Certificate Course in Clinical Research (CCCR)

Certificate Course in Clinical Research (CCCR), available at $64.99, has an average rating of 4.17, with 36 lectures, 1 quizzes, based on 390 reviews, and has 1828 subscribers.

You will learn about Basic understanding of Clinical Research Historical background of US Drug Law and Regulations Drug approval process in USA, New drug development-Preclinical Steps, IND, NDA, ANDA Essential Documents in Clinical Research Protocol Source Documents Informed Consent Form (IC Form) Investigator's Brochure (IB) Patient Information Sheet Case Report Form (CRF) Inclusion-Exclusion Criteria Information related to Sponsor, Investigator, Clinical Research Coordinator (CRC), Clinical Research Associate (CRA) Discover how to navigate important websites including ICH Guidelines to find more relevant information. Professional reputation building and career success enhancement through proper understanding of Clinical Research and related concepts and many more… This course is ideal for individuals who are This course is for Clinical Research Professionals, Pharma entrepreneurs, Pharma Consultants, Pharma Industry Professionals dealing with Clinical Research and related activities. or Pharma Faculties, Graduates, Postgraduates, PhD. Students (Pharmacy, PharmD, Science, Medical). or Anyone who is eligible and wants to make a career in Clinical Research. It is particularly useful for This course is for Clinical Research Professionals, Pharma entrepreneurs, Pharma Consultants, Pharma Industry Professionals dealing with Clinical Research and related activities. or Pharma Faculties, Graduates, Postgraduates, PhD. Students (Pharmacy, PharmD, Science, Medical). or Anyone who is eligible and wants to make a career in Clinical Research.

Enroll now: Certificate Course in Clinical Research (CCCR)

Summary

Title: Certificate Course in Clinical Research (CCCR)

Price: $64.99

Average Rating: 4.17

Number of Lectures: 36

Number of Quizzes: 1

Number of Published Lectures: 36

Number of Published Quizzes: 1

Number of Curriculum Items: 37

Number of Published Curriculum Objects: 37

Original Price: $199.99

Quality Status: approved

Status: Live

What You Will Learn

Basic understanding of Clinical Research
Historical background of US Drug Law and Regulations
Drug approval process in USA, New drug development-Preclinical Steps, IND, NDA, ANDA
Essential Documents in Clinical Research
Protocol
Source Documents
Informed Consent Form (IC Form)
Investigator's Brochure (IB)
Patient Information Sheet
Case Report Form (CRF)
Inclusion-Exclusion Criteria
Information related to Sponsor, Investigator, Clinical Research Coordinator (CRC), Clinical Research Associate (CRA)
Discover how to navigate important websites including ICH Guidelines to find more relevant information.
Professional reputation building and career success enhancement through proper understanding of Clinical Research and related concepts and many more…

Who Should Attend

This course is for Clinical Research Professionals, Pharma entrepreneurs, Pharma Consultants, Pharma Industry Professionals dealing with Clinical Research and related activities.
Pharma Faculties, Graduates, Postgraduates, PhD. Students (Pharmacy, PharmD, Science, Medical).
Anyone who is eligible and wants to make a career in Clinical Research.

Target Audiences

This course is for Clinical Research Professionals, Pharma entrepreneurs, Pharma Consultants, Pharma Industry Professionals dealing with Clinical Research and related activities.
Pharma Faculties, Graduates, Postgraduates, PhD. Students (Pharmacy, PharmD, Science, Medical).
Anyone who is eligible and wants to make a career in Clinical Research.

If you find the Clinical Research field challenging, well, in that case, this is the best course for you.

The pharmaceutical industry is one of the extremely regulated industries, with several government regulations to protect public health. Therefore, the important target of the pharmaceutical industry is to develop a Drug product passing the regulatory requirements. On the other hand, regulation of drug development, manufacturing, marketing, and sales involves paradoxical objectives. It must ensure that safe and effective pharmaceutical formulations reach the public quickly while concurrently protecting against ineffective/unsafe/harmful therapies. This course will provide you with a strong understanding of the Drug development process, Clinical Research and related documents, GCP, Roles, and responsibilities of major players in Clinical Research in a summarized manner which will help to work towards shaping your career in Clinical Research.

