BIOINFORMATICS INSTITUTE OF INDIA

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DETAILED SYLLABUS FOR ADVANCE PROGRAM
IN CLINICAL TRIAL, RESEARCH AND DATA
MANAGEMENT
BIOINFORMATICS INSTITUTE OF INDIA
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SYLLABUS OF ADVANCE PROGRAM IN CLINICAL
TRIAL, RESEARCH AND DATA MANAGEMENT
ModuleI Clinical Trials and Clinical
Trials Environment
Module-II Statistics for Clinical Trials
BIOINFORMATICS INSTITUTE OF INDIA
Module-III Clinical Data Management
Module-IV Contract Research
Module-V Regulatory Affairs, GCP,
Pharmacovigilance and Ethics
Module-VI Practical Medical Writing and
Documentation
Module-VII Research Study
ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
DATA MANAGEMENT
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MODULE-I
CLINICAL TRIALS CLINICAL TRIALS ENVIRONMENT
Clinical trials are conducted to allow safety
and efficacy data to be collected for new drugs
or devices. These trials can only take place once
satisfactory information has been gathered on
the quality of the product and its non-clinical
safety, and Health Authority/Ethics Committee
approval is granted in the country where the
trial is taking place.
BIOINFORMATICS INSTITUTE OF INDIA
CONTENT

• About Introduction, Features of clinical trials,
  Bioavailability Studies,
• Designing of Clinical Trials Studies,
  Clinical Trials Delivery Model,
• Clinical Trial Environment, Non-Clinical
  Safety Studies,
• Choice of Control Group, Patient Recruitment,
  
• Case Studies Audit Of Clinical Trials.

ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
DATA MANAGEMENT
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MODULE-II
STATISTICS FOR CLINICAL TRIALS
Statistics play an essential part throughout any
clinical trial, from planning, conduct, interim
analysis and final analysis and reporting. The
statistician devises the randomization schedules.
Advice on sample size criteria for measuring
treatment differences and analysis of response
rates are all the responsibility of the
statistician. Time to an event of interest is
often used as an endpoint for evaluation of
therapies in clinical trials. Time to recurrence
of disease, duration of complete remission, and
overall survival are examples.
BIOINFORMATICS INSTITUTE OF INDIA
CONTENT

• About Types of Data, Descriptive Statistics,
  measure of
• central tendency, percentiles variability
  measure, normal distribution,
• statistical inference, sampling distribution,
  The Central Limit theorem,
• interval estimation-distribution, types of
  error, ANOVA, chi- square,
• The randomized complete block design,
  regression and correlation.

ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
DATA MANAGEMENT
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MODULE-III
CLINICAL DATA MANAGEMENT
A Clinical Data Management System or CDMS is used
in clinical research to manage the data of a
clinical trial. The clinical trial data gathered
at the investigator site in the Case Report Form
are stored in the CDMS. To reduce the
possibility of errors due to human entry, the
systems employ different means to verify the
entry. The most popular method being double data
entry. Once the data has been screened for
typographical errors, the data can be validated
to check for logical errors. An example is a
check of the subject's age to ensure that they
are within the inclusion criteria for the study.
These errors are raised for review to determine
if there is an error in the data or clarification
from the investigator is required.
BIOINFORMATICS INSTITUTE OF INDIA
CONTENT

• Introduction, data definition, clinical
  databases and types,
• Computers in clinical trials, Data Acquisition
  and storage,
• Electronic Data Capture, CRF (clinical
  research form),
• coding of data, software tools,SAS
  programming,
• program documentation, program validation,
• and development of data entry platforms.

ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
DATA MANAGEMENT
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MODULE-IV
CONTRACT RESEARCH
A Contract Research Organization (CRO) is an
organization that offers clients a wide range of
pharmaceutical research services. In the Code of
Federal Regulations (CFR), the U.S. Food and Drug
Administration regulations state that a CRO is
"a person i.e., a legal person, which may be a
corporation that assumes, as an independent
contractor with the sponsor, one or more of the
obligations of a sponsor, e.g., design of a
protocol, selection or monitoring of
investigations, evaluation of reports, and
preparation of materials to be submitted to the
Food and Drug Administration
BIOINFORMATICS INSTITUTE OF INDIA
CONTENT

• Introduction of Contract Research Organization,
  Contract Research
• Areas, Delivery Models, Business Environment,
  Information Source,
• IT and Contract Research, Regulatory affairs
  and contract research and
• case- studies.

ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
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MODULE-V
Regulatory affairs, Good clinical Practices,
Pharmacovigilance and Ethics
Good Clinical Practice is an international
quality standard that is provided by
International Conference on Harmonization (ICH),
an international body that defines standards,
which governments can transpose into regulations
for clinical trials
Pharmacovigilance is the science of collecting,
monitoring, researching, assessing and
evaluating information from healthcare providers
and patients on the adverse effects of
medications, , herbalism and traditional
medicines with a view to identifying new
information about hazards associated with
medicines preventing harm to patients.
BIOINFORMATICS INSTITUTE OF INDIA
CONTENT

• Schedule-Y, application of permission, approval
  of clinical trials,
• responsibility of sponsor, informed consent,
  principles of ICH-GCP,
• Institutional Review Board/Independent Ethics
  Committee (IRB/IEC),
• Bioethics, Ethics, Pharmacovigilance, Drug
  approvals ,
• Drug Registry and safety.

ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
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MODULE-VI
Practical Medical Writing and documentation
Medical writing is the activity of writing
scientific documentation by someone who is a
specialized writer (a medical writer) and is
generally not one of the scientists or doctors
who performed the research. A medical writer is
anyone engaged in communication in the medical or
allied professions and sciences. The purpose
of medical writing is to have a writing
specialist work together with the people who
produce the scientific data in order to create
documents that effectively and clearly express
the messages the data have to tell. The medical
writer also serves to make sure that the
documents comply with any regulatory, journal or
other guidelines in terms of content, format and
structure.
BIOINFORMATICS INSTITUTE OF INDIA
CONTENT

• Preparation of Protocol, Design a Research Study,
• Tabulation of Data, Analysis, Technical
  writing of a Report and
• Drafting of the protocol for clinical trial
  study.

ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
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MODULE-VII
RESEARCH STUDY

• To provide skills to scrutinize information,
  to critically analyze
• and carry out research, and to communicate
  effectively.
• To describe the uses and applications of the
  main types of
• intervention studies clinical trials and
  community trials.
• To describe the essential features and stages
  in the conduct of a clinical trial,
• and the role of randomization, use of
  placebo, blinding / masking and
• intention-to-treat analysis.
• To discuss the ethical issues involved in the
  conduct of a clinical trial.
• Arranging site visits for practical exposure
  of the students.

BIOINFORMATICS INSTITUTE OF INDIA
ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
DATA MANAGEMENT
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CAREER PROSPECTS AND JOB PROFILES IN CLINICAL
RESEARCH
Career prospects include a professional career in
Clinical Research industry either as a clinical
investigator, site coordinator in at a hospital
conducting clinical investigations or CRO
(Clinical Research Organization). Jobs are also
available in pharmaceutical industry, drug
development, medical writing, biostatistics or
as a Manager of Clinical Project, Clinical
Research Business Development, Clinical
Operations, Data Management, Regulatory Affairs
and Auditing of Clinical Trials. You can build
up your carrier in clinical trials as
BIOINFORMATICS INSTITUTE OF INDIA
Clinical Research Associate

• The main function of a clinical research
  associate is to monitor clinical trials.
• He or she may work directly with the sponsor
  company of a clinical trial, as
• an independent freelancer or for a Contract
  Research Organization (CRO).
• A clinical research associate ensures
  compliance with the clinical trial protocol,
• checks clinical site activities, makes on-site
  visits, reviews
• Case Report Forms (CRF) and communicates with
• clinical research investigators.

..CAREER PROSPECTS
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Clinical Research Investigator

• Conduct BA/BE studies as per cGCP guidelines,
  Writing/revising
• SOP for clinical operations. Review of
  protocols, Investigators Brochures,
• ICF and CRFs Protocol, CRF and ICF
  preparation Plan conduct of
• BA/BEIEC/IRB affairs-GC.

Study Coordinator
BIOINFORMATICS INSTITUTE OF INDIA

• Study coordinators work directly with study
  volunteers, providing them safety
• and protection while collecting and managing
  the study data.
• They promote, advertise, and conduct telephone
  and face-to-face
• screenings to recruit volunteers. During the
  study process, they assess
• volunteer condition and coordinate ongoing
  clinical/laboratory testing
• and physical exams. Coordinators may assess
  vital signs (height, weight,
• blood pressure, pulse), and some are trained
  to collect blood/urine specimens
• and perform lung function testing. Study
  coordinators follow up with volunteers
• after the study and manage a great deal of
  paperwork, electronic
• correspondence and data.

..CAREER PROSPECTS
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Data Manager / Biostatistician

• Biostatisticians collaborate with researchers to
  design studies that
• may show the seriousness of a disease, predict
  a specific disease's
• seriousness, evaluate a new treatment, assess
  the safety and
• effectiveness of medications and increase
  knowledge of environmental issues.
• Additionally, biostatisticians participate in
  research design, data collection,
• choosing and implementing appropriate
  methodologies,
• and interpreting the results.

