1.2.30 Participation in clinical studies Estimated reading: 1 minute 621 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 Patient orientation - Previous 1.2.29 Establishment of an ethics consultation and ethical case discussion Next - 1.2 Patient orientation 1.2.31 Organ and tissue donation
