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| Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents | | |
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Glossary of DAIDS Terms
Please note that the Glossary is currently under revision.
A | B | C | D | E | F | G | H | I | J | K | L | M
N | O | P | Q | R | S | T | U | V | W | X | Y | Z
A
Adverse Drug Reaction (ADR)
In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. (ICH E6)
Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a patient of clinical investigation subject administered a pharmaceutical product and which does not necessarily have a casual relationship with this treatment. An AE can therefore 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. (ICH E6)
Auditing
Independent on-site quality assurance of monitoring performed at clinical research sites (including pharmacies and laboratories). Auditors must be fully distinct and independent from entities providing site monitoring services. (DAIDS)
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B
Basic Sciences Program (BSP)
The BSP is a program within DAIDS that focuses on the fields of pathogenesis, basic virology, immunobiology, and the discovery of novel therapeutic approaches, efficacy evaluation in lentivirus animal models, and epidemiology. (DAIDS)
Biological product
Any virus, therapeutic serum, toxin, antitoxin, or analogous product available to prevent, treat or cure diseases or injuries in man. The terms "biological product" or "biologic" are deemed to be synonymous within DAIDS policies. (DAIDS)
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C
Central Data Management Facility
The group responsible for managing the database and handling and processing the data gathered during a clinical trial. The location can be the same as the data collection site. (DAIDS)
Clinical Investigation
Any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. (21 CFR 312)
Clinical research
Research conducted on human subjects or on material of human origin identifiable with the source person. Clinical research includes large and small-scale, exploratory, and observational studies. There are three types:
- Patient-oriented research
- Epidemiologic and behavioral studie
- Outcomes and health services research
Clinical Research Site
Discrete locations (e.g. hospitals, outpatient clinics, health maintenance organizations, community health centers, private practices, clinics, etc.) where qualified professionals conduct clinical trial research in accordance with Good Clinical Practices. (DAIDS
CRS (Clinical Research Site) Leader
The on site senior research scientist responsible for the administrative and scientific components of the CRS. The CRS leader is responsible for overall site activities, including day-to-day operations, performance, and compliance at the site level.
Clinical Sciences Review Committee (CSRC)
The Division of AIDS internal scientific review committee responsible for the programmatic review of therapeutic protocols sponsored by DAIDS. The review will include careful assessment of the scientific objectives, design, safety, ethics, and feasibility of proposed research protocols. Scientific representatives from collaborating NIH Institutes and Centers participate as appropriate. (DAIDS)
Clinical Site Monitoring Group (CSMG)
The group delegated by DAIDS to conduct periodic on-site monitoring visits to DAIDS Clinical Trial Units to evaluate the quality and validity of study data, compliance with Good Clinical Practices, and protection of research subjects. Reports findings to DAIDS. (DAIDS)
Clinical Trial
A prospective study of human subjects designed to answer questions about biomedical or behavioral interventions, e.g., drugs, treatments, devices, or new ways of using known treatments to determine whether they are safe and effective. (NIAID)
Clinical Trials Agreements (CTAS)
An agreement negotiated between DAIDS and a pharmaceutical collaborator providing an investigational agent for a Network study and DAIDS (as the study sponsor). Describes CTA's respective responsibilities and rights includes IND sponsorship, safety and data monitoring, and access to data. (DAIDS)
Clinical Trial Unit (CTU)
Clinical Trials Units (CTUs) are entities composed of an administrative component and one or more Clinical Research Sites that contribute to the Network clinical research plan by conducting the clinical research (that is, executing clinical protocols). CTUs also may contribute scientific and clinical research expertise to the development of the Network clinical research plan. CTUs are responsible for developing and maintaining effective community relationships; enabling community participation in Clinical Research Sites, CTU, and Network activities; and ensuring that all clinical research is conducted in compliance with Network bylaws, policies and procedures, DAIDS policy and procedures, Federal regulations, and any applicable local requirements. (DAIDS)
Code of Federal Regulations (CFR)
The codification of the general and permanent rules published in the US Federal Register by the executive departments and agencies of the US federal government. It is divided into 50 titles that represent broad areas subject to US federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis. (NIH)
Community Advisory Board (CAB)
Community Advisory Board (CAB) is an active group representing the local population(s) impacted by HIV/AIDS. CAB members work in close communication with CTU investigators and staff to include the local perspective in the implementation of the HIV/AIDS clinical research plan. (DAIDS)
CTU Administrative Unit
This CTU component provides oversight of the grantee award. Each CTU must have an administrative structure that resides within the Awardee institution. It is not a requirement that this component function as a clinical trial site. (DAIDS)
CTU Principal Investigator
The Principal Investigator is listed as the Grantee on the Notice of Award and is responsible for all CTU activities and CTU performance. This includes responsibility for affiliated clinical research sites (CRS), including communications, site performance and financial management. The principal investigator also provides CTU scientific and administrative representation to the Network(s).
