WHO Registry criteria

Primary Registries in the WHO Registry Network as well as Partner Registries need to meet certain criteria so WHO can be sure that the data collected meets the standards of the ICTRP. These criteria can be categorized into 6 main areas:

1. Content
2. Quality and Validity
3. Accessibility
4. Unambiguous Identification
5. Technical Capacity
6. Administration and Governance

Primary Registries in the WHO Registry Network will:

• Accept prospective registration of interventional clinical trials submitted by responsible registrants
• Be open to all prospective registrants (ICMJE)
• Either internationally or within one or more specific countries
• Be able to collect and publicly display the WHO Trial Registration Data Set (ICMJE)
• Some registries may choose to make all the data items mandatory before they will accept registration
• Endeavour to keep registered information up-to-date
• Never remove a trial once it has been registered

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

Primary Registries in the WHO Registry Network will:

• Ensure that the WHO Trial Registration Data Set for all registered trials will be:
• Accessible to the public at no charge (ICMJE)
• Electronically searchable (ICMJE)
• Made available to the ICTRP in English
• Allow registrants to submit a trial for registration at any time of day on any day of the week (24 hours a day, seven days a week)
• Allow the register to be searched at any time of day on any day of the week (24 hours a day, seven days a week)

It is desirable that Primary Registries in the WHO Registry Network also make the WHO Trial Registration Data Set available in the language(s) of the country or countries served by the registry.

Primary Registries in the WHO Registry Network will:

• Have in place processes to prevent the registration of a single trial more than once on their database
• Facilitate the retrospective linking (or  bridging) on the WHO Search Portal of a single trial registered with more than one registry by entering secondary identifiers. This includes the UTN, and the unique identifiers allocated by other Primary Registries in the WHO Registry Network

It is desirable that Primary Registries in the WHO Registry Network as part of the registration process, search the ICTRP Search Portal and attempt to determine if the trial has already been registered by another Primary Registry or an ICMJE approved registry.

Primary Registries in the WHO Registry Network will:

• Submit the WHO Trial Registration Data Set for all records on their registry, in English, to the Central Repository
• Have access to a database that is used to store and manage the submitted data
• Primary registries are not required to develop their own database. See the Data Providers section for more information
• Be able to demonstrate that they have access to adequate information technology support
• Have adequate security and other provisions against data corruption and loss

Primary Registries in the WHO Registry Network will:

• Have at least a national remit, and the support of government within the country (or region) to act as the WHO Primary Registry for that country (or region) (*)
• All WHO Primary Registries are required to provide a letter of support from the Ministry of Health or other relevant national or regional agency
• Publicly disclose ownership, governance structure and not/for-profit status
• Be managed by a not-for-profit agency (ICMJE)
• Should a registry cease to function the registry agrees that at least the WHO Trial Registration Data Set (original and updated) for all trial records will be transferred to a Primary Registries in the WHO Registry Network or appropriate alternative

It is desirable that Primary Registries in the WHO Registry Network have a strategy in place addressing the medium to long term sustainability of the registry.

(*) A "region" is considered to be a group of countries and not a group of states within a country.