Clinical Research Administration

You will develop a topic for the Capstone Project that synthesizes major themes from the entire program. Topics for the project, as well as your approach, should be personally tailored to suit your unique perspectives and areas of interest or an area of concentration that you intend to pursue. You will submit a project title and a summary of your topic in which you identify topical concepts from the Clinical Research Administration program that you will integrate. You should include a rationale for your project to your Instructor for guidance and approval. Include a title page, sources to support your rationale, a reference page, and follow APA format. Sample topical areas of interest might include: Issues in the IRB approval process Challenges in subject enrollment, protection, and informed consent Good Clinical Practice and the International Conference on Harmonization The impact of regulatory requirements on product development Ethics and legal issues in domestic and international clinical trials Developments in monitoring and protocol compliance Using technology in managing data in clinical trials Trends in pharmaceutical product and device development Important links between pre-clinical and clinical research Economics and financial management of clinical trials Internationalization of the clinical research enterprise