CERTIFICATE COURSE IN CR PV CDM
The Clinical Research industry has grown around the Wor ld and India at an
unparalleled rate. With the number of clinical trials conducted in India increasing
and the government keen on planning and executing several initiatives to
strengthen the industry, a world of opportunities exist. This certificate course in CR
PV CDM is aimed at imparting core competencies and skill set essential for a fresher
to make a career in Clinical Research, Pharmacovigilance & Clinical Data
Management.
Topics
Weekly assignments
Group Presentations
Mock Interviews
Evaluation exams
1. Introduction to Clinical Research and Study
Designs.
2. Interpreting Guidelines in Clinical research
(CT rules 2019, ICH GCP etc.)
3. Study Start-up Process.
8. Adverse Events & Serious Adverse Events.
(Differences, Timeline of Submission, Reporting,
Compensation).
9. Clinical Trials Monitoring, Auditing and Regulatory
Inspections
10. Introduction to Medical Devices.
11. Informed Consent Form.
12. Elements of Protocol Development.
13. Changes in Clinical Research During COVID 19.
14. Resume Preparation, Email Etiquette, How to Find
a Job, How to Ace Interview.
4. Essential Documents in Clinical Research
and Storage of Clinical Documents.
5. Subject Retention Strategy.
6. Responsibility of the Study Team.
7. IP accountability (storage, handling,
administration, discarding)
Also includes
Dr. Karthik Rakam: +917569692853
Dr. Karthik Rakam: +917569692853
1. Introduction and History of Pharmacovigilance
2. Pharmacovigilance Basics
3. Case Processing
4. DiLi – Drug Induced Liver Injury and Risk
Management
5. Signal Management
6. Pharmacovigilance Quality
7. Digital Initiatives
8. Pharmacogenomics in Pharmacovigilance
Theme: Introduction to Clinical Research and Clinical Data
Management
1. Clinical Research Overview
2. Basics of CDM
3. CDM Overview stepwise
4. Data Entry in e-Case Report Form
Theme: Roles & Responsibilities of CDM
1. Project Initiation
2. Internal Testing
3. Data Review and Discrepancy Management
4. SAE Reconciliation
5. External Reconciliation
6. Protocol Deviation
7. CRF Completion Guidelines
Theme: Fundamentals to Focus
1. Clinical Research Stakeholders
2. Structure of Protocol: How to read
Theme: Tools used for Clinical Data Management
1. Rave
2. Inform
Soft skills:
1. Proactive and timely communication.
2. Delivering first time quality
3. Teamwork
4. Time Management
Te c hni c a l S k i l ls
1. Protocol Interpretation Skills
2. Discrepancy Management Skills: Learning
and Implementation
3. Query Writing Skills
Topics
Topics
11. Clinical Safety Management and Clinical Trials
12. Medical Information
13. Hemovigilance / Blood Vigilance
14. Pharmacovigilance Requirements, Setting up
Pharmacovigilance
15. Cosmeto Vigilance
16. Medical Device Vigilance
17. Career Opportunities in Pharmacovigilance and
Interview Questions
18. Effective LinkedIn Profile, CV and Advertising
Dr. Karthik Rakam: +917569692853
‟
The knowledge I gained from Karthik sir and Vardhan sir has helped a lot in clearing the interview and helping
me to be an efficient team member in the organization I'm working.
- Dr. Kishore Kumar Ramoju,
Pharm D
Operations Specialist, Regulatory Reporting
IQVIA
‟
The only thing I would like to say is " it's all about getting connected to the right people. For me Avenida is one
such right choice to get connected with. Thank you!
- Dr. Achanta Sivaprasad,
Pharm. D
Junior Regulatory Affairs Associate
Parexel
‟
The beauty of our profession is we have a wide variety of opportunities and its upto us to choose the right ones
depending upon our priorities and interests. Dr. Karthik Rakam sir is a guide, mentor and above all a big
motivation for me both in his professional as well as in spiritual journey.
- Dr. Jishnu,
Pharm. D
Drug Safety Associate
PPD
‟
My journey being a part of Avenida helped me decide Clinical Research as my choice of interest. The module was
very useful to crack the interview. Thank you, Dr. Karthik Rakam and Team Avenida.
- Dr. T. Narmada,
Pharm. D
Clinical Trial Coordinator
PPD
(Parexel International)
‟
Choosing the right mentor always plays a vital role in career path. My journey being part of Avenida, identifying
CDM as my interest and getting guidance towards it, is one such classic example. Thank you, Dr.Karthik sir and
Team Avenida.
- Dr. P. S. K. Srikanth,
Pharm. D
Clinical Data Analyst
COVANCE
‟
All the sessions were insightful and knowledgeable, it was during this program I was able to capture the sets of
prerequisites in my career building and was able to enhance my skills and subject proficiency, which gradually
helped me to get into Pharmacovigilance.
Thank you, Team Avenida.
- Dr. Indumathi H,
Pharm. D
Drug Safety Associate- I
Novo Nordisk
