Top distance clinical research courses in India | Syllabus | Interview preparation

Clinical Research is one of the developing field these days. Demand of clinical research partners is expanding step by step. In this article, we will educate you regarding the distance clinical research course.

We will likewise be going to share data about the schedule and a few hints to break the meeting.


Module 1:

Introduction to distance clinical research course

2.Pharmacology and tranquilize improvement

Module 3:Ethics and Guidelines in Clinical Research

Module 4: Regulation in Clinical Research

Module 5: Clinical Trial Management

Module 6: Clinical Data Management and Biostatistics

Module 1: Introduction to Clinical Research

1. Prologue to Clinical Research

2. Phrasings and definition in Clinical Research

3. Source and History of Clinical Research

4. Distinction between Clinical Research and Clinical Practice

5. Kinds of Clinical Research

6. Periods of clinical research

7. Clinical Trials in Republic of India – The National Perspective

8. Post advertising observation

9. Pharmaceutical Industry – ****** and Indian Perspective

10. Clinical Trial advertise

11. Vocation in Clinical Research

Module 2: Pharmacology and medication advancement

1. Prologue to Pharmacology

2. Idea of Essential Drugs

3. Courses of Drug Administration

4. Prologue to Drug Discovery and Development

5. Obstacles in Drug Development

6. Wellsprings of Drugs

7. Rudiments of Drug Discovery and Development

8. Ways to deal with Drug Discovery

9. Developmental Classification of the systems for Drug Discovery

10. Rising advances in Drug Discovery

11. Preclinical Testing

12. Investigational New Drug Application

13. Clinical preliminaries

14. New Drug Application and Approval

15. Pharmacokinetics

16. Pharmacodynamics

1. Late advances – Pharmacogenomics and Protein based treatments Appendix I FDA 1571 Investigational New Drug Application Appendix II FDA 1572 Statement of Investigator

Module 3: moral concerns and Guideline in Clinical analysis

1. Authentic rules in Clinical Research

Nuremberg code Declaration of Helsinki Belmont report

2. Universal Conference on Harmonization (ICH)

Brief history of ICH Structure of ICH

ICH Harmonization Process

3. Rules for Good Clinical Practice


The Principles of ICH GCP

Institutional Review Board/Independent Ethics Committee Investigator


Clinical Trial Protocol and Protocol Amendment(S) Investigator’s Brochure

Fundamental Documents for the direct of a Clinical Trial

4. Self Assessment Questions

Module 4: Regulation in Clinical Research

1. Presentation of Clinical Trial Regulation

2. European Medicine Agency

3. Nourishment and Drug Administration (US FDA)

4. Medication and corrective act

5. Timetable Y

6. ICMR Guideline

Module 5: Clinical Trial Management

1. Task Management

2. Convention in Clinical Research

3. Educated Consent

4. Case Report Form

5. Examiner’s Brochure (IB)

6. Choice of an Investigator and Site

7. Clinical Trial Stakeholder

8. Contract Research Organization (CRO)

9. Site the board associations (SMO)

10. Moral and Regulatory Submissions

11. Enrollment Techniques

12. Maintenance of Clinical Trial Subjects

13. Checking Visits

14. Examiner Meeting

15. Documentation in Clinical Trials

16. Administrative Binder

17. Record Retention

18. Pharmacovigilance

19. Preparing in clinical Research

20. Undertaking Auditing

21. Examination

22. Misrepresentation and Misconduct

23. Jobs and Responsibilities of Clinical Research Professionals


25. Module 6: Clinical Data Management


27. Prologue to CDM

28. CRF Design

29. Clinical Data Entry

30. Electronic Data Capture

31. Information Validation

32. Error Management

33. Clinical Data Coding

34. SAE Reconciliation

35. Quality Assurance and clinical Data Management

Rule and Regulation in Clinical preliminary information

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