Phase 1: Preparation

Goal:

  • Protocol and PIF are complete and ready to submit to MEC
  • Feasibility and budget are clear

Research proposal

  • Have a valid BROK certificate
  • Contact local science office
  • Contact datacenter, statistician & monitor
  • Inform research group
  • Install writing committee
  • Prepare draft budget
  • Make an inventory of subsidy providers

Funding

  • Determine where to apply for funding
  • Inform about the conditions

Feasibility

  • Check patiënt availability
  • Perform site selection

Study design

  • Write protocol & PIF
  • Contact patient association
  • Write nursing protocol & lab manual
  • Compose DSMB
  • Have datamanagement & monitor plan made
  • Have the eCRF composed
  • Discuss logistics of pharmacy, biobank, PA, imaging

Budget

  • Identify costs of (extra) clinical procedures
  • Make inventory of additional costs
  • Request quotes for required services