NIS Considerations – Mexico (2018)

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

  • Title: NIS Considerations – Mexico (2018)
  • Publication Date: 22 January 2018
  • No. of Pages: 13
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – Mexico

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

  1. DISCLAIMER
  2. REGULATORY BODIES
  3. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    1. REGULATORY SUBMISSIONS ROADMAP
    2. REGULATORY SUBMISSIONS DOCUMENT CHECKLIST TO GET CA AUTHORIZATION
    3. REGULATORY SUBMISSIONS DOCUMENT CHECKLIST TO ETHIC COMMITTEE
    4. WHICH DOCUMENTS NEED TO BE TRANSLATED?
    5. WHO IS RESPONSIBLE FOR WHAT?
  4. STUDY CONDUCT CONSIDERATIONS
    1. COMPETENT AUTHORITY APPROVAL
    2. ETHICS COMMITTEE APPROVAL
    3. HOSPITAL MANAGER APPROVAL
    4. STUDY REGISTRATION
    5. DATA PROTECTION AGENCY NOTIFICATION
    6. INFORMED CONSENT
    7. AMENDMENTS
    8. PEDIATRIC/ MENTAL INCAPACITY STUDY REQUIREMENTS
    9. RESEARCH HUMAN TISSUE
    10. SAFETY REPORTING
    11. PROGRESS REPORTS
    12. NOTIFICATION OF THE END OF STUDY OR EARLY TERMINATION OF THE STUDY
    13. FINAL STUDY REPORT
    14. CONTRACTS
    15. TRANSFERS OF VALUE
  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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