The new core curriculum in clinical research is off to a resounding start -- with more than 90 people applying for the first course that ran from April 17 through June 7. The 25 people who took part in the initial offering of this new training program were selected because they will be leaving NIH this summer. A second course will be conducted from late summer to early fall to help meet the remaining demand.
The 44-hour, accredited Continuing Medical Education course, which was organized by a committee of NIH faculty led by John Gallin and administered by the NIH Office of Education, was taught by 30 staff members. The curriculum is divided into four modules, and it uses both didactic lectures and practical experience, such as participating in "meetings" of mock Institutional Review Panels. The first module, which deals with methods and epidemiology, provides instruction on study design and development, measurements and biostatistics, and use of meta-analysis. The second module, which is devoted to ethical and regulatory issues, reviews legal matters, the role of Institutional Review Boards, gender and race diversity in study populations, and scientific conduct. The third module, which centers on the oversight of patient-oriented research, discusses quality assurance, monitoring of clinical trials, relations with the FDA, information systems and data management, and dissemination of information to the research community and the public. The last module, which focuses on preparing and funding a clinical research study, covers the infrastructure and resources for clinical research, writing clinical research and grant proposals, and technology-transfer issues.
For more information on the core curriculum in clinical research, contact Cindy Parker at the Office of Education (phone: 496-3887; e-mail: cfp@helix.nih.gov).