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Measured Values | Reference Drug 150 mgTest Drug 150 mg Number of Participants [units: Participants] 14 14 Plasma Decay Half-Life (t1/2) [units: hours] Least Squares Mean ± Standard Deviation 29.99 ± 4.84 29.99 ± 4.34 U.S. National Library of Medicine, Contact Help Desk U.S. National Institutes of Health, U.S. Department of Health & Hum... | [
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | FDAAA_Helpful_Hints_ResultsExamples.pdf | pdf | glossary.json | null | null |
ANOVA | P-Value [3] 0.784755 Other Estimated Parameter [Ratio of AUC (0 - ∞) values] [4] 100.73 90% Confidence Interval (97.96 to 103.36) [1] Additional details about the analysis, such as null hypothesis and power calculation: | [
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | FDAAA_Helpful_Hints_ResultsExamples.pdf | pdf | glossary.json | null | null |
No text entered | [2] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance: No text entered. [3] Other relevant information, such as adjustments or degrees of freedom: No text entered. [4] Other relevant estimation information: Ratio of AU... | [
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | FDAAA_Helpful_Hints_ResultsExamples.pdf | pdf | glossary.json | null | null |
Test Drug | 150 mg Number of Participants [units: Participants] 14 14 Time to Reach Maximum Observed Plasma Concentration (Tmax) [units: hours] Mean ± Standard Deviation 2.96 ± 1.00 2.79 ± 1.26 3. Primary Outcome Measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | [
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | FDAAA_Helpful_Hints_ResultsExamples.pdf | pdf | glossary.json | null | null |
mg | Number of Participants [units: Participants] 14 14 Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [units: mcg*h/mL] Mean ± Standard Deviation 153.33 ± 35.96 154.45 ± 36.81 Statistical Analysis 1 for Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] Groups [... | [
"FDAAA_Helpful_Hints_ResultsExamples.pdf"
] | FDAAA_Helpful_Hints_ResultsExamples.pdf | pdf | glossary.json | null | null |
access control | Policy and procedure that defines accessibility to a physical space or electronic source of information. The policy usually includes the concept of audit trails, either paper (e.g., signature log) or electronic. adverse drug reaction (ADR) In the pre-approval clinical experience with a new medicinal product or with its... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
analysis dataset | The final data set, including derived items and excluding redundant data points, which is used to perform the analyses required for safety assessment, efficacy assessment, submission to regulatory authorities, or other review. Can be comprised of one or more data files. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
analysis file | Same as analysis dataset in the context of the GCDMP. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
annotated crf | A document that maps the names of the collected items to their corresponding database tables, variable item names, forms, visits and any other objects needed for a person to correctly analyze data collected in a clinical trial. Annotated collection documents are required so that any person can understand where variable... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
audit | A systematic and independent examination of trial-related activities and documents to determine whether the trial-related activities being evaluated were conducted and the data were recorded, analyzed and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), GCP, and the app... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
audit certificate | A declaration of confirmation by the auditor that an audit has taken place. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
audit report | A written evaluation by the sponsor’s auditor of the results of the audit. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
audit trail | Documentation that allows reconstruction of the course of events. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
batch job | A series of processes run in an electronic system that perform specific tasks, such as data validation, query generation, external data upload, or lab reference range normalization. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
biologics | A biological product (as a vaccine or blood serum) used in medicine. blinding/masking A procedure in which one or more parties to the trial is 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(... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
case report form (CRF) | A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
CDISC | Acronym for the Clinical Data Interchange Standards Consortium. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
central lab | A vendor contracted for a clinical trial that processes samples collected from subjects and provides the results of laboratory tests or other medical analyses (e.g., ECG results, pathology results) to the sponsor. Refer to the Laboratory Data Handling chapter. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
change control | A procedure that defines how planned changes to any part of a computer system are handled in a manner as to maintain compliance with required functionality of that system. The procedure ensures that changes applied to the system do not unexpectedly impact the functionality of the system in question, or any other comput... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
checklist | (ASQ) A tool used to ensure that all important steps or actions in an operation have been taken. Checklists contain items that are important or relevant to an issue or situation. Checklists are often confused with check sheets and data sheets. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
CLIA | See Clinical Laboratory Improvement Amendments. Clinical Laboratory Improvement Amendments (CLIA) Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless ... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
code libraries | A repository of validated programming logic that can be used during the programming of edit checks or other programs used in the collection, review, or analysis of clinical trial data. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
common causes | (ASQ) Causes of variation that are inherent in a process over time. They affect every outcome of the process and everyone working in the process. See also special causes. comparator (product) An investigational or marketed product (i.e., active control) or placebo used as a reference in a clinical trial. compliance (in... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
composite endpoint | Overall outcome that the protocol is designed to evaluate based on more than one common endpoint such as myocardial infarction plus repeat intervention. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
compound | A chemical molecule with potential pharmacological activity. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
confidentiality | Prevention of disclosure of a sponsor’s proprietary information or of a subject’s identity to unauthorized individuals. See also MRCT Center Clinical Research Glossary definition. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
conformance | (ASQ) An affirmative indication or judgment that a product or service has met the requirements of a relevant specification, contract, or regulation. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
contract | A written, dated, and signed agreement that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters between two or more involved parties. The protocol may serve as the basis of a contract. coordinating committee A committee that a sponsor may organize ... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
control chart | (ASQ) A chart with upper and lower control limits on which values of some statistical measure for a series of samples or subgroups are plotted. The chart frequently shows a central line to help detect a trend of plotted values toward either control limit. corrective action (CA) (ASQ) The implementation of solutions tha... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
CS | Clinically Significant. See also MRCT Center Clinical Research Glossary definition. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
