A

Administrator

A person with access rights to all advanced features in the system for a specific module or for the entire system.

Audit

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). (ICH Guideline for Good Clinical Practice)

Audit Trail

Documentation that allows reconstruction of the course of events. (ICH Guideline for Good Clinical Practice)

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C

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21CFRpart11 21CFRpart11

21 CFR part 11 compliant

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

Capping

Capping is the setting that allows a maximum number of Subjects with a certain feature that can pass the test as 'true'. When that number is reached, all following Subjects with this feature are considered 'false'. 

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. (ICH Guideline for Good Clinical Practice)

CDISC

CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. (CDISC website)

Clinical Data Management System

CDMS is a tool used to collect and manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.

Clinical Trial/Study 

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. (ICH Guideline for Good Clinical Practice)

Clinical Trial/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, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports). (ICH Guideline for Good Clinical Practice)

Comparator (Product)

An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. (ICH Guideline for Good Clinical Practice)

Confidentiality

Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH Guideline for Good Clinical Practice)

Contract 

A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. (ICH Guideline for Good Clinical Practice)

Convention

A convention is a non-query based, self-evident correction applied by the data manager in order to ensure consistency in the reporting of specific data point. Conventions have to be endorsed by the site as per GCP and are listed in in the Data Validation Checks menu in the Study Design module

Coordinating Investigator

An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial. (ICH Guideline for Good Clinical Practice)

Contract Research Organization (CRO)

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.  (ICH Guideline for Good Clinical Practice)

D

Data Management Plan (DMP)

DMP document is a road map to handle the data under foreseeable circumstances and describes the CDM activities to be followed in the trial. A list of CDM activities is provided in Table 1. The DMP describes the database design, data entry and data tracking guidelines, quality control measures, SAE reconciliation guideline

Data Validation Plan (DVP)

The DVP is a study specific document describing the process for data review and validation.

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 applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information. (ICH Guideline for Good Clinical Practice)

E

EORTC

The European Organisation for Research and Treatment of Cancer (EORTC) is both multinational and multidisciplinary and aims to develop, conduct, coordinate, and stimulate translational and clinical research in Europe to improve the management of cancer and related problems by increasing survival but also patient quality of life. EORTC Headquarters, a unique pan European clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.

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G

Good Clinical Practice (GCP)

GCP is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. GCP provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are respected and protected.  (ICH Guideline for Good Clinical Practice) 

GU-ID

A globally unique identifier (GU-ID) is a unique reference number used as an identifier in computer software. All clinical data in Vista Trials (values, queries, activities etc.) have this unique identifier and it can be used to search for specific data.

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I

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.  (ICH Guideline for Good Clinical Practice)

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) 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 organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).  (ICH Guideline for Good Clinical Practice)

Institution (medical)

Any public or private entity or agency or medical or dental facility where clinical trials are conducted. (ICH Guideline for Good Clinical Practice)

Investigational Product

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. (ICH Guideline for Good Clinical Practice)

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. (ICH Guideline for Good Clinical Practice)

Inconsistency Queries

Queries specifically designed for confirming or declining the deletion of data that became obsolete when conditions were changed. If a User claims that the data is correct and as such should not be deleted, regardless of the conditional inconsistency, a reasons shall be provided. Inconsistency queries have a predefined query workflow (and as such it shall not be possible to modify this query workFlow).

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M

Medical Expertise

The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this purpose.  (ICH Guideline for Good Clinical Practice)

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Monitoring Monitoring

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). (ICH Guideline for Good Clinical Practice)

Multicentre Trial

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. (ICH Guideline for Good Clinical Practice)

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O

Operational Data Model (ODM) 

ODM is a vendor neutral, platform-independent format for interchange and archive of clinical study data. The model includes clinical data along with its associated metadata, administrative data, reference data and audit information. All the information that needs to be shared among different software systems during the study setup, operation, analysis, submission or for long-term retention as part of an archive is included in the model. The CDISC Operational Data Model (ODM), is designed to facilitate the regulatory-compliant acquisition, archive and interchange of metadata and data for clinical research studies. (CDISC)

Object Identifier (OID)

Object identifier is an identifier used to name an object

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Python

Python is the programming language used to write the formal expressions in Vista Trials.

Principal Investigator (PI)

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.

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Protocol Protocol

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 could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. (ICH Guideline for Good Clinical Practice)

Protocol Amendment

A written description of a change(s) to or formal clarification of a protocol. (ICH Guideline for Good Clinical Practice)

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Protocoldeviation Protocoldeviation

Protocol Deviation 

Guidelines on GCP: The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in monitor(s), change of telephone number(s)).

Q

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 the applicable regulatory requirement(s). (ICH Guideline for Good Clinical Practice)

R

Randomization

The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (ICH Guideline for Good Clinical Practice)

S

SDTM

The Study Data Tabulation Model (SDTM), is a standard way to organize and format study data, evolved as the standard for regulatory submissions.

Study/Clinical Trial 

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. (ICH Guideline for Good Clinical Practice)

Source Data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). (ICH Guideline for Good Clinical Practice)

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, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial). (ICH Guideline for Good Clinical Practice)

Sponsor

An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. (ICH Guideline for Good Clinical Practice)

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 agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. (ICH Guideline for Good Clinical Practice)

Standard Operating Procedures (SOPs)

Detailed, written instructions to achieve uniformity of the performance of a specific function. (ICH Guideline for Good Clinical Practice)

Stratification

Stratification of clinical trials, is the partitioning of subjects and results by a factor other than the treatment given. Stratification can be used to ensure equal allocation of subgroups of participants to each experimental condition.

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 make important trial-related decisions (e.g., associates, residents, research fellows). See also Investigator. (ICH Guideline for Good Clinical Practice)

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Subject Subject

Subject/Trial Subject

An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. (ICH Guideline for Good Clinical Practice)

Subject Identification Code

A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data. (ICH Guideline for Good Clinical Practice)

T

Trial Site

The location(s) where trial-related activities are actually conducted.

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V

Vista

Visual Information System for Trial Analysis

Vista Trials Administrator 

Vista Trials Administrator is a predefined Role in Vista Trials, which gives all rights to a Contact Person to perform ALL features in Vista Trials.

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