Content - Preparation of the trial proposal for a SAKK trial

Step 2: Preparation of the trial proposal for a SAKK trial

For initial (re-) assessment the following documents are to be provided by the Coordinating Investigators to proposals@anti-cluttersakk.ch, in case of questions please contact the responsible person at the SAKK CC:

  • Trial proposal discussed and approved by project group/section/working groups for initial assessment and stated in groups’ minutes
  • In case of interdisciplinary study proposal discussed by respective co-group/section
  • Completed SAKK Trial Proposal Form or completed Trial Proposal Form of a pharmaceutical company (please check that all the topics given by the SAKK trial proposal form are covered)
  • List of participating sites and committed accrual
  • Completed Conflict of Interest Form of the designated Coordinating Investigator
  • 4-5 important publications relevant to the proposed project (please be aware that we need references for the assumption concerning the primary endpoint)
  • Ideas of financing (see also field 39-41 in the SAKK Trial Proposal Form)

In case the documents provided to the SAKK CC (please sent the documents to proposals @sakk.ch) are not considered as final due to open essential questions, the PRC may decide to postpone the submission of the proposal to the SAKK board.

The proposal has to be sent six weeks prior to a SAKK board meeting (subsite 5) to proposals@anti-cluttersakk.ch. Within 7 days a formal check is taking place concerning the completeness of the documentation. Then, a Proposal Review Committee meeting (PRC) will take place.

 

In case of Initial re-Assessment only:

  • All conditions from previous discussions in the Board fulfilled

In case the documents provided to the SAKK CC (please sent the documents to proposals@anti-cluttersakk.ch) are not considered as final due to open essential questions, the PRC may decide to postpone the submission of the proposal to the SAKK board.