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PGD – Clinical Data Management

PGD – Clinical Data Management

50,000.00

Post Graduate Diploma in Clinical Data Management is a blended (Online + 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.

Course Curriculum:

Clinical Research:

o

1. Introduction to Clinical Research

2. ICH GCP Guidelines

3. New Drug Development Process

4. Project Management

 Clinical Data Management:

 Study Start up
2. Clinical Trials Primer
3. The Data Management Plan
4. CRF Design Considerations
5. Database Design Considerations
6. Edit Checks
7. Preparing to Receive Data

 Study Conduct

1. Receiving Data on Paper
2. Overseeing Data Collection
3. Cleaning Data
4. Managing Lab Data
5. Non-CRF Data
6. Collecting Adverse Event Data
7. Creating Reports and Transferring Data

 Study Closeout

0. Study Database Lock
1. After Database Lock
2. Standard Operating Procedures (SOPs)
3. Controlling Access and Security

 CDM Systems

0. Clinical Data Management Systems
1. EDC Systems
2. Choosing Vendor Products
3. Implementing New Systems
4. Test Procedures
5. Migrating and Archiving Data

 CDM – Guidelines, Standards & Regulations

0. Intro & ICH GCP Guidelines
1. GCDMP & CDISC
2. 21 CFR Part 11

Eligibility:

MD/MS/MDS/MBBS/MPharm/BAMS/BHMS/BDS/BPharm
B Sc/M Sc Life Science [Microbiology/Biotech/Biochem/Bioinfo/Zoology]
Nursing Graduates

Course : Post Graduate Diploma in Clinical Data Management

Duration : 4 Months theoretical + 2 Months Practical Internship

Total fee is 50000/- (with GST)

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