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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
Ankita Todkar
Ankita Todkar
2022-11-08
Best Institute,Excellent faculty,my personal experience was really great, I learnt a lot of new things differently. Lots of appreciation & Great thanks to Dr.Supriya Phadke mam as well as Vaidehi Limaye mam & Limaye sir. JCL is best institute to learn - study about research oriented courses.
Om Salunke
Om Salunke
2022-11-08
Jehangir Center of Learning (JCL) is excellent Institute to complete your PG diploma in Clinical research. I have recently completed my PG diploma in clinical research, teaching staff is very experienced and management staff is also very good. Very good experience in JCL.
Nupur Bhosale
Nupur Bhosale
2022-11-07
Jehangir Center For Learning has been a blessing for me since Day 1. They have been impeccable in their way they teach clinical research with the help of experienced and talented tutors. In regards to placement "Rahul Sir" has been a major support. I'd suggest everyone to take a leap of faith into this institution and give it a try, you wouldn't be disappointed.
Mithilesh Rangari
Mithilesh Rangari
2022-11-07
Jehangir Center for Learning is the bestest and trustworthy center for freshers and experienced students to gain the right exposure in the field of Clinical Trials Certification with hands-on experience. Clinical Trials guidelines are universally accepted guidelines by every countries. The faculty here is very rich in experience who makes students understand the clinical Trial course with correct directions and attitude of work towards the healthcare Industry. They groom the students professionally making them understand the importance of ethical knowledge and in-depth understanding of the subject in the field of clinical Trials. I Thank you "The JCDC team and Teachers" for carving us in the field of Clinical Trials with right attitude and knowledge.
Prajakta Jagadale
Prajakta Jagadale
2022-11-07
Jahangir is one of the greatest learning center of clinical research. All teachers are motivated and supported to the student.
Aries Jadhav
Aries Jadhav
2022-11-07
Its the best learning center if you want to explore and discover about clinical research. We gain a lot of knowledge and experience through this course.The sessions they conduct were so much helpful and easy to learn. I'm glad i took a step and join this course
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