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