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

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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

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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 does clinical trial management do?

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.

What is clinical trial project management?

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.

How can I become a clinical trial manager?

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.

What is a clinical trial program?

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.

Is there scope for clinical trial management in India?

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.

Syllabus-Clinical Trails Management

Syllabus-Clinical Trails Management

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