PHUSE Update – Country Clinical Trial Disclosure Requirements
PHUSE updated their spreadsheet of country clinical trial disclosure requirements on May 12, 2020. The CTT Country-level Worksheet provides the following information for each country:
- Categorization of national clinical trial registries*
- Registration of trials/studies
- Results posting required
- Information entered into the registry by…
- Route of data in registry.
PHUSE is an independent, not-for-profit global membership organisation and platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers and eClinical IT professionals.
*1) Not aware of any regulation or public registry/database
2) Country requiring / recommending ClinicalTrials.gov use
3a) EU CTR via Clinical Trial Applications
3b) EU PAS – ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [PASS & PAES requirements])
4) Countries with their own Registries/Database
4a) Mandatory National Database (includes Ethics Requirement)
4b) Additional National Registry/Database (may be mandatory)
4c) Pan African Clinical Trial Registry
4d) National- or Registry that Supplements information from other Registries
4e) Academic / Patient Registries / Voluntary”National database/registry (with hyperlinks to the database)
