POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Socrates School Health Pvt. Ltd.: Ajeet Nanda Programme Coordinator Socrates - School of Health New Delhi Office: +91-11-43594466. Mobile: +91-9910104842, 07428386898 Fax No: +91-11-42437231. E-mail: nanda.ajeet@gmail.com, info@socrateschool.com Website: www.socrateschool.com

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Introduction
what is Clinical Research? Clinical Research involves methodical and systematic study of drugs, devices, and biological, vaccines used in the diagnosis, prevention or treatment of disease. During the process of clinical research, the physician is treating an individual with an aim to developing intervention for the patient of tomorrow.

Objective
Post Graduation Diploma in Clinical Research (PGDCR) is a research program of 6 months duration with a primary focus on site training, Drug development, Designing Clinical research, clinical trial processes, Good Clinical Practices (GCP) guidelines, Drug regulatory affairs, Roles and responsibilities of various clinical trial . The mission is to provide on site training thereby enhancing the employment prospects of the participants.

Growth Prospects
India is becoming a hub for clinical research; the demand for professionals in this field is growing rapidly. Clinical research business in India will be worth $1 billion by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential. There are various growth opportunities along the way for those willing to learn. Specialization in branches of pharmacy, life sciences, biochemistry will be useful. Studying further will also help one in bettering their current job profile. For instance doing a masters will enhance the job prospects of a CRA to become a Project Manager. Similarly a PhD in a related discipline is needed to become a Medical Director. According to industry reports, India is the second largest pharmaceutical market in Asia growing by more than nine per cent annually. According to a report, there are more than 50,000 jobs in clinical research in India .Lack of experience is no longer a hindrance and companies are hiring from other streams too. With the influx of multinationals setting up research facilities here, the industry is poised to grow exponentially.

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Job Prospects
Following positions are available to pursue a career in clinical research. Clinical Research branches off into various categories at the entry level.

Clinical Research Associate (CRA)

The main role of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, or from a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, checks source documentation, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. They shoulder the responsibility of planning and implementing all activities required to conduct and monitor complex clinical trials and ensure that Good Clinical Practices are followed.

Business Development Manager

Set sales targets and define strategy to achieve these targets and to follow the set strategy punctually Manage the proposal development process and maintain the time-lines for the proposal teams Coordinate with sponsors concerning size, standards, conditions and timing of research Develop draft proposals based on team meetings and discussions Maintain the Business Development databases Support marketing activities, including trade/ scientific shows, mailings, etc.

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Clinical Data Manager

Maintaining the accuracy, integrity and security of complex, large computerized records system; Applying knowledge of regulations, policies, protocols and/or procedures to control and maintain accurate records; Dealing with a large volume of information which may require the need to be screened, grouped, summarized, transcribed, coded etc. Assisting in standardizing data management procedures; Solving operational/data problems in consultation with other employees and/or supervisors; Maintaining confidentiality of data as required; Preparing a variety of standard statistical reports. General clerical/secretarial duties include data entry, collating library searches, and other related tasks

Project Manager
The Project Manager is responsible for the overall coordination and management of a clinical research project. May be responsible for management of multiple protocols. Provides monitoring, review and tracking of clinical data and preparation of study specific documents according to FDA regulations. Oversees training of site personnel and project team as appropriate. Will work to ensure project moves forward based on both time and budget. The Project Manager will play an integral role in the communication between client and team members and will act as liaison with other divisions necessary to complete the study (i.e., Data Management, Biostats, Medical Writing, Regulatory Compliance, etc.)

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Eligibility
Medical, Dental, Veterinary, Pharmacy, Physiotherapy, Nursing, Biotechnology, Biochemistry, Microbiology, Homeopathy, Ayurveda, Siddha and Graduates / Post Graduates in Life Sciences with any of the following Subjects, Chemistry, Zoology, Biochemistry, Microbiology, Genetics & Biotechnology background are ideal candidates for this unique course.

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Course Curriculum
The Post Graduate Certificate Course in Clinical Research is comprised of the following segments
Module - 1 Introduction to Clinical Research Introduction History of clinical research Drug discovery & development IND & NDA Submit ion Phases in Clinical Research Principal of ICH-GCP guidelines + Indian GCP Schedule Y ICMR Guidelines Assignment Presentation

Module - 2 Responsibility & Documents in Clinical Research

Sponsor's & investigators responsibilities Investigator responsibility Role of CRC & CRA in clinical trail Ethics committee & institutional Board General Pharmacology Clinical Trail Design Protocol Design CRF Design IB Design Essential Documentation in CR Inform Consent Process Assignment Presentation

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Module - 3 Site Activity & Management Site Selection and pre Site Visit Site Initiation Subject recruitment & retention Plan Site monitoring Visit CRF review & source data Verification Drug Safety reporting Site Close out Finance & Budgeting in CR Project planning management CRO/SMO Assignment Presentation

