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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.
The doctrine of informed consent relates to professional negligence and establishes a breach of the duty of care owed to the patient (see duty of care, breach of the duty, and respect for persons). The doctrine of informed consent also has significant implications for medical trials of medications, devices, or procedures.
In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases.
Digital images of the patient, flowsheets from operations/intensive care units, informed consent forms, EKG tracings, outputs from medical devices (such as pacemakers), chemotherapy protocols, and numerous other important pieces of information form part of the record depending on the patient and his or her set of illnesses/treatments.
The Belmont Report allows for the protection of participants in clinical trials and research studies. Seven things nurses, as primary caregivers for individuals participating in a study, must do to ensure the rights of the participant are met are. [9] Ensure the study is approved by an IRB; Get informed consent from the patient
The sponsor sets informed consent requirements, as does the IRB. Each local IRB must review and approve the informed consent, but the CRC is responsible for communication between the IRB and the sponsor. §46.116 of the Code of Federal Regulations outlines the basic elements of informed consent as a: [5]
Informed consent is documented by means of a written, signed, and dated informed consent form. (ICH E6) Informed consent document A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained ...
Reibl v Hughes [1980] 2 S.C.R. 880 is a leading decision of the Supreme Court of Canada on negligence, medical malpractice, informed consent, the duty to warn, and causation. The case settled the issue of when a physician may be sued for battery and when it is more appropriate to sue the doctor in negligence. The Court wrote unanimously that ...
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