Research governance, good clinical practice and ethics |
Score |
|
1-3 |
Is not able to understand the role of research governance in the conduct of clinical trials |
4-6 |
Attends a local research ethics committee meeting and understands the roles of local and multicentre committees |
|
Successfully completes the International Committee on Harmonisation good clinical practice tutorial |
|
Obtains patients' consent appropriately for clinical studies |
7-9 |
Understands the role of the NHS trust research and development office in study approval processes and event reporting during clinical studies |
|
Demonstrates a good understanding of the key ethical issues in the design and conduct of clinical studies |
|
Contributes to the writing of patient information leaflets and consent forms |
Research study design and planning |
Score |
|
1-3 |
Is unable to understand the requirements for the design of clinical/laboratory studies |
4-6 |
Comprehends the key requirements for the design of a research study, in particular hypothesis testing, statistical power and patient recruitment |
|
Is able to discuss the design of a study with colleagues |
|
Appropriately reviews clinical study patients and gains experience in data handling |
7-9 |
Understands the complexity of multicentre randomized controlled trial standard operating procedures, clinical reviews, event reporting and termination |
|
Contributes to the design and writing of a clinical study |