Best Clinical Research Courses in Bangalore

BY
TechnoBridge

Mode

Online

Duration

3 Months

Quick Facts

particular details
Medium of instructions English
Mode of learning Self study
Mode of Delivery Video and Text Based

Course and certificate fees

certificate availability

Yes

certificate providing authority

TechnoBridge

The syllabus

Introduction to Clinical Research

  • Introduction to Clinical Research
  • Terminologies
  • Advantages of CR in India
  • Introduction to CR- Notes
  • Introduction to CR- Quiz

Pharmacovigilance

  • Adverse Event Reporting
  • Recording of Event
  • Medical Management of Adverse Events
  • Handling Death
  • Unblinding of Drug
  • Clinical Safety and Pharmacovigilance
  • E2A- Clinical Safety and Data Management
  • Media 436
  • Naranjo Assessment
  • Order and Formulate to Determine the Quantum

Good Clinical Practice (GCP)-ICH E6

  • History Development of International Regulations in Clinical Research
  • Good Clinical Practices
  • Ethics committee
  • Investigator Responsibilities
  • Sponsor Responsibilities
  • Protocol and Investigator Brochure
  • Essential Documents

Monitoring of Trials

  • Audits and Inspections
  • Flow of Events
  • Investigational Drug Management
  • Routine Monitoring Visits
  • Site Visit Flow

Clinical Data Management

  • CFR Part 11
  • CRF_Design_2
  • Introduction to CDM
  • Data Entry Methods
  • Query Management
  • Source data validation
  • Future of Data Management

Regulatory Affairs

  • Application of Permission
  • Approval of Clinical Trial
  • CDSCO
  • Code of Federal Regulation (CFR)
  • CT_Rules_2019
  • ICMR Guidelines
  • Medical Devices
  • ICMR Guidelines
  • DoH Oct 2013
  • Guidelines for Industry

Drug Development Process

  • Overview of Drug Development
  • Clinical trial phases
  • BA/BE Studies
  • Drug Development Notes
  • Drug Development Quiz

Protocol Designing

  • Drafting a study protocol
  • Study Design
  • Informed Consent
  • Design of Trial- Notes
  • Protocol Designing- Quiz

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