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Course overview
Description
You want to upgrade your skills and start a career in ever-growing clinical research industry in Clinical Data Management and Pharmacovigilance profiles, then this the course is perfect for you!
Start learning CDM and PV to start your career in the most growing field of Pharma & life-Science Industry!
Either you're completely brand new to Clinical Research, or you've played around it but want to get more comfortable with Clinical Research. Either way, this course will be great for you. Clinical Data Management (CDM) is an important phase in clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from the clinical trials. Whereas Pharmacovigilance (PV) is also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products
What makes Did I qualify to teach you?
My name is Mrs. Deshpande and I've been in the Clinical Research domain for over Two decades. Plus I'm the creator of some of the most popular online courses - with over 2000+ students like these ones:
Awesome course, easy to follow! – Radha Jaiswal
Your course is amazing, so I can say that I am learning a lot. Your English is very easy to understand ( I'm from Brazil). Thanks for sharing your amazing knowledge. – Santosh Chame
My Promise to You
I'll be here for you every step of the way. If you have any questions about the course content or anything related to this topic, you can always post a question in the course or send me a direct message.
I want to make this the best course on CDM and PV. So if there is any way I can improve this course, just tell me and I'll make it happen.
What is this CDM and PV course all about?
In this complete guide, you'll not only learn all of the topics and segments of CDM and PV, but also how to implement in real Industry so that you can crack any interview and start your career with a bang.
What will i learn?
- Become a Clinical Data Management and Pharmacovigilance Professional and work with world's leading Contract Research Organisations.
- Understand more about adverse drug reactions
- Get familiarize with various roles in CDM and PV
Requirements
- Ideally who has completed their graduation in science, pharmacy or ailed branch also who are interested in medicine field
Curriculum for this course
55 Lessons
11:34:25 Hours
Introduction to Clinical Research
5 Lessons
00:39:49 Hours
-
Introduction to Clinical Research
00:15:29
-
Terminologies in Clinical Research
00:16:32
-
Advantages of CR in India
00:07:48
-
Introduction to Clinical Research- Notes
.
-
Introduction to Clinical Research- Quiz
00:00:00
Drug Development Process
9 Lessons
01:39:25 Hours
-
Overview of Drug Development
00:22:54
-
Clinical Trial Phase 0
00:04:05
-
Clinical Trial Phase I
00:19:41
-
Clinical Trial Phase II
00:10:57
-
Clinical Trial Phase III
00:15:33
-
Clinical Trial Phase IV
00:07:26
-
BA/BE Studies
00:18:49
-
Drug Development Notes
.
-
Drug Development Quiz
00:00:00
Good Clinical Practices (GCP)- ICH E6
10 Lessons
02:48:41 Hours
-
Responsibilities of Ethics Committee Members
00:31:35
-
History Development of International Regulations in Clinical Research
00:18:14
-
Good Clinical Practices
00:12:04
-
Ethics Committee
00:13:46
-
Investigator Responsibilities
00:13:40
-
Sponsor Responsibilities
00:38:22
-
Protocol and Investigator Brochure
00:06:56
-
Essential Documents
00:34:04
-
Good Clinical Practices- Notes
.
-
Good Clinical Practices- Quiz
00:00:00
Safety Reporting
12 Lessons
01:15:23 Hours
-
Adverse Event Reporting
00:22:38
-
Recording of Event
00:11:15
-
Medical Management of Adverse Events
00:09:43
-
Handling Death
00:04:22
-
Unblinding of Drug
00:02:47
-
Clinical Safety and Pharmacovigilance
00:24:38
-
E2A- Clinical Safety and Data Management
.
-
Media 436
.
-
Naranjo Assessment
.
-
Order and Formulate to Determine the Quantum
.
-
SAE Reporting
.
-
Safety Reporting- Quiz
00:00:00
Pharmacovigilance
7 Lessons
01:50:46 Hours
-
Overview of PV
00:14:23
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History of PV
00:10:44
-
ADR Classifications
00:16:54
-
AE_SAE Reporting Process
00:15:34
-
Introduction to Aggregate Reporting
00:07:27
-
Medical Assessment -1
00:15:29
-
Medical Assessment -2
00:30:15
Clinical Data Management
12 Lessons
03:20:21 Hours
-
CDM- 21 CFR Part 11
00:15:10
-
CRF Design_2
00:26:16
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Introduction to CDM
00:10:44
-
Data Entry Methods
00:15:19
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Query Management
00:20:14
-
Source data validation
00:26:29
-
Future of Data Management
00:07:08
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Clinical Trial Start Up
00:28:43
-
Clinical Trial Conduct
00:28:59
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Clinical Trial Close Out
00:21:19
-
Clinical Data Management- Notes
.
-
Clinical Data Management- Quiz
00:00:00
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About instructor
Student feedback
Reviews
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Kajal ShindeI want to thank TechnoBridge for their support and valuable guidance. After the completion of my B.Pharm(2019), I have joined TechnoBridge Systems for Online Clinical Data Management and Pharmacovigilance Training for 3 Months Online program. Before the completion of my training duration I got placed in Pharmacovigilance Department. -
A Vinita Mary
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