T H E   N I H    C A T A L Y S T      M A R C H  –  A P R I L   2004


by Cherry Graziosi, program assistant,
and Frederick Ognibene, director,
Office of Clinical Research Training
and Medical Education, CC

Long-distance learning for medical professionals has been made a lot easier, thanks to the NIH Clinical Center (CC) Office of Clinical Research Training and Medical Education. Established in May 2003, the office currently directs five distance-learning courses. Here’s the line-up:


The Office of Clinical Research Training and Medical Education also administers the Clinical Research Curriculum Certificate program.

Fellows and other allied health-care professionals who successfully complete the mandatory portion of the program receive a certificate.

An additional commendation is awarded with the completion of at least one of four supplemental or elective components.

The mandatory components of this certificate program are:

Enrollment in Introduction to the Principles and Practice of Clinical Research, including a final examination.

Successful participation in the course on Ethical and Regulatory Aspects of Human Subjects Research (videocast access).

Successful completion of on-line Clinical Research Training for all principal investigators; registration information can be found here; content information can be found here.

Successful completion of computer-based training course for NIH IRB members and either 1) IRB protocol approval as a principal investigator, or 2) a three-month "term" or attendance at at least four IRB meetings as an ad hoc member with responsibility for a protocol’s review, or 3) if one cannot be a principal investigator on a protocol (IC variable), then serving as either a "protocol chairperson" (NCI model, for example) or "providing significant contribution to the writing of a protocol."

The supplemental or elective components are:

Successful completion of Principles of Clinical Pharmacology, based on 75 percent attendance requirement

Successful completion of an FAES course in statistics or epidemiology

Completion of approved IC-based programs in clinical research

FDA experience (with, for instance, INDs, data monitoring, audits) through the annual Reviewer Training: Introduction to the Regulatory Process course offered by FDA/CBER.

Introduction to the Principles and Practice of Clinical Research. Begun in 1995 with 25 students, the course attracted more than 650 health-care professionals in the 2003–2004 academic year, including students participating from as far away as Lima, Peru. To date, 3,417 health professionals have availed themselves of this program, which teaches medical researchers how to design and conduct a successful clinical trial.

In addition to the U.S. Naval Medical Research Center Detachment in Lima, other off-site locations this year include Meharry Medical College in Nashville; Morehouse School of Medicine in Atlanta; Children’s National Medical Center, George Washington University Medical Center, and Georgetown University Medical Center in Washington, D.C.; the State University of New York Medical University in Syracuse; the University of Texas Southwestern Medical Center in Dallas; and the University of Puerto Rico in San Juan.

Clinical Research Training. All clinical principal investigators with a protocol approved through the CC are required to take the course and successfully complete a final examination.

Principles of Clinical Pharmacology. Established in 1998, this course provides an introductory review of pharmacokinetics, drug metabolism and transport, assessment of drug effects, drug therapy in special populations, and contemporary drug development. In addition to the NIH location in Bethesda, Md., five off-site locations participated in the 2003–2004 course: Georgetown University School of Medicine, Washington, D.C.; Indiana University School of Medicine, Indianapolis; NIA, Baltimore; Northwestern University Medical School, Chicago; and the David Geffen School of Medicine of the University of California, Los Angeles. The program has enrolled 1,574 students since its inception and runs from September through April, one day a week, at the CC.

NIH-Duke Training Program in Clinical Research. Designed primarily for clinical fellows and other health professionals who are training for careers in clinical research, this course teaches research design, statistical analysis, research ethics, and research management. It’s taught at the CC via videoconference from Duke and also by adjunct faculty on campus. Thus far, 31 students have received a Master of Health Sciences in Clinical Research from Duke University.

The University of Pittsburgh’s Training in Clinical Research Program. Like the NIH-Duke program, this program offers advanced training in clinical research through ideoconferenced courses at the CC. The University of Pittsburgh confers either a Master of Science Degree upon completion of core curriculum courses plus 15 credits of elective courses. The university also offers a certificate to those who do not take the full course but complete an extensive summer program and seminars.

CC Director John Gallin observes that improving clinical research training is a major initiative of the NIH Roadmap, introduced by NIH Director Elias Zerhouni last November.

"In the past," Gallin says, "researchers relied on mentors to teach them how to conduct clinical trials. We have established a formalized training program to fill this critical gap, and we’re extending it worldwide."

For more information on any courses or programs offered by the Office of Clinical Research Training and Medical Education, call 301-496-9425.


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