Development of a Research Handbook: A Guide for New Researchers
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Working at an institution with a budding Research Department necessitates the development of additional resources for the education of new researchers. Such an educational gap was noted by key research personnel at Kadlec Regional Medical Center (KRMC). When examining the resources at outside institutions, it was noted that many institutions provided some type of a research handbook for their researchers. The objective of this Capstone Project was to develop a research handbook for the use at KRMC. When developing a resource such as this, it is important to compile pertinent regulations and institutional requirements so that the handbook is not only useful, but easy to understand. A literature review was conducted of various warning letters issued from the U.S. Food and Drug Administration to institutional sites conducting clinical trials. This examination was vital in the determination of high-risk areas to KRMC so to ensure that these areas were included in the content of the Research Handbook. Other material for the handbook came from assessments of research handbooks from outside institutions. These resources were used to validate content and format so that the most useful information was included in an easy to follow layout. Upon completion of the initial draft of the Research Handbook, the document was sent to key institutional research stakeholders for review and recommendations. These recommendations were included in the final draft of the document which will be submitted for review and approval at the quarterly Research Committee in January 2019. Once approved, the Research Handbook will be rolled out to KRMC so that all institutional staff has access to the document via the central policy repository. This same portal will route the Research Handbook to designated staff for biennial review to ensure that the information remains up to date and relevant to the institution.
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