Board of CTU Directors Meeting Minutes

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1 Board of CTU Directors Meeting Minutes Meeting date time I 10:15-13:15h Meeting location SNSF Bern, Room 66 Chair: SCTO Annette Magnin () Minutes by: Participants: CTU network Thomas Fabbro (TF, USB), Sven Trelle (ST, Insel Bern), Françoise Lascombes (FL, HUG), Gabriela Senti (GS, USZ), Christoph Driessen (CD) and Reinhard Maier (RM) KSSG, Gregoire Würzner (GW, CHUV) Absent: SNSF guest Christoph Meier (CM) I = Information A = Action item D = Decision I/A/D Topic Details 1 Approval / follow-up minutes A/D Minutes The following minutes were approved without changes: BCD meeting, No input to minutes of the General Assembly / Joint meeting, to finalise minutes of I Agenda for today No changes for today, but add to agenda next meeting: General discussion point how the SCTO should handle CTUs with variable degrees of organisation in different hospitals. (Input CD) Short information about International Network Collaboration Office (GS) Person responsible Deadline 2 SERI funding period / application under RIPA Art 15 by end of June Application See also presentation attached (Att_1) and revised application document dated Some minor corrections are executed but not mentioned below see revised application. D/A Changes as compared to report dated SERI confirmed the following procedure: Implement initial budget (report ) minus difference based on SCTO budget SCTO_BCD_Minutes_150506_finaldraft.docx 13/05/ of 5

2 I/A/D Topic Details proposal regarding collaboration with SAKK (report ). Use their template for the financial plan / matching funds. Furthermore, changes within boards were reflected, suggestion distribution key and information about planned performance measurement added, changes SwissPedNet application implemented. D/A Budget As mentioned above, the initial budget was considered for the application and the initial report submitted in November (with reduction scenarios) attached as annex (in agreement with SERI). The BCD suggested to directly referring to the preferred reduction scenario agreed on by SB and BCD in order to avoid other ways of reduction by SERI. D/A Distribution key The application should show more clearly to what part of the budget the distribution key refers to. Add numbers of concerned budget items (1-8, 11) D/A Work Package (WP) IT clinical data This WP should also get a number (11). Furthermore for transparency reasons, GW to provide more information to the group on other applications mentioned (not to be implemented in the report). GS emphasised that she still does not agree with the actual content of the WP, although she recognises the importance of this activity in general. Person responsible GW Deadline done done D/A Matching funds: new template as per SERI BCD agrees in general, however, they asked to add a line hospital as financial source. done I Performance and impact evaluation BCD was informed that a task force (lead Ch. Pauli-Magnus) will start to work on this topic, to keep BCD informed. A Next steps to revise application as discussed today and send it for a last review to BCD (feedback within 1 week). Thereafter it will be sent to SB. Work Package (WP) application process D/A WP lead It was emphasised that the competitive application for WP means at the same time that the lead for these WP may change again. D/A Propose application process Representatives from BS (lead), LS, SG and LS agreed to draft a proposal for the competitive application process, which should then be submitted to the SB. (done) / BCD / EO reps 1 st input meeting SCTO_BCD_Minutes_150506_finaldraft.docx 13/05/ of 5

3 3 SNSF network report on services CTU network reporting period new template D/A New report template ST prepared a new template as discussed during last BCD meeting. New proposal was discussed and ST will implement last changes after this meeting to finalise it for future use. 4 Update on different SCTO activities ST I EUPATI Patient empowerment on agenda of different organisations now. EUPATI CH proceeds well and raises a lot of attention. E.g. ethics committees / SNSF etc. observe the ongoing activities and are interested in learning more about expert patients. I ECRIN In agreement with SERI / SNSF and the Steering Board: We prepare the application for an observer role in ECRIN-ERIC (only possible way for Switzerland to participate after ). Although ECRIN does not (yet) lead to many good multinational projects, it is all the same a very important link to Europe. I SwissPedNet They are discussing to add an additional package to their application: SwissPedPhae: a Swiss Center for Pediatric Pharmacology, current collaboration BS/ZH/GE/LS Infrastructure of national (and even international) relevance. SERI agrees and it does not directly concern the SCTO application. 5 SCTO Working Groups (WG) Short updates on selected items only see Att_1 for full information. D/A Functioning of WGs in general The BCD would welcome receiving a flowchart showing how WG are organised, how they function in general and how the standard communication flow with BCD (and others as applicable) looks like. mentions that there is a description per single WG, however, not a general document for all WG yet. Furthermore the BCD is responsible for the local communication of news concerning the SERI application process, no action for the EO and no harmonised information required. D/A QA WG ZH (R. Grossmann) takes lead for further network activities in auditing, BCD agrees. GMP issues, B-simplified procedure : shortly summarised the proposal mentioning that unfortunately, there are finally no major simplifications expected. BCD agrees that the document serves as discussion basis for Swissmedic and swissethics. Q2 15 QA WG TBD D/A DM WG ECs allowing use of excel sheets to capture data: DM WG does not agree and will bring this issue into next roundtable: BCD fully agrees and TF offers to join this roundtable in order to DM WG Next SCTO_BCD_Minutes_150506_finaldraft.docx 13/05/ of 5

4 give a good rationale to ECs. Combined p-medicine - ECRIN Workshop for data manager, 11 June 2015, Paris: programme just received, to forward to BCD and if no objection, a representative of the network may join. meeting I EDU WG GS: HRA online tool (E/F): please send information to EDU WG EO 6 Any other business Short updates on selected items only see Att_1 for full information. I Associate members SCTO Template contract ok, EO should inform about conditions for this membership category on a regular basis. I Project funding for academic clinical research Political motion on that topic adopted by National Council. SERI are forced to do something. SCTO offered help, SERI s answer expected mid May. EO EO I Horizon 2020 stakeholder meeting SERI SCTO is now a permanent member of this H2020 stakeholder group and will inform regularly. I SNSF call investigator initiated research Shortly before the meeting, was informed, that the SNSF will launch the mentioned call soon. Since CTUs will be involved, the BCD asked, if it would be possible to review the call before it goes public. to contact SNSF. I Communication The more activities the SCTO is handling, the more information is distributed. The EO should continue to find ways forwarding this information without bombarding people. Next meetings One option is to send all s sent between two meetings once again just before the next BCD meeting takes place. Furthermore, a dropbox solution (for files) could be explored instead of the rather cumbersome intranet. To be followed-up. I Next meetings for BCD (day before Symposium 2015), Zurich, 14:15-17:15h joint meeting (new!): SNSF Bern, 10:15-13:15h joint meeting : SNSF Bern, 10:15-13:15h (new!): SNSF Bern, 10:15-13:15h joint meeting / EO Done, no answer yet SCTO_BCD_Minutes_150506_finaldraft.docx 13/05/ of 5

5 Next meeting: See above Signatures Dates: Annette Magnin / Managing Director [Name, Position] SCTO_BCD_Minutes_150506_finaldraft.docx 13/05/ of 5

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