Phase 2: Start up & initiation

Goal:

  • Study is ready to start because MEC and institutional board approval are arranged and logistics are ready

Research file & registration

  • Compose research file
  • Register the study in CTIS
  • Sign up study at Onderzoekbijkanker.nl

Contracts

  • Contact legal department
  • Have CTA send to participating centers
  • Have other parties contracted: pharma, service providers
  • Have Clinical trial Insurance arranged

Study team start up

  • Organize a study team start up meeting
  • Define goals & endpoints
  • Identify potential risks

Site suitability: VGO/SSCTS

  • Fill out sponsor sections of VGO part A+B
  • Communicate submission date to sites
  • Receive signed VGO part A form sites (=conditional approval)

For sponsor as participating center:

  • Make agreements with involved departments
  • Have VGO part A signed by the institutional board (=conditional approval)

Approval: drug research

A. Central MEC

  • Submit research file to CTIS
  • Be available for Requests For Information (RFI)
  • Receive approval
  • Inform participating centers

B. Local

  • Central MEC approval & signed CTA turn conditional into full approval

Initiation

  • Invite participating centers
  • Instruct about patient inclusion
  • Instruct about non-standard care
  • Provide QoL instructions
  • Inform about timelines for data entry
  • Instruct about how to handle (S)AE’s