1. Sanjeevani Clinical Research Academy

2. SYLLABUS OF
PROGRAM
IN CLINICAL TRIAL,
RESEARCH AND DATA MANAGEMENT
Module–I
Clinical Trials and Clinical Trials Environment
Module-II
Statistics for Clinical Trials
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
PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

3. 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.
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.
PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

4. 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.
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.
PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

5. 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.
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.
PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

6. 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
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.
PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

7. MODULE-V
Regulatory affairs, Good clinical Practices, Pharmacovigilance and Ethics
Good Clinical Practice is an international quality standard that is
provided by International conference of 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.
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.
PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

8. 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.
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.
PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

9. 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.
PROGRAM IN CLINICAL TRIAL, RESEARCH AND DATA MANAGEMENT

10. 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:
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…………………

11. 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
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…………………

12. 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
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…………………

13. 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.
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…………………

14. 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.
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…………………