What is Clinical Research?
The term clinical research refers to the entire spectrum of activities involving human subjects within the process of drug development. The foundation of clinical research is the determination of the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use that may be used for prevention, treatment, diagnosis or for relief of symptoms in any disease.
What is a Clinical Trial?
Clinical trials are systematic investigations in human subjects intended to gather safety and efficacy data of a new drug. The clinical trials conducted all over the world follow universally accepted guidelines and regulations. These trials for new drugs are conducted on human subjects or patients only after abundant satisfactory information has been collected on its quality and safety through pre-clinical or animal studies and which have an approval from the required health and ethical authorities.
What is the St. Xavier’s College Diploma in Clinical Research all about?
Clinical research activities in Asia have seen a tremendous growth, as predicted by several companies such as McKinsey & Co. According to a recent article published by Frost & Sullivan, India, the current outsourced clinical trial activity in India is at around Rs. 3.5 billion (about US $ 75 million) and is estimated to go up to Rs.13.2 billion (about US $ 281 million) by 2010.
However, what has not been predicted and addressed adequately is the fact that the increasing number of companies engaging in clinical research has given rise to a huge demand for trained clinical research professionals. In response to interactions with industry personnel, we understand that the need of the hour is a clinical research course that produces quality professionals. The St. Xavier’s College Diploma in Clinical Research aims to achieve this by implementing a carefully designed curriculum, run by experienced faculty from the industry, exposure to practical aspects of clinical research and more importantly, selecting students who are high-potential candidates with necessary competencies for excelling in this industry.
In addition, this course invites clinical research professionals to upgrade their clinical research knowledge by enrolling into specific modules as outlined in the course curriculum.
The course will be taught via lectures, discussions, group assignments, case studies, workshops and field visits conducted by prominent industry professionals. These include national and international faculty with 5-10 years of hands-on clinical research industry experience, who currently work in senior positions in multinational pharmaceuticals or contract research organizations.
The course content has been designed to cover the requirements of a Diploma such that a minimum of 120 credits (1 credit = 10 contact hours) has to be completed by each student:
- 28 weekend lectures (Saturday- 4 hrs, Sunday-6 hrs): 24 credits
- Home assignments and assessments (10 hrs per week): 24 credits over 28 weeks
- 4-month industry internship program or dissertation project: 64 credits
For students enrolling for the complete diploma, all the above-mentioned components will need to be completed. However, for industry participants, the modules are offered as stand-alone courses and a certificate will be provided for the specific modules for which the participant has registered.
The curriculum is designed to provide basic and practical knowledge on clinical research, clinical trial conduct, the regulations governing it, and the required communication & organizational skills.
The curriculum is sub-divided into 6 modules and the topics covered under each module are as follows:
Module 1: Clinical Research – An Overview; Ethics, Guidelines and Regulations (11 credits)
Module 2: Clinical Trial Planning and Design (9 credits)
Module 3: Clinical Trial Conduct, Compliance and Quality Assurance (9 credits)
Module 4: Pharmacovigilance (4 credits)
Module 5: Data Analysis & Management in Clinical Research (Theory + Practicals)
Module 6: Clinical Research Management and Interpersonal Skills (5 credits)
Examination conducted after each Module as a Part of Student evaluation process.
Course Timings & Duration:
Saturday: 14.00-18.30 hrs
Sunday: 09.00-15.30 hrs
Internship: Monday to Friday /Saturday (as applicable)
(After completion of the course)
Total Course Duration: 28 weeks (480 hrs) of teaching + 16 weeks of internship
At the end of every module, a written test will be administered to the students. In addition, the exercises and assignments submitted during the course will be evaluated and discussed with the individuals during every module. Evaluations and grading will be made based on objective and subjective written tests at the end of each module and the final presentation made by every student, judged for its content & delivery by the core committee.
All diploma students will be recommended for internship positions to the industry once the lectures and evaluations have been completed and will also be assisted with job placements at the end of their course.