NIS Considerations – USA (2017)

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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 (2017)
  • Publication Date: 7 November 2017
  • No. of Pages: 33
  • 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. REGULATORY ROADMAP FOR SUBMISSION OF OBSERVATIONAL STUDIES (NON-IND)
    2. DEFINITIONS AND TERMS
  3. REGULATORY SUBMISSIONS
    1. REGULATORY SUBMISSIONS DOCUMENTS
    2. WHICH DOCUMENTS NEED TO BE TRANSLATED?
    3. WHO IS RESPONSIBLE FOR WHAT?
  4. STUDY CONDUCT CONSIDERATION
    1. IRB APPROVAL
      1. A COOPERATIVE REVIEW
      2. EXPEDITED REVIEW PROCESS
      3. CONTINUING REVIEW PROCESS
    2. SUBSTANTIAL AMENDMENTS
    3. ANNUAL REPORTS
      1. FINAL STUDY REPORT
    4. INFORMED CONSENT FORM
      1. WAIVER FOR SIGNED CONSENT FORM
      2. WAIVER OR ALTERATION FOR INFORMED CONSENT FORM PROCEDURE
    5. HIPPA PRIVACY RULE
      1. ACTIVITIES PREPARATORY TO RESEARCH & CONTACTING RESEARCH PARTICIPANTS
      2. WAIVER OR ALTERATION OF THE AUTHORIZATION REQUIREMENT
      3. RESEARCH ON DECEDENTS’ PROTECTED HEALTH INFORMATION
    6. DATA PROTECTION
      1. GENETIC INFORMATION NONDISCRIMINATION ACT GUIDANCE (2009)
    7. POST-MARKETING REQUIREMENTS/ COMMITMENTS 25 6.8 SAFETY REPORTING
    8. ARCHIVE OR RECORD RETENTION
    9. CONFLICT OF INTEREST
    10. TRANSPARENCY IN PAYMENTS
  5. APPLICABLE LEGISLATION AND GUIDELINES
  6. USEFUL LINKS
    1. REGULATORY REQUIREMENTS
    2. DATA PRIVACY CONSIDERATIONS
    3. STUDY CONDUCT CONSIDERATIONS
    4. BEST PRACTICE CONSIDERATIONS
  7. DOCUMENT HISTORY

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