For each new trial idea the HOVON working group delegate involved, will fill out a trial proposal form. Based on this form the future PI is invited for a feasibility meeting to look at the possibilities to start up this trial and determine the timelines.
HOVON uses its own templates to ensure uniformity within all the Investigator Initiated Trials which makes setting up a trial and rolling it out efficient. All start up documents (like the trial proposal form, HOVON protocol template and ICF template) can be found after log in in trial start-up document section.
The HDC will submit the general trial documents to the authorities. At the trial section you can view per trial the expected vs. real timelines for the different phases (development / submission / activation).
As soon as we receive approval from both the Competent Authority and Ethical Committee, an Investigator Trial File (ITF) is set up and send out to the sites.
As soon as the trial is approved by the authorities, the participating sites that were selected to participate receive the Investigator Trial File (ITF) together with a Site Document Checklist that indicates which (filled out / signed) forms we need back to be able to activate your site. These are also available (after log in) at the trial section > Downloads.
When we receive all required documents (like a signed signature page of the protocol and Clinical Trial Agreement), we will start up the process of the IMP delivery to your site (if applicable). If you (or your pharmacy department) indicates that the medication has been received in good order and released, we shall activate your site in our system (both the Trial Management System and in ALEA (if applicable)). We also send out messages to the local trial team with information that the activation took place. Certain trials might deviate slightly on these described set of steps.
Once you have received the message that your site has been activated, you can start screening and enrolling patients in the trial.
The HOVON takes out insurance for every trial, to cover claims arising from participation in a trial, and which are not covered by the general liability of the hospitals. If you participate in a trial within HOVON, you therefore need not take out this insurance yourself.
For more information about insurance, we refer you to the CCMO website.