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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.
It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention. The ICH guidelines on good clinical practice (GCP) use the term ‘case report form’ (CRF) to refer to these systems. No matter what CRF is utilized, the quality and integrity of the data is of primary importance.
Case series have a descriptive study design; unlike studies that employ an analytic design (e.g. cohort studies, case-control studies or randomized controlled trials), case series do not, in themselves, involve hypothesis testing to look for evidence of cause and effect (though case-only analyses are sometimes performed in genetic epidemiology ...
Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number.
Exclusion criteria concern properties of the study sample, defining reasons for which patients from the target population are to be excluded from the current study sample. Typical exclusion criteria are defined for either ethical reasons (e.g., children, pregnant women, patients with psychological illnesses, patients who are not able or willing ...
When choosing a study design, many factors must be taken into account. Different types of studies are subject to different types of bias. For example, recall bias is likely to occur in cross-sectional or case-control studies where subjects are asked to recall exposure to risk factors. Subjects with the relevant condition (e.g. breast cancer ...