Final answer:
The Sponsor may provide an informed consent template for a clinical trial, but clinical investigators are responsible for ensuring the document is adequate and meets the requirements.
Step-by-step explanation:
True.
The Sponsor of a clinical trial may provide an informed consent template to be used for a new clinical trial, but it is the responsibility of the clinical investigators to ensure that the informed consent document is adequate and contains the requirements listed in ICH-GCP (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Good Clinical Practice) and the FDA's (Food and Drug Administration) regulations.
The informed consent process is vital in protecting the rights and welfare of research participants. It ensures that participants have a clear understanding of the study, its risks and benefits, and their rights and responsibilities as participants. Clinical investigators must review and approve the provided template, making any necessary modifications to meet the specific requirements of the study and ensure that it appropriately informs and protects the participants.