This glossary applies to the terms found in the documents on the Division of AIDS Clinical Research Policies and Other Information website.
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 Event (AE)
Any untoward medical occurrence in a study participant administered a study product and which 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 temporally associated with the use of a medicinal (investigational) agent, whether or not related to the medicinal (investigational) agent. (HHS)
Advocate
An individual who has the background and experience to act in, and agrees to act in, the best interests of the child throughout the duration of the child’s participation in the research and who is not associated in any way (except in the role as an advocate or member of the IRB/EC) with the research, the investigator(s), or the guardian organization. The advocate is in addition to any other individual acting on behalf of the child as guardian or in loco parentis. (HHS and FDA)
ALCOA+
Attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.
1. Attributable: The data is traceable to a person and date
2. Legible: The data is clear enough to read
3. Contemporaneous: The data is recorded as it happened
4. Original: First-place the data is recorded
5. Accurate: All the details of the data are correct
6. Complete: The data is whole
7. Consistent: The data is repeatable and traceable
8. Enduring: The data will last over time
9. Available: The data is easily accessible and will remain easily accessible over
time
10. Credible: The data is trustworthy
11. Corroborated: The data can be confirmed (FDA)
Assent
A child’s affirmative agreement to participate in research. Mere failure to object should not, absent of affirmative agreement, be construed as assent. (HHS & FDA)
Audit
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)
Audit Trail
Documentation that allows reconstruction of the course of events. (ICH E6)
Awardee
The institution receiving a grant, cooperative agreement, or contract that assumes legal, financial, and scientific responsibility for the funds and research. (DAIDS)
B
Biological product
Biological products are regulated by the Food and Drug Administration (FDA) and are used to diagnose, prevent, treat, and cure diseases and medical conditions. Biological products are a diverse category of products and are generally large, complex molecules. (FDA)
Blinding
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 E6)
C
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 E6)
Children
Persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted. (HHS and FDA)
Clinical Laboratory Improvement Amendments [CLIA]
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct. (FDA)
Clinical Research
Clinical Research is research that involves human subjects and is defined by the NIH as:
a. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes: (i) mechanisms of human disease, (ii), therapeutic interventions, (iii) clinical trials, or (iv) development of new technologies.
b. Epidemiological and behavioral studies.
c. Outcomes research and health services research.
(NIH)
Clinical Research Records
The records that describe or record the methods, conduct, and/or results of a clinical trial, and the actions taken. The records may be in any form, including written, electronic, magnetic, and optical records. Clinical research records include case histories and source documents. (DAIDS)
Clinical Research Site (CRS)
Discrete locations (e.g., hospitals, outpatient clinics, health maintenance organizations, community health centers, private practices, clinics) supported and/or sponsored by NIAID (DAIDS) where qualified professionals conduct clinical research in accordance with Good Clinical Practice and applicable regulations. (DAIDS)
Clinical Research Site (CRS) Leader
The onsite 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. (DAIDS)
Clinical Trial
HHS and NIH:
Research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
ICH E6:
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.
