Clinical Trials Flashcards
Name 4 characteristics of a successful clinical trial design
- addresses simple and relevant clinical questions
- results would be useful for everyday clinical practice
- clearly defined endpoints, statistical input and analysis
- Blinding
What is meant by GCP
Good Clinical Practice - internationally recognised ethical and scientific quality requirements for clinical trials
What is meant by IB
Investigator brochure - summary of all preclinical and clinical data
What is meant by IMP
Investigational Medicinal Product - a Pharmaceutical form of an active substance or placebo being tested or used as reference in a clinical trial
What is meant by IMPD
Investigational Medicinal Product Dossier - contains information related to the quality, manufacture and control of the IMP
What is meant by SmPC
Summary of Product Characteristics - a legal document after licensing that contains all information on the drug (it is freely available)
What is the Clinical Trials Regulations purpose
- Protects the clinical trials participants- rights, safety and welfare
- Quality assurance of the data
- Harmonise and simplify administrative procedures
- Authorisation e.g. MHRA, ethics committee and HRA
What is the chief investigator
the individual with overall responsibility for the conduct of the whole project in the UK
What is the principal investigator
the individual responsible for the conduct of research at the research site - there is one PI for each site - if it is a single-site study the PI and chief investigator are the same person
List 4 ways in which we can reduce bias in a clinical trial
- randomise
- double-blind
- controlled
- Pre-specify data analysis as analysing data after unblinding can induce bias
What form is used to collect data
Case Report Form (CRF)
