Syllabus – Clinical Research

Clinical Research

Introduction of clinical researchClinical Trial Phases
Pharmacological Principal Of Clinical Research
Drug Development And Launch
Indian Regulation (domestic regulation)ICH GCP
Schedule Y
ICMR
Indian GCP
Key Stakeholders In Clinical ResearchEthics Committees And Institutional Review Board
Responsibilities Of Sponsor
Responsibilities Of Investigator
Responsibilities Of Sponsor – Investigator
Responsibilities Of Sponsor – Vendor
Clinical Trial Design And Project ManagementsClinical Trial Design
Vendor Selection And Managements
Project Planning
Project Managements

Principles of good clinical practicesProtocol Design
CRF Design
Essential documents in clinical research and regulatory requirementsEssential Documents
IND Application
Clinical Study Report
NDA Application
Informed Consent process And Documentation
Study setup processSite Selection And Pre- Study VIsits
Site Initiation
Subject Recruitment And Retention Planning
Site Contract And Budgeting

Quality Assurance GCP Audits & Inspections

QC & QA, Compliance & Auditing & Inspections21 CRF Part 11
Site Auditing
Sponsor Compliance And Auditing
SOP For Clinical Research

Roles & Responsibility Lead & Principle investigator

Clinical Monitoring ActivitiesCRF Review & Source Data Verification
Drug Safety Reporting
Drug Accountability Work
Routine Site Monitoring
Site Close Out Visit

GCP Audits & Inspection

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GIHS provides the best courses helps you to get the start up in the healthcare field. These courses are ad-hoc to your professional career and provide you the additional benefit to be the part of an organization.

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Certificate 3 Months- 22000/- INR & Fees for International Candidates – 450$ USD

PG DIploma One Year – 32000/- INR & Fees for International Candidates – 699$ USD

FT PG Diploma 4 Months – 36000/- INR & Fees for International Candidates – 750$ USD

Cheque / Demand Draft/Cash in the name of “Global Institute of Health Science”

Online Transfer through NEFT or RTGS

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Disclaimer: This course details are for the purpose of awareness about the program and career opportunities.

The exact information on course structure may vary from this information.

Frequently Asked Questions

What is GCP in quality assurance?

GCP stands for Good Clinical Practice, a set of international ethical and scientific quality standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials involving human participants. GCP ensures the safety and well-being of trial subjects and data integrity.

What is a GCP inspection?

A GCP inspection is a regulatory review conducted by health authorities to ensure that clinical trials adhere to GCP guidelines. The inspection evaluates the processes, documentation, and overall conduct of the clinical trial.

What is the difference between audit and inspection in GCP?

In GCP, an audit is an independent examination of trial-related activities and documents to determine whether the evaluated processes comply with protocols, Standard Operating Procedures (SOPs), and regulatory requirements. An inspection, on the other hand, is a regulatory review conducted by health authorities to assess overall compliance with GCP guidelines.

What is the role of audit in clinical trials?

The role of an audit is to systematically review and evaluate trial-related processes and documentation to ensure compliance with GCP, protocols, and SOPs.

How do I become a GCP auditor?

To become a GCP auditor, you need a background in clinical research or related fields. Practical experience in conducting or managing clinical trials is also appreciated. You can then consider getting certifications in clinical research or auditing.

Syllabus – Clinical Research

Syllabus – Clinical Research

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