clinical research - handbook
TRANSCRIPT
CLINICAL RESEARCH TRAINING PROGRAM
PROGRAM HANDBOOK
Facilitator: IHET
About Texila American University
Texila American University (TAU) is located in Guyana, the only English-speaking country in South America.
TAU offers Health Science programs with a high level of professionalism, exactness and problem solving
skills, upon which the foundations of specialist training and an independent medical practice can be built,
which facilitates further education and development of their knowledge throughout their life.
The curriculum at the TAU is structured after the best U.S. medical schools. The academic program is both
accelerated and rigorous, with a focus on preparing students for licensure in the United States, Caribbean
and India. The Program curriculums are designed to reinforce the enduring tenets of the practice of
medicine and ensure the ability of understanding and handling the changing demands of heath service in
the various fields of society
Students at TAU are presented with, and challenged to adopt, the ethics and values that apply to all health
professions. Putting the patient first, improving the lives of the underserved, emphasizing health care for
rural populations, celebrating diversity wherever we find it and developing cultural competency are all
essential to the daily practice of health professionals.
In clerkships students acquire in-depth clinical experiences to sharpen their communication and healthcare
problem-solving abilities. Students are advised to participate in an outreach & volunteer programs where
they receive practical training in delivering health care services.
TAU offers full-time programs in MD-Medicine, Dentistry, Nursing, Pharmacy and other Allied Health
Science programs. TAU also offers PhD in Clinical Research through on line learning. TAU operates on a
system in which classes begin in January June and October.
ABOUT GUYANA
Living in Guyana is a wonderful experience and would be one of the finest environment and climatic
conditions for your studies. Guyana is an amazing blend of the Caribbean and South America and is the
only English speaking Country in South America. The beautiful country is a tropical paradise and has much
to offer; adventure, tranquility, history, beauty, nature and an inimitable blend of warm and friendly
people with the richness of many cultures.
The Republic of Guyana lies in the north-east of South America, north of the equator. It is bordered by
Suriname on the east, Brazil on the south and Venezuela on the west, and to the north and east, extends to
the North Atlantic Ocean.
The coastal plain, along which the majority of the population lives, is flat but the country is famous for its
mountain ranges, lush forests, vast savannahs and above all the majestic Kaieteur Falls with an overall drop
of 251 meters and a sheer drop of 226 meters. It is richly endowed with natural resources, extensive areas
of fertile agricultural land, vast stretches of tropical hardwood forests most of which are still untouched, a
rich fishing and scrimping continental shelf, a wide variety of minerals (including gold, diamond and some
semi-precious stones, bauxite and manganese) impressive resources for hydropower generation and
potential for petroleum
ABOUT ALLTERE
Alliance Learning, Training & Education REsources [ALLTERE], Education Management Company is an
education project management company managing projects in China & Philippines from 2003. ALLTERE has
a wide experience in transnational education in India and abroad. ALLTERE has been recruiting students
from over 25 countries to study in China and Philippines in the last 3 years. ALLTERE has its registered
office in Hong Kong and operational regional offices in India, China, Malaysia, Mauritius and USA.
•••• ALLTERE is an Education Management Company, and is the Project management arm of Texila
American University
•••• ALLTERE manages campus programs in partnership with world class universities in China,
Philippines & India and has over 1500 students from over 40 nationalities in these countries studying
in ALLTERE programs.
•••• ALLTERE have offices in Guyana, India, China, UAE, Philippines, Thailand, Mauritius and Kenya.
•••• ALLTERE manages a network of over 300 Recruitment associates in over 40 Countries.
•••• ALLTERE LIFE VARSITY delivers online programme which is backed up by tutor support. Students
are able to download research materials, interact with tutors and fellow students, submit work and
check assessment results.
ABOUT INTERNATIONAL HEALTH AND EDUCATIONAL TRUST (IHET)
ALLTERE operates IHET: Non profit, Non- Government organization was set up in 2003 with Padmashree Dr
P.R.Krishna Kumar as the Managing Trustee. This Non-profit organization has interests in establishment of
medical and health science programs all over India. IHET stemmed the idea of creation of ALLTERE [Alliance
Learning Training and Education Resources] in Hong Kong which works with various leading medical
university worldwide and has established various programs in health science and related faculties.
Currently IHET is involved in establishment of post graduate medical training programs, Continuing medical
programs and clinical research worldwide in association with TAU. IHET also runs pre medical programs in
India.
