1. Introduction to Clinical Trials Flashcards
1
Q
What does GCP stand for?
A
Good Clinical Practice
2
Q
What is Good Clinical Practice? (10)
DCP
MTA
RAR
D
A
A standard for clinical trials that includes
Design Conduct Performance Monitoring Termination Auditing Recording Analysing Reporting Documenting
3
Q
The key motivation behind Good Clinical Practice in a nutshell
A
Protect Human Subjects and collect quality data
4
Q
Who are the 6 key stakeholders of clinical trials?
A
- Study Participant
- Sponsor
- CRO
- Principal Investigator / Clinical Team
- Regulatory Authorities
- IRB/IEC Ethic Committees
5
Q
Why do we conduct clinical trials? (3)
A
To find out whether new biomedical or behavioural interventions are:
- safe
- efficient
- effective
6
Q
A good research question fullfills following criteria (5)
A
Clear Specific Answerable Interconnected Relevant
7
Q
What is the first stage of the management of clinical trials?
A
- Define Question, Design Study, Regulatory Requirements
8
Q
What is the second stage of the management of clinical trials?
A
- Planning and Training
9
Q
What is the third stage of the management of clinical trials?
A
- Conduct and Closing
