Intro To Clinical Research Governance Flashcards
Governance define
The act or process of governing or overseeing the control and direction of something
Research governance define:
System of administration and supervision through which research is managed, participants and staff are protected and accountability is assured
Why do need clinical research governance?
Misconduct eg US syphilis study, Nazi medical experiments
Managing risk and protecting subjects eg thalidomide
Fraud eg MMR vaccine and autism
Clinical research governance and good clinical practice aims
- Protect research participants
- Assurance of data quality and integrity
- Harmonise and simplify administrative procedures
Clinical trial documentation: for approval to conduct a trial
Protocol
Patient information sheet PIS
Patient consent form
Integrated research application system IRAS
Investigators brochure involving an IMP- investigational medicinal product
Clinical trial documentation: later in trials
Case report form
Analysis plan
Monitoring plan
Public disclosures
Study reports
Sponsor define
Organisation that takes on the management and indemnity of research; au clinical research in the UK needs to be supported
Types of sponsor
Commercial sponsor eg pharmaceutical company
Non-commercial sponsor - employer of the chief/principal in estimator
GCP- good clinical practice
A standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials or studies
Internationally recognised
Training required to conduct clinical research
GCP
Human tissue act HTA
Policies and standard operating procedures at the research site
Clinical trial specific training
NB: academic institutions provide training courses for GCP/HTA usually renewed every 2 years
What body carries out inspections of trial sites and or sponsor record/ procedures
MHRA
