Phase 3: Conduct

Goal:

  • Reach the endpoint defined in the protocol in a timely and safe manner

Patient inclusion

  • Register the trial
  • Provide accounts for registration & randomization
  • Monitor inclusion
  • Monitor exclusion & drop-out
  • Inform MEC about first & last inclusion

Study treatment

  • Remind centers about non-standard care
  • Distribute lab-kits & medication
  • Remind centers how to act upon (S)AE’s
  • Discuss progress and difficulties

Data collection

  • Instruct centers what data will be collected
  • Remind centers about timelines
  • Monitor data entry
  • Distribute & collect QoL

Data cleaning

  • Send out queries & data requests
  • Lock dataset

Interim analysis & progress reports

  • Analyse data with statistician
  • Inform participating centers about results
  • Inform MEC
  • Inform funding providers

Safety reports

  • Report SAE’s & SUSAR’s
  • Submit safety reports to MEC

Monitoring

  • Have visits planned
  • Arrange monitor accounts
  • Review monitor reports & take action

DSMB - if applicable

  • Provide data
  • Receive advice and suggestions

Trial closure

  • Notify centers inclusion is closed
  • Instruct centers about data collection & FU
  • Inactivate registration/randomization accounts
  • Inform MEC about end of trial