NIS Considerations – USA (2019)

£200.00

This report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies (NIS) in the US.

  • Title: NIS Considerations – United States (2019)
  • Publication Date: 15 Jan 2019
  • No. of Pages: 31
  • Format: PDF
  • Author/ Editor: Patricia Garcia

Description

NIS Considerations – United States of America 

 

This 31-page report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies in the US.  All sources of information are referenced and hyperlinked.  Topics covered include:

 

  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • The Common Rule (2018)
    • Research Involving Human Subjects
    • What is a NON-IND Study?
    • Post-Marketing Requirements / Commitments
  • REGULATORY SUBMISSIONS DOCUMENTS
    • Regulatory Submissions Document Checklist for IRBs
    • Translation Requirements
    • Submission Responsibilities (Who is Responsible for What?)
  • STUDY CONDUCT CONSIDERATIONS
    • IRB Approval, Expedited Review, Continued Review Process, Progress and Safety Reporting, End of Study Guidance and More
  • APPLICABLE LEGISLATION AND GUIDELINES
  • USEFUL LINKS
    • Regulatory Requirements
    • Study Conduct Considerations
    • Data Privacy Considerations
    • Human Tissue and Genetic Research Considerations
    • Best Practice Considerations

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