Trial close-out

 

Each HOVON trial will have the timelines shared on this website at section Trials. Both scheduled and actual timelines are shown. These include also Close-out in progress / Last patient out.

The Last patient out will differ per site, based upon the last patient that was included for that site. We have the following guidelines we adhere to in assessing the Follow up duration (measured from the date of registration):

  • Phase I studies: duration of follow up from end of treatment 6 months
  • Phase II studies: duration of follow up from inclusion 5 years or shorter in line with the expected response duration
  • Phase III studies: duration of follow up from inclusion 5 years preferably (with a maximum of 10 years)

The above general timelines do not take into account trials with maintenance, for these trials please refer to the protocol.


Site Close-out

The HOVON Data Center will try to perform the site close-out as soon as possible, once the last patient out date has been reached and all data has been send in and no queries left open.

The participating site will be contacted by the Trial manager of the trial once the close-out can take place. He / she will provide information on the next steps to take in order to fully close down the trial at the site.

If you think your site is sooner ready for a close-out, please let the trial manager know (contact details can be found at the Participating parties section of the trial – after log in).

Please do not forget to check if you requested reimbursement for all patients enrolled at your site.

 

 

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