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Serial No
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Topic of the Module
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Topics to be covered
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01
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Introduction to
Clinical Research
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- Introduction to Biological Systems and Basics of Human Anatomy and
Physiology
- Global Clinical Research Environment, Pharma industry & Opportunities
- Introduction to Clinical Trials & Terminology
- Principles of Pharmacology – Pharmacodynamics & Pharmacokinetics
- Obtaining appropriate laboratory data supporting
clinical trials
- Issues regarding animal research components related
to clinical research
- Legal issues related to clinical research,
including conflict of interest, research fraud, and patent and material
transfer agreements
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02
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Drug discovery process
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- Stages
of drug discovery process, steps required for a new drug to be approved
for human use
- Basic
concepts of clinical pharmacology including pharmacokinetics, pharmacodynamics, drug and food interactions, and
issues related to special populations
- Pharmacoeconomic principles and tools used to
evaluate new treatments
- Brief
about pre-clinical trials( In-silico &
In-vivo trials)
- Rationale
for Clinical Research
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03
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Principles of Good Clinical Practice
&
Ethics in Clinical Research
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- The evolution
of Good Clinical Practice, including historical events leading to the
regulation of medical product development
- Principles
of Good Clinical Practice, Declaration of Helsinki
- Consolidated
guidelines on GCP-E3, GCP-E6 etc
- Roles
of the sponsors, Investigators, CROs in
maintaining GCP
- Overview
of ethics and the history of the protection of human subjects
- Ethical
Theories and Foundations
- Constitution
and Roles of Independent Ethics Committee/ Institutional Review Board
- Informed
consent and vulnerable subjects
- Integrity
& Misconduct in Clinical Research
- The
health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Ethical
issues in clinical research in the developing world.
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04
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Clinical Trials – Design & Phases
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- Phases
of Clinical Trials (I-IV)
- Clinical
research methodology: Designing of Protocol, CRF Designing, e-CRF,
IB, ICF, SOP, Report writing
- Informed
consent— elements and documentation, process and exceptions
- Benefits
and drawbacks of different allocation schemes in terms of reducing bias,
producing balanced comparisons, and quantifying errors attributable to
chance
- Trial
Site Management
- Global
clinical trials
- Safety
reporting; study close-out
- Methods
for evaluating clinical trials before their completion, and the impact
of interim analysis.
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05
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Site management & Monitoring of clinical trials
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- Roles
& Responsibilities of Key Stakeholders
- Preparations
& Planning for Clinical Trials
- Essential
Documentation in Clinical Research
- Study
site management- Responsibilities, Investigator's meeting and GCP
training, The clinical trial protocol, The investigator's brochure, Case
report forms, Study organisation and planning,
The institutional review board, Informed consent, Recruitment of subjects, Laboratory investigations, Research
pharmacy, Blinding: codes and
code breaking, Adverse event detection and reporting, Monitoring, Data
clarification, Study closure, Archiving, Audits and inspections
- Compliance,
Auditing & Quality Control in Clinical Research
- Financial
Management
- Key
Management Skills – Presentation, Communication, Time Management
& Teamwork
- Trial
material supply- manufacturing, regulatory permission, import and
customs clearance, abelling, storage,
packaging and distibution,accounting,destruction
or returing / retention of study
drug samples .
- Volunteer
recruitment process
- Study
data archival and submission ot
regulatory authorities or the sponsor.
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06
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Pharmacovigilance & Clinical
Safety
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- Introduction
to Pharmacovigilance
- Adverse
events and ADR
- Recognition,
Recording, management, Reporting of Adverse Events
- Responsibilities
of Investigators, Sponsors in clinical safety of trial participants.
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07
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Bioequivalence and Bioavailability Trials
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- The concept
of Bioavailability and Bioequivalence-Regulatory Terminology
- Regulatory
ascepts of BE studies
- Need
of Bioequivalence Studies- NCEs & Generic
Drugs, Intellectual Property Rights
- Generic
Drugs - ANDA approval
- Approaches
to Bioequivalence studies
- Types
of BA/BE studies
- Study
personnel required for conduct of BE studies and their role and
responsibility
- Facilities
for conducting BA/BE studies
- Departments
– Clinical, Bio-Analytical and Quality Assurance, data
management and documentation
- Managing
BE Studies
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08
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Quality Assurance and Quality auditing practices
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- The expectations of GxP
- Total Quality
Management (TQM)
- ISO –
International Standard Organization
- Business Excellence
Model (BEM)
- Six Sigma
- Requirements of a good
quality management system in clinical research
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09
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Basics of Biostatistics
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- Role
of Statistics in clinical practice.
- Sample
size and power for a given study design
- Non-parametric
methods; sample size determination
- Probability
distributions and conditional probability
- Descriptive
statistics - Statistical inference to include concepts of population,
sample, parameter, and estimate
- Issues
relevant to clinical investigation emphasized, particularly the use of
randomization, blocking, stratification and adequate sample size
- Statistical
principles for clinical trials (ICH GCP E9)
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10
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Clinical Data Management
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- Clinical
Database & Types
- Management
of Clinical Data
- Data
Management Plan
- Electronic
Data Capture, eCRF Design Considerations and
tracking
- Data
Entry, Remote Data Entry
- Collecting
Adverse Event Data and meDRA
- Medical
Coding
- Creating
Reports and Transferring Data
- Database
Closure
- Database
management and statistical analysis software, (e.g. Epi-info,
SAS, SPSS)
- Use
of STATA for managing, cleaning, describing, and analyzing data.
- Computer
security
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11
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Good laboratory Practices and Good Documentation Practices
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- Introduction
to GLP
- Requirements
for GLP in medical research
- Monitoring
for Good Laboratory Practices
- Brief
introduction to Good Documentation Practices
- Importance
of Good Documentation Practices in medical research
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N.B: The above
mentioned modules include both Theory and Practical sessions in 60:40
(approximately).
The practical sessions includes but not limited to :
1. Training on preparation of Protocols
2. Training on preparation of Informed Consent Form/
Document
3. Training on preparation of SOPs(Standard Operating
Procedure)
4. Training on preparation of Investigator Brochure
5. Basic exposure to Statistical software
6. Basic exposure to pharmacokinetic software
7. Basic exposure to volunteer/patient management system
8. Basic exposure to HPLC & LCMS/MS operations
9. Periodic visits to CRO/ Hospital/ Data Management
organization/ IEC to understand the practicalities etc.
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