TAU and IHET specialize in garnering education and medical resources worldwide in giving great learning
experience to the students in providing complete guidance, in the form of structuring the courses and the
curriculum, the Study materials, etc. . . . And award Certificates, Diplomas and Degrees after due process
of Conducting examinations and evaluations.
Texila American University and IHET are now in set out providing an international magnitude to Clinical
Research Education in India.
WHY TAU
•••• Texila American University is recognized by NAC and is also going for various accreditations
worldwide like WHO , FAIMER and IMED
•••• Texila American University is having MOU’s with various CRO’s and hospitals in USA and Brazil. Hence the
university delivers the not only the course but organize clinical rotation for the student if needed
•••• Texila American University provides dual degree programs in association with University of Guyana
which is the top ranked university in Guyana
•••• Mou’s are signed with hospitals like Georgetown Public Hospital Corporation (GPHC), which is rated
as the best hospital in the country
•••• Certification by a premier university recognized globally
•••• Courses designed and developed by experts in clinical research
•••• Teaching by experienced professionals from industry and academia
CLINICAL RESEASRCH – AN OVERVIEW
Clinical Research - a multinational, multibillion, multidisciplinary industry
Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering
Or verifying the Clinical, Pharmacological (including pharmacodynamic and pharmacokinetic) or adverse
Effects with the objective of determining safety and efficacy of the new drug.
Clinical Research is conducted in 4 phases:
Phase I trials This is the first time the new drug is administered to a small number, around 20-80 healthy, informed
Volunteers under the close supervision of a doctor which may take several months to complete. The study
is designed to determine the effects of the drug on humans including how it is absorbed, metabolized, and
excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70%
of experimental drugs pass this phase of testing.
Phase II trials In this phase, the medicine is administered to a group of approximately 100-300 informed patients to
determine the efficacy of the drug. Most phase II studies are randomized trials where one group of
patients receives the experimental drug, while a second "control" group receives a standard treatment or
placebo. Often these studies are "blinded" which means that neither the patients nor the researchers
know who has received the experimental drug. This allows investigators to provide the comparative
information about the relative safety and effectiveness of the new drug. About one-third of experimental
drugs successfully complete both Phase I and Phase II studies.
Phase III trials It involves randomized and blind testing in several hundred to several thousands of patients and can last
for years, This provides a more thorough understanding of the effectiveness of the drug, the benefits and
the possible adverse reactions if any. If the results are favorable, the data is presented to the licensing
authorities for a commercial license.
Phase IV trials
Also Called Post Marketing Surveillance. This is a surveillance operation phase after the drug has been
approved for consumer sale. The main objectives at this stage is : (1) to compare a drug with other drugs
already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of
life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new
therapies. Phase IV studies can result in a drug being taken off the market or restrictions of use could be
placed on the product depending on the findings in the study.
Clinical research is a branch of medical science that determines the safety and effectiveness of edications,
devices, diagnostic products and treatment regimens intended for human use. These may be used for
prevention, treatment, diagnosis or for relieving symptoms of a disease. The term clinical research refers
to the entire biography of a drug from its discovery in the lab to its introduction to the consumer market
and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-
clinical (animal) and Clinical (Human) studies where different aspects of the drug including its efficacy and
toxicity are studied.
The global pharmaceutical market is estimated at US$ 427 billion and Research & Development cost is
estimated at US$ 60-65 billion annually. Two thirds of this amount is spent on Drug Development, ie,
approximately US$ 40 billion. Clinical Trials involve almost 70% of time and money of new Drug
Development. Cost of conducting Clinical Trials for a new drug is approximate US$ 200-250 million
sometimes extending to $ 800 million.
Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has
opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is
worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over
70,000 people in the UK and they form one third of the total Research and Development staff. These large
numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The
average nominal annual salary growth across all the positions is 4% as against less than 1% for other
segments
AN INDIAN PERSPECTIVE
India is fast becoming a significant hub for conducting global clinical trials. From a small base India is
accelerating and on course to potentially conduct nearly 5%of all global clinical trials by 2012. Also, India
has several prized attributes for clinical trial development, some of which are:
Availability of Medical, Pharmacy and Science graduate
1. Excellent infrastructure facilities
2. Comparative cost advantage,
3. Large and diverse patients pool for conducting clinical trials
4. Changes in the Patent Laws
6. State of the art and yet cost effective trial sites
5. High percentage of English speaking Medical
6. Professionalism and timely completion of projects
With India offering 10-year tax concessions on revenue to local companies making Research &
Development (R&D) investments, a substantial increase in R&D activities of both multinational and
domestic biopharmaceutical companies is inevitable. Analysts are projecting that total Clinical Research
spending in India will increase by more than 30% annually through 2010. A study by Ernst and Young
indicates that the total market value of Clinical Research activities performed in India is expected to grow
to around USD 1.5-2 billion. Many pharmaceutical and Clinical Research organizations have already come
forward to unlock the vast potential that India has, and are conducting Clinical Trials in India. Thus, there is
expected to be a huge demand for qualified and trained Clinical Research professionals. Salaries start at Rs.
1.5 lacs p.a. and go to over Rs. 15 lacs p.a. for professionals with less than 5 years’ experience. Clinical
Research, therefore, promises to be an interesting career option in India.
India is increasingly being recognized as a quality player and a preferred partner for global clinical trials.
According to McKinsey Report, the global clinical trial outsourcing to India in the pharmaceutical industry is
estimated to reach around Rs 5,000 crores by the year 2010 and there will be requirement of
approximately 50,000 Clinical Research professionals.
Research spending in India will increase by more than 30% annually through 2010. A study by Ernst and
Young indicates that the total market value of Clinical Research activities performed in India is expected to
grow to around USD 1.5-2 billion. Many pharmaceutical and Clinical Research organizations have already
come forward to unlock the vast potential that India has, and are conducting Clinical Trials in India. Thus,
there is expected to be a huge demand for qualified and trained Clinical Research professionals. Salaries
start at Rs. 1.5 lacs p.a. and go to
over Rs. 15 lacs p.a. for professionals with less than 5 years’ experience. Clinical Research, therefore,
promises to be an interesting career option in India.
DEVELOPING A CAREER IN CLINICAL RESEARCH
• When recruiting staff the industry often looks to other health professions and to those with health
or science related backgrounds, perhaps working in more junior roles in pharmaceutical companies
or clinical research organizations.
• The industry traditionally attracts professionals from a range of backgrounds, including pharmacy,
nursing, medicine, life science graduates and academic researchers.
• These are the type of professionals who can quickly develop into good clinical trial managers as
they already have experience in a relevant area.
• Reaching a senior position in the clinical trials industry can be more lucrative than the reaching the
top of the pay scale in many other health fields, such as nursing or dietetics. For these health
professionals it can be a good career move as it allows the opportunity to capitalize on existing
expertise as well as to develop new skills.
• Working in clinical trials also allows a high degree of patient contact to be maintained, something
which can be lost as people progress through a more traditional career path, often ending up in
managerial positions.
• As outlined above, the clinical trial sector is expanding at a fast pace, and has a growing need for
professionally qualified, experienced staff to manage clinical trials now and into the future.
• Increased legislation, introduced over the last five years, and more rigorous protocols and
processes, mean academic qualifications are becoming more important.
• According to industry reports, India is the second largest pharmaceutical market in Asia growing by
more than 9% annually. According to a report, there are more than 50,000 jobs in clinical research
in India alone.
Recognizing this issue, the TAU and its delivery partner IHET Education Management Company have
launched Programs in Clinical Research to help meet the need and increase the talent pool of qualified
individuals available to the sector.
CAREERS IN CLINICAL RESEARCH:
• Clinical Research Associate,
• Clinical Trial Administrator,
• Project Manager,
• Medical Writer,
• Quality Assurance Manager/ Executive,
• Medical Advisor (These positions are exclusively for medical professionals, the rest are available for
any life sciences graduate/post graduates),
• Medical Monitor,
• Data Entry Operator, Data Manager, Data Validator, Bio-statistician,
• Manager- Regulatory Affairs.
SELECTION PROCESS /CRITERIA
Will be based on Merit / Interview:
The selection process will be open, transparent and accountable. Every applicant who fulfils the eligibility criteria will be given an opportunity to compete for the available seats.
TEACHING METHODOLOGY
The courses will have regular classroom lectures, seminars, readings, tutorials, group discussions,
assignments, , case presentations, home work and lectures by eminent guests from academia and industry
SCHEDULE OF COURSES
1. Ph. D. (Doctorate in Clinical Research)
� Distance Learning with Online Support with the help of Webinars, Video Lectures and Audio
Lectures.