(HHS and NIH; ICH E6)
Clinical Trial Unit (CTU)
An entity 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. A CTU may also contribute scientific and clinical research expertise to the development of the Network clinical research plan. A CTU is 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)
Clinical Trials Agreement (CTA)
An agreement negotiated between DAIDS and a pharmaceutical collaborator providing a study product for a DAIDS sponsored or funded study. A CTA establishes the parties’ respective responsibilities and rights, covering IND sponsorship, safety and data monitoring, access to data, publications, human subject protection, confidentiality, and supply, distribution and use of study product. (DAIDS)
Commercial Off the Shelf (COTS)
Commercially available ready-made systems that are purchased and adapted as necessary. (DAIDS)
Completion of a Clinical Research Study:
Occurs when the following activities are finished:
1. all research-related interventions or interactions with human subjects (e.g. when all subjects are off study);
2. all protocol-required data collection of identifiable private information described in the IRB/EC-approved research plan;
3. all analysis of identifiable private information described in the IRB/EC-approved research plan; and
4. primary analysis of either identifiable private or deidentified information. (DAIDS)
D
DAIDS Clinical and Prevention Science Review Committees (C/PSRC)
The DAIDS Clinical Science Review Committee (CSRC) is the internal SRC responsible for the programmatic review of DAIDS-sponsored therapeutic protocols. The DAIDS Prevention Sciences Review Committee (PSRC) is the internal SRC responsible for the programmatic review of DAIDS-sponsored prevention protocols. Reviews 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)
DAIDS Clinical Laboratory Oversight Team (DCLOT)
A cross-DAIDS team that includes staff from the Vaccine Research, Prevention Sciences, and Therapeutic Research Programs. DCLOT develops, evaluates, coordinates, communicates, and oversees the implementation of harmonized guidelines, standards, and requirements for determining the readiness and on-going ability of clinical laboratories to participate in DAIDS-supported and/or -sponsored clinical trials and clinical research projects. (DAIDS)
DAIDS Funded
NIAID (DAIDS) is providing financial support for the clinical trial or study. (DAIDS)
DAIDS Good Clinical Laboratory Practice (GCLP) Guidelines
A comprehensive document outlining the guidelines for quality laboratory testing and operations, intended to ensure consistent, reproducible, and auditable laboratory data and results that can support study reconstruction. (DAIDS)
DAIDS Protection of Participants, Evaluation and Policy Branch (ProPEP)
ProPEP is a branch within Office of Clinical Research Policy and Resources (OPCRO) tasked with serving as DAIDS’ Human Subject (Participant) Protection Experts and with overseeing the development and maintenance of DAIDS’ clinical research policies. (DAIDS)
DAIDS Protocol Registration Office (PRO)
An office within the DAIDS Regulatory Support Contract (RSC) that receives and processes all protocol registration materials for DAIDS. (DAIDS)
DAIDS Protocol Registration Team (PRT)
A DAIDS team within the Office of Clinical Research Policy and Resources (OPCRO) that is responsible for managing the Protocol Registration (PR) process, which includes oversight of the DAIDS RSC PRO. (DAIDS)
DAIDS 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)
DAIDS Regulatory Support Center (RSC)
A contract that provides clinical, regulatory, and technical support services for NIAID (DAIDS)-supported and -sponsored clinical trials. (DAIDS)
DAIDS RSC Case Report Form Management Team
The DAIDS RSC works closely with DAIDS RAB and DAIDS ProPEP to facilitate this process for the sites and to ensure that only documents that were approved by DAIDS are received for storage. The DAIDS RSC CRF Team reviews the submitted documents, and once any issues are resolved, transports them to a government storage facility. (DAIDS)
DAIDS RSC Clinical Study Information Office (CSIO)
The DAIDS RSC Clinical Study Information Office (CSIO) receives and abstracts protocol and/or contact information into the DAIDS-Enterprise System (DAIDS-ES) within NCRMS for use by the NIAID/DAIDS and their collaborators in support of DAIDS-supported and/or -sponsored clinical trials. (DAIDS)
DAIDS RSC Clinical Trials Agreement (CTA) Team
The DAIDS RSC Clinical Trials Agreement (CTA) Team supports DAIDS CTAT in negotiating CTAs and other research agreements between DAIDS and collaborators. (DAIDS)
DAIDS RSC Human Subjects Protection (HSP) Team
The DAIDS RSC Human Subjects Protection (HSP) Team conducts reviews of the Sample Informed Consents (SICs) of protocols at DAIDS-specified stages of protocol development, and coordinates the translation of SICs and related documents into Spanish. (DAIDS)
DAIDS RSC Regulatory Team
The DAIDS RSC Regulatory Team works closely with DAIDS RAB and provides support by reviewing protocol documents for regulatory compliance, and preparing and filing new Investigational New Drug Applications (INDs) and amendments to existing INDs in compliance with the procedural and substantive requirements of 21 CFR 312. (DAIDS)
DAIDS RSC Safety Office
