Integrated Clinical Research Program

MODULES:

Six core modules, each focusing on key aspects of clinical research.

Module 1:

Introduction to Clinical Research: A strong foundation in research principles and ethics

1. Introduction to Clinical Research & Advancement of ICH-GCP
a. Clinical Research in India
b. Phases of Clinical Trials
c. History & Background of Good Clinical Practice
d. Introduction to ICH, ICH-GCP Guideline & its advancement

2. Ethical & Regulatory Aspects of Clinical Trials
a. Ethics Committee
b. Indian Council of Medical Research
c. Declaration of Helsinki
d. Drug & Cosmetic Act 1940, Schedule Y & its appendices

3. Operations Aspects of Clinical Trials
a. Clinical Trial Design

Module 2:

Clinical Data Management: Skills in data collection, analysis, and reporting

1. Data Safety Monitoring Board (DSMB)
2. Clinical Data Management (CDM)
3. Course review, Q&A
4. Case Studies

Module 3:

1. Introduction to Pharmacovigilance
2. Pharmacovigilance-Glossary and related terms
3. Pharmacovigilance Methods
4. Pharmacovigilance Data Management and Case Processing
5. Signal Management, ADR Reporting System & Dictionaries
a. Signal Identification, Development and Analysis
b. Adverse Drug Reaction Reporting System
6. Medical Dictionary for Regulatory Activities
7. WHO Drug Dictionary
8. Regulatory Aspects of Pharmacovigilance
a. Different ICH & Other requirements for Drug Safety
b. Periodic Safety Update Report (PSUR)
c. Good Pharmacovigilance Practice (GPP)
9. Course review, Q&A
10. Case Studies

Module 4:

Regulatory Affairs: Navigating complex regulatory requirements and industry standards

1. Introduction to Regulatory Affairs
2. Drug regulatory and accrediting agencies of the world
3. Clinical Trials (E3)
4. Provisions related to the Import of Drugs
5. Overview related to manufacturing & sale
6. Labelling and packaging
7. DMF- preparation, submission, responding to regulatory deficiencies
8. Importance of GMP Compliance
9. Orange book
10. Biologics License Application (BLA) and Purple Book
11. QA/QC Documentation
12. Hatch Waxman Act- 180-day exclusivity
13. HIPPA Act
14. Course review, Q&A
15. Case Studies

Module 5:

Medical Writing: Effective scientific communication through medical writing.

1. Medical Writing in Clinical Trials
2. Overview and Sample of Reports
3. Guidelines to publish clinical data
4. Medico-Marketing Writing
5. Medical & Scientific Style guides
6. Data Citation & referencing
7. Plagiarism & Copyright
8. Course review, Q&A
9. Case Studies

Module 6:

Pharmacology: Understanding drug interactions with the human body.

1. Overview of Drug Discovery Process
2. Introduction to major drug classes (e.g., antibiotics, analgesics, antihypertensives).
3. Antibiotics and antimicrobial agents.
4. Analgesics and anti-inflammatory drugs.
5. Antihypertensives and cardiovascular drugs.
6. Psychopharmacology and CNS agents.
7. Gastrointestinal drugs.
8. Respiratory drugs.
9. Endocrine and reproductive system drugs.
10. Anticancer drugs.
11. Immunomodulatory drugs
12. Adverse drug reactions and drug safety.
13. Drug development and regulation
14. Herbal and alternative medicine.
15. Pharmacology in practice (clinical cases and scenarios).
16. Course review, Q&A, and assessment preparation.
17. Course review, Q&A
18. Case Studies

Flexible Learning for Every Student

Our program is crafted to provide utmost flexibility. Students can embark on their clinical research journey during their first, second, or third year of undergraduate studies. This flexible approach ensures that every student can take advantage of this exceptional opportunity.

WHY CHOOSE OUR PROGRAM

• Flexible learning modes
• Experienced faculty
• Practical experience
• Abundant career opportunities
• Certifications
• Placement support

About Reva University, Bangalore

Established in 2012, REVA University is a forerunner in delivering technology-based education.

Recognised as one of the Top 50 private universities in India, REVA University, with innovative pedagogy, exemplary infrastructure, and an industry-resilient curriculum that is designed for the future job market, strives to benchmark new milestones in modern education. In less than two decades, the University has grown from a small community of 150 students to a vast institution that is educating and empowering 15,000+ students on campus. University currently offers UG, PG, Ph. D, Diploma and Certificate Programs in Engineering, Architecture, Science & Technology, Commerce, Management Studies, Law, Arts & Humanities, and Performing Arts.

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