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In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [1]
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. All data on each patient participating in a clinical trial are held and/or documented in the CRF ...
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.
Valderas JM, Alonso J. Patient reported outcome measures: a model-based classification system for research and clinical practice. Qual Life Res. 2008; 17: 1125–35. Wiklund I., Assessment of patient-reported outcomes in clinical trials: the example of health-related quality of life, Fundam Clin Pharmacol. 2004 Jun;18(3):351-63.
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 ...
The LOCF method allows for the analysis of the data. However, recent research shows that this method gives a biased estimate of the treatment effect and underestimates the variability of the estimated result. [8] [9] As an example, assume that there are 8 weekly assessments after the baseline observation. If a patient drops out of the study ...
Progress notes are written in a variety of formats and detail, depending on the clinical situation at hand and the information the clinician wishes to record. One example is the SOAP note , where the note is organized into S ubjective, O bjective, A ssessment, and P lan sections.
The following outline is provided as an overview of and topical guide to clinical research: Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans.