Ph.D DEGREE IN CLINCAL &TRANSLATIONAL RESEARCH

Texila American University

PREFACE

Texila American University, college of Medical and Allied Health

Sciences welcomes the prospective candidates for the Ph.D Programme in

Clinical & Translational Research. This hand book provides information

to the Indian Nationals on the rules, regulations, policies and procedures

pertaining to the award of PhD degree in Clinical and Translational Re-

search.

The material containing in the hand book is subject to periodical review at

least once in a year and the changes if any will be updated and posted on

the University website.

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 prob-

lem solving skills, upon which the foundations of specialist training and an independent medical prac-

tice 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 pro-

gram is both accelerated and rigorous, with a focus on preparing students for licensure in the United

States, Caribbean and India. TAU offers full-time programs in Medicine, Dentistry, Nursing, Pharmacy

and other Allied Health Science programs including Clinical Research.

TAU offers National Accreditation Commission (NAC) registered Programs with more number of prac-

tical and lab based education system. Class room learning is complemented by online learning support

with the most Modern Learning management systems with access to thousands of hours of digital learn-

ing contents , open course ware materials and virtual labs.

Realizing the importance and significance of Clinical Research in the process of discovering and intro-

ducing new drugs and regimens in the treatment and management of diseases. TAU has taken an initia-

tive to offer training programs in Clinical and Translational Research from Certificate to Doctoral (Ph.D.)

level, giving this new and exciting field a much deserving impetus and status at global level. TAU oper-

ates on a system in which classes begin in January, May and September.

Accredited Caribbean Medical School

WHO: Texila American University (TAU) is listed in the World Health Organisation - The AVICENNA Directories,

which is a publicly accessible database of schools, colleges, and universities for education of academic profes-sions in health.

UN GLOBAL: Texila American University has been added to register of participants in United Nations Global Compact pro-gram.

IMED TAU is listed in the International Medical Education Directory (IMED). This is an accurate and up-to-date compi-

lation of international medical schools recognized by the appropriate government agency in the medical school's respective country. Recognition by the ECFMG depends directly on whether or not the school is listed in this di-rectory.

IADR The International Association for Dental Research (IADR), headquartered in Alexandria, Va., is a non-profit or-ganization with more than 11,000 members worldwide. Its mission is: (1) to advance research and increase

knowledge for the improvement of oral health worldwide; (2) to support and represent the oral health research community; and (3) to facilitate the communication and application of research findings.

GAME Global Alliance for Medical Education (GAME) is dedicated to the advancement of innovation in medical educa-

tion throughout the world.

AMEE AMEE is an International Association For Medical Education delivers courses on teaching, assessment and re-

search skills for teachers in medicine and the healthcare professions.

NAC TAU is recognised by the Department of Education Via registration with the National Accrediation Council of

Guyana.

SwAPP Our Clinical research program has received accreditation from Swiss Association of Pharmaceutical Professionals

IADL TAU is approved Member with International Association for Distance Learning, United Kingdom.

Accredited Caribbean Medical School

1. Overview of Ph.D. Program:

TAU is committed to promote academic and research activities In basic and applied aspects of medical and related

health sciences. Clinical research is now recognized as critical to advancement of Medical science and public health.

Conducting Clinical research and trials is a complex and resource intensive endeavor and involves a multitude of

disciplines, processes, actors and informational resources. There is an ample need of highly competent and resource-

ful manpower to meet the most demanding expertise to tackle and analyze and present the results of studies in a

meaningful and acceptable manner to the scientific community in particular and to the public at large. Hence Recog-

nizing this issue, TAU has launched Programs in Clinical Research at Doctoral (Ph.D.) level to help meet the increas-

ing need of the talent pool of qualified individuals available to the sector.

1.1 Objectives & Advantage:

TAU has designed the Ph.D. program in Clinical Research to train and provide highly competent and resourceful

manpower to the field with special emphasis on the conduct of Clinical trials in a scientific and ethical environment.

A special feature of the program is the training of the students simultaneously in both the didactic course work and

Practical research. The course is offered on a Part time and Online basis in order to give opportunity to a large num-

ber of aspirants across the country and abroad. Advancement of credits in the coursework for students with MSC in

Clinical research from TAU

1.2 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 pharmaceutical/ biopharmaceutical companies in drug development, CROs offering clinical research and clinical data management services, to pharmacology or biotech industry, or academic research institutions or as clinical investigators at hospitals/ medical sites conducting Clinical trials.

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 multi-centric sites in India and Overseas.

