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Course / Course Details

Certificate Course in Clinical Research[CR]

  • Rajashri Ojha image

    By - Rajashri Ojha

  • 2 students
  • 10 Min
  • (0)

Course Requirements

B.Pharm/M.Pharm/PhD/B.Tech/M.tech/BSc/MSc/BAMS/BHMS/MDS/MBBS/MD etc. All those who would like to make a career in Regulatory Affairs, QA, Clinical Research, and Medical Affairs.


Working Professional from department like RA, QA, R&D, Production in Pharma/Biotech/ Medical Device/BPO/KPO/CRO etc

Course Description

This course will cover Introduction to Clinical Profession, Overview of Drug Development Process including clinical trials, Regulatory process in preclinical drug development, Ethical Principles and their origin, Ethics in clinical research: As per ICMR & GCP, ICH E6. Fundamentals of Monitoring Clinical Trials, Principles of Project Management, Clinical Safety & Pharmacovigilance

Course Curriculum

  • 10 chapters
  • 50 lectures
  • 9 quizzes
  • 10 Min total length
Toggle all chapters
1 SOP for Clinical Research Course
15 Min

2 Table of Content
15 Min

1 Clinical Research as a Profession, Role and its importance
15 Min

2 Article
15 Min

3 PPT - 1
15 Min

4 PPT - 2
15 Min

5 Clinical Trials video 1
15 Min

6 Clinical Trials video 2
15 Min

7 MCQs 1 [Quiz]
5 Min

1 Overview of the Drug Development Process
15 Min

2 Article
15 Min

3 PPT
15 Min

4 Phases of clinicl trial, forms and fees- Video
15 Min

5 Rules governing clinical trials Video
15 Min

6 Clinical trial Mayur Kanchalwar Lecture Video - 1
15 Min

7 Clinical trial Mayur Kanchalwar Lecture Video - 2
15 Min

8 Clinical trial Mayur Kanchalwar Lecture Video - 3
15 Min

9 MCQs 2 [Quiz]
5 Min

1 Good Clinical Practice (GCP)
15 Min

2 Article
15 Min

3 PPT
15 Min

4 GCP Video
15 Min

5 MCQs 3 [Quiz]
5 Min

1 Fundamentals of Monitoring Clinical Trials
15 Min

2 Article
15 Min

3 PPT
15 Min

4 Clinical Trial Monitoring Video
15 Min

5 MCQ 4 [Quiz]
5 Min

1 Project Management
15 Min

2 Article
15 Min

3 Managing the clinical process video
15 Min

4 MCQs 5 [Quiz]
5 Min

1 Clinical Trial Documentation and Report
15 Min

2 Guidance/Article 1
15 Min

3 Guidance/Article 2
15 Min

4 Article-Good documentation practice in clinical research
15 Min

5 Requirements of clinical trial documents Video
15 Min

6 MCQs 6 [Quiz]
10 Min

1 Clinical data management (CDM)
15 Min

2 Guidance/Article 1
15 Min

3 Guidance/Article 2
15 Min

4 Video-Clinical Data management System-A process Overview
15 Min

5 Quiz 7 [Quiz]
10 Min

1 Clinical Safety and Pharmacovigilance
15 Min

2 Article
15 Min

3 PPT
15 Min

4 Pharmacovigilance video 1
15 Min

5 Pharmacovigilance video 2
15 Min

6 MCQs 8 [Quiz]
5 Min

1 Final Exam [Quiz]
1 Hour 20 Min

Instructor

Rajashri Ojha

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  • Duration 10 Min

  • Lectures 50 lessons

  • Enrolled 2 students

  • Category: Pharmaceuticals

  • 9 Quizzes

  • Language: English

  • Skill Level Long Courses

  • Certificate of Completion

  • 90 Days Access

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