WHO ICTRP Registry Criteria
Quality and Validity
Primary Registries in the WHO Registry Network will:
- Have a mechanism in place to ensure the validity of the registered data (ICMJE)
- Registries must have processes in place to maximize the possibility that the data registered is complete and accurate. These processes should be documented as Standard Operating Procedures (SOPs)
- This will include processes to make certain that:
- the person registering the trial exists and is the appropriate Responsible Registrant
- the trial exists
- the data submitted is complete
- It is the responsibility of the Responsible Registrant to make sure that the data provided to the Registry is complete and accurate
- Maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set for an individual trial can be tracked
- Participate in the development of WHO Best Practice Guidelines for Clinical Trial Registries