5. Have an understanding of evolving regulatory process standards and practices of ICH and GCP in conduct of dif-ferent therapeutic trials for preparing the submissions to the regulatory authorities for seeking market authorization in India and other countries

2. Registration & Enrollment

2.1 Eligibility (for working professionals)

Applicants for Ph.D. program in Clinical Research must posess:

Any graduate or Post graduate in MBBS/ Pharma/ Clinical Research/ Life Sciences + PG Diploma in Clinical

Research/ Clinical Data Management/ Pharmacovigilance

Min. of 3 Years of experience in Clinical Research/ Clinical Data Management/ Pharmacovigilance & allied

Sciences

Working professionals in Clinical Research Industry with out Master’s/PG Diploma in Clinical Research need to

undertake start up course for 15 credits conducted by Texila American University

2.2 Selection Process

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.

Candidates will be selected on the basis of Entrance Test/Merit/Interview and recommended in-service candidates

from Universities and Industry.

2.3.Admission Requirements

1. Attested copies of Certificates and Transcripts from high School to the last highest qualification in duplicate.

2. Record of any previous research experience.

3. Personal statement or Statement of Purpose, giving details of how the program of study will

help in enhancing their ability and reach career goals and finally contribute to the betterment

of medical and a health care systems.

4. Letters of Recommendation from the Head of the Department or Research guide and two faculty members from

the last college / center of study.

2.4 Application Process

1. Application can be downloaded from www.tauedu.org or it can be send to us via e-mail.

2. An Application Fees of $80(USD) to be filled along with the application.

3. The student need to fill it and e-mail us , as scanned copy with the requested documents.

4. Personal statement and details of the research experience can be uploaded with the online application or can be

submitted to the office, along with scanned copy of the application form.

3.Teaching Methodology:

3.1 Course Work

The courses will have classroom or online lectures, seminars/webinars, readings, tutorials, group discussions, as-

signments, journal clubs, case presentations, home work and lectures by eminent guests from academia and indus-

try. Distance Learning with Online Support with the help of Webinars, Video Lectures and Audio Lectures.

3.2 Thesis

A dissertation or thesis is a document submitted in support of candidature for a degree or professional qualification

presenting the candidate's research work and findings.

3.3 Mentored Research

• Conduct of an independent and original research under the guidance of a mentor /guide along with a co-guide or

a research team is central and significant part of the Ph.D. program

• It is the prerogative of the candidate to choose a suitable primary mentor in relation to his/her Research Topic.

• In special circumstances TAU may provide a mentor from a pool of resource persons registered with the

university

• The selected person should be a recognized Guide.

• The Mentor / Guide for candidates should be a Ph.D. in Medical and allied health and Pharmaceutical Sciences or

life sciences or Ph.D. in Pharmacology or Clinical Medicine with at least three years of teaching and research experi-

ence . TAU will appoint a co- guide

3.4 Selecting a Mentor/ Guide/Co-Guide

Your Mentor/ Guide is likely to be the single most significant individual in influencing the success of

your PhD. Choosing your Mentor, understanding their roles and understanding their advice will be crucial to a

smooth, successful PhD experience.

• I f you do not understand any advice, ask for further explanation

• Do not overburden them with too many similar drafts -

Co-Guide

Co-Guide will be appointed by TAU and acts as a bridge between a student, his guide and the University.

Co- Guide will monitor the student's progress, evaluate and assist the student during his study period.

3.4.1 How to find a Guide

1. The candidates can themselves find their Mentor/ Guide in their own work place, or they can find a guide in Col-

leges of Medicine, Pharmacy and Allied health sciences.

2. Alternatively- They can request university to check if there is any one from their region or neighboring region

who are approved guides of the university.

3.5 The Role of a Guide

• Help a student to define a small project in the first year with a definite deadline, say before April of the second

year (for September start). This will highlight problems in approach and if conducted to conclusion can lead to a

conference paper.

• Make sure the student is familiar with the professional standards of published work by suggesting at least one

good PhD dissertation to read and attend regular reading groups

Ensure that the student understands that original research can only come about after extensive review and analysis

of existing work (published or otherwise), and requires dedicating time.

• Help the student to write concisely and logically. Graphical illustrations can lead to dramatic improvements in

the effectiveness o f writing.

• Ensure the student has a professional attitude to research:

Present legible written work at mutually convenient deadlines.

• Attend weekly supervision meetings and research reading groups with notes on research in

progress, methods attempted, and papers read.

• Treat research like a job and maintain average though flexible working hours (Minimum 8 hrs per working day).

• Encourage the student to give informal seminars and "dry-runs" of conference presentations.

Help the student to learn how to face criticism and acquire presentational skills.