data cleaning | The process of collecting, reviewing, and confirming modifications to clinical data in such a way that data provided for statistical analysis is complete, accurate, and consistent with other data points. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
data module | A category of a type of data, such as CRF. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
database backup | A duplicate copy of all electronic data and metadata that can be retrieved in the event of system failure or data corruption. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
database lock | The closing of a database after all clinical trial data has been reviewed, queries resolved and issues addressed, such that the database cannot be altered in any way. development/test environment Computer system instances that are used for study build and test, prior to release to the production instance. Defined quali... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
device | I. A means of data collection such as a paper CRF, Personal Digital Assistant, or medical instrumentation. II. An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
direct access | Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor’s monitors and auditors) with direct access should take all reasonable precautions within the constraints of the appli... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
discrepancy | Inconsistency in two or more data points collected in a clinical trial that must be addressed prior to database lock. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
documentation | All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, or results of a trial; the factors affecting a trial; and the actions taken. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
double data entry | The process of purposely entering clinical trial data twice for studies with paper collection media. The two entries are done independently. The goal is to ensure entry into the electronic system is completed without transcription errors. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
e-CRF | Acronym for electronic case report form. An auditable electronic record designed to record information to be reported to the sponsor on each trial subject, as required by the clinical trial protocol. See also case report form. edits - hard and soft edit Programmed or manual verifications performed on a clinical databas... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
electronic record | Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
electronic signature | Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
electronic submission | The set of required documents for a submission, rendered in an acceptable electronic format that is transmitted to a regulatory agency in lieu of paper documents for review and approval. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
endpoint | Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. See also MRCT Center Clinical Research Glossary definition. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
essential documents | Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see ICH E6, Section 8. “Essential Documents for the Conduct of a Clinical Trial”). | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
exposure | The condition of being subject to some effect or influence; in context of a clinical trial this generally refers to exposure to the test article/drug. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
external data | Data that are collected externally and merged in the CDMS or analyzed together with data collected on the e/CRF. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
false negative | A test result that is erroneously classified in a negative category (as of diagnosis) because of imperfect testing methods or procedures. In statistics a Type II error. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
false positive | A test result that shows evidence of a result or condition although it is not actually present. In statistics, a Type I error. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
field | A particular area (as of a record in a database) in which the same type of information is regularly recorded. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
flag | A tag placed on a data point that defines a status (e.g., discrepant, closed, or other status) that indicates an action is required. flow diagram, flow chart A graphic means for depicting the steps or activities that constitute a process. The flow diagram (flow chart) is constructed from standard symbols (the delay and... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
frozen | A temporary locked state for data that allows the generation of queries but does not allow a change to data points. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
global library | In a Clinical Data Management System, the superset of all standard objects (e.g., CRF modules, edit checks, fields, etc.). Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and r... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
hard coding | Computer programs utilize logic and hardware to allow dynamic responses based on user input. For example, Web site can be programmed to tabulate the total bill when books are selected for purchase on-line or the average weight of the patients in the active treatment arm each time a program is run on a dataset. “Hard co... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
hard lock | The final state of the database where no changes are permitted and all user access is removed. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
impartial witness | A person who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
in-control process | (ASQ) A process in which the statistical measure being evaluated is in a state of statistical control (i.e., the variations among the observed sampling results can be attributed to a constant system of chance causes). See also out-of-control process. independent data-monitoring committee (IDMC) (data and safety monitor... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
informed consent | 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. ... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
inspection | I. (ICH) The act by a regulatory authority (or authorities) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organiz... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
instrument | A device for capturing or measuring the present value of a quantity under observation. interim clinical trial/study report A report of intermediate results and their evaluation based on analyses performed during the course of a trial. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
intervention | A method of interfering with the outcome or course, especially of a condition or process. See also MRCT Center Clinical Research Glossary definition. Investigational New Drug application (IND) An IND application is submitted to the FDA when a sponsor or investigator wishes to initiate trials with human subjects. The IN... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
investigator | A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also subinvestigator. See also MRCT Center Clinical Research Glossary def... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
investigator meeting | The kickoff meeting for an upcoming trial where the participating investigators review and provide feedback on the protocol or procedures in a protocol. Training of the principal investigator or other site staff on protocol procedures and/or EDC system entry is conducted at the investigator meeting as well. investigato... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
ISO | (ASQ) English acronym for International Organization for Standardization. ISO 9000 series standards (ASQ) A set of five individual, but related, international standards on quality management and quality assurance developed to help companies effectively document the elements that should be implemented to maintain an eff... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
legacy system | An electronic system previously in production, but no longer actively used, that may contain data needed for current analysis or other use and therefore must be maintained by the sponsor organization. legally acceptable representative An individual, juridical, or other type of body that is authorized under applicable l... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