� It is the prerogative of the candidate to choose a suitable recognized Guide in relation to
His/her Research Topic.
� The selected person should be a recognized Guide.
� The Guide for candidates should be a Ph.D. /MD in Pharmacology with at least three years teaching
experience
� TAU University will appoint a co- guide.
2. M.Sc. (Clinical Research)
a) Full time :( Mondays- Fridays + Online Support)
b) Part Time: (Weekends on Saturdays & Sundays + Online Support)
c) Distance Learning: (Online Support and the help of Webinars, Videos Lectures and Audio
Lectures.)
3. Post-Graduate Diploma in Clinical Research (PGDCR):
a) Full time: (Mondays- Fridays + Online Support)
b) Part Time (Weekends on Saturdays & Sundays + Online Support)
c) Distance Learning: (Online Support with the help of Webinars, Videos Lectures and Audio
Lectures.)
4. Certificate Courses (PG Certificates in Clinical Research)
Part Time (Weekends on Saturdays & Sundays + Online Support
EVALUATION CRITERIA
1) Internal Assessments:
Internal assessment comprises of two internal tests and one assignment in each subject. Maximum
weight age for internal assessment is 40% of the total marks in each subject.
2) Course End Final Examination:
The weight age for the Final examination will be 60% of the total marks for each subject.
AWARD OF CERTIFICATES
Candidates who successfully complete the course and pass the examination will be awarded relevant
Certificates by Texila American University
FAQ’s IN CLINICAL RESEARCH
Q. What opportunities does Clinical research industry offer?
Clinical research is all set to become the next big thing in India. Indian pharmaceutical industry is one of the
fastest growing sectors of the Indian economy and has made rapid strides over the years. . According to
industry reports, India is the second largest pharmaceutical market in Asia growing by more than 9%
annually. A number of factors favor India as a clinical research hub.
• There are numerous government-funded medical and pharmaceutical institutions with state-of-the-
art facilities, which can serve as ideal centers for multi-centered clinical trials.
• India boasts of well-trained and qualified manpower well versed in English.
• The research and the development process in India can be done at a more affordable price.
• More importantly, there is vast clinical material, which can be utilized, due to the prevalence of a
large variety of diseases, including widespread cases of cancer and diabetes.
• India is viewed the world over as the ideal location for clinical research trials for the
pharmaceutical industry.
Q. What will be the outcome of this course?
After completion of course the Participants should be able to:
1. Have better understanding of Good Clinical Practice and Standard Operating Procedure for Clinical
Research and Clinical Data Management.
2. Contribute more effectively in their profession pharmaceutical/ biopharmaceutical companies in drug
development, CROs offering clinical research and clinical data management services, to pharma or biotech
industry, or academic research institution or as clinical investigators at hospitals/ medical sites conducting
trials on subjects.
3. Support overall clinical trial process electronically by implementing Electronic Data Capture (EDC)
system and Project Monitoring.
4. Participate in design, conduct and management of global clinical trials conducted at multicentre sites
in India and Overseas.
5. Have an understanding of evolving regulatory process standards and practices of ICH GCP in conduct
of different therapeutic trials for preparing the submissions made to the regulatory authorities for seeking
market authorization in India, US, EU, Japan etc
Q .How does Full Time/Part Time Program differs with Distance Learning?
Distance learning modules are suitable for the students who cannot attend the class room programs due to
the logistical and financial reasons. Distance learning programs offer such students an equal opportunity to
increase their skills in the field of clinical research. However, in the distance learning we offer limited
contact program in some cities. The workshops and seminars in a center near the students’ location will be
organized periodically.
Q .What does Distance Learning study material consists of?
Webinars to be conducted so as to provide an interaction with the student and faculty. Study materials will
be put up in websites so as to take printout of study materials for the students. Lot of learning videos and
other resources are available in the platform.
Q. What are the prospects in Clinical research industry?
Job 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. According to a survey, there are 2, 50,000 vacancies available worldwide 50,000 job
openings in India by 2010. Highest remuneration packages owing to the shortage of skilled professionals.
