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 Commencement Date
Why study this program?
The global market for clinical trials was worth $50 billion in 2008 and is steadily growing at a rate of 10% each year (Visiongain report). India has come a long way since the first GCP clinical trial in 1995 and has emerged as an outsourcing hub. Multiple factors have led to the outsourcing of clinical studies to the emerging markets like India. The most noticeable ones are cost-effectiveness, availability of a large patient pool willing to volunteer for research, a large number of English speaking qualified physicians and clinical trial management staff.
This influx of sponsored clinical studies into India has received favorable attention from the government with the establishment of regulatory agencies for an efficient conduct of ethical clinical trials. Even though there are a large number of highly qualified physicians in India in all specialties, only a few have developed their skills or have access to the clinical research industry. The rewards for becoming clinical investigators are many. Besides being handsomely remunerated for the services offered, physicians who participate in clinical research get more recognition in the scientific community. Since clinical research is a global endeavor, clinical investigators get an opportunity to travel to many countries and meet other physicians and scientists from other parts of the word. In many cases, having authorship of any manuscripts that get published based upon the clinical trials they participated, is also looked as a well-deserved reward for clinical investigators.
At James Lind Institute, we have developed a special course that trains practicing physicians to become clinical research investigators. Our primary objective is to update and equip doctors with the knowledge they will require to enter in the field of clinical research. Our endeavor does not end there. We provide support to all JLI certified physician investigators to build a clinical research unit at their practice site or hospital. This involves development of ICH-GCP compliant site specific SOPs, infrastructure management, providing well trained clinical research coordinators, and any other intellectual and logistic support that may be required.
We also facilitate all JLI certified clinical research investigators in joining various site management organizations (SMO) and investigator networks so that they immediately interface with the industry.
This certificate course at James Lind Institute is completely online, and delivered through a state of the art learning management system. This certificate course in clinical research for physicians is an industry driven effort for transformation of qualified physicians into qualified and trained 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?
Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.
Each student enrolled in the Advanced Certificate in Clinical Research for Physicians Course (ACCRP) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
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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.