4 - 6 Months (Self Paced)
Maximum Allowed Duration: 18 Months
Expected Effort: 10 hours/week
This is a unique online training program exclusively for practicing physicians that provides you with the clinical research knowledge, site level understanding of clinical trials and trains you to become a clinical trial investigator.
TOTAL CREDITS: 14
Next Start Date
Why study this program?
The international clinical trial market was valued at $50 billion in 2008 and it is gradually growing at an annual rate of 10% as per a Visiongain report. Developing countries such as China, India, Brazil etc have progressed significantly in this domain and surfaced as locations with huge potential. Various positive aspects have attracted pharmaceutical companies from the West to outsource clinical trials to developing and strengthening economies like India. The most recognizable ones are low cost, presence of a huge patient population ready to participate in clinical trials, a significant number of English speaking certified medical doctors and clinical trial management staff.
This inflow of pharma-biotech funded clinical trials into India has met with a positive interest from the government and led to the formation of regulatory bodies and guidelines for effective conduct of ethical clinical trials. Although a huge number of extremely qualified and competent medical doctors across all therapeutic areas are available in the country, very few have developed their skills for research or hardly have access to the clinical research industry. There are multiple benefits of becoming a trained clinical investigator. In addition to getting paid well by the sponsors for the services offered, doctors who get involved in clinical trials gain more recognition in the medical fraternity. Being a global undertaking, clinical trial investigators get multiple opportunities to travel abroad, participate in meetings, and meet doctors and researchers from other regions of the world. In many instances, clinical investigators get authorship of manuscripts pertaining to the clinical trials in which they participate as investigators which helps them further to gain more recognition.
At James Lind Institute, we have designed a unique online training program, exclusively for practicing physicians that trains them to become clinical research investigators. Our main objective is to provide doctors with the knowledge that they need to get into the clinical research industry as clinical research investigators.
Through this program we also assist all JLI certified clinical research investigators in becoming a part of various site management organizations (SMO) and investigator networks. It is an industry driven effort towards the transformation of qualified medical doctors into trained successful clinical research investigators.
What will be taught?
MODULE 01: FUNDAMENTALS OF CLINICAL RESEARCH
MODULE 02: ETHICS IN CLINICAL RESEARCH
MODULE 03: ROLES AND RESPONSIBILITIES
MODULE 04: CLINICAL TRIAL PREPARATION
MODULE 05: ESSENTIAL DOCUMENTS AND REGULATORY AFFAIRS
MODULE 06: STUDY START-UP
MODULE 07: CLINICAL TRIAL MONITORING & SUCCESSFUL CONDUCT
MODULE 08: COMPLIANCE AND AUDITS
MODULE 09: FINANCIAL MANAGEMENT OF CLINICAL TRIALS
TOTAL CREDITS: 14
MODE OF STUDY: ONLINE
How will I be assessed?
Program assessment is done via online multiple choice questions for each lesson taught in the e-Campus.
Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System
Am I eligible?
The minimum eligibility criteria for the course would include either of the following:
- MBBS / MD / MS
- DM / DNB
- BDS / MDS
- FCPS / MRCP / FRCP / MCh
What support will I receive?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC).
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This program specifically trains physicians on how to become a principal investigator for clinical trials by upgrading their medical practice into well equipped clinical trial sites. This program also opens up a number of other career opportunities for physicians who intend to work in the field of drug development. Positions that can be explored include Clinical Research Associate, Clinical Research Coordinator, Site Monitor, Clinical Trial Manager etc.
If required, JLI can provide reasonable support to all physicians to set-up a clinical trial unit at their place of practice which may be a private clinic or hospital. This support includes assistance in the development of ICH-GCP compliant SOPs, management of facilities available at the site, providing trained and competent clinical research coordinators, etc as may be needed.