Module - 4 Various Accepts of Clinical Research

Drug Accountability Sop S In CR Audits & Inspection Logs & Forms Introduction to Clinical data management Clinical trial for herbal drugs & traditional medicines Introduction to Pharmacovigilance Biostatics Assignment Presentation

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Two Months on Site Training Regular

Case studies Training on y Protocol y Informed consent process y Screening procedures y Randomization process(IVRS/IWRS) y Subject retention y Subject scheduled and unscheduled visit y Reporting of SAE/AE y EC Communication y Archival GCP training Online GCP training Certificate Exploring Various Visits y Site Selection Visit y Investigator Meeting y Site Initiation Visit y Monitoring Visit y Audits y Interim y Close Out CRF Overview y e CRF y RDC y Paper CRF Handling IP Goods y Drug Receipt & Acknowledgement y Drug Dispensing y Drug Compliance y Drug Reconciliation y Drug Destruction Handling Lab samples y Processing of Samples y Packaging (Ambient & Frozen) Source Documentation IT skill development Periodic communication and personality development sessions.

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Socrates School of Health Pvt. Ltd. An Overview

Socrates School of Health is Clinical Research education and training institute, New Delhi. Established in 2011.Socrates School of Health offers a wide range of job oriented training and educational programs with strong placement support. Students from Medical, Dental, Veterinary, Pharmacy, Physiotherapy, Nursing, Biotechnology, Biochemistry, Microbiology, Homeopathy, Ayurveda, Siddha and BSc, MSc graduates with Life Science background are ideal candidates for this unique course. Some special features of Socrates School of Health courses are three months industry internships, guest lectures by Industry personal, top faculty from industry & academia. We have Clinical Research courses in which we have internships for the period of 02 months as the part of curriculum and we would be keen to send our students for training to Sir Ganga Ram Hospital, Escort Hospital, Max devki devi Hospital, Kalra Hospital, Agarsen Hospital, B.L Kapoor Hospital and other reputated hospital.

From Advisor Vision: - To be at the forefront of education and research through the prerequisite and
application of high quality services exceeding the beliefs of all our stakeholders. Our Endeavour is to constantly deliver the promise of cogent and lucid professional for rendering paramount services in the field of research Drs. JPS Sawhney Chairman Department of Cardiology, Sir Ganga Ram Hospital for a considerable period of time, winner of Gold medals and numerous esteemed National and International awards for his contribution and incessant medical quest for research in the field of Cardiology. His pioneering works include bringing Global clinical trials to our country. He has been principal investigator to multitude of clinical trials the results of which has changed the procedures and process of cardiology in the world.

Directors Foreword
Top Reasons to Join this Institute

y In Six months regular course we provide on site Training for three months.

y We have Clinical Research course in which we have internship for the period of 3 months as the part of curriculum and we would be keen to send our students for training to Sir Ganga Ram Hospital, Escort Hospital, Max devki devi Hospital, Kalra Hospital, Agarsen Hospital and other reputated hospital.
y Onsite Training for Correspondence course can also be provided with an additional payment of INR 50000. y Growth
Job Placement 100% Job Placement for Starting batches. 100% placement assistance for all the candidates.

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Application and Fee

Weekdays course Fee - INR 1 .7Lakh Weekends course Fee - INR 80,000 Correspondence - INR 30,000 Payment Mode Cash/Demand Draft

Assessment Criteria
For Regular Course The written exam is based on the grading mentioned below. For Correspondence Course - The assessment will be sent to the candidate by the institute. The assignment is based on the grading mentioned below. The assignments are required to be submitted to the Institute on or before the scheduled date. After the scheduled dates assignment reaching will not be considered for the evaluation.

Grading
A Excellent 80% and above B Very Good 60% and < 80% C Good 50% and < 60% D Satisfactory 40% and < 50% E Unsatisfactory < 40% Candidates securing D grade and above in all four modules would be eligible to receive Post Graduation Diploma in Clinical Research.

POST GRADUATION DIPLOMA IN CLINICAL RESEARCH (PGDCR) Information Brochure (2012-2013)

Issue of Fresh set of Assignments

Candidates who are not qualifying the written exam or assignment in the first attempt can make a written request for the re-examination and candidate will pay fee of Rs 5000/- . Note : Due to the inability to qualify in the first attempt, failure to which would lead to cancellation of the candidature thereby requiring a fresh enrolment.

Applications
All the applications complete in all respects should be sent to the: The Director Socrates School of Health Head Office: 4A/59, Main Shankar Road, Old Rajinder Nagar, New Delhi-110 060 Ph: 011-42478100, 07428386898, 09910104842 Email: Socrates.schoolofhealth@gmail.com Web: www.socrateschoolofhealth.com