Q. What could be your expected remuneration on completing a course in clinical research?
Remuneration: There is a high demand for trained professionals in this field; the pay package is impressive
at the entry level. Fresher’s can expect a pay packet of around three lakh or more per annum. If you have a
master's degree backing your qualifications, then the amount is almost doubles. Clinical research is an
industry where experience counts, thus the longer you are in this field; higher the salary you can expect.
Q. What is the scope abroad for Clinical Research?
Scope Abroad: The clinical research industry worldwide is growing at unparalleled rate. It has opened up
new vistas for employment for a large number of trained professionals. The clinical trials market worldwide
is worth over USD 26 billion and the industry has employed an estimated 2,10,000 people in the US and
over 70,000 in the UK, and they form one-third of the total research & development staff. There are
more than 2,50,000 positions vacant globally and salaries vary in the region of approximately USD 40,000
per annum for a Clinical Research Coordinator.
Q. How TAU – IHET Programs differ from others?
The validation of the programs is through TAU which has international standard faculty. The online
instructors are an internationally diverse group based around the world. They are recruited both for their
expertise and their ability to be catalysts for high-level discussion in the online learning environment.
CLINICAL RESEARCH PROGRAMS OFFERED
1. Ph.D. Clinical Research (Part Time /Online)
2. M.Sc. Clinical Research (Full Time/Part Time course/Online)
3. PG Diploma in Clinical Research (Full Time/Part Time course/Online)
4. PG Diploma in Clinical Research and Regulatory Affairs (Full Time/Part Time course/Online)
5. PG Diploma in Clinical Research and Clinical Data Management (Full Time/Part Time course/Online)
6. PG Diploma in Clinical Research and Pharmacovigilance. (Full Time/Part Time course/Online)
7. PG Certificate Course in Clinical research and GCP/GLP / ICH (Full Time/Part Time course/Online)
8. PG Certificate Course in Clinical Research (Full Time/Part Time course/Online)
SYLLABUS
1. Biomedical - Pathophysiological Basis of Diseases: (3 Credits)
Pathophysiology of Diseases of, Neurological, Cardiovascular Haematological, Respiratory, Renal,
Gastrointestinal, Endocrine system, Lymphatic system, musculoskeletal system, Reproductive and
Endocrine system
2. Pharmacology and Pharmacotherapeutics –I: (3 Credits)
Basic Principles of Pharmacology, Mechanism of Drug action, Adverse Drug Reactions, Pharmacogenetics
and Pharmacogenomics. Drugs acting on Autonomic nervous system, Central nervous system,
Cardiovascular, Haematological, Respiratory, Gastrointestinal ,Renal, Endocrine Lymphatic,Musculoskeletal
Reproductive systems . Pharmacology of Autocoides
3. Pharmacology and Pharmacotherapeutics – ІІ: (3 Credits)
Pharmacology of Antimicrobial and Chemotherapeutic Agents, Antineoplastic agents, Immunosuppressants
and Immunostimulants, Hormones and Antagonists, Dermatologic and Ocular agents.
4. Drug Discovery and Drug Development Process: (2 Credits)
History of Drug Discovery and Drug development Process. Strategies, Techniques and Approaches
employed in Drug Discovery, New Chemical Entity Identification. Preclinical and Clinical studies, Ethical
and Regulatory Issues.
5. Fundamentals of Biostatistics: (1 Credit)
Fundamentals of Statistical Concepts applicable to Medical and Clinical Research. Application of various
Statistical Analysis Methods, Research Designs to Data commonly encountered in the Biological, Clinical,
and Medical studies and Research. Basic concepts in Statistics which includes Sampling procedures ,
Presentation of Data, Descriptive and Inferential Statistics, Probability, Confidence Intervals, Hypothesis
testing, , Regression, Parametric and Non-parametric methods and Design of Experiments.
6. Introduction to Clinical Trials: (2 Credits)
History of Clinical Research, Phases of Clinical Trials. Responsible Persons involved in the Trial. Trial
Process from Initiation to close out. Randomization, blinding, Regulatory and Ethical aspects, Audit,
Monitoring. Responsibilities and duties of Organizations and Personnel involved in Clinical Trials.
7. Principles and Practice of Clinical Trials: (3 Credits)
Historical, Ethical and Regulatory Foundations of Current Requirements for Research involving Human
Subjects. Detailed Clinical Trial Process. Primary and Secondary Objectives of Clinical Research. Protocol
Development and writing of Clinical Research Protocols, SOPs, IND, NDA Applications for Approval.
