1.2.30 Participation in clinical studies

1 Aim and purpose

Participation in clinical trials should be regulated in accordance with the Declaration of Helsinki with regard to the specifics of information, consent and refusal of participation. Randomisation, placebo administration and additional examination dates must be regulated.

2 Scope of application

3 Description

4 Documentation

5 Resources

5.1 Time required

6 Risks

7 Responsibilities, qualification

8 Notes and comments

9 Applicable documents

9.1 Literature, regulations

9.2 Terms

Attachments