Implementation of the Standards

To apply for, achieve and retain the status of a Primary (or Partner) Registry in the WHO Registry Network, registries must comply with all the minimum standards outlined in the Standards document.
The main aim of the minimum standards is to promote harmonization in the way data are collected and validated by different trial registries, and hence to ensure a minimum standard for the quality of registered data. This will improve the usability of the ICTRP Search Portal, and the reliability of the data it contains, and will therefore benefit all those seeking information about clinical trials.
The implementation of the minimum standards will occur in the following ways:
  • The minimum standards in this document will apply to all Primary and Partner Registries.
  • Registries in the WHO Registry Network that cease to comply with WHO criteria will be placed on a time-limited probation. If after this probation period a registry remains non-compliant then their status as a Primary (or Partner) Registry will be withdrawn.
  • All Primary and Partner Registries in the WHO Registry Network not meeting the minimum standards by 31 January 2019 may be placed on probation.
  • If a registry is on probation then this will be indicated on the ICTRP website.
  • Registries will be required to adapt and apply the minimum standards to their local settings: that is, the minimum standards will provide registries with the framework for the creation of registry-specific SOPs that outline specific processes and procedures relevant to each individual registry, to ensure each of the minimum standards are fulfilled by each registry.
  • Each registry will be required to produce written SOPs that document how each of the minimum standards are fulfilled by that registry. These SOPs will be required to be submitted to the ICTRP upon request at any time and/or as part of a random audit process or site visit.
  • Each registry will be required to provide a written commitment to comply with the minimum standards and agree to site visits and random audits by the ICTRP Secretariat and/or delegated auditors.
  • All registries in the WHO Registry Network will be monitored by the ICTRP Secretariat, which will annually review the updated Registry Profile forms of each registry.
  • All registries should conduct regular internal audits and monitor their continued compliance with the Standards, as well as their own SOPs.