• Arrange periodical progress reviews for the student with the doctoral committee.

• Encourage independence and make sure a student is able to set ones own goals and meet deadlines. Help the stu-

dent to understand underlying problems when one fails to meet deadlines.

Encourage students to give group seminars before writing dissertation and to help organize the structure o f thesis

to be written and presented.

4. Evaluation Criteria

4.1 Course work

4.1.1 Internal Assessments:

• Internal assessment comprises o f two internal tests and one assignment in each subject .

• Maximum weightage for internal assessment is 40% of the total marks in each subject.

4.1.2 External Assessment /Course End Final Examination:

The weightage for the Final examination will be 60% of the total marks for each subject.

The candidate must secure a minimum of 40% for a pass grade.

4.1.3 Comprehensive Examination

After a student has completed all his coursework (typically by the end of 3rd/4th trimester) the comprehensive exami-

nation shall be scheduled with the Ph.D student co-ordinator. The goal of the exam is to :-

Assess the student's understanding of the major areas of the curriculum in the student's specific content area that

is reflected by the student's Course work and advanced electives.

Assess the student's ability to apply that knowledge to answer specific research questions in clinical and transla-

tional science.

Comprehensive examinations will include:-

4.1.3.1 Written Portion

The written portion will include:

Paper I: Research Methodology 100 marks

Paper II: Course work 100 Marks

(Pass grade: Minimum 40% in each paper and aggregate 50%)

4.1.3.2 Oral Portion of the Comprehensive Exam

The student must schedule an oral defense o f the comprehensive exam through the PhD Student Coordinator and

provide the completed written exam report to the Doctoral Program Committee.

A majority of the PhD Program Committee members and at least 1 of the student's research mentors must attend the

oral comprehensive defense, which is otherwise closed to the public.

Comprehensive Exam Outcome Options:

Taking into account both the written and oral portions, the following options are available to the examination com-

mittee when a student takes comprehensive examination:

(i) Pass with distinction

(ii) Pass the overall exam

(iii) Fail the overall exam

4.2. Thesis work

After successful completion of course work and comprehensive examination the candidate will be admitted to

candidacy for Ph.D.

4.2.1 Admission to Candidacy

Admission to candidacy for the PhD degree in Clinical Research constitutes a promotion o f the student to the most

advanced stage of study and provides formal approval to devote essentially exclusive attention to the research and

writing o f the dissertation.

To qualify for admission to candidacy, students must:

• have completed formal course work

• have passed the comprehensive examination

• Students will be informed o f admission to candidacy by written notification.

4.2.2 Formation of Doctoral Committee

Before being admitted to candidacy, TAU will form a Doctoral Committee for each student that will consist of:

Three faculty members, including two members of the TAU faculty, and one member from outside the

Texila University

The doctoral committee will review and approve the research proposal submitted by the candidate under the ad-

vice of his/her Mentor.

If the research proposed in the overview or prospectus involves human subjects, the proposed research must be

approved by the University Institutional Review Board (IRB).

4.2.3 Semester wise Progress Reports

After admission to candidacy for Ph.D programme and approval of his/her project by the doctoral committee the

candidate will start working on his/her project under the guidance of the mentor and submit progress report at the

end of every trimester.

The candidate is required to give 3 copies of progress report in prescribed format to the doctoral committee. The

progress report submitted at the end of each trimester will be assisted by the doctoral committee and their comments

and observations will be communicated to the concerned candidate and the mentor. Any corrective measures or

alterations will be suggested for implementation.

4.2.4 Submission of Ph.D Thesis

Candidates who have completed the minimum period prescribed for thesis work from the date of his/her admission

to candidacy may submit 5 copies of thesis along with synopsis and a soft copy in the form of CD to the doctoral

committee.

The candidate will also submit:

A. Certificate from the mentor and guide under he/she has worked to the affect that the thesis

submitted is a bonafied record of work done by the candidate during his/her period of study and that it has not

previously formed the basis for the award of any degree.

B. No –Due certificate (regarding Fees and Library) from the head of institution where research work was carried out

and the administrative department of learning centre and TAU.

4.2.5 Adjudication of Ph.D. Thesis

The copies of thesis submitted will be sent to at least 3 examiners including 2 from TAU and 1 outside TAU after

ascertaining their willingness to act as Examiners.

The External and the Internal Examiners will adjudicate the thesis and shall send a report based on the following

criteria to the Doctoral Committee within 6 weeks from the date of receipt of thesis.

