course of managing the adverse events and the adverse event related standard operating procedure in the regulation of each institutional review board. METHODS: In order to identify the issues of the management of adverse events of each institution, this research surveyed the IRB administrators in fifty two university hospitals nation-wide. This survey is conducted among one chairman and one IRB member from the IRB members per each IRB who have experience in reviewing adverse events. The survey also includes investigators and sponsors who engage in reporting adverse events. RESULTS: The result of this survey demonstrates that the objects and the terms of adverse event reports provided by the Standard Operating Procedure and the KGCP of each institution are not very different from each other. However, according to the survey, any cases reported to the IRBs, although they are not specified as the object of reports in the institution, have been reviewed by the IRB members. To sum up the results of the survey, the major issues include ambiguous regulations on adverse event reports and reviews, the use of different report formats for each institution, and the difficulty with evaluating the causal relationship with Investigational Product. CONCLUSION: It is necessary to develop concrete and specified guidelines on the objects and the terms of reports, the standard for the causal relationship and the adequate measures for adverse events after review and to standardize the format of adverse event reporting.

The Study of Education and Qualification for the Maintenance of Clinical Research Associate (CRA) Professionalism

BACKGROUND: The aim of the current study is to investigate perspectives on the quality and validity of the current clinical research associate (CRA) education program. The trainee program of other healthcare professions including medical doctors, registered nurses, and pharmacists, has been already reviewed as an advance research. Thus, the current study evaluates the CRA education system to assist in building a more suitable CRA education infrastructure in the future. METHODS: A questionnaire was handed out to CRAs with at least 3 months working experience among 30 pharmaceutical corporations, and 10 Contract Research Organizations (CROs) affiliated with the Korean Pharmaceutical Association and the Korean Clinical Research Committee. A total of 118 questionnaires were utilized for data analysis. RESULTS: The poll shows that 93.2 % of the survey participants consider the role of a CRA as a specialized healthcare profession and 58.6 % of those respondents reason that becoming a CRA requires specialized knowledge. 95.9 % of survey participants attend a CRA trainee program for the maintenance of CRA professionalism. The respondents are inclined to attend the Government hosted CRA education program. 59.3 % of survey participants answered that implementing a CRA qualification system is necessary to establish a CRA specialty validation. CONCLUSION: The current study demonstrates the importance of qualification and what is necessary for being a CRA. The study result will provide a guideline for those who wish to become a CRA as part of their career. In addition, the result will also be used in developing an improved CRA education program in the future.

Institutional Review Board (IRB) Mutual Recognition Program and Its Feasibility in Korea

BACKGROUND: The use of Cooperative Institutional Review Board (Co-IRB) has become subject to continuous discussion. As a result, leading mainly by the Korea Association of Institutional Review Boards (KAIRB), "IRB mutual recognition program (MR-IRB)" was proposed. However operational methods of the program are still controversial. The object of this research is to examine domestically feasible scope and operation methods of MR-IRB by conducting survey. METHODS: 71 survey data was collected from chairman or specialist of each IRB and 29 IRB members of one institution running Central IRB was included. RESULTS: 76.5 % of respondents selected phase 3 multi-national, multi-center clinical Sponsor Initiated Trial as a suitable subject of MR-IRB, but only 50 % supported Investigator initiated trials, and answered early-stage clinical trials such as phase 1 clinical trials or biological agent trials are unsuitable due to relatively insufficient knowledge on risk level. In order to operate MR-IRB, standardized review criteria and agreement of institutions in building mutual trust is essential. Also it was learned from the survey that the most desirable way to adopt MR-IRB is to be initiated by the representing organization such as KAIRB based on mutual trust from institutional agreement. CONCLUSION: MR-IRB was recognized as one of Co-IRB. A suitable subjects of MR-IRB were preferred the phase 3 multi-national, multi-center clinical sponsor initiated trials to all kinds of clinical trials. This study suggests that based on real operation experience from MR-IRB pilot study, further study should be conducted to analyze pros and cons of MR-IRB and identify domestically eligible model to facilitate MR-IRB.