Registered trials should be updated at least once every 12 months (forms in Spanish and English). If the trial is recruiting subjects / patients, this frequency should be lower. After 12 months of last update, the status of trial changes from "Registered" to "Outdated Registered"
To update the forms of a registered trial, the responsible registrant will complete the following steps:
- 1. If the trial is “Registered” then he will change the forms to the status "Outdated Registered".
- 2. To update the data in both forms
- 3. Change the forms to the status "Revision"
Updates are also approved by the team of RPCEC (updates review process). In the process of reviewing and approving updates new data and /or confirmations that were not made in the registration process can be requested. This is because requirements may vary over time.
All updates are part of the forms and can be seen in Reviews. However, in the former version of the website, updates on the forms of the trials were not recorded as part of the form itself, but in a document created for this purpose called Changes log. In order to show trials updates made during version one, we provide the following table containing all trials (original forms and changes records) that had updates while the previous version functioned (June 2007-June 2013).