NIS Considerations – USA (2015)

£200.00

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

  • Title: NIS Considerations – USA (2015)
  • Publication Date: 14 September 2015
  • No. of Pages: 11
  • Format: PDF
  • Author/ Editor: Stuart McCully
SKU: NIS-C-US-2015 Categories: , , Tags: , , ,

Description

NIS Considerations – USA

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

  1. REGULATORY BODIES
  2. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    1. Study Classification
    2. Regulatory Roadmap for Observational Research
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. IRB Submissions Document Checklist
    2. Which Documents Need to Be Translated?
    3. Who Is Responsible for What?
  4. STUDY CONDUCT CONSIDERATIONS
  5. APPLICABLE LEGISLATION AND GUIDELINES
  6. USEFUL LINKS
    1. Regulatory Requirements
    2. Study Conduct Considerations
    3. Best Practice Considerations
    4. Data Privacy Considerations

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