What is the process to register an organization with OMS?
If an organization is not yet registered with OMS when starting to use CTIS, the registration must be carried out. There are two ways to carry out the registration of an organization:
- Directly through the OMS portal.
- While working in CTIS.
Regardless of the route used to carry out the registration, the necessary documentation which supports the process must always be provided (this documentation will depend on the type of organization to be registered, and whether or not the organization is registered in a national business registry), and the application will be validated within a maximum of 10 business days:
- For organizations located in European Economic Area (EEA) countries, the name of the organization will be validated against the national business registry (where available) and the data (e.g., the name of the organization) will be standardized according to OMS data quality standards.
- For organizations located in non-EEA countries, the name of the organization will be validated with the DUNS website (when available) and the data, as above, will also be standardized according to OMS data quality standards.
- The organization’s location data will be validated and standardized by the OMS address verification tool (AddressDoctor).
In case the submitted application is incorrect or not supported by proper documentation, the validation in OMS will fail and the organization’s data will not be registered in OMS.
What is new in the registration process of organizations in OMS?
As of the 3rd of November 2022, OMS allows any sponsor that is not registered in a national business registry (e.g., in the case of organizations based in Spain that are not registered in the National Business Census) to use a specific application to register with OMS and allow their information to be included in CTIS. To do so, the application for registration must be made including the specific registration letter, called CT registration Headed letter (whose template is available on the OMS web page), with all the necessary information:
- The name of the organization and its address details.
- Public information regarding the organization, e.g., information available at fda.gov or local clinic/physician registries.
- The organization’s contact details (e.g., website/link/public e-mail).
- Information regarding the clinical trial.
In this way, all sponsors that are not registered in a national business registry will be able to register with OMS without the need for a name validation process. OMS will maintain registrations for a sponsor active as long as it can be verified that the sponsor’s information is currently being used in a CTIS trial application. This verification will be performed during the periodic OMS revalidation, with the goal of ensuring that organizations that have remained unchanged for more than 2 years are still valid. Please note that any sponsor registered via the CT registration Headed letter will be deactivated if not used in CTIS as a sponsor or if contact cannot be established after 3 consecutive attempts via the e-mail provided upon registration.
In addition, as of the 3rd of November 2022 OMS has also implemented a temporary process to support the registration of clinical trial sites that are not registered in a national business registry, following the same process as described above for sponsors, whereby the name of the organization does not need to be validated. This will be possible until a new functionality is implemented in CTIS, scheduled for the 6th of December. This functionality will allow the registration of clinical trial sites directly in CTIS.
Once the CTIS change is implemented, the OMS team will deactivate all clinical trial sites registered through the CT registration Headed letter and these organizations will not be subject to any further periodic revalidation checks. Only sites that can be validated by national business registries will remain active in the OMS dictionary. In addition, only new centers that can be validated by national business registries will be registered and all site registrations that are applied for via the CT registration Headed letter will be rejected.