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AU-KBC RESEARCH CENTRE

 

Course Contents

 

 (Broad  modules in which the ACC-CTM Course would be delivered are listed below . The organizers however reserve the right to modify these contents as felt necessary in the interest of greater effectiveness and value of the courses)

 

PART – I: Theory Classes ( 4 months)

(At AU-KBC Centre, Anna University Chennai)

 

MODULE No

TOPIC OF THE MODULE

NO.OF SESSIONS*

1

FUDAMENTALS OF BASIC & SPECIALITY MEDICAL SCIENCE

14

2

INTRODUCTION TO PHARMACEUTICAL INDUSTRY & CLINICAL RESEARCH

10

3

DRUG DISCOVERY & DEVELOPMENT PROCESS (MOLECULE TO MARKET)

10

4

GOOD CLINICAL PRACTICES

10

5

REGULATIONS IN CLINICAL RESEARCH

10

6

PHASES OF DRUG DEVELOPMENTAL RESEARCH

10

7

CLINICAL TRIAL DESIGNS

10

8

CLINICAL TRIAL DEVELOPMENT

10

9

CLINICAL TRIAL MANAGEMENT

10

10

CLINICAL TRIAL STATISTICS

10

11

CLINICAL TRIAL FINANCE & OUTSOURCING

8

12

PHARMACOVIGILLANCE

10

13

QUALITY CONTROL & QUALITY MANAGEMENT IN CLINICAL TRIAL

10

14

CLINICAL DATA MANAGEMENT

10

15

BIOEQUIVALANCE STUDIES AND MAGNITUDE OF BIOANALYTICAL DOMAIN IN C.R

10

16

PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

8

 

Total

160  (480 Hrs)

 

* One session is 3 hours.

 

PART- II: Onsite Training (2 months)

(At AHERF, Chennai)

 

 

MODULE No

TOPIC OF THE MODULE

NO.OF WEEKS*

1

PRE TRIAL MANAGEMENT

2

2

TRIAL ACTIVITIES

2

3

POST TRIAL MANAGEMENT

2

4

MOCK TRIAL MANAGEMENT

2

 

Total

8 weeks (336 hrs)

                       

*   Each week is 5 days (Mon-Fri), 9.00AM – 5.00PM

 

 

PART- III: Internship (6 Months)

(At the different locations of Apollo Hospitals)

 

 

On completion of the four months Theory course at AU-KBC Centre (PART –I), and two months on site training at AHERF, Chennai (PART-II), the students will do 6 months’ internship as CLIINICAL RESEARCH COORDINATOR (TRAINEE- CRC) at an AHERF site of one of the Apollo Hospital centres of Ahmedabad, Bangalore, Chennai, Hyderabad, Madurai and Mysore.

 

The interns will work as per the available trials in areas of Cardiology/Oncology/ Diabetology/ Neurology/ Gastro-enterology/ Respiratory/ Medicine/Pediatrics, etc.

 

In general, the interns will carry out the following coordination activities as relevant:

 

  • Site selection.
  • Ethics committee Process
  • Site Initiation
  • Patient recruitment
  • Documentation
  • Monitoring
  • Trial closure
  • Visit to facilities.Laboratory testing procedures with lab kit accountability

 

 

 

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