local lab | Local labs are labs in close proximity to individual clinical study sites or patients and are most often used when timely results are needed. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
MedDRA | Medical Dictionary for Regulatory Activities is a medical terminology used to classify adverse event information associated with the use of biopharmaceuticals and other medical products. See www.meddra.org for additional information. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
medical monitor | An individual, other than the principle investigator, who evaluates clinical trial data from a safety perspective. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
medical monitoring | The act of evaluating the clinical trial data from a safety perspective. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
monitoring | 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). See also MRCT Center Clinical Research Glossary definitio... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
monitoring report | A written report to the sponsor that is produced by the monitor after each site visit and/or other trial-related communication, as specified by the sponsor’s SOPs. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
multi-center trial | A clinical trial that is conducted according to a single protocol but at more than one site and therefore is carried out by more than one investigator. See also MRCT Center Clinical Research Glossary definition. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
NCS | Non Clinically Significant. new drug application (NDA) The documentation submitted to the U.S. Food and Drug Administration. As described by the FDA: The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions: Whether the drug is safe and effective in its proposed... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
non-clinical study | Biomedical studies that are not performed on human subjects. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
open access | See National Cancer Institute’s cancer Biomedical Informatics Grid (caBIG®) for additional details. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
open development | See National Cancer Institute’s cancer Biomedical Informatics Grid (caBIG®) for additional details. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
open source | See National Cancer Institute’s cancer Biomedical Informatics Grid (caBIG®) for additional details. opinion (in relation to an independent ethics committee) The judgment and/or the advice provided by an independent ethics committee (IEC). See also independent ethics committee. out-of-control process (ASQ) A process in ... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
Pareto Principle / 80-20 rule | An observation that 20% of the input creates 80% of the result. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
phase I - IV | Refer to the FDA glossary (clinicaltrials.gov). See also MRCT Center Clinical Research Glossary definition. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
predicate rule | The overreaching regulations that the industry must follow for GxP (Good “Anything” Practice or any collection of quality guidelines). production environment The location (e.g., website, server, EDC) where real clinical data is entered and stored. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
protocol | A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these details could be provided in other protocol-referenced documents. Throughout the ICH GCP Guideline, the term “pr... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
protocol amendment | A written description of a change (or changes) to, or formal clarification of, a protocol. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
protocol deviation | Any alteration/modification to the IRB-approved protocol. The protocol includes the detailed protocol, protocol summary, consent form, recruitment materials, questionnaires, and any other information relating to the research study. (Partners Human Research Committee; http://healthcare.partners.org) | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
protocol violation | Any protocol deviation that is not approved by the IRB prior to its initiation or implementation. (Partners Human Research Committee; http://healthcare.partners.org ) | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
quality assurance (QA) | 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 with the applicable regulatory requirement(s). quality control (QC) The operational techniques and activ... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
quality audit | (ASQ) A systematic, independent examination and review to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the objectives. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
random sampling | (ASQ) A commonly used sampling technique in which sample units are selected in such a manner that all combinations of n units under consideration have an equal chance of being selected as the sample. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
randomization | The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments. Used to reduce bias. See also MRCT Center Clinical Research Glossary definition. regulatory authorities Bodies having the power to regulate. In the ICH GCP Guideline, the expression “regulator... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
research misconduct | Falsification of data in proposing, designing, performing, recording, supervising, or reviewing research or in reporting research results. Falsification includes acts of omission and commission. Deliberate noncompliance with the regulations can be considered misconduct but is secondary to falsification of data. Researc... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
safety database | A database typically used by Drug Safety or Pharmacovigilence departments to collect adverse event data. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
SAS transport file | A machine-independent file that allows you to move a SAS data set from one operation system to another. ( http://kb.iu.edu/data/aevb.html) serious adverse event (SAE); serious adverse drug reaction (serious ADR) Any untoward medical occurrence that at any dose: Results in death; Is life-threatening; Requires hosp... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
source data | All information that is necessary for the reconstruction and evaluation of the trial, including information about clinical findings, observations, or other activities in a clinical trial. Source data are contained in source documents such as original records or certified copies of original records. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
source documents | Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, micro... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
special causes | (ASQ) Causes of variation that arise because of special circumstances. These causes are not an inherent part of a process. Special causes are also referred to as assignable causes. See also common causes. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
specification | (ASQ) A document that states the requirements to which a given product or service must conform. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
sponsor | An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. See also MRCT Center Clinical Research Glossary definition. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
sponsor-investigator | 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 agen... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
sub-investigator | Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). See also investigator. subject/trial subject An individual who par... | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
trial site | The location(s) where trial-related activities are actually conducted. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
trigger | An event that precipitates other events. | [
"GCDMP_Glossary.pdf"
] | GCDMP_Glossary.pdf | pdf | glossary.json | null | null |
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