Glossary A through G
Abbreviated New Drug Application (ANDA) – Simplified submission for products with the same or very closely related active ingredients, dosage form, use, strength, administration route, and labeling as a product that has already been shown to be safe and effective. An ANDA includes all the information on chemistry and manufacturing controls found in an NDA but does not usually have to include efficacy and safety data from studies in animals and humans. It must, however, contain evidence that the duplicate drug is bioequivalent to the previously approved drug.
Administrative Change – Change to a protocol involving only administrative details and having no impact on study design or subject safety. An administrative change requires IRB/IEC notification but does not require notification of regulatory agencies prior to implementation.
Adverse Event (AE) – Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporarily associated with the use of a medicinal (investigational) product, whether related to the medicinal (investigational) product or not. (See the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.) (ICH)
Altered Data – Generating biased data or changed data that is legitimately obtained. An example of an altered document includes unsupported changes to data on a document, such as exam dates, date of birth, etc. An example of altered data can include unsupported changes to data in the source document and/or the CRF.
Amended Protocol – A Protocol that has been revised or an amendment to the Protocol.
ANDA – Abbreviated New Drug Application.
ANDA Protocol Outline – Document that defines study design, reference formulation, and basic pharmacokinetics of compound to be tested.
Application – A formal request for review and approval, where issue of an opinion/approval by the regulatory authority is required for the trial commencement.
Archival – The process of performing a full backup of a project’s study data, metadata, and associated files to tape for long-term storage at an offsite facility.
ARSAC – Administration of Radioactive Substances Advisory Committee.
Audit – A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and whether the data was recorded, analyzed, and accurately reported according to the Protocol, Sponsor’s SOPs, GCP, and the applicable regulatory requirement(s). (ICH GCP 1.6)
Audit-Related Documents – Written evaluations by a regulatory agency or a quality assurance group (internal or external) that contain findings and observations about PPD activities.
Author – Person writing any section of the Investigator Brochure. May be a member of the medical writing, clinical pharmacology, medical affairs, or regulatory affairs staff.
Becquerel – (Bq) Radiological unit, source strength.
Bind – To place yourself under legal obligation and/or to cause you to be legally responsible.
Blinding/Masking – A procedure in which one or more parties to the trial are 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(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). (ICH)
Blood – Means human blood, human blood components, and products made from human blood.
Bloodborne Pathogens – Means pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, HBV virus (HBV) and human immunodeficiency virus (HIV).
BMI (Body Mass Index) – This is a value obtained when weight is divided by height. The formula used for calculation of this value is BMI = Weight (Kg) / Height
(m) x Height (m).
Call Center Services (CCS) – The area where the telephone operators use computers and telephone equipment to assist in subject/site recruitment and/or site support programs.
Call Center Services Questionnaire – The combined document of standardized opening remarks relative to the nature of clinical research, research subject rights, and confidentiality along with standardized study specific questions used to collect data from potential subjects; sometimes referred to as “script” or “transcript.”
Call Center Services Site – Participating institutions or clinics that have provided documentation of respective advertisement approval, as needed, and that are Sponsor- or Clincal Operations-approved recipients of CCS efforts.
Call Center Services Staff (Operators) – Personnel who receive and record information by telephone from prospective study subjects and/or consumers pursuant to CCS advertising and recruitment programs.
Call Report – For purposes of this procedure, record of a specific Technical Support Communication. Use of the word “call” does not imply that these reports originate exclusively from telephone contact.
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)
Casebook Guide – Instructions for completing the CRF that may include sample completed CRF pages.
Causality – Relationship of an investigational product to an AE. Many causality categories are used to describe the degree of attributability of a product to an AE, such as Definite, Probable, Possible, Remote, Not Related; however, currently, there is no standard nomenclature.
Central Laboratory – Primary laboratory used by all investigators participating in a study for the analysis of specimens (e.g., biological fluids and tissue).
Clintrial Database Administrator – The individual who provides user support and administration, security, and other operational support for Clintrial database activities.
Co-investigators – Investigators having equal power and responsibilities for a clinical trial.
Communications – Communications include written, verbal, or electronic communication such as, but not limited to, letters, memoranda, facsimile transmissions, electronic mail messages, voice mail messages, telephone conversations, and meetings.
Compassionate Use – Sometimes used to describe a request by a practitioner to treat a single patient with an investigational product. The request is usually in response to a desperate situation, such as the lack of approved or generally recognized treatments or the patient being unresponsive to other therapies.
Computer System Validation – Documented evidence, to a high degree of assurance, that the computer system performs its intended functions accurately and reliably.
Confidentiality – Prevention of disclosure, to other than authorized individuals, and/or Sponsor’s propriety information or of a subject’s identity. (ICH derived)
Confidentiality Agreement – Document preventing disclosure of facts to third parties. Also synonymous with Secrecy Agreement.
Contact Report – Written record of contact between a Sponsor’s employee and trial site staff, client company, contract service agency, or regulatory agency.
Contaminated Laundry – Laundry that has been soiled with blood, body fluids, or other potentially infectious materials.
Contaminated Sharps – Any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires.
Contamination – The presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.
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 GCP 1.20)
Debarment – The FDA, authorized by the U.S. Generic Drug Enforcement Act (1992), has the right to forbid or deny individuals and/or firms from participation in the development of an investigational product. Those individuals/firms having been debarred are published in the U.S. Federal Register.
Declaration of Helsinki – International document defining the ethical principles under which clinical research is to be conducted.
Decontamination – The use of physical or chemical means to remove, inactivate, and destroy bloodborne pathogens. Pathogens must be destroyed on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal.
Deliverable – Any report text, table, listing, and figure or database produced for de-
livery to the client.
Designee -Individual empowered to sign agreements or perform actions through their position in an organization.
Dispensing Investigational Product – The act of providing investigational product to a subject wherein the study personnel inject, apply, or observe the physical administration of investigational product on or by the subject.
Dosing – The act of providing a unit dose or applying an investigational product to a subject wherein the study personnel inject, apply, or observe the physical administration of the investigational product on or by the subject.
Dosing – Error When an incorrect dose of investigational product has been inadvertently given to a subject, or taken by a subject, including dispensing or administering to the wrong subject or taking/administering the study medication on the wrong day or time, having taken/administered the wrong investigational product.
Drug Enforcement Administration (DEA) – Lead agency in the U.S. responsible for enforcing the controlled substance laws and regulations of the U.S.
Exposure Incident – A specific eye, mouth, other mucous membrane, nonintact skin, or parenteral contact with blood or other potentially infectious materials that result from the performance of an employee’s duties.
FDA – Food and Drug Administration.
Financial Agreement – Document containing details of all financial arrangements entered into between the client company and/or a trial site. The financial agreement may form part of the Study Site Agreement (e.g., Statement of Agreement).
Fraud – Deliberate reporting of false or misleading data or the withholding of reportable data. Fraud does not include the submitting of poor quality data without the intent to deceive.
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 are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. (ICH)