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Clinical Data Management – Post Graduate Diploma

Clinical data Management

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 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.

 

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

Duration: 6 Months ( 4 Months Theoretical + 2 Months Practical Internship )

Placement: 100% Internship with placement assistance

 

Course Curriculum:

Clinical Research:

        1. Introduction to Clinical Research 

         

        1. ICH GCP Guidelines

         

        1. New Drug Development Process

         

        1. Project Management
        • Clinical Data Management:
            • Study Start up
          1. Clinical Trials Primer
          2. The Data Management Plan
          3. CRF Design Considerations
          4. Database Design Considerations
          5. Edit Checks
          6. 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
            1. Study Database Lock
            2. After Database Lock
            3. Standard Operating Procedures (SOPs)
            4. Controlling Access and Security
            • CDM Systems
            1. Clinical Data Management Systems
            2. EDC Systems
            3. Choosing Vendor Products
            4. Implementing New Systems
            5. Test Procedures
            6. Migrating and Archiving Data
            • CDM – Guidelines, Standards & Regulations
            1. Intro & ICH GCP Guidelines
            2. GCDMP & CDISC
            3. 21 CFR Part 11

 

Other benefits:

      • 100% Internship with placement assistance
      • Industry Based Learning
      • Faculty with 20+ years of Clinical research Industry Experience
      • Live Interactive Sessions
      • Limited Seats Batch
      • Digital Notes
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Contact Us on +91 90280 68979 for Enquiry