The Post Graduate Diploma/Executive Diploma in Clinical Research has been structured by experts from the industry themselves and thus comprehensive coverage and understanding of the industry and its functional areas is promised. The online course has following tempting features which are definite to benefit one to all participants of the course:

Comprehensive information, clearly targeting the healthcare industry; Well-structured course, intelligently put together under guidance of industry experts from same field; Easy to use, browse and explore e-tools woven remarkably well into the course make the study material, lectures, online database, examination preparation modules as well as assessment papers easily accessible.
E-tools make the course self-paced and online exams make things easier and less complicated for the participants. Clinical Research Industry in constantly growing and recessions proof but at the same time very challenging and dynamic. Only professionally trained employees get to make their mark and reach pinnacles of success in this fast moving sector of the health care industry. Thus IGMPI targets to teach, train and polish aspirants in Clinical Research professionals with clear understanding and complete knowledge of this industry and its working.
The course is meant for all those keen on being a part of Clinical Research industry, so all graduates, post graduates and even working professionals can apply for the programme and affirm a strong position in the industry.

Programme Modules

Module 1: Introduction to Clinical Research Process

• Clinical Research Industry
• Difference between Clinical Research and Clinical Trials
• Clinical Research Terminologies
• General Medical Terminologies

Module 2: General Pharmacology and Mechanism of Drug Action

• Basics of Pharmacology
• Pharmacodynamics
• Pharmacokinetics
• Routes of Administration
• Dosage forms

Module 3: Drug Development Process and Clinical Drug Development Phases

• Drug discovery
• Target Identification
• Lead Identification
• Lead Optimization
• Preclinical studies

Module 4: Historical Perspectives of Clinical Research

• Evolution of Ethical and Regulatory Framework
• Nuremberg Code, 1946
• Declaration of Helsinki
• Thalidomide Tragedy
• Belmont Report
• Schedule Y, Drugs and Cosmetics Act 1945

Module 5: Ethical Issues in Clinical Research

• History of ICH
• ICH Guidelines
• ICH GCP- E6 R2
• ICMR Ethical Guidelines
• Ethics on use of Placebo in Clinical Trials

Module 6: National and International Regulations Governing Clinical Trials

• CDSCO, India
• ICMR, India
• USFDA, USA
• EMEA, Europe
• MHRA, UK
• TGA, Australia

Module 7: Clinical Research Stakeholders and Core Team: Roles and Responsibilities

• Investigator
• Sponsor
• Contract Research Organization (CRO)
• Clinical Research Coordinator (CRC)
• Clinical Research Associate (CRA)

Module 8: Research Methodology and Applied Biostatistics

• Defining the Research Problem
• Sampling Design
• Hypothesis testing
• Parametric and Non parametric test
• Scientific Writing

Module 9: Types and Designs used in Clinical Research

• Diagnostic and Treatment Trials
• Interventional and Observational studies
• Case control and Cohort studies
• Randomized controlled trials
• Quasi experiments

Module 10: Clinical Research Documentation

• Essential Documents before, during and after the trial_ICH GCP
• Protocol
• Informed Consent Documents
• Investigator’s Brochure
• Case Report Form
• Clinical Study Report

Module 11: Clinical Trial Data Management

• Introduction to data management
• Electronic Data Records
• E-CRF & Interactive Web Response Systems
• Database locking and unlocking
• Good Documentation Practices

Module 12: Pharmacovigilance and Safety Monitoring

• Adverse Drug Reaction
• Serious Adverse Events (SAE)
• SAE Reporting timelines
• Pharmacovigilance methods
• Signal Detection and Data Mining
• PvPI
• Risk Management Plan

Module 13: Quality Assurance and Quality Control in Clinical Trials

• Introduction to Quality Management System
• Quality Assurance
• Quality Control
• Audits and Inspection
• Types of Audits
• General Audit Observations

Module 14: Pharmacoepidemiology and Pharmacoeconomics

• Pharmacoepidemiology- Methods
• Clinical Application of Pharmacoepidemiology
• Principles of pharmacoeconomic analysis
• Pharmaceutical Outcomes evaluations

Module 15: Medical Device Clinical Trials (MDCTs)

• Medical Devices Rules, 2017
• Classification of Medical Devices
• Materiovigilance
• Phases of Medical Device Clinical Trials

Module 16: Medical Writing (Protocol, ICD, CRF, CSR) for Clinical Trial and Regulatory Submission

• Case reports
• Article writing
• Designing Clinical Trial protocol
• CRF Designing
• Informed Consent Documents
• Clinical Study Reports

Module 17: Virtual Clinical Trial (Role of Artificial Intelligence (AI) and Machine Learning (ML))

• E-Consent (Audio visual consent)
• E-Patient Reported Outcomes (e-PRO)
• IWRS
• Telemedicine
• Patient e Diaries
• Remote Patient Monitoring

Module 18: Clinical Trial- Latest Updates

• ICH-GCP_E6 R3
• NDCT Rules: 2019 & its Amendment (2023)
• ICMR-HMSC
• Recent CDSCO Notices
• NABH Ethics Committee Standards, etc.)

Module 19: Industry Based Case Studies

Eligibility

Any Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHMS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

The duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Executive Diploma).

Programme Mode

Registrations are currently open for regular and online both modes.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• – Assignments for all the programme modules for continuous evaluation and guidance.
• – Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• – Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination.
• – All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• – Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• – At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• – All learning and training delivery initiatives shall be conducted in English.

Examination & Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme. This programme is approved by Quality Council of India (QCI), Government of India

All the participants are obliged to timely submit completed assessment assignments (during the programme, usually after every module) and appear for an online exam at the end of the programme. After successful completion, the participants will receive a certificate of Post Graduate Diploma/Executive Diploma in Clinical Research by Faculty of Clinical Research, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical like IQVIA, Parexel, Syneos Health, Fisher Clinical Services, Dr. Reddy’s Laboratories, Divi’s Laboratories, GVK Biosciences, Avra Labs, SRL Ranbaxy, Torrent Pharmaceutical Ltd., Novartis Life Sciences, Jubilant Lifesciences Ltd., Aurobindo Pharmaceuticals Ltd., Venus Remedies Ltd., etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects of Training in Clinical Research

IGMPI offers professional and industry oriented training in Clinical Research thus opening doors for entry into the industry. PG diploma in CR adds advantage for those already in the industry as a tag of professional training and those new to the industry feel comfortable with backing of apt and up-to-date information and training required to sustain and grow in the industry.
PG Diploma in Clinical Research is a broad spectrum programme which offers to entail the candidate with knowledge and practically important information about the industry type, working modalities, methodology of trials, techniques of quality control, drug development, post marketing safety checks and all other aspects related to the clinical research industry. With the completion of this programme the candidate gets to select from varied work areas of the industry/sector of his/her interest. Knowing all faces of the industry, candidate can target to specifically enter the drug development, CTs, Data Management, Regulatory Affairs, Quality Assurance or Post marketing Surveillance teams of various Pharmaceutical companies. Same is true for the professionals who are already a part of the industry but are keen on making lateral movement in their company by shifting to other department.

 

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Programme Fee Details

For further enquiries, write to or call us on:
info@igmpi.ac.in / 18001031071 (Toll Free),  Phone: +91 11 26512850

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