Any UK centres wishing to participate in the PT1 Trial should contact Cathy MacLean in the first instance to obtain all of the current documentation. Then please follow the steps below:

1. Forward all of the documentation to your local R&D department for approval. You will need to add your local header to the patient information sheet and two consent forms (they will be sent to you in Word format). The R&D departments are now also responsible for obtaining local ethics approval. Once the trial has been approved locally, please forward a copy of the approval letter to the trial coordinator.
2. A participating site agreement will need to be signed before patients can be recruited. You will be sent a template agreement with the rest of the current documentation. Please amend the agreement with your local details and add the Principle Investigator’s name to the signature page and email the document back to the trial coordinator. The agreement will be signed by the designated signatories in Cambridge and two copies will be posted to you for signatures at the local centre. Please then send one fully-signed copy back to the trial coordinator.
3. Please forward the contact details of the PI, a copy of their CV, and the contact details of a local coordinator, to the trial coordinator.
4. Your site and new PI will be named on a substantial amendment and approval will be given from the main Research Ethics Committee and the MHRA. You will then be contacted by the trial coordinator in order to open to recruitment.