A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. P. Q. R. S. T. U. V. W. X. Y. Z.
A.
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In software development, user acceptance testing (UAT) - also called beta testing, application testing, and end user testing - is a phase of software development in which the software is tested in the "real world" by the intended audience. http://searchsoftwarequality.techtarget.com/definition/user-acceptance-testing-UAT |
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“accreditation refers to a rigorous assessment, conducted by an independent science-based organization, to assure the overall capability and competency of a laboratory and its Quality Management Systems. An accredited laboratory should have established standard operating procedures that are routinely followed and have quality systems in place for identifying and correcting deviations from those procedures. The independent organizations that accredit laboratories are known as "accreditation bodies." http://www.fda.gov/regulatoryinformation/guidances/ucm125434.htm |
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the degree to which data exhibits certain characteristics and how these are maintained throughout the data life-cycle. The data characteristics are often referred to as ALCOA or ALCOA+. A= Attributable, L = Legible, C = Contemporaneous, O = Original, A =Accurate, C=Complete, C = Consistent, E = Enduring, A = Available |
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"A portion of a specimen or product used for testing." |
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Techniques used to draw statistical inferences including multiple regression, path analysis, discriminate analysis and logistic analysis. https://medical-dictionary.thefreedictionary.com/analytical+methods |
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"A formal authorised document that describes all aspects of the work to be performed by the laboratory." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"The individual within the laboratory responsible for the overall conduct of the work defined by the analytical plan." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"A formal report which may be issued on completion of the work as detailed in the analytical plan". http://www.who.int/tdr/publications/documents/gclp-web.pdf |
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"A document[s] containing the results of the analyses issued on completion of sample analysis". http://www.who.int/tdr/publications/documents/gclp-web.pdf |
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"The person or organisation responsible for the management of the archive." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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A secure, computer generated, time-stamped electronic record that allows reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record. https://www.fda.gov/iceci/enforcementactions/bioresearchmonitoring/ucm135196.htm |
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A self-locking apparatus for the sterilization of materials by steam under pressure. The autoclave allows steam to flow around each article placed in the chamber. The vapor penetrates cloth or paper used to package the articles being sterilized. Autoclaving is one of the most effective methods for destruction of all types of microorganisms, including spores. The amount of time and degree of temperature necessary for sterilization depend on the articles to be sterilized and whether they are wrapped or left directly exposed to the steam. |
B.
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"A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s)". http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
C.
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"The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements." https://www.niaid.nih.gov/sites/default/files/gclp.pdf |
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"A motorized piece of laboratory equipment which spins liquid samples to separate their components." http://chemistry.about.com/od/imagesclipartstructures/ig/Lab-Equipment---Instruments/Centrifuge.htm |
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"Procedures to account for the integrity of each specimen by tracking its handling and storage from point of specimen collection to final disposition of the specimen." |
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"The clinical trial protocol approved by the sponsor which describes all activities which make up the clinical trial: its objectives, design, methodology, statistical considerations and organisation." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous" http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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“Complete set of supplies provided to an investigator by the trial sponsor” https://www.cdisc.org/standards/glossary |
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A systematic process that allows for a measurable assessment of the laboratory personnel’s ability to perform their required activities as per their job descriptions. |
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"A system (consisting of one or more hardware components and associated software) that is involved with the direct or indirect capture of data, processing or manipulation of data, reporting and storage of data, and may be an integral part of automated equipment. Examples include a programmable analytical instrument or a personal computer linked to a Laboratory Information System (LIMS)." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions." |
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This is an endeavor taken to eliminate the causes of a detected non-conformance, defect or other undesirable situation in order to prevent reoccurrence. https://www.fda.gov/downloads/ScienceResearch/FieldScience/LaboratoryManual/UCM092062.pdf |
D.
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"In the process of validating data during the trial any discrepancies arising are highlighted and recorded using 'Data Clarification Forms'" http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326906/ |
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Destructive testing, in an IT context, is a software assessment method used to find points of failure in a program. Essentially, the method involves interacting with the software incorrectly, for example entering data that is corrupt or in the wrong format, to determine whether the application would fail were an end user to make that error. |
E.
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"The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease at the dose tested and against the illness (and patient population) for which it is designed" https://www.cdisc.org/standards/glossary |
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External Quality Assessment (EQA) sometimes referred to as Proficiency Testing (PT) is an essential aspect of any laboratory operation providing a means of assessing analytical performance compared to other laboratories using the same method and instrument. EQA is designed to retrospectively monitor laboratory performance using 'blind' samples analysed as if they were patient samples. EQA results are submitted to the scheme organiser on a regular basis for statistical analysis; each individual laboratory will then receive a report comparing their performance to others participating in the same programme. http://www.riqas.com/eqa-proficiency-testing |
F.
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"Records that confirm and support non-trial activities essential to the reconstruction of the work performed. This may include supporting data such as fridge/freezer temperature records, equipment service, maintenance and calibration records" http://www.who.int/tdr/publications/documents/gclp-web.pdf |
G.