The DAIDS RSC Safety Office works closely with DAIDS SPT and provides support by collecting adverse events reported by sites participating in DAIDS-supported studies, processing the events for review by the DAIDS Medical Officer, and preparing the reports for transmittal to the Food and Drug Administration (FDA), if required. They also support DAIDS SPT in establishing internal procedures and developing Safety training for the Clinical Research Sites. (DAIDS)
DAIDS RSC Safety Information Center (RIC)
The DAIDS RSC Safety Information Center (RIC) distributes safety information from drug company collaborators (Investigator Brochures and Package Inserts), findings in DAIDS studies (IND safety reports and MedWatch reports), studies being conducted by the pharmaceutical company using the same study agent as in a DAIDS-sponsored/supported study (Safety Memos), as well as publicly available safety information (Safety Alerts and Safety Notices). (DAIDS)
DAIDS RSC Scientific Review Committee (SRC) Team
The DAIDS RSC SRC Team supports the DAIDS CSRC and PSRC, providing technical and administrative support for the SRC reviews of concept proposals and protocols. (DAIDS)
DAIDS Safety and Pharmacovigilance Team (SPT)
A DAIDS team within the Office of Clinical Research Policy and Resources (OPCRO) that is responsible for safety and pharmacovigilance activities related to clinical trials sponsored/funded by DAIDS. (DAIDS)
DAIDS Sponsored
A clinical trial or study for which DAIDS takes responsibility for the initiation, management and/or arrangement of the financing of the trial/study. (DAIDS)
DAIDS Supported
Clinical research activities would be considered to be supported by NIAID (DAIDS) under one or more of the following circumstances:
- NIAID (DAIDS) provides direct funding to an institution via a grant, contract or cooperative agreement for the clinical research activities; or (b) indirect funding via a subcontract executed under a NIAID (DAIDS) supported award to another institution; and/or
- NIAID (DAIDS) provides other tangible support for the clinical research activities which includes, but is not limited to, regulatory support, site monitoring services, study product supply, management and distribution services; and/or
- NIAID (DAIDS)-supported central laboratory or data management center receives from other organization specimens or data for processing or analysis and the results or analyses will be used to direct involvement of some or all subjects in the conduct of the clinical research activities. (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)
Data Management Center (DMC)
A grant-based organization charged with providing data management support for DAIDS sponsored or funded clinical trials. The DMC maybe charged with housing and managing clinical trial databases used for DAIDS sponsored trials; and maybe involved with database design, data collection, data cleaning and accuracy, clinical site monitoring, quality management, safety monitoring, statistical design and data analysis. (DAIDS)
Data Originators
The original source of data. Each data element is associated with an origination type that identifies the source of its capture in the electronic case report form (eCRF). This could be a person, a computer system, a device, or an instrument that is authorized to enter, change, or transmit data elements into the eCRF (also sometimes known as an author). (FDA)
Data Reports
Descriptive documents, tables, listings, and figures containing data (including safety) and analysis results generated for the review by the designated Independent Data-Monitoring Committees (IDMCs). (DAIDS)
Direct Entry
Recording data where an electronic record is the original capture of the data. (FDA)
Division of AIDS (DAIDS)
The Division within the NIAID that has the primary responsibility for basic and clinical research on HIV/AIDS. (DAIDS)
E
Electronic Data Capture (EDC) Systems
Electronic systems designed to collect and manage clinical trial data in an electronic format into the electronic case report form (eCRF). Data entered onto the eCRF may be derived from a variety of sources including electronic health record systems (EHRs). (DAIDS)
Electronic Health Record (EHR)
An electronic record for healthcare providers to create, import, store, and use clinical information for patient care, according to nationally recognized interoperability standards. NOTE: The EHR has the following distinguishing features: able to be obtained from multiple sources, shareable, interoperable, accessible to authorized parties. (FDA)
Electronic Record
Any combination of text, graphics, data, audio, pictorial, or any other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. (FDA)
Electronic Source Data
The data that are initially recorded in an electronic format. (FDA)
Electronic System
Computer hardware, software, and associated documents (e.g., user manual) that create, modify, maintain, archive, retrieve, or transmit in digital form information related to the conduct of a clinical trial. (FDA)
Encryption
Encoding information in a way that only authorized individuals may access it. (FDA)
Enrolling
The study has enrolled the first participant and continues to enroll participants. (DAIDS)
Essential Documents
Essential Documents are those documents that 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 the standards of GCP and with all applicable regulatory requirements. (ICH E6)
