Data Integrity in Clinical Trials - Webinar CD/Transcript

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Data Integrity in Clinical Trials

Let’s face it. You’re under more pressure than ever to conduct more complex and larger trials — and to do them faster.

This webinar will provide invaluable guidance on how to keep your focus on data collection and integrity, with specific lessons that make data integrity even better and more compliant. Here are the areas of focus for this practical, no-holds-barred webinar:

Common BIMO Inspections Findings:

  • Failure to follow investigational plan and/or regulations
  • Protocol deviations
  • Inadequate recordkeeping
  • Inadequate accountability for the investigational product
  • Inadequate communication with the IRB
  • Inadequate subject protection — failure to report AEs and informed consent issues
  • Inadequate monitoring
  • Failure to bring investigators into compliance
  • Inadequate accountability for the investigational product
  • Failure to obtain FDA and/or IRB approval prior to study initiation

Violations Leading To Approval Delay or Complete Response Letter:

  • Sponsor/CRO: Data entry quality control
  • Sponsor/CRO: Database changes after initial database lock and study unblinding
  • Investigators: Systemic deficiencies, including the persistence of critical errors across study sites that raise questions about the reliability of data at other, non-inspected sites and sponsor oversight, such as:
    • Enrollment of subjects who violate eligibility criteria
    • Inaccurate administration of the test product
    • Omission of procedures critical to interpret study endpoint

Prevent and Identify Potential Clinical Data Integrity Issues

  • Realdiligence in selecting and engaging involving;
    • Clinical investigators and sites
    • Site monitors
    • Clinical research organizations
    • Internal or external parties responsible for database management
  • Real  risk-based site and data monitoring (not less monitoring)
  • Audits
    • Who and what data will be audited, who sees results, who is accountable for decision-making?
  • Who is responsible for remediation, including GCP “CAPA”
  • Quality by Design

Remediation Strategies and Corrective Actions

  • How to develop a remediation plan that meets all the criteria for compliance
  • How to prioritize remediation by risk:
    • Immediate risk to human subject safety and welfare, breach of eligibility, failure to administer test product per protocol, failure to conduct evaluations critical to major efficacy and safety endpoints (including under-reporting of adverse events)
    • Data falsification issues
  • How to directly communicate with the clinical investigator and not just the study coordinator
  • How to, as a sponsor, ensure the prompt securing of compliance

Order today to get ready to develop and maintain data integrity during your clinical trials.

  • Medical Affairs Officers
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers

Dr. Beverly Lorell, Senior Medical and Policy Advisor, FDA & Life Sciences Practice Group, King & Spalding
Beverly Lorell is the senior medical and policy advisor with the firm’s FDA & Life Sciences Practice Group in Washington, D.C. She specializes in the clinical trial design for drug, device and biologics studies; review of pre-market submissions; recalls; and assessment of matters involving a risk to health. She also specializes in physician and industry relations and develops independent scientific panels to advise health industries.