The criteria include:

1. The critical account of the Research work of the candidate

2. An evaluation of the work in relation to advancement of knowledge.

3. Any points to be clarified and clarification needed at the time of oral examination.

Further the examiner will recommend:

1. That the thesis can be accepted for the award of the degree of Ph.D in the present form.

2. Thesis can be accepted for the award of degree after minor corrections as suggested.

3. The thesis is rejected on the basis of failure to achieve the desired standards.

4.2.6 Scheduling of Defense

Once the thesis is approved and recommended for the award of the degree the dissertation defense must be

scheduled through the PhD Program Coordinator at a time that is convenient for the student and all committee mem-

bers.

The date, place, and time of the examination should be informed well in advance to the student and all committee

members.

4.2.7 Defense of Thesis (Oral)

a. The Dissertation defense is an oral presentation and examination of the student's research.

b. In the defense, the student should provide an overview of the following:

Aims o f the project

Literature from which the project is an outgrowth

Significance and contribution of the project to the research area; methods, analysis, and results; and implications

of the research findings.

The final oral examination in defense o f the doctoral thesis is conducted by the Student's doctoral committee and

can be attended by:

Any member of the Graduate Faculty o f the University may attend and Participate in the examination.

Other qualified individuals may be invited by the committee to participate in the examination.

Only members of the dissertation committee may vote on the passing o f the candidate.

1. A Report of this examination, signed by all the members of the Doctoral Committee, must be sent to the

Dean of the College of Medical and Allied Health Sciences in a Sealed Cover.

2. If the decision of the committee is not unanimous, the case is referred to the Dean for resolution.

5. Applying For Graduation

Students must submit the Graduate Application Form by the due date for the term in which they expect to complete

all degree requirements.

Students should be aware that according to University policy they are responsible for the completion of their degree

requirements. Incomplete grades (G/I) for coursework required for degree satisfaction should be completed before the

week o f final exams o f the term in which a student intends to graduate

6. Award of Degree

The Candidate has to do three publications in any of the reputed journals before the course completion. Based on the

reports and recommendations o f the Doctoral Committee, the University shall award the Ph .D Degree to the candi-

date. The Ph .D degree will be awarded in the field o f Clinical and Translational Research and shall be designated as

a Doctor of Philosophy.

A degree under the seal o f the University and signed by the President will be given to each successful candidate at

the next convocation held for conferring degree.

TABLE SHOWING CREDIT LOAD, ELIGIBILITY AND DURATION FOR PH.D COURSES IN CLINICAL RESEARCH

* Note: Students with out M.Sc. /PG Diploma In Clinical Research/ CDM/PV need to under take a start up course for

15 credits (min 6 months duration) conducted by the university

S. No Eligibility Trimesters Months Credits

1

Any graduate/ Post graduates in Life

Sciences + PG Diploma in Clinical Re-

search/Clinical Data Management/

Pharmacovigilance + Min 3 Years Exp

in Clinical Research Industry

06

30

60 (30+30)

Theory+ Thesis

TABLE SHOWING ALLOTMENT OF COURSES IN CLINICAL RESEARCH IN Ph.D DEGREE

Trimester Course Code Credits

TRIMESTER- I

Computer methods PH001 1

Clinical research Methods PH002 3

Measurement In Clinical Research PH003 2

Introduction To Translational Research PH004 2

Seminar PH005 1

Journal Club PH006 1

TRIMESTER- II

Principles & practices in Palliative care PH007 1

Principle Topics in Medical Informatics PH008 3

Special Issues in Clinical Trials in Older Patients PH009 2

Behavior & Community Health Sciences PH010 2

Seminar PH011 1

Journal Club PH012 1

TRIMESTER- III

Introduction to Systemic Reviews & Meta Analysis PH013 3

Pharmaceutical Biotechnology PH014 2

Statistical Methods & Issues in Clinical Trials PH015 3

Seminar PH016 1

Journal Club PH010 1

TOTAL CREDITS 30

TRIMESTER- IV, V, VI THESIS PH011 30

Advantages of being a Texilla American University student

• Certification by a premier university recognized globally

• Courses designed and developed by experts in clinical research

Teaching by experienced professionals from industry and academia

For more details feel free to contact us at

India– Hyderabad Sub Center Campus

Texila American University Critchlow, Woolford Avenue Georgetown, Guyana, South America.

Telephone: (+592) 2318118 Fax: (+592) 2318111 Website: http://www.tauedu.org

ClinFOX International Off. No: 14 & 15, 1st Floor

Soni Business Complex Prashanthi Nagar, Kukatpally

Hyderabad– 500 072 (India) Contact: Sreedhar Singamala

Mob: +91 9052108526 E-mail– sreedhar@clinfoxintl.com