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