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D
Data and Safety Monitoring Board (DSMB)
The DSMB is an independent panel of experts established by NIAID and charged with the responsibility of monitoring the progress of trials, the safety of participants, and the efficacy of treatments being tested. The DSMB also makes recommendations to NIAID concerning continuation, termination or modification of the studies based on observed beneficial or adverse effects of any of the interventions under study. This panel is funded separately by NIAID. (DAIDS)
Data Collection Site
The location where clinical trial data is collected and case report forms are completed (usually the trial site). (DAIDS)
Division of AIDS (DAIDS)
The Division within the NIAID that has the primary responsibility for basic and clinical research on HIV/AIDS. (DAIDS)
Division of AIDS (DAIDS) Funded
DAIDS is providing financial support for trial or study. (DAIDS)
Division of AIDS (DAIDS) Safety Office
The Office to which adverse events requiring expedited reporting are submitted. Currently located in the Regulatory Affairs Branch (RAB) support contract and managed through RAB. (DAIDS)
Division of AIDS (DAIDS) Sponsored
DAIDS is responsible for the management (including submission of the Investigational New Drug Application (IND) to FDA, and initiation of the study), and oversight for the trial. (DAIDS)
DAIDS Tables for Grading Adult and Pedicatric Adverse Experiences (Toxicity Tables)
Lists of common terms and severity (intensity) parameters used to describe adverse events occurring in DAIDS-sponsored clinical studies/trials. (DAIDS)
Drug
Article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals. (FDA)
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E
Essential Documents
Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH E6)
Expedited Adverse Event (EAE)
An adverse event that meets the criteria for expedited reporting to DAIDS. See Manual for Expedited Reporting of Adverse Events to DAIDS. (DAIDS)
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F
Federal Wide Assurance (FWA)
As regulated by the Department of Health and Human Services (DHHS), 45 CFR. 46.103, an assurance of compliance approved by the Office for Human Research Protections (OHRP). This assurance formalizes the institution’s commitment to protect human subjects and must be obtained by every institution engaged in human subjects research supported or conducted by DHHS. (DAIDS)
Form FDA 1572
FDA required document in which clinical investigators agree to conduct IND the clinical trials according to Federal Regulations. The Form FDA 1572 is signed and submitted to the IND sponsor by the clinical investigator. (DAIDS)
Full Regulatory Review
The final review of the protocol, including the sample informed consent(s), by the Regulatory Affairs Branch (RAB) prior to medical officer sign off and distribution to the sites. (DAIDS)
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G
Good Clinical Practices (GCP)
An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. (ICH E6)
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H
I
Independent Safety Monitor
The physician or other appropriate expert who is independent of the study and available to review SAEs and other safety data in a timely fashion and recommends appropriate actions to the study team and the National Institutes of Allergy and Infectious Diseases (NIAID). (DAIDS)
Informed Consent Form (ICF)
A document that provides the elements of informed consent as found in 21 CFR 50.25 and 45 CFR 46.116 (DAIDS)
Informed Consent Process
A process by which a participant voluntarily confirms his or her willingness to participate in a particular study after having been informed of all aspects of the trial that are relevant to the participant’s decision to participate. (ICH E6)
Institutional Review Board/Ethics Committee (IRB/EC)
The board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of participants in research. IRB/EC reviewing DHHS sponsored research must be registered with OHRP and identified on the institute FWA. (DAIDS)
International Conference on Harmonisation (ICH) Guidelines
Developed, through a collaboration between the FDA and regulatory agencies in Japan and the European Union, to “harmonize” regulatory requirements to produce marketing applications acceptable to the United States, Japan, and the countries of the European Union. (DAIDS)
Investigational New Drug
A new drug or biological product that is used in a clinical investigation. The terms "investigational new drug" and "investigational drug" are deemed to be synonymous within DAIDS policies. (DAIDS)
Investigational New Drug Application (IND)
Application required by the US FDA before clinical trials of a new drug or new biological agent may be initiated. An IND is also required if the US FDA has not approved the route of administration, dosage level, or patient population for the drug or biological agent. (FDA)
Investigator IND
An IND submitted by an physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. (DAIDS)
Investigator of Record (IOR)
The person responsible for the conduct of the clinical trial, at a clinical research site. This person is the signatory for the FDA Form 1572 (IND studies), or IoR Agreement (Non-IND studies). Written delegation of authority for specific study responsibilities may be given to qualified individuals. (ICH E6)
Investigator of Record Agreement
Documentation required by DAIDS for non-IND studies. The Agreement contains the same information as the FDA Form 1572. (DAIDS)
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J
K
Key Personnel
Individuals who are involved in the design and conduct of NIH-funded human subjects’ clinical research. This includes all individuals named on the Form FDA 1572 or DAIDS Investigator of Record Agreement and any clinical research site personnel who have more than minimal involvement with the conduct of the research (performing study evaluations or procedures or providing intervention) or more than minimal study conduct-related contact with study subjects or confidential study data, records, or specimens. (NIH)
