Clinical Trial Design Flashcards
1
Q
What is a protocol and what purpose does it serve
A
set of instructions to carry out experimental procedures to address primary research question
its purpose is for scientific basis and ethics committee
2
Q
What is included in a protocol
A
- background
- objectives - research Q
- design
- intervention
- follow up visits and schedule
- ascertainment of response variables
- safety assessments
- data analysis
- end of study/termination policy
- organisation