This course focuses on the following points that could make Clinical Research activities smooth without any significant delays/failures,

• Basic Understanding of Clinical Research,

• Major players in Clinical Research,

• Historical background of US Drug Law and Regulations,

• Drug Approval Process,

• New Drug Development-Preclinical Steps

• Investigational New Drug Application (INDA),

• New Drug Application (NDA),

• Abbreviated New Drug Application (ANDA),

• Essential Documents,

• Protocol,

• Source Documents,

• Informed Consent form,

• Investigator’s Brochure,

• Case Report Form (CRF),

• Inclusion-Exclusion criteria,

• Sponsor,

• Investigator,

• Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC),

• Important Literature Search Websites for Clinical Research Professional,

• Many more…

There will be several downloadable documents so that you can follow along with them whenever you need them.

This course contains Commonly Asked Questions that will help you while preparing for Clinical Research interviews.

Last but not the least, this course also contains a bonus course entitled “Meeting etiquettes” which will help you to shape your career in which the points that must be taken into consideration while attending/conducting meetings are covered.

In this course, more than 30 informative videos are included and are designed in an easily digestible format and going to take you through step by step approach to understand Clinical Research and relevant activities.

I believe “Quality improvement is a continuous and lifetime process”. Upon completion of this course, you will be a whole different professional with improved Clinical Research knowledge which will help you to garner more respect from your team members, managers, clients, or anyone with whom you are communicating/interacting.

Course Curriculum

Chapter 1: Introduction

Lecture 1: Introduction

Lecture 2: Historical background of US Drug Law and Regulations

Lecture 3: Drug Approval Process

Lecture 4: New Drug Development-Preclinical Steps

Lecture 5: Investigational New Drug Application (INDA)

Lecture 6: New Drug Application (NDA)

Lecture 7: Abbreviated New Drug Application (ANDA)-1

Lecture 8: Abbreviated New Drug Application (ANDA)-2

Lecture 9: Abbreviated New Drug Application (ANDA)-3

Lecture 10: Generic Products

Lecture 11: Innovator-Generics-Common and Differentiating Points-1

Lecture 12: Innovator-Generics-Common and Differentiating Points-2

Lecture 13: NDA Vs ANDA

Lecture 14: Clinical Research-Inclusion-Exclusion Criteria

Chapter 2: Major Players in Clinical Research

Lecture 1: Major Players in Clinical Research

Lecture 2: Sponsor-1

Lecture 3: Sponsor-2

Lecture 4: Sponsor-3

Lecture 5: Investigator-1

Lecture 6: Investigator-2

Lecture 7: Investigator-3

Lecture 8: Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC)

Chapter 3: Important Documents In Clinical Research

Lecture 1: Essential Documents-1

Lecture 2: Essential Documents-2

Lecture 3: Protocol

Lecture 4: Source Documents

Lecture 5: Informed Consent-1

Lecture 6: Informed Consent-2

Lecture 7: Investigator's Brochure

Lecture 8: Patient Information Sheet-Patient Information Brochure

Lecture 9: Case Report Form (CRF)

Lecture 10: Bonus Materials

Chapter 4: Final Words

Lecture 1: Meeting etiquettes Part 1

Lecture 2: Meeting etiquettes Part 2

Lecture 3: Congratulations, Thank you, Certification, Celebration!

Lecture 4: Bonus Lecture

Instructors

Dr. Sachin Potawale
Quality improvement is a continuous and lifetime process.

Rating Distribution

1 stars: 18 votes
2 stars: 16 votes
3 stars: 73 votes
4 stars: 137 votes
5 stars: 146 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

Menu