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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 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
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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