Glossary of Terms
Purpose:
This document contains all abbreviations and definitions used in the University of Birmingham Clinical Trials Quality Management System. This Glossary of Terms is to be used in conjunction with any other documents captured in the University of Birmingham Clinical Trials Quality Management System.
Abbreviations and Definitions:
Term / DescriptionAdvanced Therapy Investigational Medicinal Product
(ATIMP) / Advanced Therapy Investigational Medicinal Products (ATIMPs) are ATMPs which are tested or used in a clinical trial.
Advanced Therapy Medicinal Product
(ATMP) / Advanced Therapy Medicinal Products (ATMPs) are medicinal products which are prepared industrially or manufactured by a method involving an industrial process. ATMPs fall into three categories: gene therapies, somatic cell therapies and tissue engineered products. For more guidance see references.
Adverse Event (AE) / Any untoward medical occurrence in a participant or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Comment:
An Adverse Event can therefore be any unfavourable and unintended sign (including abnormal laboratory findings), symptom or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product).
Adverse Reaction (AR) / For CTIMPs, all untoward and unintended responses to an Investigational Medicinal Product related to any dose administered.
AE / See ‘Adverse Event’.
AR / See ‘Adverse Reaction’.
Archive system / A collection of documents detailing the content, location, transfer details and review outcomes of archived documents pertaining to a clinical trial.
Archivist / The person who defines and maintains an archive index recording all essential documents that have been entered into the archive, and approves, tracks and retrieves documents on loan from the archive.
ARSAC / Administration of Radioactive Substances Advisory Committee.
ATIMP / See ‘Advanced Therapy Investigational Medicinal Product(s)’.
ATMP / See ‘Advanced Therapy Medicinal Product(s).’
Audit / A systematic, independent and documented process for obtaining audit evidence (records, statements of fact or other information which are relevant and verifiable) and evaluating it objectively to determine the extent to which the audit criteria (set of policies, procedures or requirements used as a reference) are fulfilled.
For clinical trials: 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, analysed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), GCP and the applicable regulatory requirement(s).
Audit Manager / For the purpose of this SOP: the person responsible for setting up and executing the audit programme. This role may be taken on by a Quality Assurance (QA) Manager.
Audit Plan / An audit plan describes the aims and objectives of the audit, the scope, the resources required, the audit methodology, the audit sites and timing of the audit. The audit plan also describes how the audit will be reported.
Audit Programme / A description of the specific audit(s) planned for a specific time frame, which is agreed upon by the relevant oversight committee.
Audit Report / A written evaluation by the auditor of the results of the audit.
BCCT / See ‘Birmingham Centre for Clinical Trials’.
Birmingham Centre for Clinical Trials (BCCT) / An overarching centre set up to further improve the links between stakeholders involved in clinical research within the University of Birmingham.
Birmingham region Research Training Collaborative (BRTC) / The BRTC supports the delivery of high quality clinical research in its member organisations by providing access to research related training activities and a communication forum whereby learning resources and local events can be shared.
Blinding / Blinding is the process that keeps one or more parties involved in a trial (for example, the sponsor, the investigator team, and/or the subject) unaware of what treatment arm subjects have been randomised to. In relation to an Investigational Medicinal Product, blinding is the deliberate disguising of the identity of the product in accordance with the instructions of the sponsor.
Branded product / The brand name is the name given to a medicine by the pharmaceutical company that makes it. This is also called the "proprietary name".
BRTC / See 'Birmingham region Research Training Collaborative'.
CA / Competent Authority.
CAPA plan / See 'Corrective And Preventive Action' plan.
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.
Chief Investigator (CI) / The person who takes overall responsibility for the design, conduct and reporting of a study if it is at one site; or if the study involves researchers at more than one site, the person who takes primary responsibility for the design, conduct and reporting of the study, whether or not that person is an investigator at any particular site.
Note that for CTIMPs the Chief Investigator must be an authorised health professional.
CI / See ‘Chief Investigator’.
Clinical research / Any health related research on humans.
Clinical Research Compliance Team (CRCT) / The Clinical Research Compliance Team (CRCT) forms part of the College of Medical and Dental Sciences Research and Knowledge Transfer Office, and is responsible for developing an infrastructure for researchers involved in clinical studies. In addition, the team takes on responsibilities relating to Sponsor oversight such as audits and quality checks.
Clinical study / Any health related research study on humans. This includes:
o Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
o Study involving qualitative methods only
o Study limited to working with human tissue samples (or other human biological samples) and data (specific project only)
o Study limited to working with data (specific project only).
Clinical trial / For clinical trials using an Investigational Medicinal Product:
Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more Investigational Medicinal Product(s), and/or to identify any adverse reactions to one or more Investigational Medicinal Product(s) and/or to study absorption, distribution, metabolism and excretion of one or more Investigational Medicinal Product(s) with the object of ascertaining its (their) safety and/or efficacy.
For all other clinical trials:
Prospective biomedical research on human subjects that are conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions. Examples include devices, surgery and radiotherapy trials.
Clinical Trial Authorisation (CTA) / The regulatory approval for a clinical trial of an Investigational Medicinal Product, issued by the MHRA.
Clinical Trials Oversight Committee (CTOC) / The Clinical Trials Oversight Committee (CTOC) provides sponsor oversight of UoB’s portfolio of Clinical Trials of Investigational Medicinal Products (CTIMPs). The CTOC also provides a means for the Research Governance Team to obtain expert advice relating to non-CTIMPs. The CTOC reports to the Pro-Vice Chancellor for Research & Knowledge Transfer through the University Research Governance and Ethics Group, and to the University of Birmingham Internal Audit Office.
Closed site / Site where any site closure procedures have been completed and where all outstanding action points have been completed.
Closed trial / Trial where any trial closure procedures have been completed and where all outstanding action points have been completed.
Code Break / Also known as breaking the blind. Is the mechanism that permits the rapid identification of the trial treatment received by a subject in the case of a medical emergency, pre-specified protocol indication or safety reporting requirement, but does not permit undetectable breaks of the blinding.
Conclusion of a trial / The point in time where all trial closure procedures have been completed, including final analysis.
Coordinating Centre / A term commonly used to refer to the team responsible for the overall management of the trial and their physical location. A Coordinating Centre may be based in a Clinical Trials Unit, and may also be referred to as a Trials Office. There may be more Coordinating Centres involved in a trial, e.g. for international trials the international and national Coordinating Centre, and for trials managed regionally the central and local Coordinating Centre.
Corrective and Preventive Action (CAPA) plan / A plan produced by the auditee detailing the actions to be taken following an audit to correct the issues found and to prevent the issues from reoccurring.
CRCT / See ‘Clinical Research Compliance Team’.
CRF / See ‘Case Report Form’.
Critical Data Item / Information that is essential for the successful analysis of the primary and key secondary endpoints of a clinical trial.
CTA / See ‘Clinical Trial Authorisation’.
CTIMP / A Clinical Trial of an Investigational Medicinal Product(s).
CTOC / See ‘Clinical Trials Oversight Committee’.
CTU / Clinical Trials Unit.
CTU hosted study / A study for which the CTU undertakes some individual tasks related to the conduct of the study, but for which the CTU has not been delegated the overall task of managing the entire study on behalf of the Sponsor. Examples, though not exhaustive, would be acting as or supporting the investigator site, and/or undertaking one or more individual tasks such as Monitoring, Pharmacovigilance, IMP Supply, Data Management, Statistics. Where the CTU undertakes such specific tasks, the CTU is responsible for ensuring those tasks are conducted as expected and in line with the relevant QMS. Where all or the majority of the functions listed above are being carried out, it may be appropriate to regard the study as CTU managed.
