Update: Clinical Trial Site Information Forms (CTSIFs)
We recently communicated with our clients and partners about the recent changes Health Canada has made regarding the electronic submission of Clinical Trial Site Information Forms (CTSIFs), and we share them now with you.
First is a reminder that CTSIFs must be provided to Health Canada prior to commencement of the trial.
The new CTSIF is already available for submissions and will be mandatory as of January 2nd, 2020. The current form will not be accepted after that date.
There are 3 changes to be aware of in the new form and for online submissions:
- Drug Product and Sponsor information sections have been removed, as they are already found with the Clinical Trial Application.
- Previous versions of a completed form can be used to make revisions and it will be possible to identify precisely which sections of the form are revised.
- ‘Submit’ buttons on the form allow for direct electronic filing to Health Canada. An application control number is required prior to submitting a CTSIF, so that Health Canada can make the necessary link between the application and relevant CTSIFs.
Want to walk through the changes specifically for your trials? The experts at SPharm are available to discuss your needs.
With over 20 years of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.
Après plus de 20 ans de résultats et de succès constants, SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.