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1.2.30 Participation in clinical trials - good hospital practice

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QM according to DIN EN 15224 / ISO 9001

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1.2.30 Participation in clinical studies

Estimated reading: 1 minute 2758 views Authors

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

1.2.30 Participation in clinical trials - Previous1.2.29 Establishment of an ethics consultation and ethical case discussionNext - 1.2.30 Participation in clinical trials1.2.31 Organ and tissue donation

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