Difference between revisions of "Glossary"
|(2 intermediate revisions by 2 users not shown)|
|Line 72:||Line 72:|
|A person within the organization / research unit who has the necessary resources or access to them, the competence and the authority to implement
|A person within the organization / research unit who has the necessary resources or access to them, the competence and the authority to implement the EQIPD Quality System.
|Line 96:||Line 96:|
|An answer to an identified challenge.
|An answer to an identified challenge.
Revision as of 11:54, 16 August 2021
|Bias||Systematic error in an estimate (e.g., variance, effect size) caused by violations of assumptions, inadequacies in the design, conduct, or analysis of an experiment.|
|Data traceability||The ability to find the source of data (raw and analyzed) that is presented in a report or other presentation and a contemporaneous description of the experiment in which the data were generated. This concept maintains that a qualified reviewer should be able to link figures, graphs, conclusions, and other summary data to the raw data that was processed/analyzed in such as way that the entire data processing and analysis can be reconstructed; link the summary data to the corresponding experiment described in a lab notebook entry; and, likewise, link the lab notebook entry to the raw data (e.g., where generated by an automated instrument).|
|Dashboard||A Planning Tool page that provides an overview of Challenges, Solutions and associated activities and risks for a research unit.|
|Challenge||An unmet requirement that must be appropriately matched by a specific solution.|
|Continuous improvement||The process ensuring that new risks and challenges are identified and appropriately met by adapting the existing quality system (e.g., updating the EQIPD Dossier).|
|Core Requirements||Tasks defined by EQIPD for all users/institutions that must be fulfilled to reach the status of a functional quality system.|
|Dossier (EQIPD Dossier)||A structured and categorized collection of various quality-related items (such as protocols for experimental methods and training records) that are developed and stored by a research unit as solutions to challenges specific to their needs.|
|Experiment||An operation or procedure carried out under controlled conditions in order to discover an unknown effect, law, characteristic of an object, subject or substance, to test or establish a hypothesis, or to illustrate a known law (based on definition in the Merriam-Webster’s dictionary).|
|Experimental procedure||Refers to description of specific manipulations, techniques, operations or methods. (compare to "Study protocol").|
|Experimental Record||A research diary entry for an experiment recording all data and pertinent details of an experiment, such that a peer could repeat it. For complex studies that include more than one experiment, several experiments can be part of one record (under one study ID). Each experimental record should include:
All of the above should be thoroughly documented, recorded in a timely manner, and accurately described.
|Framework (EQIPD Framework)||The concept, implementation strategy, software and tools developed by EQIPD that direct and support the users in building the fit-for-purpose EQIPD Quality System.|
|Key process||An action or series of actions that directly impact the experimental generation of research products, data and their quality.|
|Knowledge claim||A formal knowledge claim can be thought of as a statement that a research project or study has established new knowledge, or consolidated existing knowledge, with sufficient certainty that that knowledge can now be acted upon. The required level of certainty might depend on the nature (risk and potential benefits) of the possible action. For instance, the required level of confidence in the efficacy of a molecule will be different for a decision to proceed to a clinical trial compared to deciding to publish the results of a study or to initiate a lead identification campaign for a newly validated target.|
|Needs||Reasons to introduce and maintain high quality derived from a research unit's mission and research objectives that can be dictated by stakeholders (e.g., funders) or defined by EQIPD. They are identified by the research unit and presented in the Planning tool.|
|Must||Indicates actions that EQIPD considers as imperative and mandatory or as a requirement.|
|Phase 1 of EQIPD QS implementation||Completion of the initial set of core requirements that constitutes the basis to build the EQIPD Quality System and enables the next steps.|
|Phase 2 of EQIPD QS implementation||Development and implementation of solutions to address Core Requirements and challenges associated with the user's needs.|
|Phase 3 of EQIPD QS implementation||Development and implementation of solutions to address Core Requirements defined by EQIPD that were not addressed or completed during Phase 2 and that are necessary to complete the fully functional EQIPD Quality System.|
|Performance standards||Performance standards define the desired outcome in detail and provide measurable criteria for assessing whether the outcome is achieved, but do not specify in detail a method or technique for achieving the desired outcome.|
|Planning tool (EQIPD Planning tool)||A software tool supporting the research unit in order to implement the EQIPD Quality System in a given institution.|
|Process owner||A person within the organization / research unit who has the necessary resources or access to them, the competence and the authority to implement and maintain the EQIPD Quality System.|
|Processed data||Raw data that has been processed in a manner that allows scientists and managers to draw conclusions and determine the need for/direction of further experiments and/or analysis.|
|Raw data||All original records and documentation which are the result of the observations and activities in a study, such as:
or research subject to regulation
|Research activities for which national (e.g. FDA) or international (e.g. EMA, OECD) governmental bodies and agencies have specific responsibility for regulating the research activity as well as setting expectations and inspections.
Regulated research is typically subject to compliance with the formally defined good practices such as Good Laboratory Practice, Good Manufacturing Practice, Good Clinical Practice, Good Pharmacovigilance Practice, etc.
|Robust||A data set is said to be robust if it is not sensitive to departures from the assumptions on which its validity is strictly predicted (e.g., that the study plans used to generate data are protected against risks of bias).|
|Should||Indicates a strong recommendation; however, EQIPD recognizes that individual circumstances might justify an alternative strategy.|
|Solution||An answer to an identified challenge.|
|Spot check||A focused review of a selection of experimental records, reports, procedures or lab environment at random or scheduled timepoints against predefined expectations and performance standards.|
|Study||One or more experiments, which may also be referred to as tests or trials, that are described in one study protocol, address the same research question(s) or objective(s), share key resources, and are part of one experimental record.|
|Study protocol||Involving more than one experiment, should include a dedicated section explaining the sequence and relationships between different experimental operations or procedures. (compare to "Experimental record").|
|Support process||An action or series of actions that provide the means needed to execute key processes in a quality-oriented manner.|
|Toolbox (EQIPD Toolbox) ||A structured and categorized online collection of various quality-related information, such as guidelines, protocols, and tools. The toolbox is used as a source of potential solutions by the EQIPD planning tool to populate the EQIPD Dossier.|
Back to the EQIPD Quality System.