Sat,26May2018

Alphabetical Training Listings

• GCP: INVESTIGATOR ROLE AND RESPONSIBILITIES. TOPICS MAY INCLUDE

  • Investigator Qualifications & Agreements
  • Adequate Resources for conducting trial
  • Medical Care of Trial Subjects
  • Communication with IRB/IEC
  • Compliance with Protocol
  • Investigational Product
  • Randomization Procedures & Un-blinding
  • Informed Consent of Trial Subjects
  • Records & Reports
  • Progress Reporting/ Final Reports
  • Safety Reporting
  • Premature Termination or Suspension of Trial
  • Investigator Qualifications & Agreements
  • Adequate Resources for conducting trial
  • Medical Care of Trial Subjects
  • Communication with IRB/IEC
  • Compliance with Protocol
  • Investigational Product
  • Randomization Procedures & Un-blinding
  • Informed Consent of Trial Subjects
  • Records & Reports
  • Progress Reporting/ Final Reports
  • Safety Reporting
  • Premature Termination or Suspension of Trial

• FRAUD AND MISCONDUCT (F/M) IN CLINICAL RESEARCH: AN OVERVIEW. TOPICS MAY

  • Difference between F/M
  • Circumstances of conducting F/M
  • Identifying F/M
  • Impact of F/M
  • Different Types of F/M
  • Initiatives to prevent F/M

• GCP: SPONSOR ROLE AND RESPONSIBILITIES. TOPICS MAY INCLUDE

  • Selection of Investigator / CRO
  • Delegation of Responsibilities
  • Compliance with Protocol and Procedures
  • Product Information
  • Safety Information
  • Investigational Product
  • Trial Management & Handling of Data
  • Standard Operating Procedures
  • Monitoring
  • Quality Assurance
  • Study Reports
  • Handling of Adverse Events
  • Termination of Trial

• GCP: SPONSOR ROLE AND RESPONSIBILITIES. TOPICS MAY INCLUDE

  • Remote data monitoring – uses and methods
  • Remote data monitoring – a see through a monitors eye.
  • Qualifications of monitor
  • Assessment of the Trial Site
  • Staff Education & Compliance
  • Data Management
  • Case Report Forms
  • Investigational Product
  • Communication
  • Regulatory Authority
  • Reports

• QUALITY ASSURANCE IN CLINICAL RESEARCH

  •  Quality assurance and quality control
  •  Qualification of auditors
  •  Types of audits
  •  Planning, scheduling conduct of audit
  •  Auditing procedures
  •  Audit report
  •  Audit closure

© 2018 PACRA. All Rights Reserved.
Powered by: Visual Sparks Technologies