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Comprehensive Clinical Research Training Program

This intensive training program is designed for healthcare professionals and faculty involved in clinical research. It covers essential topics across four key modules: Clinical Operations, Data Management, Pharmacovigilance, and Soft Skills. Participants will gain hands-on experience and theoretical knowledge in clinical trial design, regulatory compliance, data management, adverse event reporting, and effective communication. By the end of the course, attendees will be equipped with the practical skills necessary to excel in the dynamic field of clinical research, enhancing their contributions to patient safety and scientific advancement.
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Descriptions

A Clinical Research is a systematic study for new drugs in human subjects to generate data

for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and

pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of

the new drug.

Clinical Research Industry has grown around the world at an unparalleled rate in the past few

years. It has opened up new vistas of employment for a large number of people. The Clinical

Trials market worldwide is worth over US$ 45 billion and the industry and the requirement of

potential candidates for various roles in the clinical research industry is increasing day by

day.

Clinical research business is gaining grounds in all parts of the world, hence new frontiers

have been achieved in the healthcare and pharma industry. Good enough, the clinical research

line of business is open to aspiring entrepreneurs who have the required qualifications and

experience to run such business in regulatory, clinical operations, Insurance and IT sector.

This industry is highly profitable even though level of profitability is dependent on our ability

to come up with breakthrough clinical research work.

Asia has become the fastest-growing pharmaceutical market globally. The region is home to

60% of the world’s population, offering tremendous market potential. This factor, together

with people’s growing ability to spend more on healthcare have all helped to attract an

increasing amount of pharmaceutical research and development activities to Asia.

A high population density in metropolitan areas combined with a large hospital infrastructure

allows individual study sites to recruit more patients more cost effectively while study

timelines can be kept on target. Whereas traditional study countries in Europe and America

have become expensive and may be saturated with clinical trials competing for the same

patient population.

Pharma giants like, Pfizer, J & J, GSK, Dr. Reddy’s, Sun pharma, Cipla, Lupin, Serum

Institute, Mylan, Sanofi Aventis etc are focus their R & D through clinical trials.

Regulatory authorities across all the countries are more vigilant while approving any new

molecule or drug into the market and they want to see how the product development went

through and how ethically and scientifically the clinical study has been conducted. This puts

the pharma Sponsors into major responsible role with greater man power to look over each

step with quality outcome.

Clinical research is an attractive industry for researchers in India because it foresees

enormous growth and job opportunities not only for trained medical, pharmaceutical, and

paramedical professionals but also for project management staff, regulatory authorities,

government, and the society at large

Course content

  • Overview of Clinical Trials
  • Drug Development Cycle
  • History of Clinical Research
  • Types and Phases of Clinical Trials
  • Introduction to ICH GCP (Good Clinical Practice)
  • New Drug Clinical Trial Rules 2019
  • Introduction to Various Regulatory Authorities Worldwide
  • ICMR Guidelines (Indian Council of Medical Research)
  • Roles and Responsibilities of Key Stakeholders in Clinical Trials
  • Investigator Site Pre-requisites
  • Project Management in Clinical Trials
  • Protocol Design, Development, and Compliance
  • Study Design
  • Investigator Site Selection
  • Patient Selection and Retention
  • Types of Monitoring Visits - Traditional and Central
  • Review of Source Documentation and Performing Source Data Verification (SDV)
  • Preparation of Sites for Audits and Inspections
  • Identification and Handling of Protocol Deviations
  • Adverse Event (AE) Identification
  • AE and Serious Adverse Event (SAE) Management
  • Investigational Medicinal Product (IMP) Handling
  • Trial Master File (TMF) Management - Paper and Electronic
  • Site Closeout and Document Archival
  1. Introduction to Clinical Data Management
  2. Data and Databases
  3. Data Entry
  4. Transcribing Data
  5. Case Report Form (CRF) Data Tracking
  6. Data Cleaning
  7. Discrepancy Management
  8. Data Management Plan
  9. CRF Review and Source Documents
  10. Electronic Data Capture (EDC)
  11. Design Considerations
  12. Study Setup
  13. Managing Laboratory Data (Lab Data Reconciliation)
  14. Collection of Adverse Events and SAE Data
  15. SAE Data Reconciliation
  16. Medical Coding (MedDRA & WHODD)
  17. Creating Reports
  18. Database Closure and Database Lock
  19. Data Transfers
  20. Audit Trail
  21. Quality Assurance in Clinical Data Management
  22. 21 CFR Part 11 Compliance

 

  1. History of Pharmacovigilance (PV)
  2. Drug Development and Clinical Trials
  3. Types of Adverse Event Reporting Forms: E2B, Med-Watch, CIOMS; Overview of Eudra-Vigilance
  4. Good Pharmacovigilance Practices (GVP) Module VI
  5. Overview of Argus Database
  6. Narrative Writing and Grammar
  7. Overview of Literature Case Management
  8. Special Case Scenarios - Definition and Examples
  9. MedDRA Coding
  10. Data Privacy Requirements
  11. Effective Business Communication
  12. Basic Excel Skills

 

  1. Introduction to the Corporate World
  2. Basic Management Skills
  3. Selling Yourself for the Job
  4. Group Discussion and Interactive Sessions
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Instructors
Manjulika Gurav

HOD Clinical Research

This course includes:
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