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L
Label
The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging. (ICH E6)
Legally marketed product
A product that received licensure or approval for marketing in the United States (U.S.) (FDA)
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M
Medical Officers
A DAIDS staff member or member from another sponsoring Institute or Centers that monitors the safety and efficacy of the intervention(s) for ongoing studies and those in development. (DAIDS)
Monitors
Individuals qualified by education or experience, whose primary role is to ensure compliance with the applicable regulations, policies, and standard procedures, as well as compliance with the study protocol as approved by the institutional review board or research ethics board. (DAIDS)
DAIDS Monitor
A monitor who is contracted by DAIDS. (DAIDS)
External Non-DAIDS Monitor
A qualified monitor not contracted by DAIDS and not employed or supervised by the study investigators, network, or site, has no affiliation with any of the participating clinical research sites, and has no role in trial conduct except as a site monitor. The monitor must be contracted or supplied by an organization (i.e. pharmaceutical sponsor, CRO, or academic institution) that conducts independent clinical site monitoring utilizing its own monitoring and reporting SOPs and having a distinct and independent supervisory structure for monitoring services. (DAIDS)
Internal Non-DAIDS Monitor
A qualified employee of a network involved with conduct of the clinical trial having no affiliation with any of the participating clinical research sites and not involved with the conduct of the trial at any participating clinical research site except for his/her role as a monitor. (DAIDS)
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N
Notice of Grant Award (NGA)
The legally binding document that notifies the grantee and others that an award has been made. It contains or references all terms and conditions of the award, and documents the obligation of US federal funds. (NIH)
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O
Office for Policy in Clinical Research Operations (OPCRO)
An office in the Division of AIDS (DAIDS) that provides a variety of clinical trials management resources and oversight to DAIDS clinical research portfolio. This includes overseeing the development, standardization, implementation and execution of policies, procedures and standards of conduct for all of DAIDS domestic and international clinical research. (DAIDS)
P
Pharmacist of Record
A licensed/registered pharmacist who performs the day to day pharmacy activities and study product management including but not limited to the procurement, storage, preparation, dispensing and final disposition of study products for DAIDS sponsored or funded clinical research trial(s) must be identified as the Pharmacist of Record. (DAIDS)
Pharmacy
Any facility, building, or room used to perform one or more of the following functions: storage, preparation, dispensing, management of study products, (example: dispensary, drug storage unit, drug store). (DAIDS)
Pharmacy Ancillary Supplies
Any materials or tools that may be used in a pharmacy to perform and support the day to day activities and functions of the pharmacist, such as needles and syringes, oral syringes, prescription vials and lids, gowns, masks, IV solutions, diluents. (DAIDS)
Pharmacy Equipment
Apparatus (device or machinery) that is utilized to ensure the physical and scientific integrity of the study product during shipment, storage, handling, and preparation. Examples of pharmacy equipment are; biological safety cabinets, refrigerators, -20 C freezers, -70 C freezers, air conditioners, dehumidifiers, thermometers, vortex machines, temperature alarm systems, limited access/security systems (alarms, key lock) in study product and pharmacy regulatory file storage areas, locking file and storage cabinets, shelving, counting trays for tablets and capsules, graduated cylinders, spatulas, study product containers, fax machines, computers, and printers. (ICH E6)
Principal Investigator (PI)
The qualified person designated by the applicant institution to direct the research. PIs oversee the scientific and technical aspects of a grant and the day-to-day management of the research. (NIH)
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. (ICH E6)
Protocol Amendment
A written description of a change(s) to or formal clarification of a protocol. (ICH E6)
Protocol Registration
The process established by DAIDS Regulatory Affairs Branch (RAB) to ensure that all sites participating in DAIDS-sponsored research conduct the research in accordance with requirements for human subjects protection and the use of investigational new drugs (where applicable). (DAIDS)
Protocol Registration Office (PRO)
An office within the RCC managing all aspects of the protocol registration process. (ICH E6)
Prevention Sciences Review Committee (PSRC)
The Division of AIDS internal scientific review committee responsible for the programmatic review of vaccine and prevention protocols sponsored by DAIDS. The review will include careful assessment of the scientific objectives, design, safety, ethics, and feasibility of proposed research protocols. Scientific representatives from collaborating NIH Institutes and Centers participate as appropriate. (DAIDS)
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Q
Quality Assurance (QA)
A periodic, systematic, objective and comprehensive examination of the total work effort to determine the level of compliance with accepted Good Clinical Practice (GCP) standards. For example, a monthly peer review of source documents compared to CRF pages to determine adherence to protocol requirements. (DAIDS)
