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The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
It documents the approved standard procedures for performing operations safely to produce goods and provide services. [2] Compliance with the operations manual will generally be considered as activity approved by the persons legally responsible for the organisation. [3] The operations manual is intended to remind employees of how to do their job.
A clinical pathway is a multidisciplinary management tool based on evidence-based practice for a specific group of patients with a predictable clinical course, in which the different tasks (interventions) by the professionals involved in the patient care are defined, optimized and sequenced either by hour (ED), day (acute care) or visit (homecare).
All analytical procedures should be validated. Identification tests are conducted to ensure the identity of an analyte in a sample through comparison of the sample to a reference standard through methods such as spectrum, chromatographic behavior, and chemical reactivity. [5] Impurity testing can either be a quantitative test or a limit test.
Lab orders in the LIMS module of the GNU Health project.. A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations.
The patient health record is the primary legal record documenting the health care services provided to a person in any aspect of the health care system. The term includes routine clinical or office records, records of care in any health related setting, preventive care, lifestyle evaluation, research protocols and various clinical databases.
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A medical procedure with the intention of determining, measuring, or diagnosing a patient condition or parameter is also called a medical test. Other common kinds of procedures are therapeutic (i.e., intended to treat, cure, or restore function or structure), such as surgical and physical rehabilitation procedures.