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Supporting Education and QI in Research (SEQuR)

Definitions and Abbreviations

A complete listing is also available in PDF format.

Adverse event: An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Approval in relation to Institutional Review Boards (IRBs): The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements.

Associated with the use of the drug: When there is a reasonable possibility that an experience may have been caused by the drug, the determination of association should ultimately be made by the Principal Investigator

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).

Audit Trail: Documentation that allows reconstruction of the course of events.

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).

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.

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.

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.

Code of Federal Regulations: Printed annually, it codifies federal agency regulations.  Title 21, chapter 1, for example, contains eight volumes of the FDA's regulations governing food and drugs.

Compliance (in relation to trials): Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements.

Confidentiality: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity.

Confidentiality Agreement: An agreement between the investigator and the sponsor where the investigator promises to keep all information regarding the study, investigational drug, protocol, investigational process, and information discovered during the investigation, confidential.

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.

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.

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, sponsors, 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.

Disability:  A substantial disruption of a person's ability to conduct normal life functions.

Documentation: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Essential Documents: Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.

Federal Register: Printed daily, Monday through Friday to record the actions of the federal agencies.

Food and Drug Administration: The FDA is an agency of the federal government's Department of Health and Human Services.  The FDA is responsible for ensuring that: foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe; regulated products are in compliance with the law and FDA regulations; noncompliance is identified and corrected; and any unsafe or unlawful products are removed from the marketplace.

Form 1572: A document that is filed with an Investigational New Drug Application (IND) that provides the FDA with a list of investigators and subinvestigators, their credentials, site(s) where the study is being conducted, laboratories used for tests, and assurance of IRB review.

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.

Health Insurance Portability and Accountability Act (HIPAA): This rule was issued in 1996 and is designed to protect the confidentiality of personal health information.

Impartial witness: A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

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.

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).

Institutional Review Board (IRB): An independent body constituted of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

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.

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.

Investigator's Brochure (IB): A summary of all preclinical drug data that includes chemical structure, pharmacology, toxicology studies, manufacturing procedures and previous human experience.  Also described as a compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects.

Legally acceptable representative: An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.

Life-threatening adverse drug experience: Any adverse drug experience that places the patient, in the view of the investigator, at immediate risk of death from the reaction as it occurred, i.e., it does not include a reaction that had it occurred in a more severe form, might have caused death.

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), GCP, and the applicable regulatory requirement(s).

Occupational Safety and Health Administration (OSHA): OSHA is administered by the federal government to provide safe and healthful working conditions by preventing injuries, saving lives and protecting the health of American workers.

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.

Protocol Amendment: A written description of a change(s) to or formal clarification of a protocol.

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 GCP and the applicable regulatory requirement(s).

Quality Control (QC): The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

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.

Regulatory Files: Files that contain all study correspondence and documents.

Scientific Review- The peer assessment of the significance, innovation and conceptual and technical soundness of the proposed activity by individuals qualified to evaluate the worthiness of the project by their status in the same discipline, or closely related field.

Serious adverse drug experience (ADE): Any experience that results in death, in a life-threatening ADE, inpatient hospitalization or prolongation of hospitalization, a persistent or significant disability or incapacity, or congenital anomaly.

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR): Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or requires medical or surgical interventions to prevent any of the above outcomes.

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 and complete, 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).

Sponsor: The FDA defines a sponsor as an individual, pharmaceutical company, government agency, academic institution, private organization, or other organization that takes responsibility for the initiation, management and /or financing of a clinical trial.

Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity of the performance of a specific function.

Sub-investigator: 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).

Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

Unexpected adverse drug experience: Any adverse experience the specificity or severity of which is not consistent with the current Investigator Brochure, or if an Investigator Brochure is not required, that is not consistent with the specificity or severity in the risk information described in the general investigational plan or elsewhere in the current application, as amended.

Vulnerable subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, and patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Well-being of the trial subjects: The physical and mental integrity of the subjects participating in a clinical trial.

  

Abbreviations

ADE                Adverse Drug Event/Experience

AE                   Adverse Event

CFR                Code of Federal Regulations

CRA                Clinical Research Associate

CRF                Case Report Form

CONFMSG        Confidential Message

CRO                Contract Research Organizations

FAA                Federal Aviation Administration

FDA                Food and Drug Administration

GCP                Good Clinical Practice

HIPAA           Health Insurance portability and Accountability Act

ICF                  Informed Consent Form

ICH                 International Conference on Harmonisation

IDE                 Investigational Device Exemption

IND                 Investigational New Drug

IVRS               Interactive Voice Response System

RB                   Institutional Review Board

OHRP             Office of Human Research Protection

OSHA             Occupational Safety and Health Administration

PI                    Principal Investigator

PHS                 Public Health System

SAE                Serious Adverse Event

SCM                Sunrise Clinical Manager

SEQuR            Supporting Education and Quality Improvement in Research

SOP                 Standard Operating Procedure

SRM                Sunrise Record Manager

Maine Medical Center Research Institute 81 Research Dr Scarborough, ME 04074 (207)396-8100

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