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  2. Clinical data management - Wikipedia

    en.wikipedia.org/wiki/Clinical_data_management

    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

  3. Standard operating procedure - Wikipedia

    en.wikipedia.org/wiki/Standard_operating_procedure

    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 .

  4. Protocol (science) - Wikipedia

    en.wikipedia.org/wiki/Protocol_(science)

    In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment.Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories.

  5. Biorepository - Wikipedia

    en.wikipedia.org/wiki/Biorepository

    A biorepository is a facility that collects, catalogs, and stores samples of biological material for laboratory research. Biorepositories collect and manage specimens from animals, plants, and other living organisms. Biorepositories store many different types of specimens, including samples of blood, urine, tissue, cells, DNA, RNA, and proteins ...

  6. Operations manual - Wikipedia

    en.wikipedia.org/wiki/Operations_manual

    The operations manual is intended to remind employees of how to do their job. The manual is either a book or folder of printed documents containing the standard operating procedures, a description of the organisational hierarchy, contact details for key personnel and emergency procedures.

  7. Test method - Wikipedia

    en.wikipedia.org/wiki/Test_method

    sampling procedures (how samples are to be obtained and prepared, as well as the sample size) safety precautions; required calibrations and metrology systems; natural environment concerns and considerations; testing environment concerns and considerations; detailed procedures for conducting the test; calculation and analysis of data

  8. Monitoring in clinical trials - Wikipedia

    en.wikipedia.org/wiki/Monitoring_in_clinical_trials

    Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial.Both independent and government-run grant-funding agencies, such as the National Institutes of Health (NIH) [1] and the World Health Organization (WHO), [2] require data and safety monitoring protocols for Phase I and II clinical trials ...

  9. Glossary of clinical research - Wikipedia

    en.wikipedia.org/wiki/Glossary_of_clinical_research

    The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s). (ICH E6) Multicenter study. A clinical trial that is carried out at more than one medical institution. (NCI)

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