A clinical study that lacks a comparison (i.e., a control) group. Source: NCI
A clinical study that lacks a comparison (i.e., a control) group. Source: NCI
A de facto industry standard that provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature.
A unique number assigned to each participant who enrolls into a clinical trial.
“1. An individual (either a healthy volunteer or a patient volunteer) whose reactions or responses to certain interventions are evaluated during a clinical trial. May
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
Person who handles most of the administrative responsibilities of a clinical trial on behalf of a site investigator, acts as liaison between investigative site and
A study in which one party, either the investigator or participant, is unaware of what medication or intervention the participant is taking; also called single-masked
A process of active evaluation of potential participants for enrollment in a trial. After a patient is recruited, screening occurs during the enrollment period to
The SAS Version 5 (V5) transport file format is an open standard developed by SAS to support data transfers between systems, especially those running different
SAS (previously “Statistical Analysis System”) is a statistical software suite developed by SAS Institute for data management, advanced analytics, multivariate analysis, business intelligence, criminal investigation,
Active efforts by investigators to identify subjects who may be suitable for enrollment into a clinical trial. Subjects are selected on the basis of the
Real-world studies seek to provide a line of complementary evidence to that provided by randomized controlled trials (RCTs). While RCTs provide evidence of efficacy, real-world
A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance. Source: Clinicaltrials.gov
The process of assigning trial subjects to investigational treatment or control groups (may use a comparator) using an element of chance to determine the assignments
A question raised about a data point in a CRF, which may or may not result in a correction. Note: this may also refer to
Any change, divergence, or departure from the study design or procedures defined in the protocol Source: ICH
A written description of a change(s) to or formal clarification of a protocol. Source: ICH E6
The written description of a clinical study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information.
The person who is responsible for the scientific and technical direction of the clinical trial at a specific clinical site. In most cases the principal
An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
A clinical study designed & executed to get statistically significant evidence of efficacy and safety in order to obtain its marketing approval by regulatory authorities.
A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that
A phase of research to describe clinical trials that gather more information about a drug’s safety and effectiveness by studying different populations and different dosages
A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body.
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The
The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. Source: NLM
A type of observational study that collects information about patients’ medical conditions and/or treatments to better understand how a condition or treatment affects patients in
A drug used to treat, prevent, or diagnose an orphan disease. An orphan disease is a rare disease or condition that affects fewer than 200,000
A type of study in which both the health providers and the patients are aware of the drug or treatment being given. Source: NCI
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may
ClinicalTrials.gov identifier – The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is “NCT” followed by an 8-digit number
A clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out bymore than one investigator. Source: FDA
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs. Source: ICH E6
An oversight visit to a clinical trial site to review the progress of the study and ensure protocol adherence, accuracy of data, safety of subjects
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,
The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject. Source: FDA Glossary
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator. Source: Clinicaltrials.gov
A site at which clinical research is conducted, usually associated with a hospital or university.
See Investigational Drug
A request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product
The drug being evaluated in the trial; this definition is synonymous with “investigational new drug” or “investigational medicinal product.”
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can
Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial. Source:
An IRB (also known as an independent ethics committee (IEC), ethical review board (ERB) or research ethics board (REB)) is a group of doctors, scientists,
Representative of a Health Authority performing a GCP/TMF inspection.
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies)
The document used in the informed consent or process. [Note that there is a “model informed consent” master document and an executed informed consent that
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
An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is
A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study. Source: Clinicaltrials.gov
A subset of protocol deviations that may significantly impact the completeness, accuracy, and/or reliability of the study data or that may significantly affect a subject’s
A national or international health agency that has authority over and regulates a clinical study
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
A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study. Source: Clinicaltrials.gov
The number of participants in a clinical study. The “estimated” enrollment is the target number of participants that the researchers need for the study. Source:
Principal indicator(s) used for assessing the primary question (i.e., hypothesis) of a clinical trial. A variable that pertains to the efficacy or safety evaluations of
An outcome based on a report that comes directly from the patient about the status of a patient’s health condition without amendment or interpretation of
See Patient-Reported Outcome (PRO) – ePRO collects this information electronically with an app, wearable, web page, etc.
System capturing subject Case Report Form information.
A subject in a clinical trial who for any reason fails to continue in the trial until the last visit required of him/her by the
A study in which neither the participant nor the researcher knows whether the participant is in the treatment or control groups. Source: FDA Patient Glossary
A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose
The amount of medicine taken, or radiation given, at one time. Source: NCI
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the
A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by
Improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations, or steps taken to mitigate the results of a non-conformity.
A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all. Source: NCI
The control or “standard” treatment is compared against the investigational treatment. It is there to show that an approved treatment in the trial works, and
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
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Source: ICH E6
1. A product comprising two or more individual products. 2. Two or more separate products packaged together in a single package or as a unit.
ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health.
A submission filed with the Medicines & Healthcare Products Regulatory Agency or EMEA as necessary to commence human clinical trials of a drug in conformance
A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations,
A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional
A copy of original information that has been verified as having the same metadata and data as the original. The copy may be verified by
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. NOTE:
A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which
The ability of a drug or other substance to be absorbed and used by the body. Orally bioavailable means that a drug or other substance
An agent of a sponsor or CRO who requires access to the TMF for an internal inspection.
A declaration of confirmation by the auditor that an audit has taken place. Source: ICH E6
A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial’s protocol. Source: Clinicaltrials.gov
1. An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount
A study characterizing absorption, distribution, metabolism, and excretion (ADME) properties help to explore and explain how pharmacokinetic processes happen, so as to provide safety considerations
Clinical trial design that uses accumulating data to decide on how to modify aspects of the study as it continues, without undermining the validity and
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify
Ennov will exhibit at the International Clinical Trials Methodology Conference 2022 being held 3-6 October 2022 in Harrogate, England, UK. Ennov is a leading Life
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are
Ennov will exhibit at the 2022 World Drug Safety Congress Europe being held on 27-29 September 2022 in Amsterdam, RAI Congress Centre. As Europe’s principal Drug
As a key member of the Customer Support team, the mission of the Customer Support Engineer is to answer customer requests and issues regarding to the usage of Ennov Software, from a functional or technical perspective. When required, the Customer Support Engineer will work with or escalate within different departments at Ennov, such as Hosting, Integration, Professional Services or Developers.
In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.