A temporary halt to a research study is a stoppage (suspension) which was not envisaged in the approved protocol and where there is an intention to resume the study.
A study may be halted (suspended) for various reasons such as:
- On the recommendation of the IDMC (i.e. further review of new safety information)
- as an Urgent Safety Measure due to a serious breach.
A temporary halt applies when the suspension is imposed on all sites; suspension of the study at a single site due to logistical reasons is not considered a temporary halt (unless the study is a single-site study).