NIS Considerations – UK (2015)

£200.00

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

  • Title: NIS Considerations – UK (2015)
  • Publication Date: 16 November 2015
  • No. of Pages: 18
  • Format: PDF
  • Author/ Editor: Stuart McCully

Description

NIS Considerations – UK

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

  1. REGULATORY BODIES
  2. SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
    1. UK Regulatory Requirements
    2. Study Classification – CTIMP or Non-CTIMP?
    3. Non-CTIMP Regulatory Approvals
    4. ‘Other’ NIS
    5. Single-Country Mandatory PASS
    6. Multi-Country Mandatory PASS
  3. REGULATORY SUBMISSIONS DOCUMENTS
    1. Regulatory Submissions Document Checklist
    2. EC Submissions Document Checklist(s)
    3. Which Documents Need to Be Translated?
    4. Who Is Responsible for What?
  4. STUDY CONDUCT CONSIDERATIONS
  5. APPLICABLE LEGISLATION AND GUIDELINES
  6. USEFUL LINKS
    1. Regulatory Requirements
    2. Data Privacy Considerations
    3. Study Conduct Considerations
    4. Best Practice Considerations

Reviews

There are no reviews yet.

Be the first to review “NIS Considerations – UK (2015)”