Introduction to research governance Flashcards
1
Q
why do we need research governance?
A
for fraud and misconduct
2
Q
why is it important to have research governance
A
- to protect research ppts; rights, safety, welfare
- quality assurance of data
- harmonise and simplify administrative procedures
3
Q
what is research governance?
A
the system of administration and supervision through through which research is managed, participants and staff are protected, and accountability is assured.
4
Q
what are some key regulations/legislations for clinical research?
A
- Good clinical practice
- Human tissue Act (2004)
- MHRA
5
Q
what are the two regulatory approval authorities?
A
MHRA
Health research authority
6
Q
what is good clinical practice?
A
a standard for the design conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials/studies. they are internationally recognised
