Post Graduate Diploma in Clinical Data Management

Clinical Data Management (CDM) covers the process of collecting, validating, and preparing the data towards statistical analysis for clinical trials. This starts with setting up a clinical data collection tool(s) or a clinical database based on study protocol to collect and store data. The goal is to gather as much of such data for analysis as possible that adheres to federal, state, and local regulations.

The field of clinical data management (CDM) has come about due to demands from both the pharmaceutical industry and the regulatory authorities. As the drive to “fast-track” the development of pharmaceutical products continues to accelerate, regulatory entities have responded by requiring quality-assurance standards to be met in collecting the data used in the drug evaluation process.

Post Graduate Diploma in Clinical Data Management is a Offline training course intended to deliver training from knowledge in clinical research, ICH GCP guidelines and advance clinical data management. In this program we aim to provide you an deep knowledge and pleasant learning experience so as to transform you into a competent, proficient and successful professional who is highly employable and equipped to perform in your clinical data management career.

Eligibility: Life science/ Medical/ Pharma graduates and post graduates

Duration: 8 Months ( 6 Months Theoretical + 2 Months Practical Internship )

Placement: 100% Internship with placement assistance

Course Curriculum:

Clinical Research:

1. Introduction to Clinical Research
2. Medical terminologies
3. Evolution & Principles of ICHGCP
4. New Drug Development & Clinical Trial Rule
5. Informed Consent
6. AE/SAE Reporting

Clinical Data Management:

1. Introduction to CDM
2. CRF design considerations
3.  Database design considerations
4. Edit Checks
5.  Preparing to receive data
6.  Receiving data on paper
7. Overseeing data collection
8.  Cleaning Data
9. Managing Lab Data
10.  Managing non-CRF data
11. Collecting Adverse Event Data
12. Study Start-up Activities
13. Study Conduct Activities
14. Study Closeout Activities
15. 21 CFR Part 11
16. EDC Overview
17. Data Privacy
18. Data Standards
19. Data Validation & program
20. CRF printing & completion
21. External Data Transfer
22. Patient Reported Outcome
23. Data Quality
24. Multi Center Study
25. Future of CDM

Medical Coading:

1. Human Anatomy
   2. Human Physiology
   3. Human Pathophysiology
   4. Health Information Technology
   5. HER and EMR
   6. ICD-10
   7. US Healthcare system
   8. European Healthcare system
   9. Indian Healthcare System
   10.Communication, Time management and Problem solving skill
   11. The World of Healthcare
   • Duties and Responsibilities of Medical Coder
   • Career Opportunities

Other benefits:

• • • 100% Internship with placement assistance
    • Industry Based Learning
    • Faculty with 20+ years of Clinical research Industry Experience
    • Offline Live Interactive Sessions
    • Limited Seats Batch
    • Digital Notes