Content - Final assessment

Step 4: Final assessment

The SAKK Board takes a final vote on the proposal, taking into consideration the international experts’ opinion, budget (incl. decision on the amount of the patient fee), external financial support and available resources. SAKK trials, but also trial synopsis or protocols of cooperative groups.

Requirement for Final Assessment:

  • Conditions of the board from previous assessments are fulfilled
  • If necessary, updated/revised SAKK Trial Proposal Form
  • If necessary, updated/revised list of participating sites and committed accrual
  • Written commitment for financing (Letter of Intent from companies)
  • If applicable, written commitment for guaranteeing drug/device supply
  • If necessary, statement to comments of international reviewersBudget and a suggestion for the compensation for inclusion of patients (Patient fee) is compiled by the
  • SAKK CC and discussed with the Coordinating Investigator before submission to the board

In case the documents provided to the SAKK CC (please send the documents to the responsible person at SAKK CC who took care about the initial assessment) are not considered to be final, the PRC may decide not to submit the proposal to the SAKK board.