Post Graduate Diploma in Clinical Research

Module 1. INTRODUCTION TO CLINICAL RESEARCH

Terminologies and definition in Clinical Research:

Clinical research/ Clinical trial, Adverse event, blinding, Randomization, Bios, Case Report form, Informed Consent Process, Essential Document, Good clinical practice, Investigator, Monitoring, Protocol, Investigator Brochure, Source document, Pre-Clinical Studies, Safety reporting etc.

Origin of Clinical Research and Historical Breakthroughs in Clinical Research

Historical perspective of clinical research and the significance; Discussion on the following incidences.

- Nazi war crime trials,

- Japan's war crime trial,

- Tuskegee syphilis studies,

- Sulphonilamide tragedy,

- Thalidomide disaster,

- TGN 1412

Difference between Clinical Research and Clinical Practice

Types of Clinical Research

Classification of clinical research and the significance

Phases of clinical research

- Phase I- Human Pharmacology studies,

- Phase II- Exploratory trial,

- Phase III- Confirmatory trial,

- Phase IV- Post marketing Surveillance.

Special types of clinical trial

- Geriatric trials,

- Pediatric trials,

- Trial on pregnant woman,

- Quality of life trials,

- Pharmacogenomic trials,

- Pharmacoeconomic trial.

Scope of Clinical Research Indsutry

- The current scenario and prospect of global clinical research industry and its scope

- India as a Clinical research Hub

- Careers prospects in Clinical Research

MODULE 2: PHARMACOLOGY AND DRUG DEVELOPMENT

INTRODUCTION TO CLINICAL PHARMACOLOGY

Definitions:

Drug, Pharmacology, Pharmacokinetics, Pharmacodynamics, Therapeutics, Toxicology, Chemotherapy, Pharmacoepidemiology, Agonist, Antagonist, Receptors, Bioavailability, Area under curve (AUC), Bioequivalence, Chemiequivalence, Therapeutic equivalence, ADME ( Absorption, Distribution, Metabolism, Excretion.)

Pharmacokinetics:

Routes of Drug Administration, advantages and disadvantages, Bioavailability and Bioequivalence (Definitions, Types Factors affecting bioavailability), Significance of BA-BE studies in Clinical Trial.

Pharmacodynamics:

Drug receptors and Modes of drug action

Factors modifying drug action

Adrenergic and Cholinergic drugs

Definitions, Classification and Significance/ uses.

THE DRUG DEVELOPMENT PROCESS

- Drug Discovery: Sources of drug, Drug targets, Target identification, Target validation, Lead identification and lead optimization

- Bioassays and bioanalytic techniques: Different types of Bioassays and their significance; bioanalytical techniques- HPLC, chromatography etc.

- Preformulation and formulation and development Studies: Drug Stability studies, Structure activity relationship (SAR), Dosage form considerations- Different types of dosage forms.

- Preclinical Studies: Animal models and toxicity studies- Acute, Sub-acute, repeated dose, male and female reproductive system, Local toxicity studies, allergenicity and genotoxicity studies, determination of first human dose.

- Clinical development: Phases of clinical research- Phase I, Phase II, Phase III and Phase IV of clinical trials, IND and NDA submissions.

MODULE 3: ETHICS AND GUIDELINES IN CLINICAL RESEARCH

ETHICAL CONSIDERATIONS IN CLINICAL RESEARCH

- Historical guidelines: Nuremberg code, Declaration of Helsinki and Belmont report

- Ethics Committee: Institutional Review Board (IRB), Independent Ethics Committee (IEC), Composition, Requirements, Operations and Functions

- Ethical guideline for biomedical research: ICMR guidelines on human subjects- statement of principles for scientific research on human subjects.

GUIDELINES IN CLINICAL RESEARCH

- International Conference on Harmonization (ICH): Brief history, Structure, Steering Committee, Harmonization Process, ICH finalized Guidelines

- ICH GCP Guidelines

- Indian GCP Guidelines

- ICMR Guidelines for Biomedical Research on Human subjects.

MODULE 4. REGULATIONS IN CLINICAL RESEARCH

- Historical Regulations in Clinical Research and their significance: Nuremberg code, Belmont Report, Declaration of Helsinki

- FDA- Codes of Federal Regulations, IND, NDA and ANDA Requirements

- Indian Regulatory system: DCGI and Schedule Y

- Introduction to other Regulatory Authorities: EMEA, EU, MHRA, TGA, etc.

MODULE 5: CLINICAL TRIAL MANAGEMENT

SPONSOR/CRO/SMO/SITE

Project Management:

- Preparation of a clinical study: Trial Study design- Elements of trial design, Cross over and parallel study design, Randomization and Blinding, Designing a multicentre trial, Protocol - Definition and purpose of protocol, Writing a Protocol, Protocol amendment, Case Report Form (CRF) - Need of CRF, Designing a CRF, Informed Consent Form (ICF) - Designing, Ethical consideration in Informed consent process, Investigator's Brochure (IB)

- Budgeting In Clinical Research

- Outsourcing in Clinical research: Contract Research Organizations (CRO), Site Management Organizations (SMO) and other vendors' roles and responsibilities

- Investigator and Site Selection

- Clinical Trial Supplies (CTS)

Site Management:

- Ethical and Regulatory Submissions

- Recruitment and Retention of Study subjects

- Monitoring Visits (Pre-study Site visit, Initiation Visit, Routine monitoring visit, Interim monitoring visit and Site Close out Visit or Termination)

- Investigators Meeting

- Documentation in clinical research- Investigator site file, Source documents, Regulatory binders, Central Investigator file, Trial master file, Essential documents, appearance and contents etc.

- Adverse Event, Safety Reporting and Pharmacovigillance

- Training in clinical research

Project Auditing

- Audit and Inspection in Clinical Research: Definition, Types and Significance of Audits, Audits trails, Inspections by regulatory authorities- FDA Inspection

- Errors, Misconduct And Fraud In Clinical Research: Definitions, Types and differences among error, misconduct and fraud; the rectification

ROLES AND RESPONSIBILITIES OF CLINICAL RESEARCH PROFESSIONALS

- Sponsor: Sponsor perspective, Monitoring

- Investigator: Site perspective

- CRA (Monitor)- Job description in entry and advanced level

- CRC

- Responsibilities of other staffs

MODULE 6: AN INTRODUCTION TO CLINICAL DATA MANAGEMENT

Concept of clinical data, Data entry methods, Data validation techniques, Quality control in data management, data base management, data conciliation, Data lock; eCRF; an introduction of tools and Software used in clinical data management. Statistical Tools Used in Clinical Research

Basic Issues in clinical trial design, the role of Biostatistician, Concept of sample and population, distribution of samples, sampling, sample size and power calculation; standard errors, type I and type II errors, intervals, hypothesis testing- p values, t tests and chi squared tests.