Declaration of Helsinki definition
Examples of Declaration of Helsinki in a sentence
The Parties agree to conduct the Clinical Trial and maintain records and data during and after the term of this Agreement in compliance with all applicable legal and regulatory requirements, as well as with generally accepted conventions such as the Declaration of Helsinki and ICH-GCP guidelines.
Good Clinical Practices or GCPs: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonised Tripartite Guideline for Good Clinical Practice as amended from time to time and the principles set out in the Declaration of Helsinki as revised from time to time.
This trial will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the referenced directives, regulations, guidelines, and/or standards.
In accordance with the Declaration of Helsinki, information about the availability or non-availability of post-trial access by the Sponsor should be made known to the Trial participants in the informed consent documents.
The World Medical Association has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version.
The Parties agree to comply with the World Medical Association Declaration of Helsinki, titled “Ethical Principles for Medical Research Involving Human Subjects” and the UK Policy Framework for Health and Social Care Research.
The informed consent form must be in accordance with the Declaration of Helsinki, ICH and GCP guidelines, and be approved by the Sponsor and the IRB/IEC.
The Parties agree to comply with the following relevant guidance: The World Medical Association Declaration of Helsinki, titled “Ethical Principles for Medical Research Involving Human Subjects”.
Good Clinical Practices or GCPs: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Harmonised Tripartite Guideline for Good Clinical Practice, as amended from time to time, and the principles set out in the Declaration of Helsinki, as revised from time to time.