NIS Considerations – Mexico (2018)

£200.00

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: Patricia Garcia

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:

 

  • DISCLAIMER
  • REGULATORY BODIES
  • SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    • REGULATORY SUBMISSIONS ROADMAP
    • REGULATORY SUBMISSIONS DOCUMENT CHECKLIST TO GET CA AUTHORIZATION
    • REGULATORY SUBMISSIONS DOCUMENT CHECKLIST TO ETHIC COMMITTEE
    • WHICH DOCUMENTS NEED TO BE TRANSLATED?
    • WHO IS RESPONSIBLE FOR WHAT?
  • STUDY CONDUCT CONSIDERATIONS
    • COMPETENT AUTHORITY APPROVAL
    • ETHICS COMMITTEE APPROVAL
    • HOSPITAL MANAGER APPROVAL
    • STUDY REGISTRATION
    • DATA PROTECTION AGENCY NOTIFICATION
    • INFORMED CONSENT
    • AMENDMENTS
    • PEDIATRIC/ MENTAL INCAPACITY STUDY REQUIREMENTS
    • RESEARCH HUMAN TISSUE
    • SAFETY REPORTING
    • PROGRESS REPORTS
    • NOTIFICATION OF THE END OF STUDY OR EARLY TERMINATION OF THE STUDY
    • FINAL STUDY REPORT
    • CONTRACTS
    • TRANSFERS OF VALUE
  • APPLICABLE LEGISLATION AND GUIDELINES
  • USEFUL LINKS
    • REGULATORY REQUIREMENTS
    • DATA PRIVACY CONSIDERATIONS
    • STUDY CONDUCT CONSIDERATIONS
    • BEST PRACTICE CONSIDERATIONS
  • DOCUMENT HISTORY

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