Scribd
Upload
4 views

2

Uploaded by

Anastasia Zapevalova
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
4 views

2

Uploaded by

Anastasia Zapevalova
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 2

1.

A clinical trial is a prospectively planned experiment for evaluating


potential benefit or pharmacokinetic of therapies, treatments or diagnostics in human subjects .

2. In which law/code are clinical trials locally regualted in Germany and USA?

 Code of Federal Regulations Title 21


 AMG
3. What does Q, S, E and M respectively stand for when speaking of ICH guidelines?
Quality
Safety
Efficacy
Mutidisciplinary

4. Good Clinical Pracitve (GCP) is an international ethical scientific quality standard for
designing, conducting, recording and reporting trials that involve the participation of human
subjects.

5. Name five of the 13 Principles of GCP.

Ethical Principles of Declaration of Helsinki


Benefit justifies risk,
Rights, safety, well being,
Adequate information to support trial,
Clear, scientifically sound protocol,
Favourable ethics approval,
Qualified Chief Investigator,
Researcher training, education and experience,
Freely given informed consent,
Accurate data handling and storage,
Data protection and confidentiality,
Good Manufacturing Practice,
Quality assurance system

6. An independent body constituted of medical , scientific, and non-scientific members, whose


responsibility is to ensure the protection of the rights, safety and well-being of human subjects
involved in a trial by, among other things, reviewing, approving, and providing continuing
review of trial protocol and amendments and of the methods and material to be used in obtaining
and documenting informed consent of the trial subjects.

7.
8. How must an investigator demonstrate his training and experience?
Medical license,CV,Specialised study training,GCP training

9. A person responsible for the conduct of the clinical trial at a trial site . If a trial is conducted
by a team of individuals at a trial site, the investigator is the responsible leader of the team and may
be called the principal investigator .

10. An individual , company, institution, or organization which takes responsibility for


the initiation , management , and/or financing of a clinical trial.

You might also like