Introduction to Clinical Research: Clinical Trial Phases and Design

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Introduction to Clinical Research: Clinical Trial Phases and Design

UC Berkeley Extension
Logo UC Berkeley Extension
Provider rating: starstar_borderstar_borderstar_borderstar_border 2 UC Berkeley Extension has an average rating of 2 (out of 2 reviews)

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Description

Enroll Now:

Online, Tues. March 5

Enroll Now

Revised class schedule.

  • Online course: Internet access required
  • March 5 to April 28 (revised)
  • $1,895 (EDP 846303)


Michael Dubinsky, B.S., is currently an independent consultant providing expert guidance to clients in GXP compliance. His experience includes 24 years with the Food and Drug Administration (FDA), where he performed or managed compliance and enforcement work for the Centers for Biologics, Drugs and Medical Devices. His experience while at the FDA spanned GMP, GLP and GCP activities. Dubinsky held the position of deputy director, Office of Compliance, CBER when he left the FDA in 1998.

Textbook(s) for this course: There is no text…

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Frequently asked questions

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Enroll Now:

Online, Tues. March 5

Enroll Now

Revised class schedule.

  • Online course: Internet access required
  • March 5 to April 28 (revised)
  • $1,895 (EDP 846303)


Michael Dubinsky, B.S., is currently an independent consultant providing expert guidance to clients in GXP compliance. His experience includes 24 years with the Food and Drug Administration (FDA), where he performed or managed compliance and enforcement work for the Centers for Biologics, Drugs and Medical Devices. His experience while at the FDA spanned GMP, GLP and GCP activities. Dubinsky held the position of deputy director, Office of Compliance, CBER when he left the FDA in 1998.

Textbook(s) for this course: There is no textbook or reader for this course.



X400.2 (3 semester units in Public Health)

45 hours CE Credit: BRN provider 00226

A requirement in the Certificate Program in Clinical Research Conduct and Management

Review the drug development process, principles of good clinical practice, clinical trial phases and design, principal players in clinical research, regulatory strategies and medical terminology.

Future-Term Courses and Enrollments

Courses are offered three terms per year: spring, summer, fall. Information about upcoming courses is available when enrollment opens each term.

  • Spring term: Enrollment opens in early December. Classes begin in January.
  • Summer term: Enrollment opens in early April. Classes begin in late May.
  • Fall term: Enrollment opens in early July. Classes begin in August.

Join our email list for periodic updates about course availability.


Sections Closed for Enrollment:


Online, Thurs. Oct. 25

NOTE: This section is temporarily closed. Please notify me when this section opens.

  • Online course: Internet access required
  • Oct. 25 to Dec. 20
  • $1,895 (EDP 848259) Proctored final exam



Michael Dubinsky, B.S., is currently an independent consultant providing expert guidance to clients in GXP compliance. His experience includes 24 years with the Food and Drug Administration (FDA), where he performed or managed compliance and enforcement work for the Centers for Biologics, Drugs and Medical Devices. His experience while at the FDA spanned GMP, GLP and GCP activities. Dubinsky held the position of deputy director, Office of Compliance, CBER when he left the FDA in 1998.

Online, Thurs. Jan. 3

NOTE: This section is temporarily closed. Please notify me when this section opens.

  • Online course: Internet access required
  • Jan. 3 to Feb. 28 (revised)
  • $1,895 (EDP 846329)


Michael Dubinsky, B.S., is currently an independent consultant providing expert guidance to clients in GXP compliance. His experience includes 24 years with the Food and Drug Administration (FDA), where he performed or managed compliance and enforcement work for the Centers for Biologics, Drugs and Medical Devices. His experience while at the FDA spanned GMP, GLP and GCP activities. Dubinsky held the position of deputy director, Office of Compliance, CBER when he left the FDA in 1998.

San Francisco, Sat. Jan. 5, 9 am, 4 meetings

Revised class schedule.

  • 4 meetings
  • Jan. 5 to Feb. 9: Sat., 9 am-5 pm (no meetings Jan. 12, Jan. 19, and Feb. 2); alsoFeb. 23: Sat., 9 am-3 pm(revised)
  • San Francisco: Room 813, UC Berkeley Extension Downtown Center, 425 Market St., 8th Floor (enter on Fremont St.)
  • $1,825 (EDP 406371)


Maryann Lenoci, M.A., serves as the senior project director for the Posttraumatic Stress Disorder (PTSD) Research Core of the Mental Illness Research, Education and Clinical Center (MIRECC) at the San Francisco Veterans Affairs Medical Center. She has 10 years of experience managing a number of VA, U.S. Department of Defense, National Institutes of Health and industry-funded research studies in the area of PTSD.

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There are no frequently asked questions yet. If you have any more questions or need help, contact our customer service.