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Decisions regarding the overall purpose of the audit, either as what should happen as a result of the audit, or what question you want the audit to answer, should be written as a series of statements or tasks that the audit will focus on. Collectively, these form the audit criteria. These criteria are explicit statements that define what is ...
The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs. Case report forms contain data obtained during the patient's participation in the clinical trial.
PRO methods, such as questionnaires, are used in clinical trials or other clinical settings, to help better understand a treatment's efficacy or effectiveness. The use of digitized PROs, or electronic patient-reported outcomes (ePROs), is on the rise in today's health research setting.
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This is a KFF Health News story. Preparing cancer patients for difficult decisions is an oncologist's job. At the University of Pennsylvania Health System, doctors are nudged to talk about a ...
ODM is a vendor-neutral, platform-independent format for interchange and archive of clinical study data. The model includes the clinical data along with its associated metadata, administrative data, reference data and audit information. [8] ODM was first introduced in 1999, and the latest version, 1.3.2, was released in 2012. [9]