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AU-KBC RESEARCH CENTRE

 

COURSE MODULES FOR P.G.C.T.M – AUKBC Research Centre

(Subject to modifications as felt necessary in the interest of greater effectiveness)

 

MODULE

TOPIC OF THE MODULE

SUBTOPICS IN A MODULE

M I

Fundamentals of Clinical Research &  GxP compliance in clinical research

 

1.      Introduction to Clinical Research

2.      Drug Discovery Process

3.      Principles of Good Clinical Practice & Ethics in clinical research

4.      Good Laboratory Practices

5.      Good Documentation Practices

 

 

M II

Management of Clinical Trials

 

1.      Clinical Trial Recruitment

2.      Clinical Trials – Design & Methodology

3.      Site Management & Monitoring of Clinical Trials

4.      Risk management- Pharmacovigilance and Clinical safety

5.      Bioequivalence and Bioavailability Trials

6.      Bioanalytical techniques –basics

7.      Training in Good documentation/ Medical writing

 

 

M III

 

 

Quality assurance

and Quality auditing practices &

Regulatory affairs

 

 

1.      Requirements of a good quality management system in clinical research

2.      Total Quality Management (TQM)

3.      ISO – International Standard Organization

4.      Six Sigma- basics

5.      Essential guidelines- GCP

6.      Intellectual Property rights, patents

7.      FDA CFR21

8.      EU directives governing clinical research

9.      UK statutory instruments

10.  Schedule Y

 

M IV

Basics of Biostatistics

&

Clinical Data Management

 

 

1.      Role of Statistics in clinical practice, sample size and power for a given study design

2.      Statistical principles for clinical trials (ICH GCP E9)

3.      Issues relevant to clinical investigation emphasized, particularly the use of randomization, blocking, stratification and adequate sample size

4.      Clinical Database & Types

5.      Management of Clinical Data / Data Management Plan

6.      Electronic Data Capture, eCRF design Considerations and tracking

7.      Introduction to Clinical Data Interchange Standards Consortium (CDISC)

8.      Use of STATA for managing, cleaning, describing, and analyzing data.

9.      Computer security

 

M V

 

“Personality Management”

(Personality Development, Survival skills, Team management, importance of training, Technical skills)

 

 

 

1.      Office etiquette Time and Territory management

2.      Dealing with Investigators, IEC, Auditors, Sponsors

3.      Problem solving capacity

4.      Importance of teamwork, building working relationship

5.      Significance of Training in clinical research

6.      Designing training interventions

7.      Evaluation of Training

8.      Time management

9.      Computer literacy

Industrial Visits

Industrial Visits

1.      Minimum of Three times in the entire course duration

2.      Visits covering CROs, Investigator sites( Hospitals), Diagnostic laboratories

P.P

 

Project Preparation

 

 

1.      Projects will be given to a Group of five students and they will be expected to complete within three weeks after the completion of the training program

 

* As per university norms

 

Note:

 

The practical sessions includes but not limited to

 

1. Training on preparation of Protocols

2. Training on preparation of Informed Consent Form/ Document

3. Training on preparation of SOPs (Standard Operating Procedure)

4. Training on preparation of Investigator Brochure

5. Basic exposure to Statistical software

6. Basic exposure to pharmacokinetic software

7. Basic exposure to volunteer/patient management system

8. Basic exposure to HPLC & LCMS/MS operations

9. Periodic visits to CRO/ Hospital/ Data Management organization/ IEC to understand the practicalities 

Etc...

 

 

 

 

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