Introduction to Essential Documents. Practices including Trial Designs. Analysis and interpretation of
Clinical Trials Data. Safety Monitoring Boards, FDA Regulations, Patient Recruitment and Retention and
Exclusion. Responsible persons involved in Data management in clinical trial.
8. Regulatory Affairs in Clinical Trials: (2 Credits)
Issues Relating to Regulatory Legislations, Indian GCP guidelines (Schedule Y ), USFDA, ICH, GCP and ICMR
Guidelines, Regulatory Guidelines of European Union and Japan. Responsibilities of Sponsor, Investigator,
IRB/IEC, Monitor, CRA, CRC. Detailed description of Essential Documents, Investigational New Drug
Application [IND], New Drug Application [NDA]
9. Bioethics – Ethical Aspects of Clinical Trials. (2 Credits)
Ethical aspects in the Practice of Clinical Research. An overview of the tragedies of the past. Establishment
and organization of ethics committees / IRB, Informed Consent. Ethical Principles of Autonomy,
Beneficence, Nonmaleficence , justice and application of these Principles to Clinical Research involving
Human Subjects. Use of Unproven Therapies, Placebos, Consent process, IRB submission and Review
Processes.
10. Clinical Data Management: (3 Credits)
Collection of Data and their Management prior to Analysis. Data Management Plan, CRF Design
Considerations. Data Cleaning, Data Processing, Data changing Issues. CRF Tracking, Managing Lab Data.
Collecting Adverse Event Data. Creating Reports and Transferring Data and Discrepancy Management.
Necessary infrastructure, SOPs and Guidelines, System validation, Test Procedures etc. Data Management
Systems. EDC [Electronic Data Capture], Coding Dictionaries, Migrating and Archiving Data. Quality Control
and Quality Assurance etc
11. Pharmacovigilance and Safety: (2 credits)
Basic Concepts and Definitions, Scope and Epidemiology of Adverse Events. Product Recall and Withdrawal
of Drugs with specific examples and Drug related Deaths, Causality Assessment, Dechallenge and
Dechallenge, Periodic Safety Update Reports, Pre and Post Market Risk Management. Responsibilities of
Stake holders. Regulatory Reporting Norms of different Nations.
12. Quality Control, Audit and Inspection in Clinical Trial: (2 Credits)
Introduction to Quality in Clinical Research. Quality control and Quality Assurancs of the Conduct of Clinical
Trials. Auditing and Monitoring of Sponsor. IRB, IEC. QA and QC tools for Audits, Preparation and Conduct
of Audit. Process Mapping. FDA, EMEA, MHRA, DCGI Inspections.
13. GCP/GLP/ICH.for Doctors, Pharmacists and Nurses: (2 Credits)
Introduction to Clinical research and Phases in clinical research. Principles of Good Laboratory Practices
(GLP) and Good Clinical Practices (GCP). Indian GCP, ICH. ICMR Guidelines, Declaration of Helsinki, Ethical
Considerations. Regulatory Guidelines of other Countries. Responsibilities of Sponsor, Investigator, IRB/IEC,
Monitor, CRA, CRC. Detailed Description of Essential. Documents, Investigational New Drug Application
[IND], New Drug Application [NDA].
14. Research Project; (10-15 Credits):
Project Report under the Guidance of Investigator in Clinical Trial Environment.
15. Medical writing / Reporting: (2 Credits)
Principles involved in writing and Reporting Clinical Trial Results General writing skills, Writing Scientific
Abstracts. Anatomy of a Research Article, Submitting and Revising Papers for Publications. Oral
Presentations, Use of Audio-Visual Aids, Power Point and Poster Presentation etc.
16. IPR- Intellectual Property Rights: (2 Credits)
IPR law in India, US, Europe and Japan. Filing and Protection of Patents, Copy Rights, Trade Marks, Copy
Rights, Trade Marks, Patents etc.
17. Communication Skills: (2 Credits)
Soft Skills Training, Personality Development Training, Communication and Interpersonal Skills, Goal
Setting, Public Speaking Skills, Leadership Skills. Team Building, Stress Management and Time Management
18. PK, BA, BE In Clinical Trials: (2 Credits)
Design and Conduct of PK studies. Types of BA/BE Studies. Methods to Determine BA /BE, Factors
influencing BA / BE. Comparative Clinical Trials. Documentationand Facilities for conducting BA/BE
Studies, Maintenance of Records and Retention of Samples.