CTU managed study / A study for which the overall study management or the majority of study management duties has been delegated to the CTU on behalf of a Sponsor. Examples include all or most of the activities of Registration, Site Initiation, Monitoring, IMP supply, Pharmacovigilance, Data Management and Statistical Analysis.
CTU manager / Those staff members within a CTU who take on line management responsibilities for their staff, e.g. Team Leaders, Team Managers, and Senior Trial Coordinators.
CTU member / Any member of staff who is either line managed within the CTU, or who has been invited by the Director of the CTU to join the CTU (e.g. as member of the executive committee), under the understanding that in the case of any issues or non-compliance, the Director has a right of sanction.
CTU mentorship / Clinical Trials Unit (CTU) mentorship is defined as an informal and professional relationship between an Independent Chief Investigator and/or their research team and one of the three UKCRN registered UoB CTUs, whereby there is an informal transmission of clinical trial experience, knowledge, skills, information and perspective imparted from the UoB CTU to the Independent Chief Investigator and/or their research team. The UoB CTU will not act in a supervisory capacity and the ultimate responsibility for the conduct of a trial will lie with the Independent Chief Investigator. Where CTU mentorship is agreed upon, this will be documented. Where the UoB CTU feels their mentoring provision is ignored, leaving the Sponsor open to risks, they may choose to discuss this directly with the Sponsor.
CV / Curriculum Vitae.
Data clarification / A data clarification is a query generated by the sponsor and sent to, and is completed by, the investigator site (or if applicable the subject) as part of the data validation process.
Data Clarification Form (DCF) / A Data Clarification Form is a document used to formally record a data clarification.
Data Collection Forms / All forms used to collect data for the trial dataset. This may include CRF, DCF, Quality of Life (QoL) questionnaires, health economic measures, participant diaries and/or correspondence with the site.
Data Entry Quality Check (DEQC) / A quality check performed on the data entered into the trial dataset (database) to ensure that the data entered is accurate.
Data Management / The administrative process by which trial data are acquired, processed, cleaned for analysis (verified), stored, and protected to ensure that the trial results are accurate and collected in accordance with the protocol and Good Clinical Practice.
Data snapshot (also known as frozen dataset) / A copy of a dataset as it exists at one particular point in time.
DCF / See ‘Data Clarification Form’.
DEQC / See ‘Data Entry Quality Check’.
DMC / Data Monitoring Committee.
DSUR / Development Safety Update Report.
EA / See ‘Editorial Amendment’.
Editorial amendment (EA) / An amendment to an existing document that does not affect the substantive content of the document, e.g. updating links, style, or grammar, or where reference will be made to the latest SOP.
EEA / European Economic Area.
Employee Training Record / Record of any training sessions that relate to previous and current functions and that are relevant for the current post.
End of trial / The end of trial definition is trial-specific. In most cases, it will be the date of the last visit of the last participant or the completion of any follow-up monitoring and data collection described in the protocol.
ERN / See 'Ethics Registration Number'.
Essential Documents / Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with standards of Good Clinical Practice and with all applicable regulatory requirements.
Ethics Registration Number (ERN) / Ethics Registration Number; an internal number assigned to a project following completion of a UoB Ethical Review of Research Self Assessment Form.
EudraCT / European Clinical trials Database.
Existing study / For the purposes of UoB sponsor oversight, a study that has a minimum provisional sponsor approval.
External archive facility / An off-site archive facility that is used to archive materials that are expected not to be used anymore, e.g. TMF after trial is closed and final report is generated.
Final analysis / An analysis of clinical trial data performed on the final cohort of participants with follow-up as defined by the protocol and Statistical Analysis Plan.
Follow-up Letter / A letter highlighting the key issues from the visit.
Follow-up Report / A report compromising of a list of action points that have been generated from an on-site monitoring visit. This report is closed when the action points listed in it are resolved or a new monitoring visit has taken place.