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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.
PRO data may be collected via self-administered questionnaires, which the patient completes themselves, or through patient interviews. The latter will only qualify as a PRO, however, if the interviewer is gaining the patient's views and not using the responses to make a professional assessment or judgment of the impact of a treatment on the ...
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.
Apply a color, gradient, or image to the background of any document. Easily access your recently used templates in a redesigned template chooser. Print or export a PDF of your document with comments included. Edit shared documents while offline and your changes will upload when you’re back online.
In some cases, an instrument may be developed and validated from the beginning in electronic form. More commonly, perhaps, new instruments will be developed in parallel for paper and electronic use, as is the case with the PROMIS (Patient-Reported Outcomes Measurement Information System) initiative.
The U.S. Department of Defense will consider granting honorable discharges to more than 30,000 gay and bisexual veterans who were barred from serving in the military because of their sexual ...
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...
New details about a study that warned against black plastic spatulas and other kitchen tools have come out. (Getty Creative) (Анатолий Тушенцов via Getty Images)