Syllabus-Clinical Trails Management

Syllabus-Clinical Trails Management

Clinical Trails Management
  • 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
  • QC & QA, Compliance & Auditing & Inspections21 CRF Part 11
    Site Auditing
    Sponsor Compliance And Auditing
    SOP For Clinical Research
  • Introduction of  PharmacovigilanceOverview Of Pharmacovigilance
    Standard Terms And Terminology In Pharmacovigilance
  • Medical Evaluation Of Adverse Events In PharmacovigilanceAdverse Event Reporting System And Form
    Diagnosis And Managements Of ADRs
    Medical Evaluation  Of AE
  • Case ProcessingGlobal Perspective Of Pharmacovigilance
    Single Case   Processing
    Case Narrative Writing
  • Pharmacovigilance Reporting Database , Signal Detection , Managements And Risk Assessments & EvaluationQuality System In PV
    Expedited Reporting Criteria
    PSUR & PBRER
    PV Database And Signal Detection
    Risk Assessments & Management
  • Medical Dictionary For Regulatory Activities medDRAmedDRA
  • PV laws And GuidelineRegulatory Guideline @ Laws In PV
    SOPS In PV
    PV Auditing And Inspection
    Regulatory Aspects In PV

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

Clinical trial management involves overseeing the planning, implementation, and completion of clinical trials. Managers coordinate various aspects including protocol development, participant recruitment, regulatory compliance, data collection, and communication with stakeholders, to ensure trials are conducted efficiently and ethically. 

Clinical trial project management refers to the application of project management principles to clinical trials. It involves planning, organizing, and controlling resources and activities to achieve specific trial objectives with defined timelines and budgets. 

To become a clinical trial manager, you will need a relevant educational background in life sciences, pharmacy, or a related field. You can also consider developing your project management skills by gaining field experience or pursuing certifications.

A clinical trial program refers to a series of interconnected clinical trials conducted to address a common research objective. It may involve multiple trials designed to evaluate different aspects of a treatment or intervention.

Yes, there is a significant scope for clinical trial management in India. India has now become a hub for clinical research due to our diverse patient population, skilled professionals, and cost-effective environments. This has brought numerous career opportunities for individuals interested in clinical trial management roles. 

loader

Global Institute of Health Science

×

Apply Now

Provide Details