Template research protocol (WMO): explanation 'Safety' extended
The template research protocol has been modified on two minor points. The changes only serve to clarify the submission process. The previous version (modified in September 2018) therefore remains valid.
What exactly has been changed?
- Firstly, it has been clarified that this template research protocol is intended for WMO studies. A separate template research protocol has been developed for CTR studies. Therefore, a link to the template research protocol for CTR studies has been added to the first page.
- Secondly, in Chapter 9, under the topic 'Safety Reporting', the explanation has been expanded and sample text has been added for different types of studies. This is to avoid investigators adopting the standard text on safety information, which would mean that all SAEs have to be reported via ToetsingOnline. Indeed, sometimes this is not necessary. Exceptions to the standard procedure are possible, provided they are described in the approved research protocol.
The modified template research protocol (WMO) can be consulted by clicking the link.