19. Epidemiology: (3Credits)
Principles and Concepts of Epidemiology and Methods for Assessing factors associated with the
Distribution and Etiology of Diseases. Research Study Design. Case Series and Cross Sectional Studies,
Cohort Studies, Case Control Studies. Measures of Association, Bias, Confounding, and Interactions.
Epidemiology of Communicable and Non-communicable Diseases.
20 .Molecular Biology and Biotechnology: (3 Credits)
Structure and Functions of Cell Organelles. Cell Division and Apoptosis. Structure and Propertiesz of DNA,
Discovery of DNA as the Genetic Material. Concept and Definition of the Genome, C-Value paradox,
Denaturation and Renaturation of DNA, Repetitive and Non Repetitive DNA. Prokaryotic
And Eukaryotic Genome Organization. Organization of Viral and Bacterial genome. Definition of gene,
Open Reading Frames. DNA Replication in Prokaryotes and Eukaryotes. Regulation of DNA Replication.
Gene Mutation, types of Mutation. Mutagenic Agents. DNA Repair Mechanisms, DNA Recombination .
Gene Expression, RNA Transcription, Translational Controls. Regulation of Gene Expression, Operon
Concept. Regulatory, Promoter, Operator and Structural genes. Role of CAMP and CRP in Gene
Expression, Oncogenes and their Properties.
21. Pharmaceutical qBiotechnology: (3 Credits)
Pharmaceutical Biotechnology and its future role in healthcare.
Pharmaceutical Applications of Enzymes. Enzyme Immobilization: Various techniques, immobilization of
cells and enzymes and their therapeutic applications. Recombinant DNA technology: Production of
Recombinant Pharmaceuticals: Insulin, Human Growth Factor, Factor VIII, Interferon’s Etc..
A brief introduction to immunology. Monoclonal antibodies and Hybridism technology. Formation and
selection of Hybrid Cells, Principles and productions of monoclonal Antibodies, Synthetic Peptide Vaccines,
Recombinant Antigen Vaccines, New generation Vaccines : , Preparation and Standardization, Principles of
multivalent subunit vaccines
Genetic disorders and gene therapy: Single gene disorders, its molecular genetics, common diseases, anto-
immune diseases, cancer, cardiovascular diseases, nervous disorders. Gene therapy: current Gene therapy
of genetic disorders like cystic fibrosis, Thalassaemia, Neuroblastoma, hepatitis, AIDS, diabetes, hemophilia
B etc.
22. Computer Aided Drug Designing: (3 Credits)
Bioinformatics in Drug Development; Chemo informatics and Pharmacoinformatics. Applications of Drug
Discovery and In-Silico Drug Designing Structure-based drug designing approaches: Target Identification
and Validation, homology modeling and protein folding, receptor mapping, active site analysis and
pharmacophore mapping, Grid maps. Ligand-based drug designing and Docking Ligand-based drug
Designing approaches: Lead Designing, Combinatorial chemistry, High Throughput Screening (HTS), QSAR,
Database Generation and Chemical libraries,. Introduction to docking methods to generate new structure;
Tools and Molecular docking programs:
23.. SAS Programming : ( 2 Credits )
SAS procedures for Data Analysis, Data Relationships, producing data, probability, study of randomness,
introduction to interference, interference for distribution, inference for proportion, inference for two way
tables, inference for regression, one way and two way analysis of variance, logistic regression, parametric
and non parametric tests.
24. Seminars : (1-6 Credits )
25. Assignments ( 1-6 credits)
HOW TO APPLY
Application can be requested from the office through on line.
• Personal statement and description of research experience can be uploaded with the on-line
application or can be sent personally to the office.
• CV must be included as an uploaded file with the application or sent personally.
• Transcripts and Test Scores can be mailed to the address below.
Texila American University
India Office
C/O International Health and Educational Trust (IHET)
#1274, RSB Towers,
MTP Road,
Coimbatore,
Tamil Nadu - 641043.
