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A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations .
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
GCP has been called 'a less morally authoritative document' than the Declaration of Helsinki, lacking moral principles and guidance in the following areas: [6] Disclosure of conflict of interest; Public disclosure of study design; Benefit for populations in which research is conducted; Reporting of accurate results and publication of negative ...
A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by research staff to monitor their health and to determine the safety and effectiveness of their treatment.
The operations manual is the documentation by which an organisation provides guidance for members and employees to perform their functions correctly and reasonably efficiently. [1] It documents the approved standard procedures for performing operations safely to produce goods and provide services. [ 2 ]
The scents of cinnamon and star anise add big flavors to this quick soup. Butter adds body and a silky texture. Fresh udon noodles take only a few minutes to cook, but dry udon noodles work well ...
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called a clinical trial. (NCI) A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known ...
President-elect Donald Trump complained on Friday that American flags would still be lowered to half-staff in honor of the late President Jimmy Carter during Trump's Jan. 20 inauguration.