Introduction to Clinical Data Management

Clinical Data Management (CDM) is a vital stage in clinical research protocol that results in high-quality, reliable, and statistically sound data from clinical trials. This course thoroughly explains the process involved in CDM that includes Case Report Form (CRF) design, database design, data entry and validation, discrepancy management, medical coding, database reconciliation, query creation, and database locking procedures. This course is designed to teach life science/health science graduates how to manage and report huge amounts of clinical data technically and scientifically and finally, database reconciliation. This understanding of various CDM processes will undoubtedly assist learners in working with various CDM software provided by various organizations.

Course Description

Clinical Data Management (CDM) is a critical phase in clinical research, which leads to the generation of high-quality, reliable and statistically sound data from clinical trials. Various procedures in CDM including Case Report Form (CRF) designing, database designing, data-entry and its validation, discrepancy management, medical coding, reconciliation of databases, query generation and database locking procedures are well explained in this module. This course will help the life science/health science graduates to learn about how the massive amount of clinical data is well managed and reported technically and scientifically. This understanding of various CDM processes will definitely help the learners to work with various CDM softwares offered by different companies.

Who should apply?

  • MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.
  • Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
  • Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
  • Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
  • Graduate or equivalent degree in Nursing/Allied Health.
  • Students in their final year of graduation for the above courses may also apply.

What you will learn in this course

Clinical data management program will help the life science and health science graduates to learn about how high-quality, reliable data is managed for clinical purposes, understand the many procedures in CDM including Case Report Form (CRF) designing, database designing, data entry, ethical guidelines in clinical research etc. and get to the root of how clinical data is reported technically and scientifically.

Structure of Course Delivery

The clinical data management course will be made available online. It consists of several in-depth lectures delivered by a subject matter expert, appropriately supported by slides, images, and interactive materials where necessary. The delivery has a tremendous degree of versatility. A class may be paused to allow you to take notes and refer to your textbooks (not provided). If you already know a certain part of the lecture, you can rewind it to hear it again or skip a slide or two. You are free to go back over a section at a later time if you need to review it before your assessment. You are free to take the topics in clinical data management course in whatever order you choose, even though our curriculum may prescribe otherwise.

Benefits

Many of our students felt that the way this course is taught has made it easier for them to keep up with the intense lectures in real class— it's like having a TV remote in class to self-pace your teacher.

Visuals in the presentations aid in better comprehension by making topics easier to learn... and more difficult to forget!

Chapters

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Dr Divya Sunil
Academic Mentor

Dr. Divya Sunil has graduated with a degree in Dentistry from Bangalore University and a PG Diploma in Clinical Research. She is passionately involved in training and motivating students who are new to the world of clinical research.

Dr. Divya is proficient in Pre-Clinical Studies, laws governing the production of drugs, designing the database for Clinical studies, medical coding, and guidelines for post-marketing surveillance.

Previously, Dr. Divya has worked as an academic mentor at a private dental college in Bangalore where she has taught more than 10,000 students. She has also co-authored an article in the monthly journal,” TRENDS IN PROSTHODONTICS” VOL 4, NO. 1 (2013) on Bone Implant contact and its relationship with the strain on the surrounding bone.

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Ms Amrutha Babu
Academic Mentor

Ms. Amrutha is an accomplished academic expert in the field of Food and Nutrition. She has a Master’s degree from Mahatma Gandhi University, Kottayam where she graduated with a gold medal. After undergoing training in Christian Medical College, Vellore started her career as a freelance diet counselor in 2009. She was also associated with Lybrate - an online platform for diet management and counseling.

After a remarkable experience in the field of dietetics, she received a post-graduate diploma in Clinical Research. Currently, she is associated with TrueLessons as an academic mentor. Her core strengths are providing excellent teaching and guidance to her students. Amrutha has more than 7 years of teaching experience in the field of clinical research. She has in-depth knowledge about Drug Discovery Process, Drug Approval process, Trial documents, Trial Design, Regulatory Affairs, Query writing, ICSR, and so on.

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Dr. Smitha Seshagiri
Academic Mentor

Dr. Smitha Seshagiri has completed her PGDCR from Avigna Clinical Research Institute. She has an experience of 4+ years. She is also a practicing dentist and a wellness coach.

This program will provide the students with an opportunity to work with various MNCs.

Students can get engaged in different profiles like

  • Data Entry Operator
  • Associate Clinical Data Co-ordinator
  • Data Validator
  • Medical Coder
  • Data Manager
  • Clinical Data Analyst
  • Clinical Data Programmer
  • Clinical Data Manager I
  • Clinical Data Manager II
  • Principal Clinical Data Manager
  • Manager, Clinical Data Management
  • Group Manager, Clinical Data Management
  • Associate Director, Clinical Data Management
₹29999

₹24999

  • Duration 15 hours
  • Chapters 15
  • Skill Level Beginner
  • Language English
  • Instructor Dr Divya Sunil
  • Instructor Ms Amrutha Babu
  • Instructor Dr Smitha Seshagiri
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