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"Good Clinical Laboratory Practice (GCLP) applies those principles established under GLP for data generation used in regulatory submissions relevant to the analysis of samples from a clinical trial. At the same time it ensures that the objectives of the GCP principles are carried out. This ensures the integrity of data generated by analytical laboratories." http://www.who.int/tdr/publications/documents/gclp-web.pdf |
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"A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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"Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported" http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/mc/chem%2898%2917&doclanguage=en |
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"All elements in the established practice that will collectively lead to final products or services that consistently meet appropriate specifications and compliance with defined regulations." http://www.who.int/bloodproducts/publications/GMP_Bloodestablishments.pdf?ua=1 |
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H.
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“Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.” https://www.cdisc.org/standards/glossary |
I.
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"An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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"A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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"An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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"The individual responsible for the conduct of the clinical trial, whose role is as defined by ICH GCP" http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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"The location(s) where trial-related activities are actually conducted" (http://ichgcp.net/1-glossary). In the context of GCLP the term trial site/investigator site/research site indicates the location where participant visits occur and study samples are collected and prepared for transport to the laboratory. |
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"A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
J.
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K.
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L.
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"The persons, premises and facilities that are utilised in the analysis of samples from a clinical trial" http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"Laboratory information management systems belong to the class of application software intended for storage and management of information obtained in the course of the work of the laboratory. The systems are used to control and manage samples, standards, test results, reports, laboratory staff, instruments, and work flow automation. Integration of laboratory information management systems with the enterprise’s information systems will make it possible to promptly transmit required data to the laboratory and the enterprise administration." http://link.springer.com/article/10.1007%2Fs11018-011-9638-7
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"The individual[s] within the the laboratory organisation that is responsible for ensuring the facility operates according to GCLP" http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"Records that confirm and support trial activities and are essential for the reconstruction of the work performed. This may include supporting data such as fridge/freezer temperature records, equipment service, maintenance and calibration records as examples" http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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The manual is a safety reference document for laboratory personnel. The manual provides information about hazards that personnel may encounter in the laboratory and safety precautions. All individual personnel must be familiar with the contents and the safety information which are needed to perform their duties safely. http://www.materials.ox.ac.uk/uploads/file/safety/LabSafetyManual2015.pdf |
M.
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Master Service Agreement |
"An overarching contract of general terms and conditions between two parties such as a laboratory and a sponsoring organisation which may be used to underpin work for a number of trials. Study specific terms, conditions, details, roles and responsibilities are then further defined in other documented agreements." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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See also 'Clinical Trial Materials' http://globalhealthtrainingcentre.tghn.org/good-clinical-laboratory-practice/gclp-glossary/#clinialtrialmaterials |
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Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice. |
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"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), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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is a document that provides workers with procedures for safely handling or working with a particular substance. It includes technical information like boiling points, toxicities, reactivities, and various numbers. And also, instructions regarding necessary protective equipment, how to handle spills, first aid suggestions, storage and disposal, and the general health effects. http://study.com/academy/lesson/material-safety-data-sheet-msds-definition-purpose.html |
N.
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The use of natural forces to introduce and distribute outdoor air into and out of a laboratory. http://apps.who.int/iris/bitstream/10665/77949/1/9789241504638_eng.pdf |
O.
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"represent the formal reporting and communication relationships that exist among personnel and management and between the main laboratory unit and satellite units, as applicable, must be available. These charts provide the current communication structure within the laboratory and help to ensure that the staff understands communication path options and requirements." |
P.
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"An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control" http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf see also 'Subject'- http://globalhealthtrainingcentre.tghn.org/good-clinical-laboratory-practice-course/gclp-glossary/#subject |
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Personal protective equipment and clothing may act as barriers to minimize the risk of exposure to aerosols, splashes and accidental inoculation. The choice of clothing and equipment depends on the nature of the work. Protective clothing should be worn whenever staffs work in the laboratory. http://apps.who.int/iris/bitstream/10665/77949/1/9789241504638_eng.pdf |
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The management system to direct and control a pharmaceutical company with regard to quality. ICH Q10, taken from ISO 9000:2005 |
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Preventive Action |
This is an endeavor taken to eliminate the cause of a potential nonconformity or other potentially undesirable situation to prevent occurrence. https://www.fda.gov/downloads/ScienceResearch/FieldScience/LaboratoryManual/UCM092075.pdf |
Q.
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‘a set of actions used to provide documented evidence that any piece of equipment, critical material or reagent used works reliably as intended or as specified and leads to the expected results'. WHO guidelines on good manufacturing practices for blood establishments 2003 Before initiating process validation activities, appropriate qualification of critical equipment and ancillary systems should be completed. Qualification is usually carried out by conducting the following activities, individually or combined: Design Qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose Installation Qualification (IQ): documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer's recommendations and/or user requirements Operational Qualification (OQ): documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges Performance Qualification (PQ): documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073497.pdf |
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"A defined system, including personnel, which is independent of the trial conduct and designed to assure laboratory management of trial and laboratory compliance with GCLP" http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s)." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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"In process, systematic checking to ensure the quality and accuracy of the work performed and reported, and to eliminate errors." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
R.
