Step 1: define and explain adaptive features
Adaptive features will be the faculties of pre-defined adaptations which can be built to the protocol and research conduct.
When defining adaptive features one has to establish firstly which protocol areas will or might need freedom allowing for adaptation, in other words. the groups of adaptations. Next, you need to establish the main points of possible adaptations, in other words. specific adaptive features. Making use of some adaptive features will make sure through the outset (such as for instance dosage selection in a report where doses haven’t been set within the protocol), other people will undoubtedly be optional (such as for instance addition of just about study individuals, information analysis etc.). The groups and nature of adaptive modifications which could possibly be expected as a result of evolving information are mostly predictable. (más…)