Quality Control (QC)
The real time, on-going (“day-to-day”) observation and documentation of a site’s work processes to ensure that accepted procedures are being followed. For example, reviewing demographic information for accuracy on each Case Report Form (CRFs) page prior to entry into the database. (DAIDS)
Quality Management
The overall system that includes all activities involved in Quality Assurance and Quality Control including the assignment of roles and responsibilities, the reporting of results and the resolution of issues identified during the review. (DAIDS)
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R
Regulatory Affairs Branch (RAB)
A branch of DAIDS within the Office of Clinical Research Policy and Resources (OPCRO). RAB performs regulatory surveillance over clinical trials sponsored/funded by DAIDS. (DAIDS)
Regulatory Compliance Center (RCC)
A contract based organization within Technical Resources International, Inc. charged with providing regulatory support to RAB, DAIDS. (DAIDS)
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S
Sample Informed Consent (SIC)
An informed consent developed by the protocol team for a specific protocol that will help guide participating sites in the development of their site specific informed consent. (DAIDS)
Serious Adverse Drug Experience
Any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent on of the outcomes listed in this definition. (21 CFR 312)
Scientific Review Committee (SRC)
A reviewing body within DAIDS to review the concepts and protocols developed by various programs within DAIDS (e.g., CSRC and PSRC).(DAIDS)
Serious Adverse Event (SAE)
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. This includes important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed in the definition above. (ICH E6 and E2A)
Site Specific Informed Consent
An informed consent developed by a participating site based upon the sample informed consent which is reviewed and approved by the site’s designated IRB/IEC and is used to consent subjects at the site for a specific clinical trial. (DAIDS)
Source Data
All information in original records and certified copies of original records of clinical findings, observations, or other activities in a study necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). (ICH E6)
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). (ICH E6)
Sponsor
A person (individual, corporation or agency) who initiates a clinical investigation, but who does not actually conduct the investigation. That is the test articles is administered or dispensed to or used involving, a subject under the immediate direction of another individual. A person other than an individual (e.g. corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated is considered to be a sponsor, and the employees are considered to be investigators. (FDA)
Sponsor-Investigator
An individual who both initiates and actually conducts, alone or with others, a clinical investigation. For example, under whose immediate direction the test article is administered, dispensed to, or used involving a subject and who also submitted the IND. (FDA)
Standard Operating Procedures (SOPS)
Written procedures designed to ensure data and analysis quality by requiring uniform performance of specific functions by the group(s) that fall within their scope. An SOP is designed to provide a high level overview of tasks or functions performed. An SOP, by definition, must be followed unless a documented exception is approved. (DAIDS)
Study Products
Any drug, biologic, vaccine, radiopharmaceutical, item or device that are either provided for the study or identified in the protocol as being a study product. (DAIDS)
Subject
A human who participates in an investigation, either as a recipient of the investigational new drug or as a control. A subject may be a healthy human or a patient with a disease. (21 CFR 312)
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T
Tentative Drug Approval
If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference list drug product (an approved drug product to which new generic versions are compared), FDA issues a tentative approval letter to the applicant. The tentative approval letter details the circumstances associated with the tentative approval. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product in the United States. (DAIDS)
Therapeutics Research Program (TRP)
The TRP is a program within the DAIDS that is responsible for the scientific, administrative, and operational management of the clinical therapeutic research programs funded by the Division. (DAIDS)
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U
Unanticipated Problems
Events that must be reported to Office of Human Research Protections (a) unanticipated problems involving risks to subjects or others or (b) any serious or continuing noncompliance with policy requirements or determinations of the IRB and (c) any suspension or termination of IRB approval. (OHRP)
Unexpected Adverse Drug Experience
Any adverse drug experience, the specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. (21 CFR 312)
U. S. Food and Drug Administration (FDA)
A public health agency within the United States Department of Health and Human Services. FDA’s mission is to promote and protect public health by helping safe and effective products reach the market in a timely way and monitoring of products for continued safety after they are in use as authorized by The Federal Food and Cosmetic Act. The Agency regulates all clinical investigations in support of marketing applications. (DAIDS)
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V
Vaccine and Prevention Research Program (VPRP)
The VPRP is a program within the DAIDS that supports the discovery and development of vaccines and other biomedical and behavioral interventions to prevent AIDS. (DAIDS)
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W
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