Course Highlights
Course Director: Dr. Vinitaa Jha MBBS, MBA, (Cardiff) U.K. C.C.T. Psych UK
Executive Vice President – Research & Academics Clinical Directorate, Max Healthcare
Duration: 2 years
Mode: Full-Time (Two-year degree program)
Course Objective
- Provide high quality training programs for clinical research professionals
- Achieve excellence through dedicated and committed faculty
- Leverage our state-of-the-art infrastructure along with our highly qualified faculty for the benefit of students
- Enable the students to work autonomously in a wide range of clinical and community settings
- Develop individuals valued as change catalysts who will transform the existing clinical research system in India
- Provide an intellectually stimulating and supportive environment that is respectful of diversity and that fosters individual and collective pursuits of students
- Provide career advancement and placement opportunities through the degree program
- Design and develop skilling workshops, short courses, continuous skill up programs relevant to the programme
- Cultivate critical thinking, creativity, and ethical practices in clinical research professionals
- Develop a work force with a sharp focus on service excellence to address unmet medical needs
- To place patient care at the forefront of all education and clinical research initiatives
- Deliver value-based outcomes for the community and improve quality of life
- To build a financially self-sustainable model
Course Offerings
- Interactive lectures
- Online interactions
- Clinical Lab rotations
- Research projects
- Case studies, cohort studies, case control studies
- Public health studies
- Opportunities to attend workshops and seminars scheduled by MSMAIR
- Study visits
- Site visits
- Journal Clubs
During the course, the students will get an opportunity to engage in research related activities by working on drug and device clinical trials; public health research projects in a hospital, laboratory and community setup.
Learning Outcomes of the Course
- Knowledge pertinent to drug discovery and development pipeline.
- Skills to overview clinical research operations and flow process.
- Key concepts of Clinical trials design and Biostatistics.
- Policies and protocols related to Ethics and Regulations.
- Collaborative and multi-disciplinary team work underpinning drug and device trials,public health projects.
Who can Enroll
- Graduates from a recognised university with a minimum aggregate percentage of 50% marks in any of the following:
- Bachelor’s degree in Allopathic Medicine (MBBS)
- Bachelor’s degree in other fields of Medicine/Dentistry/Nursing/Veterinary Science (BHMS/ BAMS/ BDS/ BSc Nursing/ BVSc)
- Bachelor’s degree in Pharmacy/Life Sciences/Statistics/PublicHealth/Chemistry/Physics (B Pharm/BSc/ B Tech)
- Though highly recommended, candidates need not be restricted to the above disciplines, and graduates from other backgrounds may be taken into consideration after assessing the overall aptitude and eligibility of a particular candidates
- Work experience in a healthcare-related field is highly desirable
Course Content
- Introduction to Clinical Research
- Drug discovery and development, pre-clinical studies
- Basics Principles of epidemiology
- Clinical Pharmacology
- Introductory Biostatistics
- Research Methodology
- Bioethics
- GxP
- IPR and Patenting
- Global and National Regulations in clinical trials
- Clinical trials- Design and Planning
- Application of biostatistics in Clinical Research
- Development of Study Protocol
- Setup and Conduct of Clinical Trials
- Clinical data management
- Patient engagement and Protection of Patients
- Pharmacovigilance and safety reporting
- Management of Quality in Clinical Trials
- Financial management of Clinical Trials
- Statistical Analysis in Clinical Research
- Review and Reporting of Clinical Trials
- Pharmacoeconomics and health technology assessment
- BA/BE studies, PK/PD studies
- Scientific communication and Research and Publication Ethics
What will the Course participants get?
The two-year degree program will equip the students for future health careopportunities for an academic career in the field. It will also brace them for careers in research and make them aware of the relevant skills and qualifications. This program teaches design and development of clinical trials, regulatory guidelines,drug discovery and development, scientific communication, advanced biostatistics
and epidemiology.For students interested in academia and research organisations, this program will help achieve their goals to become Principal Investigators, etc. In industry, there will
be tremendous opportunities as research experts in - Clinical Trial Operations,Pharmacology, Medical Writing, Laboratory Medicine, Pharmaceutical
Biotechnology, Molecular Biology, Clinical data management.
Evaluations and Grading
Evaluations will be based on Assessment post course completion. The students will be evaluated by continuous assessments and written examinations for all the courses (core and lab learning courses including clinical lab rotations). In addition,the student will need to submit the dissertation thesis at the end of the last semester, which will be evaluated. The examination for all the courses will be held at the end of the semester. Continuous evaluation will be conducted during and at the end of the course. The continuous evaluation and semester examination average will contribute to the course GPA. The program will follow a credit system consistent with academic post graduate degree program norms. Credits will be awarded for the successful completion of each course and thesis. A total of 80 credits and a CGPA of at least 6.5 should be obtained compulsorily for awarding the degree.
Certification
Successful candidates will be awarded a certificate by Max Institute of Medical Education