Regulatory Affairs Manager
BIOINFORMATICS INSTITUTE OF INDIA

• Responsible for review registration of
  documents as per
• country specific guidelines for export.
  Evaluation of technical data
• answer to various related queries as per
  regulated semi regulated
• requirements. Liaison with regulatory
  authorities.

Clinical Trials Auditor

• Conducts audits for the regulatory/QA function
  within the Clinical Trials
• Department in order to help assure compliance
  with GLP/GCP in
• accordance with established FDA regulations
  and company policies and
• standard operating procedures Job Requirements
  Normally B.A./B.S. in
• Science w/1-2 years of experience.

..CAREER PROSPECTS
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Clinical Project Manager

• Responsible for ensuring compliance across
  projects to all
• applicable Clinical Trial regulations,
  guidelines, SOPs Protocols and
• procedures. Coordinate project start-up,
  project maintenance and project
• close-out activities, Serve as the primary
  contact for the Sponsor and
• all project team members, Direct supervisory
  responsibility for project
• Coordinators, project Assistants, CRAs, etc.

Clinical Research Manager

• Manage interdisciplinary clinical research
  projects, as Project.
• Supervise, train, and mentor Clinical Research
  staff, Approve investigator
• study budgets and contracts, Review and approve
  regulatory and
• administrative documents, develop protocols and
  approve
• Case Report Forms (CRFs), Review Tables and
  Listings generated
• from study data. Author Clinical Study Reports.
  Train CRAs on monitoring,
• internal procedures, and query, resolution.

BIOINFORMATICS INSTITUTE OF INDIA
Business Development Manager

• Identify potential clients establish business
  relations
• convert into real business. Responsible for
  all Business Development
• functions Meeting new clients, following up on
  leads, CRM.
• Continuously monitor the Competition and
  Global Market.

..CAREER PROSPECTS
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Drug Safety Associate

• Manage and relay drug safety information,
  maintain current knowledge
• of global drug safety regulations, summaries
  clinical safety data, participate
• in meetings with potential and actual study
  sponsors, write narratives with
• medical input from a physician, report SADRs
  to the Regulatory Authorities,
• participate in the training of operational
  staff on drug safety issues, quality control
• work of other staff in the department, take on
  any other task as assigned by the manager
• or Medical Director within the capabilities of
  the Drug Safety Associate.

Medical Writer

• To prepare high quality documents, manuscripts,
  abstracts and
• other communication tools (slide presentations,
  posters etc.) for
• publishing in indexed scientific/medical
  journals or for presentation
• in scientific/Health Authority meetings.

BIOINFORMATICS INSTITUTE OF INDIA
Clinical Data Manager

• The Clinical Data Manager (CDM) ensures complete,
  accurate
• and consistent data for reporting to regulatory
  bodies. A CDM is involved
• in the setting up, running and reporting of
  clinical trials.
• The CDM processes data using a range of computer
  applications
• and database systems to support collection,
  cleaning
• and management of patient data.

..CAREER PROSPECTS
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PROGRAM FACULTY / TEAM
Dr. Neena Valecha (Scientist F) (National
Institute of Malaria Research )
Dr. Kumud Sarin (Ph.D, Delhi University)
Mr.G.K.Srivastava M.Sc. (Molecular Biology and
Biotechnology) (Tezpur university) PG DIP. in
Clinical Research and Clinical Data Management
Dr.Anirban Das (M.Tech IIT,Delhi) ( Ph.D, Jamia
Milia Islamia University )
BIOINFORMATICS INSTITUTE OF INDIA
Ms Charu Agarwal (MBA, Biotechnology, Amity
University)
Mr. Jitendra Chaudhary (MBA,Mktng, Symbiosis,
Pune)
Ms Shikha Kaushik (B.Pharma, UPTU)
Many more expert faculties from industry
FOR PROFILE VIEW CLICK HERE
http//www.bii.in/page/academic_program/Advance_Pr
ogram_crct_prospectus.asp
ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
DATA MANAGEMENT
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For more details of BII you can visit on
following links
BIOINFORMATICS INSTITUTE OF INDIA
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ex.asp
ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
DATA MANAGEMENT
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PROGRAM AWARD
After completion of the Program the participant
will be provided with the following certificate
(Sample)
BIOINFORMATICS INSTITUTE OF INDIA
ADVANCE PROGRAM IN CLINICAL TRIAL, RESEARCH AND
DATA MANAGEMENT
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THANK YOU
BIOINFORMATICS INSTITUTE OF INDIA
For Further Details Enquiries
Contact Bioinformatics Institute of India C-56A
/ 28, Sector 62 Noida 2010301, U.P Tel
0120-4320801/02 Mobile [phone],
9810535368 Email info_at_bii.in Visit www.bii.in