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Carl Marshall edited this page Jun 23, 2015 · 8 revisions

Terms and Definitions

  • Trial - Is each recipient, or each donor, or each organ the basis of a single trial?
  • Donor
  • Retrieval Team
  • Retrieval Hospital
  • Procedure
  • Perfusion
  • Specimen

People in the project

  • Sarah to send document about roles and what they do
  • First two forms and the first seven days follow up form
  • Will send me screenshots on WP2 & 3 follow up screens with notes

From Julie De Deken:

As you are new to the COPE COMPARE trial I’ll first give you some logistic background information first. This will hopefully help you understand the specifics and difficulties concerning different user profiles for this specific trial. You can skip this if this was already explained to you J.

The trial will run in the Netherlands, Belgium and the UK. KULeuven (Belgium) is the PI of the trial and Oxford is the sponsor. All transplant centers in these three countries will be helping with including patient and recording follow up (FU) information. If a donor is registered, the transplant technicians (‘logistical team) will go to the donor hospital to help with placing the kidney on the machine, take samples and collect data. Another transplant technician will thereafter go to the recipient hospital to take samples and collect data there. As these transplant technicians will build up the machine, they will not be blinded. As they are unblinded, they can never see/fill in any FU data as they might be biased. The logistical coordinators are the direct supervisors of these transplant technicians and will therefore be unblinded and unable to see FU as well. Everyone else in the trial should be blinded. FU information will be collected by the different transplant centers in the Netherlands, Belgium and the UK. As the local transplant centers (local investigators) are not part of the COPE consortium, they should not see any data that was collected in other hospitals (this is an important privacy concern!). They should therefore only have access to the FU pages of their own center. The different national/central study coordinators are responsible for tracking the completeness of all data and to, if needed, contact transplant technicians/local centers to ask for missing data. Therefore they should be able to see all data (except for randomization) of all centers and they should be notified by email if a new patient is included in the trial. The central study coordinators would be KULeuven and Oxford (as PI and Sponsor), the Netherlands will have a national studycoordinator.

I put all of this in a short overview in the excel file. You can find some more information on the role of the different roles in the word file. I used a couple of different categories as ‘building blocks’ for the different user profiles.

So this are the categories I used:

Login:

  • Super admin user: can provide login for anyone
  • National super user: can provide login for people in own country
  • Centre specific super user: can provide login for investigators in own centre

eCRF:

  • Randomise: can randomise and are unblinded
  • Add/Edit/View donor Data
  • Add/Edit/View recipient Data
  • Add/Edit/View all FU Data: can Add/Edit/View FU Data of all centres in all countries
  • Add/Edit/View centre specific FU Data: can Add/Edit/View FU Data of own centre

Email notifications:

  • Global list: will receive email notification when Donor is Created/Recipient Added/ Kidney randomised/ SAE in any centre in any country
  • Centre specific list: will receive email notification when Donor is Created/Recipient Added/ Kidney randomised/SAE in own centre
  • SAE: will receive email notification when SAE is reported in any centre in any country

From meeting with RJP and ML (8-5-15):

  • Transplant technician - do Randomisation, Donor data, Preservation data, Recipient Data. Will pick up the perfusion file and upload it.
  • Follow-up/Research Nurse - Follow-up data. Flags in the system for when events are coming up. Able to flag up events at next scheduled visit. Quality Forms - paper collection, and nurse entry.
  • Admin wise - National co-ordinator: View follow-up data, chase individual cases (notifications system?) (no editing globally)
  • Central Co-ordinator: Can see everything
  • Biobank co-ordinator: Can see samples. Notifications for her to let her know if samples have not been taken.
  • Statistician: Can see everything and retrieve
  • Sys-admin: Does everything
  • Recipient: No defined role.

Users can have multiple roles

Randomisation data should be limited to Technicians and Central-co-ordinator! Kidney Pairs are used for primary analysis, but singles can be recorded. Two groups, 50/50.

Technicians in the field may be disconnected.

Donor (Procurement Form) as first priority.

Email reports to be determined later. Serious Adverse Event reporting is a key priority too.

Donor surgery takes about 4 hours, so there's downtime for the technician to enter donor info from the paperwork. Similarly for the Transplant side. Perfusion data comes at the very end when the overall transfer is done.

Aim to launch in UK at start of June, and then roll out to other locations soon thereafter.

== Randomisation Lists are pregenerated, so not random from the machine. Link the list record to the case. Randomisation will have to stay to protocol so there will be limits on what the technicians can enter before that stage.

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