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SkillDevelopment

Certified course in Biomedical ethics, ICH -Good Clinical Practice, Research Methodology and Protocol design

Overview Course Content Instructor

Course Description

Biomedical ethical guidelines and ethical conduct of research , research protocol design learning, ethical conduct of research

Course Fee Seats Limited

₹1000.00

Course Details

Duration

30 HRS

Course Label

SkillDevelopment

Certificate

Yes

Course Language

English

Course Mode

Online

Timings

6 PM - 7 PM

Days

Friday-Saturday-Sunday

Registration Till

09 Jun 2026

Tentative ClassStart Date

2nd Week of June

Eligible Schools:

All Schools

Certificate Criteria

75% attendance, 50% score in all Exams/CA

Curriculum Snapshot

Explore the comprehensive course modules

1 Responsible Conduct of Research:Values of research:

Responsible Conduct of Research: Policies: Responsible Conduct of Research: Planning and conducting research – Specific Issues Responsible Conduct of Research: Planning and conducting research – Specific Issues: Registration with Clinical Trials Registry–India

2 Collaborative research: Ethical considerations in collaborative research

Collaborative research: Responsibilities of ethics committees, researchers and institutions International collaboration Ethical Review Procedures: Requirements for EC members: Composition, affiliations, qualifications, member specific roles and responsibilities of an EC

3 Roles and responsibilities of the EC

Submission and review procedures: Details of documents to be submitted for EC review Details of documents to be included in the protocol Types of review: Exemption from review, Expedited review, Full committee review Documents to be maintained by EC for record

4 Informed Consent Process: Essential information for prospective research participants

Informed Consent Process: Responsibility of researchers Informed Consent Process: Documentation of informed consent process Protocol Design for IEC Submission

5 Introduction and History of Clinical and Biomedical Research

ICH Overview and Good clinical Practice ICMR 2017 Guidelines General Principles General Ethical Issues: Benefit-risk assessment: Categories of Risk General Ethical Issues: Informed consent process

6 General Ethical Issues: Privacy and confidentiality

General Ethical Issues: Payment for participation, Compensation for research-related harm General Ethical Issues: Conflict of interest General Ethical Issues: Selection of vulnerable and special groups as research participants, Community engagement

Instructor Spotlight

Learn from leading experts in stem cell research

Dr. Kanav Khera

Professor

Working as Professor, Dept of Pharmacy Practice with more than 17 years of experience in clinical research/biomedical ethics/evidence-based medicine, antibiotic stewardship programs, pharmacovigilance, drug safety, clinical trials, and outcome research. Dr Kanav Khera is also an associate member secretory of the Institutional Ethics Committee at School of Pharmaceutical Sciences, LPU. Dr Kanav Khera had vast experience in providing pharmaceutical care services in Tertiary care hospitals and handling medication errors and related problems. Had published more than 40 research papers in national and international journals and was invited as a guest speaker at various events. Dr Kanav Khera has been honoured with Best teacher and excellence in teaching awards and and also worked as Scientist 1 in a clinical research organization conducting clinical trials