Expedited Adverse Event (EAE)
An Adverse Event that meets the criteria for expedited reporting to DAIDS. (DAIDS)
Expedited Adverse Event Form
The Expedited Adverse Event (EAE) paper form to be completed if DAERS system is not available. (DAIDS)
Expedited Adverse Event Reporting Days
The days that count toward the three-day timeline provided for reporting of EAEs to DAIDS. Refer to the Manual for Expedited Reporting of Adverse Events to DAIDS for criteria used to determine reporting days. (DAIDS EAE Manual)
F
Form FDA 1572
FDA required document in which clinical investigators agree to conduct the clinical trials according to Federal Regulations. The Form FDA 1572 is signed and submitted to the IND sponsor. (DAIDS)
G
Good Clinical Practice (GCP)
An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. (ICH E6)
Good Documentation Practices (GDP)
Documentation that presents a clear set of work instructions that when followed prevents mix-ups and misbranding or adulteration of regulated materials and documents. Such measures that collectively and individually ensure documentation, whether paper or electronic, is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available, credible, and corroborated. (DAIDS)
Guardian
An individual who is authorized to consent on behalf of a child to general medical care under applicable local law where the research is being conducted. (HHS)
For clinical trials conducted under FDA regulations, a guardian is an individual who is authorized to consent on behalf of a child to general medical care when general medical care includes participation in research under the applicable local law where the research is being conducted. A guardian is also an individual who is authorized to consent on behalf of a child to participate in research. (FDA)
H
Human Subject
A living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
This term is used interchangeably with the term 'participant'. (HHS)
I
Independent Data-Monitoring Committee (IDMC)
An independent data monitoring committee that may be established by the sponsor (Data and Safety Monitoring Board), or the network (Safety Monitoring Board or Committee, or equivalent) to assess, at predetermined intervals or ad hoc if required, the progress of a clinical trial, the safety data, outcome measures, and the critical efficacy endpoints when applicable, and to recommend to the sponsor whether to continue, modify, or stop a trial. (DAIDS)
Information System
A discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information. (NIST)
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 Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
An initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. As it relates to GCP, ICH provides a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. (ICH E6)
Interoperability
The ability of two or more products, technologies, or systems to exchange information and to use the information that has been exchanged without special effort on the part of the user. (FDA)
Investigational Device Exemption (IDE)
An FDA exemption that allows an unapproved medical device to be used for investigational purposes. (FDA)
Investigational New Drug (IND)
A request from a clinical study sponsor to obtain authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. (FDA CBER Guidance)
Guidance: "Investigational New Drug Applications (INDs) for CBER-Regulated Products"
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. (ICH E6)
Investigator of Record (IoR)
The individual at the CRS responsible for ensuring that a clinical trial is conducted in accordance with the protocol, applicable U.S. federal regulations, in-country regulations and any provisions imposed by the reviewing IRB/EC/other regulatory entity. This person is the signatory for the Form FDA 1572 for studies conducted under an IND or the DAIDS Investigator of Record Agreement for non-IND studies. (DAIDS)
Investigator’s Brochure (IB)
A compilation of the clinical and nonclinical data on the investigational agent(s) relevant to the study of the investigational agent(s) in human subjects. (FDA)
J
K
L
Legally Authorized Representative
An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. If there is no applicable law addressing this issue, legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the nonresearch context on behalf of the prospective subject to the subject's participation in the procedure(s) involved in the research. (HHS)
M
Medical Officer
The DAIDS Medical Officer (MO) is the designated DAIDS clinical representative for the study. (DAIDS)
N
O
Office for Human Research Protections (OHRP)
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research. OHRP also supports the Secretary's Advisory Committee on Human Research Protections (SACHRP), which advises the HHS Secretary on issues related to protecting human subjects in research. (HHS)
Office for Policy in Clinical Research Operations (OPCRO)
The office in the Division of AIDS (DAIDS) that provides clinical research management resources, regulatory support, and regulatory oversight to the DAIDS clinical trials research portfolio. (DAIDS)
P
Parent
The child’s biological or adoptive parent. (HHS and FDA)
Parental Permission
The agreement of parent(s) or guardian to the participation of their child or ward in research. (HHS and FDA)
