Month: August 2022

TMF Reference Model

A de facto industry standard that provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature.

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Subject

“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

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Subinvestigator

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

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Study Coordinator

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

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Single-Blind Research Design

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

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Screening

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

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SAS Transport Files

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

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SAS

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,[2]

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Recruitment

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

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Real World Studies

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

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Randomized Allocation

A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance. Source: Clinicaltrials.gov

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Randomization

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

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Query

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

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Protocol

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.

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Principal Investigator

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

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Placebo

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.

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Pivotal Clinical Trial

A clinical study designed & executed to get statistically significant evidence of efficacy and safety in order to obtain its marketing approval by regulatory authorities.

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Phase 4

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

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Phase 3

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

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Phase 2

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

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Phase 1

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

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Phase

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

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Pharmacokinetics

The processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine. Source: NLM

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Patient Registry

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

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Orphan Drug

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

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Open Label Study

A type of study in which both the health providers and the patients are aware of the drug or treatment being given. Source: NCI

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Observational Study

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

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NCT Number

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

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Multicenter Trial

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

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Monitoring Visit Report

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

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Monitoring Visit

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

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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,

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Lost to Follow Up

The act of concluding participation, prior to completion of all protocol-required elements, in a trial by an enrolled subject. Source: FDA Glossary

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Investigator’s Brochure

A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.

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Investigator

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

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Investigational Drug

The drug being evaluated in the trial; this definition is synonymous with “investigational new drug” or “investigational medicinal product.”

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Interim Analysis

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:

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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)

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Informed consent form (ICF)

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

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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

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Independent Ethics Committee

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

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Inclusion Criteria

A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study. Source: Clinicaltrials.gov

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Important Protocol Deviation

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

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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 reported results

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Exclusion Criteria

A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study. Source: Clinicaltrials.gov

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Enrollment

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:

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Endpoint

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

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Dropout

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

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Dose-Ranging Study

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

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Dose

The amount of medicine taken, or radiation given, at one time. Source: NCI

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Crossover Study

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

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Controlled Study

A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all. Source: NCI

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Control

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

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Comparator

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Source: ICH E6

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Combination Product

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.

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Clinicaltrials.gov

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.

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Clinical Study Report

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,

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Clinical Study

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

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Certified Copy

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

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Case Report Form

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:

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Blinding / Masking

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

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Bioavailability

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

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Auditor

An agent of a sponsor or CRO who requires access to the TMF for an internal inspection.

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Arm

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

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Adverse Event

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

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ADME Study

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

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Adaptive Clinical Trial

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

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RIM Analytics: Dashboards with a Purpose

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

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Customer Support Engineer

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.

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