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"This is a study where people are randomly allocated to receive (or not receive) a particular intervention (this could be two different treatments or one treatment and a placebo). This is the best type of study design to determine whether a treatment is effective." https://evidence.nihr.ac.uk/glossary/ |
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"All original records and documentation, or verified copies thereof, which are the result of the original observations and activities during the conduct of the work and are necessary for the reconstruction and evaluation of the reported results. For the purposes of GCLP, 'source data' (ICH GCP) and 'raw data' are regarded as equivalent." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"A substance that is used to produce a chemical reaction that allows researchers to detect, measure, produce or change other substances." http://www.medicinenet.com/script/main/art.asp?articlekey=5232 |
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A reference range is a set of values that includes upper and lower limits of a lab test based on a group of otherwise healthy people. The values in between those limits may depend on such factors as age, sex, and specimen type (blood, urine, spinal fluid, etc.) and can also be influenced by circumstantial situations such as fasting and exercise. These intervals are thought of as "normal ranges or limits." https://labtestsonline.org/articles/laboratory-test-reference-ranges |
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"The location(s) where trial-related activities are actually conducted" (http://ichgcp.net/1-glossary). In the context of GCLP the term trial site/investigator site/research site indicates the location where participant visits occur and study samples are collected and prepared for transport to the laboratory. |
S.
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"The necessary components required to collect clinical trial samples prior to their analysis or evaluation in the laboratory" http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"An individual, company, institution or organisation which takes responsibility for the initiation, management and / or financing of a trial" http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator." http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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"Detailed, written instructions to achieve uniormity of the performance of a specific function" http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |
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Stress testing is the process of determining the ability of a computer, network, program or device to maintain a certain level of effectiveness under unfavourable conditions. The process can involve quantitative tests done in a lab, such as measuring the frequency of errors or system crashes. The term also refers to qualitative evaluation of factors such as availability or resistance to denial-of-service (DoS) attacks. Stress testing is often done in conjunction with the more general process of performance testing. http://searchsoftwarequality.techtarget.com/definition/stress-testing |
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"It is important to keep essential study documentation within a study file for quality control, monitoring, audit and inspection purposes. The maintenance of a study file is necessary for effective management of research studies during preparation, throughout the conduct and after the study has ended. For clinical trials the essential documentation is kept within a trial master file (TMF) or an investigator site file (ISF) with a dedicated individual assigned the responsibility to maintain the documentation. The Sponsor should provide index page(s) with the contents of the key study documents to be filed in accordance with their SOPs and under the relevant legal requirements." https://www.ucl.ac.uk/jro/documents/UCLHSOP8EssentialDocuments |
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"An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control" http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf See also 'Participant' - http://globalhealthtrainingcentre.tghn.org/good-clinical-laboratory-practice-course/gclp-glossary/#participant |
T.
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"The persons, premises and facilities necessary for conducting the work" http://www.who.int/tdr/publications/documents/gclp-web.pdf |
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Trial Facility Management |
"The individual[s] within an organisation performing the analysis who is responsible for ensuring that the facility operates according to Good Clinical Laboratory Practice." http://www.who.int/tdr/publications/documents/gclp-web.pdf |
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"The overall Study Protocol approved by the sponsor which describes the entire activites which make up the study" http://www.who.int/tdr/publications/documents/gclp-web.pdf |
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"Any material from a trial which is to be analysed. This may include, but is not limited to: samples (plasma, serum, urine, faeces, tissues and cells), specimens, data, results, ECG traces or x-ray plates." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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"The location(s) where trial-related activities are actually conducted" (http://ichgcp.net/1-glossary). In the context of GCLP the term trial site/investigator site/research site indicates the location where participant visits occur and study samples are collected and prepared for transport to the laboratory. |
U.
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Universal precautions is an approach to infection control to treat all human blood and certain human body fluids as if they were known to be infectious for HIV, HBV and other bloodborne pathogens. https://www.osha.gov/SLTC/etools/hospital/hazards/univprec/univ.html |
V.
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‘Action or process of proving that a procedure, process, system, equipment, or method used works as expected and achieves the intended results’. http://www.westgard.com/store/books-and-reference-manuals/basic-method-validation.-third-edition-detail.html |
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"A documented process that demonstrates that a computerised system is suitable for its intended purpose." http://www.therqa.com/assets/js/tiny_mce/plugins/filemanager/files/Publications/Booklet_Downloads/Good_Clinical_Laboratory_Practice_GCLP.pdf |
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A management document describing the approach taken for a project. The plan typically describes work to be done, resources required, methods to be used, configuration management and quality assurance procedures to be followed, schedules to be met, project organization, etc. http://www.ofnisystems.com/services/validation/validation-plans/ |
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A summary of all planned activities, their success or failure, and any deviations from the expected results or plans encountered. A satisfactory resolution should be provided to explain and resolve any deviations encountered. This test summary report may be optional. Results of all testing activities may be summarized in the Validation Summary Report rather than a separate summary for each testing phase. In practice, the validation summary report describes how the activities described in the validation plan were (or were not) accomplished. http://www.ofnisystems.com/services/validation/summary-report/ |
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“The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements". https://www.cdisc.org/standards/glossary |
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