Course Content

(Broad modules in which the ACC-CR 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 Research Centre, MIT Campus of Anna University, Chennai)

MODULE NO:	TOPIC OF THE MODULE	NO.OF SESSIONS*
1	FUNDAMENTALS 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	10
12	PHARMACOVIGILANCE	10
13	QUALITY CONTROL & QUALITY MANAGEMENT IN CLINICAL TRIAL	10
14	CLINICAL DATA MANAGEMENT	10
15	BIO-EQUIVALENCE STUDIES AND MAGNITUDE OF BIO-ANALYTICAL DOMAIN IN C.R	10
16	PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS	8
	TOTAL	160 (480 Hrs)

*One Session is Three Hours

PART – II : Onsite Training (2 Months)

9 weeks (270 Hrs)

(At AHERF, Chennai)

It will cover the following activities:

• Hospital visit to Laboratories (Hematology, Biochemistry, Microbiology and Histopathology), various departments – Cardiology (ECG, 2D Echo, TMT), Radiology department (X-ray and Ultrasound), Nuclear imaging, Pulmonary function Test lab, Renal Dialysis Units, Neurophysiology (EEG), etc.
• Assignments, Clinical Trial Documents preparation (Feasibility questionnaire, Study Protocol, Informed Consent Form, Case Report Form, etc.)
• Training on Source Documentation, Informed Consent Process, Safety reporting, Regulatory obligations, Ethics Committee submissions and notifications, Trial Agreements and Budgeting, etc.
• Case studies, MCQs.
• Interactions, Group discussions.
• GCP Workshop from sponsor Cos.
• Visits to R & D centres, Research Institutions, Preclinical testing labs, BA/BE centres, Drugs and Vaccines manufacturing units, etc.
• IT skill development
• Periodic communication and personality development sessions.

PART – III : Internship as Trainee CRC (6 Months)

(At the different locations of Apollo Hospitals Educational and Research Foundation, Clinical Trial Sites in Chennai)

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 undergo Six months Rotatory Internship as a Trainee Clinical Research Coordinator at any one of the Apollo Hospitals Educational and Research Foundation, Clinical Trial Sites in Chennai.

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

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

• Site Feasibility.
• Site selection.
• Budgeting and Finance.
• Managing the Investigator site file.
• Ethics committee submission and notification process.
• Site Initiation.
• Patient recruitment.
• Informed consent by Principal Investigator, Screening and Randomization.
• Documentation.
• Safety events reporting.
• Monitoring .
• Investigational product accountability.
• Trial close out.
• Laboratory sample collection and processing.