End of trial process pages
End of trial processes
These processes involves close up activities of a malaria clinical trial such as the final monitoring visit and archiving of study data or samples.
Close up monitoring visit
- At the end of the trial the monitor visits the site(s) to work with staff to conclude any trial activities. This ensures that standards for trial conduct are adhered to until the end of the trial and that all data are collected, any onoing safaty concerns are discussed, that there is a plan for what to do with remaining equipment and consumables, and the trial documentation.
- It is also important also to have an early termination plan, to allow easy close down when advised to terminate the trial by the data monitoring committee e.g. due to safety concerns.
- All relevant stakeholders are then contacted as to the final status of the trial, registers are updated as such, and plans made for publication.
View the related resources
Procedure
QA04
Site handling of monitoring visits
A process for sites to use to help staff involved with attending or arranging monitoring visits
Version: 2.0 Author: WWARN
Procedure
QA08
For when an investigator/institution takes responsibility for on-site monitoring of a clinical trial
Version: 2.0 Author: WWARN
Procedure
AD13
Communicating end of trial results to participants
A suggested process for communicating end of trial results to people who took part in a typical antimalarial drug trial
Version: v1.0 Author: WWARN