Syllabus – Clinical Research

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

Gihsonline Advantage

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.

  • BRINGING EXCELLENCE TO HEALTH PROFESSIONALS

    BRINGING EXCELLENCE TO HEALTH PROFESSIONALS

  • 10+ YEARS OF EXPERIENCE

    10+ YEARS OF EXPERIENCE

  • ISO & GOVT CERTIFIED

    ISO & GOVT CERTIFIED

  • PERSONALIZED TUTORING FOR SUCCESS

    PERSONALIZED TUTORING FOR SUCCESS

Fees, Payment & Program Duration

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

Fee can also be deposited in GIHS bank account (For more details Click Here).

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

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.

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. 

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.

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

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. 

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