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