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A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
Regulatory documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Document [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.
Example of informed consent document from the PARAMOUNT trial. Informed consent is a principle in medical ethics, medical law, media studies, and other fields, that a person must have sufficient information and understanding before making decisions about accepting risk, such as their medical care.
The Belmont Report is a 1978 report created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Its full title is the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
Dynamic consent is an approach to informed consent that enables on-going engagement and communication between individuals and the users and custodians of their data. It is designed to address the many issues that are raised by the use of digital technologies in research and clinical care that enable the wide-scale use, linkage, analysis and integration of diverse datasets and the use of AI and ...
Syrian leader Bashar Assad issued what appeared to be his first public statement since he was ousted and fled with his family to Russia more than a week ago.
Vasil Levski's affidavit, 16 June 1872, Bucharest, Romania. An affidavit (/ ˌ æ f ɪ ˈ d eɪ v ɪ t / ⓘ AF-ih-DAY-vit; Medieval Latin for "he has declared under oath") is a written statement voluntarily made by an affiant or deponent under an oath or affirmation which is administered by a person who is authorized to do so by law.
This week, investors digested bitcoin's rally above $100,000, Intel's leadership shakeup, and monthly jobs data that keeps the Fed on track to cut interest rates.
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