Clinical Research and Data Management

Name of the Department : Department of Botany

Course Directors : Dr. T.V. Ranganathan

Course Coordinator : Dr. S. Rajamani

Duration of the Course : 90 hrs

Total No. of Credits :3

Fees : Rs.5,000/-

Phone Number : +91-9945346132

Email ID : [email protected]

Eligibility : 1st and 2nd year UG students

Objective
 To understand the principles involved in the ethical, legal, and regulatory issues in clinical
human subjects research, including the role of IRBs.
 To become familiar with the principles and issues involved in monitoring patient-oriented
research.
 To understand the infrastructure required in performing clinical research and to have
anunderstanding of the steps involved in developing and funding research studies.
 To become familiar with the basic Biostatistical and Epidemiologic methods involved in
conducting clinical research.

Syllabus
Unit-1 Introduction to Clinical Research
 Clinical Research: An Overview, Different types of Clinical Research.
 Clinical Pharmacology: Pharmacokinetics, Pharmacodynamics, Pharmacoepidomology,
Bioavailability. Bioequivalence, Terminologies and definition in Clinical Research.
  Drug Development Process: Preclinical trail, Human Pharmacology (Phase-I), Therapeutic
Exploratory trail (Phase-II), Therapeutic Confirmatory Trail (Phase-III) and Post marketing
surveillance (Phase-IV).
Unit-2 Guidelines, Regulation and Ethics in Clinical Research
 Brief History of Clinical Research: Sulphanilamide Tragedy, Thalidomide Disaster, Nazi
Experiments, Tuskegee Study, Belmont report, Nuremberg code, Declaration of Helsinki
principles.
 Guidelines in Clinical Research-International Conference on Harmonization (ICH), Guidelines
for Good Clinical Practice, ICMR guidelines for Biomedical Research on Human Subjects,.
 Regulation in Clinical Research- Drug and cosmetic act, FDA, Schedule-Y- Ethics Committee
and their responsibilities.
 Clinical Research Regulatory Submission & approval Process- IND, NDA and ANDA
submission Procedure. DCGI submission procedure. Other Regulatory authorities- EMEA,
MHRA, PhRMA.
Unit-3 Clinical Trial Management
 Introduction: Concept of Clinical Trail Management, Stake holders in Clinical Trail project.
 Sponsors perspective: Responsibility of Sponsors, Study Preparation Initial Documents and
capability assessment, Study feasibility,Vendors/Service provider selection, Investigator
selection,Budgeting in Clinical trail, Clinical Trail Agreement(CTA),Regulatory submission and
approval, Sponsors obligation in Good Clinical Practice.
 Investigator perspective: Investigators obligation outlined in Good Clinical Practice,
Recruitment, Retention and Compliance of study subjects, Ethics committee submission, adverse
event and safety reporting.
 Service provider/Vender perspective: Contract Research Organization (CRO), Site
Management Organization (SMO), Central Lab, Clinical Data Management
Organization(CDMO), Medical Writing Organization, Logistic Management Organization,
Pharmacovigilance Organization.
 Clinical Research Operation, Monitoring and Clinical Evaluation: Project management,
Protocol in Clinical Research, Informed Consent, Case Report Form, Investigator’s Brochure
(IB), Selection of an Investigator and Site, Patient screening, Inclusion and exclusion criteria,
Randomization, Blinding, Recruitment Techniques (materials and methods),Retention and
 complaisance of study subjects, Ethics and Regulatory submission, Monitoring Visits,
Investigator Meeting, Essential Document preparation (IB, ICF, PIS, TMF, ISF, CDA.CTA etc).
 GMP, GLP, QA and QC (Quality Management): International GMP regulation, Indian GMP
regulation, Quality assurance in Pharmaceutical Industry, Quality control in Pharmaceutical
Laboratory, GLP principles: Organizational and personal, Quality assurance program, facilities,
Equipments, Reagents and Materials, Test systems, Test and Reference Items. Standard
Operating Procedure, Performance of study reporting of results, storage of records and reports.
 Responsibility of Clinical Research Professionals:Investigator, Project Manager, Regulatory
Affairs Associate, Medical Writer, Clinical Research Associate, Clinical Research Coordinator
and Safety Report Associate.
Unit-4 Clinical Data Management
 CDM Systems: Clinical data management systems, , Electronic data capture systems, Choosing
vendor products, Implementing new systems, System validation, Test procedures, Change
control, Coding dictionaries, Migrating and archiving Legacy Data,
 Clinical Data Management process-Data management Plan, CRF design considerations,
Database design considerations, Study setup, Entering Data, Tracking CRF pages, cleaning data,
Managing Lab Data, Identifying and Managing the discrepancies, Collecting Adverse Event
Data, Coding Reported terms, Creating report and Transferring data, Closing study, SAS in
Clinical data analysis, Importing data from Excel to SAS, Statistical analysisof SAS datasets.
Standard operating procedures and guidelines for data management.
Unit-5 Pharma Regulatory Affairs
 Phamacovigilance-Safety specification and risk management plan, Drug Hypersensitivity,
Guidelines in Phamacovigilance.
 Drug Regulatory Authorities- Drug policy in India, Regulation on alternative system of
Medicine, Safety of Herbal medicines, Medical and Scientific writing.