05 Nov

If an agency in a member state (such as a Ministry of Health or a National Regulatory Authority) is interested in establishing a new clinical trial registry that complies with WHO criteria (or improving an existing registry), or in establishing policies that require registration in an existing Primary Registry, then they can approach the ICTRP for support. The types of support requested will vary and depend on the specific needs of the member state. It may include:

  • Advice on how to meet the criteria required by a Primary Registry in the WHO Registry Network
  • The different models for achieving trial registration and the need to work with key agencies such as regulatory authorities and research ethics committees (or Institutional Review Boards) to ensure compliance
  • Database and software issues, including data interchange standards
  • Developing and implementing standard operating procedures to ensure high quality data
  • Facilitating collaboration with other member states, particularly those in the same region or those that speak the same language

The ICTRP works with only 1 registry per member state, and encourages collaboration across member states to build regional solutions, particularly when languages are shared. If a member state has more than one registry then it is up to that member state to determine which one will be the national registry.

Source: WHO

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