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AU-KBC RESEARCH CENTRE

Course Modules

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

PART – I Theory Classes ( 3 Months/200 Hrs )

MODULES	TOPICS FOR THE MODULES	SUBTOPICS	NO OF HOURS
A	FUDAMENTALS OF CLINICAL RESEARCH & GCP COMPLIANCE IN CLINICAL RESEARCH BASIC & SPECIALITY MEDICAL SCIENCE	Introduction to Clinical Research	04
		Drug Discovery Process	04
		Principles of Good Clinical Practice & Ethics in clinical research	10
		Good Laboratory Practices	04
		Good Documentation Practices	04
B	MANAGEMENT OF CLINICAL TRIAL	Clinical Trial Recruitment	06
		Clinical Trials – Design & Methodology	08
		Site Management & Monitoring of Clinical Trials	16
		Risk management- Pharmacovigilance and Clinical safety	16
		Bioequivalence and Bioavailability Trials	12
		Bio-analytical techniques –basics	08
		Training in Good documentation/ Medical writing	16
C	QUALITY ASSURANCE AND QUALITY AUDITING PRACTICES & REGULATORY AFFAIRS	Requirements of a good quality management system in clinical research	04
		Total Quality Management (TQM)	04
		ISO – International Standard Organization	02
		Six Sigma- basics	03
		Essential guidelines- GCP	16
		Intellectual Property rights, patents	03
		FDA CFR21	08
		EU directives governing clinical research	04
		UK statutory instruments	02
		Schedule Y	06
D	BASICS OF BIOSTATISTICS & CLINICAL DATA MANAGEMENT	Role of Statistics in clinical practice, sample size and power for a given study design	03
		Statistical principles for clinical trials (ICH GCP E9)	04
		Issues relevant to clinical investigation emphasized, particularly the use of randomization, blocking, stratification and adequate sample size	03
		Clinical Database & Types	02
		Management of Clinical Data / Data Management Plan	04
		Electronic Data Capture, e-CRF design Considerations and tracking	04
		Introduction to Clinical Data Interchange Standards Consortium (CDISC)	02
		Use of SPSS/STATA for managing, cleaning, describing, and analyzing data	04
		Computer literacy	04
E	PERSONALITY MANAGEMENT & COMMUNICATION SKILLS	Office etiquette Time and Territory management	02
		Dealing with Investigators, IEC, Auditors, Sponsors	02
		Problem solving capacity	01
		Importance of teamwork, building working relationship	01
		Significance of Training in clinical research	01
		Designing training interventions	01
		Evaluation of Training	01
		Time management	01
			Total Hours - 200

PART – II On-Site Training ( 3 Months/200 Hrs )

(Monthly Breakup)

a.	PreTrial Activities	8 days
b.	Trial Activities	8 days
c.	Post Trial Activities	8 days

PART – III Internship ( 2 Weeks/100 Hrs )

• 7 days of Practical Training at AU-KBC Research Centre,MIT campus,Anna University on Bio-Analytical Techniques/Clinical Data Management

• 7 days in AHREF, Chennai sites as Trainee Clinical Research Coordinators

• On completion of the Three months Theory course at AU-KBC Centre (PART –I), and Three months on site training at AHERF, Chennai (PART-II), the students will do 7 days internship in AHERF, Chennai sites as CLIINICAL RESEARCH COORDINATOR

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

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

i. Site selection

ii. Ethics committee Process

iii. Site Initiation

iv. Patient recruitment

v. Documentation

vi. Monitoring

vii. Trial closure

viii. Visit to facilities. Laboratory testing procedures with lab kit accountability

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