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PG Diploma in Clinical Research Practices

 

The Global Certificate Course is Foundational to Advanced Clinical Research Programme offered by Enlife Foundation to enable you to work in different roles to conduct clinical trials and BA/BE studies and enter >40 billion $ Industry of clinical research. The global clinical trials market size is expected to reach USD 68.9 billion by 2026, according to a new report by Grand View Research, Inc. It is projected to expand at a CAGR of 5.7% during the forecast period. 

‘The programme is offered to produce:

 

 Specialists in clinical research to lead Clinical Trials and BA/BE studies

Course Description

Introduction to fundamentals of clinical trials, including design, conduct, analysis and interpretation of trial results. Topics will include commonly used designs, methods for randomization, blinding, sample size determination, choice of controls, collaborative/multicenteric trial requirements and operational issues, data management and data quality issues, interim analysis methods, critical review of clinical trial results, and statistical techniques for analyzing data.

Online learning Management System

Unique course with text, audio, video, projects, etc. online

Course Objectives

This course is designed to familiarize students with clinical trials, including design, conduct, analysis and interpretation of results. After completion of the course, the students should be able to:

a. Identify basic characteristics of a clinical trial and differentiate clinical trials from other types of clinical investigations and epidemiologic studies.

b. Apply basic principles to design a clinical trial.

c. Construct randomization schemes and determine sample sizes for trials of simple designs.

d. Identify the basic ethical principles that should guide the design of clinical trials, apply them in the design of a clinical trial, and use them to critique the     designs of others.

e. Specify variables requiring special attention for quality control and set up monitoring procedures.

f. Identify and compare interim analysis options for safety and efficacy studies.

g. Review critically the published results of a clinical trial.

            h. Apply appropriate statistical techniques for the analysis of clinical trial data.

Learning Elements

This professional course is delivered through Online Learning Management System, handbook, Multimedia lecture, web-portal discussion, teleconference, online assignments and examination. Assignments will be handover for evaluation of Clinical Research practice.

 

Examination

 

Students are required to work for the assignments and submit them before scheduled time. It is mandatory to appear for online examination as per the schedule. The project work has to be submitted at the end of the session to show the credentials of the student. Students are evaluated for the theoretical and practical knowledge to determine the professional skill development during this course.



Program(s) Overview:

 

Certificate Course in Advanced Clinical Research Program consists of multi-disciplinary development of skills including Induction, Self-reading, Assignment, Project Work & Award of Credits.

Program Element

Duration

Mode

Description

Personal Induction

1 hour

Teleconference

Induction with students to give the overview on the programme.

Self-Reading

100 days

Study Handbook

Customized study literature with detailed theoretical program.

Literature Review

60 days

Literature CDs

National and International Regulatory guidelines to conduct the Clinical trials. 

Regular Assignment

10 days

Paper Based

Participant’s perception & opinion on pre-designed case studies.

Project Work

60 days

Dissertation

Dissertation submission on a relevant topic that has been mutually agreed between the participant & the program co-ordinator.

Award of Credits

30 days

Certification

Evaluation of project work by experts, compilation of credits & certification.

Participants are required to secure minimum qualifying credits at individual level and an overall 60% (and above) cumulative credits for the successful completion of the respective program. Participants unable to secure minimum qualifying credits would be given one more chance to attempt the assignment and/or project work. A fee of Rs.12000/ would be applicable for all reappearing participants. Failure to qualify the repeat chance would require a fresh enrollment (if desired by the participant).

CURRICULUM:

Modules tailored to enable you to work in Pharma company, Clinical Research Organisation, Research Institute, etc. in different capacities like CRA, CTM, PL, Medical Writer, QA Manager, PV Manager, Investigator, Lab manager, etc. 

      

Module 1: Introduction, Overview and Scope

Module 2: Good Clinical Practices

1: Ethical Conduct

2: Protocol

3: Risk Identification

4: Benefit-Risk Assessment

5: Review by Independent Ethics Committee/

Independent Review Board

6: Protocol Compliance

7: Informed Consent

8: Continuing Review/Ongoing Benefit-Risk

Assessment

9: Investigator Qualifications

10: Staff Qualifications

11: Records

12: Confidentiality/Privacy

13: Good Manufacturing Practice

14: Quality Systems

Module 3: Regulatory References: 

Documents on CD – National Good Clinical Practice and Other Guidelines

Module 4: Ethical Consideration in Biomedical Research

Module 5: Regulations in Clinical Research

Module 6: Investigator’s Standard Clinical Practice 

Module 7:  Design and conduct of Clinical Trials

Module 8: Bioavilability and Bioequivalence

                             Documents on CD [Modern Biopharmaceutics and Guidelines]

Module 9: Quality Assurance and Control in Clinical Research

Module 10: Source Documentation

Module 11: Clinical Research Software’s [CD]

Award of Certification

All the successful students excelling with considerable progress in clinical research will be awarded with the Certificate after successful completion of the program.

 

Pragramme Schedule

 

Session : 15, April 2020 – 15, Sept 2020


The minimum eligibility for admission in which is a 55% score in graduation in the Medical science courses (MBBS, BDS etc.) or Degree in Science, Pharmacology, Pharmacy, Life Sciences, Biotechnology etc. pursued from a recognized university.

 

The average tuition fee for this Diploma is INR 12000/- for the complete program with opportunity to earn internship on merit basis. Such postgraduates get to work as Investigator, Managers, Project Leaders, Medical Writers, Clinical Research Associates, Clinical Research Physicians, Clinical Research Coordinator, Bio-statistician, Clinical Research Analyst etc. Canada, Singapore, Hong Kong visa guidance given to avail channels to get giant leap. 

 

Course design based on latest guidelines, FDA regulations and sponsors systems to you to step-up

This Diploma program designed in such a way that it helps the aspiring candidates in learning about the latest regulations, bioethics, GxP, SOPs & guidelines that goes around in a hospital or a clinic. The course curriculum is such that it equips the candidates with the right skills required to assist in the preparation of presentations and manuscripts of scientific meetings and technical medicine journals.

The program is built so as to produce quality clinical research analysts having the right skill set needed to work in the clinics and hospitals. Diploma in Clinical Research course opens a wide array of career options for the candidates. From working in the medicine department such as hospitals and clinics to working as a teacher or lecturer at a college, candidates can choose to pursue anything they wish to.

Selection process

Send your biodata to contact@enlifeint.com

 

Fees

INR 12000/-  in two installment 6 monthly 

 

Next session

Session 1: April 2020 

 

Internship

Get opportunity to work on clinical trial projects based on your merit basis

 

References /readings

1. https://www.grandviewresearch.com/industry-analysis/global-clinical-trials-market

2. https://www.grandviewresearch.com/press-release/clinical-trials-market

3. http://ficci.in/sector/77/Project_docs/ficci-sector-Clinical_Research.pdf

4. https://www.phrma.org/-/media/TEConomy_PhRMA-Clinical-Trials-Impacts.pdf

 
 

CR course