Introduction to Clinical Trial Documents
Course Description
For reliable records in any clinical trial, appropriate
data collection and archiving of the study and other pertinent trial
information is essential. All trials must comply with the legal need for
trial documentation. Both evaluating the trial and reconstructing it as
it occurred are beneficial. Gain a comprehensive understanding of
essential documents in clinical trials that will contribute to the
success of the study at the clinical trial site by taking up this
module.
This course/ module is valid for 6 months. E- certificate can be downloaded once the student completes the course
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
This program will help the life science and health science graduates to learn about the good documentation practices and understand factors contributing to the success of a study at the clinical site management organization.
Structure of Course Delivery
The entire 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 this course in clinical trail documents 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
This program will provide the students with an opportunity to work with various MNCs.
Students can get engaged in different profiles like
- Clinical Research Coordinator
- Clinical Research Associate
- Scientific Document Reviewer
- Quality Control
- Quality Analyst
- Regulatory Associate
- Regulatory Specialist