Mail: [email protected]
Phone: +91 (0) 422 4384871 /09500922262
Fax; +91-422- 4382563
or Specifically write to : CEO [email protected]
TABLE 1. SHOWING CREDIT LOAD OF DIFFERENT COURSES OFFERED IN CLINICAL RESEARCH
(1 Credit is 1 hour theory per week for 16 weeks)
BASIC SUBJECTS CORE SUBJECTS OPTIONAL SUBJECTS
Code Subject Cr Code NO Subject Cr Code Subject Cr
CRB001
CRB002
CRB003
CRB004
CRB005
Biomedical /
Pathophysiologic
al basis of
Diseases
Pharmacology
and
Pharmacotherap
eutics I
Pharmacology
and
Pharmacothera-
peutics II
Drug Discovery
and Drug
Development
Fundamentals of
Biostatistics
3
3
3
2
1
CRC006
CRC007
CRC008
CRC009
CRC010
CRC011
CRC012
CRC013
CRC014
Introduction to
Clinical trials
Principles and
Practice of Clinical
trials
Regulatory affairs
in Clinical Trials
Bioethics-Ethical
aspects in Clinical
Trials
Clinical Data
Management
Pharmaco
vigilancee and
safety
Management
QC ,Audit,
Inspection in
Clinical Trails
GCP/GLP/ICH
Research Project
in Clinical Trails
2
3
2
2
3
2
2
2
10-
15
CRO015
CRO016
CRO017
CRO018
CRO019
CRO020
CRO021
CRO022
CRO022
CRO023
CRO024
Medical writing /
reporting
IPR-
Intellectual
Property Rights
Communication
skills
PK,BA,BE in
Clinical studies
Epidemiology
Molecular
Biology and
Biotechnology
Pharmaceutical
Biotechnology
Computer Aided
Drug Designing,
SAS
Programming
Seminars
Assignments /
Tutorials
2
2
2
2
3
3
3
3
2
1-6
1-6
Table No. 2: CREDIT LOAD AND DURATION FOR PG COURSES IN CLINICAL RESEARCH
S.
NO
Degree
Diploma
Certificate
Trimesters Months Credits Credit Distribution Eligibility
1 Ph.D 6 24 90
(60+30)
Theory
+ Thesis
40 credits from Basic
and Core Subjects
and 20 credits from
Optional subjects
PG Students of
Medicine / Life Science
/ Pharmaceutical /
Nursing / Allied /
Clinical Research
2 MSc 4 18 60
(45+15)
Theory
+ Thesis
30 credits from Basic
and Core Subjects
and 15 Credits from
Optional Subjects
PG / UG Students of
Medicine / Life Science
/ Pharmaceutical /
Nursing / Allied /
Clinical Research
3 PGDCR 2 10 30
(24+6)
Theory
+ Thesis
16 Credits from
Basic and Core
Subjects and
8 credits from
Optional Subjects
PG / UG Students of
Medicine / Life Science
/ Pharmaceutical /
Nursing / Allied /
Clinical Research
4 PG
Certificate
1 6 15 ( 12
+3)
Theory
+
Project
8 Credits from Basic
and Core subjects
and 4 credits from
Optional
PG / UG Students of
Medicine / Life Science
/ Pharmaceutical /
Nursing / Allied /
Clinical Research
Note: Credits earned at one stage can be carried over to another stage for higher Diploma
Or Degree
TABLE .3: Allotment OF COURSES FOR M.Sc. DEGREE IN CLINICAL
S. No
COURSES
SEMESTERS
Code I II III IV
1 Pharmacology and
Pharmacotherapeutics-I
CRB002 3 15
(Theses)
2 Pharmacology and
Pharmacotherapeutics-II
CRB003 3
3 Drug Discovery Development CRB004 2
4 Biomedical Basis of Diseases CRB001 3
5 Biostatistics CRB005 1
6 Introduction to Clinical Trials CRC006 2
7 Principle of Practice of Clinical
Trials
CRC007 3 2
8 Regulatory Affairs in Clinical Trials CRC008 2
9 Ethical Aspects in Clinical Trials CRC009 2
10 Clinical Data Management CRC 010 3
11 Pharmacovigilance CRC011 1
12 Quality Control and Audit in Clinical
Trials
CRC012 2
13 GCP/GCP in Clinical Trials CRC 013 2
14 Communication Skills CRO017 2
15 Medical Writing / Reporting CRO015 2
16 Intellectual and Property Rights CRO016 2
17 Statistical Analysis Software (SAS) CRO022 2
18 Seminar in Clinical Research CRO023 1 1 1
19 Assignments in Clinical Research CRO024 2 1 1
TOTAL CREDITS 15 15 15 15
