Home Training Program “Medical Research Ethics & Good Clinical Practice (GCP)”

CONTINUING MEDICAL EDUCATION TRAINING PROGRAM

Topic: MEDICAL RESEARCH ETHICS & GOOD CLINICAL PRACTICE (GCP)

The program is developed and implemented within the framework of the continuing education function of the Center for Support & Continuing Education (under the Vietnam Medical Association).

I. Organization & Student Management

Presiding Unit: Center for Support & Continuing Education.

Organization Conditions: Minimum of 15 students.

Student Management: Attendance check at the beginning/end of sessions and/or management via the center’s software; each group not exceeding 05 students.

Training Format: In-person and online.

Training Location: Center for Support & Continuing Education – Hall/meeting room and practice facilities (Hospital/Lab/Medical facility…)

Total Duration: 08 periods (1 period = 50 minutes).

Note: Practice facilities are adjusted according to the actual implementation of the program.

II. Program Objectives and Content

Program Objectives: Ensure the safety, rights, and dignity of research participants; maintain the honesty, objectivity, and reliability of scientific results in clinical drug trials.

Program Content:

  • Overview of clinical research methods (phases, research design)
  • Medical knowledge, pharmacology, and mechanism of action of investigational drugs
  • Ethical principles in biomedical research
  • Legal regulations and the role of the Ethics Committee (IRB/IEC)
  • Good Clinical Practice (GCP) process for clinical trials
  • Data management and reporting of adverse events in clinical trials

Training Methods

  • Combination of online & in-person for theory; in-person for practice.
  • Interactive presentations, group discussions, and analysis of actual situations.
  • Practical training using “hands-on instruction” methods at the practice facility.

III. Assessment & Certification

Participation Duration: ≥80% theory and 100% practice.

Assessment: Input – process – output; achieving a minimum of 80% total score and meeting all evaluation criteria.

Certification: CME certificate – Topic: Medical Research Ethics and Good Clinical Practice (GCP); valid for fulfilling the responsibility of updating knowledge appropriate to the scope of practice according to Circular 32/2023/TT-BYT.

Center for Support & Continuing Education

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