Module 1: Clinical Research
Drug discovery process
1. Introduction to Clinical
Position of Clinical research in the process
Research
Def: clinical research
Different phases, study designs in clinical
research, glossary
Regulatory authorities
2. Different parties involved in
IRB/IEC
Clinical Research
Sponsor
CRO
SMO
Investigator
Patients
Food drug & cosmetic act
3. Clinical Research History
Nuremberg code
Declaration of Helsinki
ICH
Kefauver-Harris Amendments
Belmont report
National Research Act
Sulfanilamide disaster
Thalidomide disaster
FDA
4. Different Regulatory Bodies
DCGI
– an overview
MHRA
MHLW
TGA
IRB/IEC
Guidelines
5. ICH – GCP
Appendices
6. Schedule Y
Regulatory requirements & forms
7. IND & NDA Application
Roles of different parties
8.
Compliance to guidelines and regulatory
Clinical Trial process & its
standards.
monitoring
Adverse event
9. Pharmacovigilance –
Adverse drug reaction its type,
overview
Safety reporting & reporting requirements
Annual safety reports
Audits & Inspections in Types of audits/inspection
10.
Clinical Trial Reporting of findings.
Module 2: PHARMACOVIGILANCE
1. Introduction to Pharmacovigilance
a) Drug development in pharmaceutical industry
b) History and objective of Pharmacovigilance
2. Introduction to Adverse events
a) Adverse events
b) Adverse drug reactions
c) Serious adverse events
d) Expected and unexpected adverse events
3. Regulatory guidelines and laws governing Pharmacovigilance
a) ICH guidelines
b) USFDA guidelines
c) European union Guidelines
4. Adverse event reporting method
a) Sources of reports
b) Reporting forms
c) Criteria of reporting
5. Pharmacovigilance in India
a) National Pharmacovigilance program
b) National Pharmacovigilance centers
6. Individual Case safety Report Processing
a) Case triage
b) Recording of ICSR information
c) Follow up of adverse events
7. Specific events scenarios
a) Drug over dose , abuse and misuse
b) Drug exposure during pregnancy
8) Narrative writing
9) Coding with MedDra
10) Expedited reporting
a) Expedited reporting for clinical trials drugs
b) Expedited reporting for post marketed drugs
11. Periodic safety updates reporting
12. Case Assessment
a) Assessment of case report as reportable or not
b) Assessment of seriousness of adverse event
c) Assessment based on expectedness of adverse event
d)Assessment of causality of adverse event
13. Pharmacovigilance Compliance
a) Purpose and scope of SOPS
b) Internal audit of PV activities within a company
c) Quality control and quality assurance
14. Qualified person for Pharmacovigilance
15. Safety data privacy and sharing
Module 3 : CDM
A. Clinical Trail Process and Design
B. ICH-GCP and GCDMP
C. Clinical Data Management (Process Flow)
1. CRF Design
2. Data Entry
3. Data Collection
4. Data Load/Transfer
5. Data Storage
6. Data Validation
7. Data Export (SDTM)
8. Query Management
9. Data Archiving
10.Quality Systems,SOPs and Audits
11.Safety Management and Pharmacovigilance
12.Data Management Systems and Tools
13.Medical Codings and Medical Dictionaries
14.CDMS,AERS,EDC,OCTMS
15.Documentation and Document Management System
D. Statistical Analysis and Reporting
1. Analytical Tools
E. Project Management
F. Security Systems
PRACTICALS
1. CDMS
2. Study Set-Up
3. DB Creation
4. Data Entry
5. Data Validation
6. Query Management
7. DB lock.
Module 4: Medical Writing
What is Medical Writing
Scope of Medical Writing
Medical Writing in Clinical Trial
Medical Writing & Scientific Writing
Fundamentals of Medical Writing
Marketing Medical Writing
Regulatory Medical Writing
The Writing Process
Good Writing Skills
Introduction to basic rules
Elements of style
Grammar and good writing
Good Clinical Practice Guidelines
The Clinical Study Report
Introduction to Publication Writing
Regulations and Industry Standards
Writing Effective Documents
Writing Standard Operating Procedures Policies, Procedures, Instructions,
and Methods
Writing Quality Manuals and Plans
