Summary most important action point F2F Jan 10 for reference

[ij-cope]

Dear all

Thank you for a productive discussion.

For my reference I am adding a short summary of the most important action points we agreed upon. This is not an exhaustive list nor is it an "issue" in the repository that needs solving.

Action points summary meeting Jan 12th to be done by our next meeting on Jan 30.

1. Top most priority: preparations for the report requested by the DMC in it’s meeting of Jan 10th. This includes:
   • adding treatment arm to AE report
   • adding recipient centre to AE report

@VirginiaChiocchia to pull out a new report as soon as @marshalc as added these data and then link with Ina and @mertenssarah to update the DMC report.

2. Preparing for the DMC of April, datalock to be set by @VirginiaChiocchia allowing enough time to get al of the data in there
   • Back log of data

o @marshalc to work on improvement of database to make this possible, cf discussion and different issues in GitHub

o @mertenssarah to send copy of Belgian follow-up forms and AE forms to @AllyBradley (courier) o @AllyBradley to contact @aukjebrat, Sijbrand, Marian to send (copy) of Donor, Transplant, follow-up, AE forms (courier) o Any originals will be returned to sender (courier)

o Entry of data (donor, transplantation, follow-up, AE) currently available on paper to be organised by @AllyBradley as soon as possible, i.e. as soon as (part of) paper forms have arrived o Entry of transplantation forms takes priority to allow local investigators to start adding follow-up data in to the database as discussed.

• Real-time data collection

o Donor and transplantation forms and AE are currently filled in by the Transplant Technicians – Jan 30 meeting should discuss how we monitor whether they are complying with this (missing data issue) o Follow-up forms and AE to be entered by local investigators or Research nurse o For this we have identified the different user profiles and their access restrictions as well as any issues that need to be solved to allow setting the restrictions (country, treatment arm blinding) o Once these have been set, national coordinator to provide passwords for any local investigator / research nurse needing one o Local investigators should start their data collection for the new data lock no later than 1/02/2017 to allow sufficient time.

3. Additions to FU forms

   • We discussed the ‘patient death’ issue and agreed to add an additional question to the follow up form
   • We also agreed to insert a ‘reminder to report AEs’ in the form of text and a link to the AE page
   • @mertenssarah to provide @marshalc with ‘bullet point’ list identifying hierarchy in data

4. Other issues discussed are retraceable to the database and less import for me to recollect at this time.

[AllyBradley]

Thanks for the summary Ina. The forms from Leuven have arrived and Sarah has provided a list of forms to be entered first. Data entry will begin today and I'll keep you updated on progress.

[VirginiaChiocchia]

Thank you for this. Can I also add the point about adding the information about consented recipients to the organ report? It was discussed that this is important as they need to be excluded to get to the final count of kidneys for the analysis. This can either be identified through a TRUE/FALSE field (not sure if there is a parameter already, but could not find it) or by just including organs going to consented recipients in the organ report.

[ij-cope]

Thanks Virginia. Time ran out before we could discuss the issue on consent. There is a field for it but there are some issues with it as some patients are consented retrospectively. I have opened an Issue on this and suggest this is picked up at our next meeting