NIS Regulatory Database

Our experts have been collating regulatory and operational considerations for non-interventional studies since 2009. As you can imagine, that’s a vast amount of information and not something that can be easily managed manually.

In 2017, we commissioned the build of a unique database/ content management system to help us (1) manage all of this great information, but also (2) provide our customers with a tool to search and access NIS data in a more user friendly and efficient way than scanning through individual NIS Considerations reports.

Search functionality
  • Search by country, considerations, keywords, study type
  • Filter search results
  • Export to Excel
Information covered
(includes, but not limited to)
  • Min/max approval timeframes
  • Official languages
  • Regulatory bodies
  • Submission requirements
  • Submission documents
  • Official languages
  • Translation requirements
  • Transfers of value
  • Study registration
  • Fees
  • Informed consent
  • Genetic research
  • Human tissue research
  • Safety reporting
  • Progress reports
  • Final reports
  • Archiving
  • Hyperlinks to country-specific resources
Downloads
  • NIS Consideration Reports
  • Submission Check Lists
  • Regulatory Roadmaps
  • Training Presentations (where available)
Countries covered (37)
(Details of additional 26 countries to be uploaded as per NIS Considerations reports listing)

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kingdom of Saudi Arabia, Latvia, Lebanon, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, UK, USA

Screenshot from the CHCUK NIS Regulatory Database

You can search the database for information on specific countries via the ‘Map View’ or the ‘List View’

 

Map View

 

List View

 

Country-specific information home page provides details on the regulatory requirements and considerations for each study type

 

Each study-type within the country includes submission requirements, documents, considerations and downloadable resources

Documents

Considerations

Resources

Hyperlinks within the country-specific table and pages lead to the relevant information and websites for that country, study-type, consideration etc