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 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. (ICH E6)
Principal Investigator (PI)
The qualified person designated by the applicant institution to direct the funded research program. PIs oversee the scientific and technical aspects of an award and the day-to-day management of the research. (DAIDS)
Protocol Registration
The process established by DAIDS to ensure that all sites participating in NIAID (DAIDS)-supported and/or -sponsored clinical research that is reviewed by a DAIDS Scientific Review Committee conduct the research in accordance with requirements for human subjects protection and the use of investigational new drugs (where applicable). The process includes initial protocol registration, amendment registration, continuing review documentation, deregistration and submission of other required documents. (DAIDS)
Protocol Registration Team (PRT)
A Team within OPCRO responsible for managing the PR System, which includes oversight of the DAIDS PRO. (DAIDS)
Protocol Team
A team of individuals comprised of grantees, investigators, statisticians, and other protocol support personnel who work to develop concepts into NIAID (DAIDS)-funded and/or -sponsored research studies. DAIDS medical officers may be involved as members of this team. (DAIDS)
Q
Quality Assurance (QA)
All those planned and systematic actions that are established to ensure that a clinical trial is performed according to the regulations and the data generated, documented (recorded), and reported are in compliance with GCP and the applicable regulatory requirement(s). (DAIDS)
Quality Control (QC)
The real time, on-going 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)
R
Regulatory Entity/Regulatory Authority
Any entity/body that has the legal authority to regulate, review, approve and/or inspect clinical research. These are entities/bodies, sometimes referred to as competent authorities, whose approval/authorization/acknowledgment of a clinical trial is required before or during the conduct of a clinical trial and includes authorities that review submitted clinical data and conduct inspections. Examples of such entities include but are not limited to federal, national, regional, state or local authorities, administrative/government entities (e.g., FDA, EMA, SAPHRA, etc.), drug agencies etc. (DAIDS)
Risk Mitigation
A strategy and steps taken to reduce or eliminate a risk or potential risk to data or systems integrity. (DAIDS)
S
Safety Monitoring Board/Committee
An independent group of experts that advises NIAID and the study investigators for some Phase I and most Phase II trials. The primary responsibility of the SMC is to monitor participant safety. (DAIDS)
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)
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 (i.e., an AE) that meets one or more of the following criteria for seriousness as defined by the International Conference on Harmonisation (ICH): • Results in death, • Is life-threatening, • Requires inpatient hospitalization or prolongation of an existing hospitalization, • Results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, • Results in a congenital anomaly or birth defect, or • Is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. (DAIDS EAE Manual)
Site Pharmacist
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-supported and/or -sponsored clinical trial(s) must be identified as the Site Pharmacist. (DAIDS)
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)
Software as a Service (SaaS)
Software available by subscription and centrally hosted by a third-party provider; a form of cloud computing. (DAIDS)
Software Validation
Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the requirements implemented through the software can be consistently fulfilled. (FDA)
Sponsor
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. (ICH E6)
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. (ICH E6)
Sponsor's Authorized Representative (SAR)
A senior regulatory affairs professional, in the Regulatory Affairs Branch, who is the official DAIDS/NIAID liaison with the FDA or other pertinent national regulatory authorities (e.g. SAHPRA) acting on behalf of the sponsor. The SAR works closely with other groups within DAIDS/NIAID to ensure that clinical trials are compliant with all applicable U.S. or other international/in-country regulations, guidelines and policies. For INDs sponsored by DAIDS/NIAID, the SAR communicates directly with the FDA about decisions and plans on behalf of DAIDS, accepts responsibilities as detailed in 21 CFR 312.50, and signs the Form FDA 1571. For both IND and Non-IND studies, the SAR is responsible for the regulatory strategy, and provides regulatory guidance to DAIDS and the Protocol Team at any time during the life cycle of the trial. (DAIDS)
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)
Statistical Data Analysis Center (SDAC)
The data processing center that promotes statistical practices in a clinical trial. Involved with study design, data collection processes, designing of CRFs, preparing data reports, data analysis plans, and analyzing interim and final clinical trials data. Responsible for generating the statistical analysis plan for individual trials. (DAIDS)
Study Product
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)
Study Progress, Data, and Safety Monitoring (SPDSM) Plan
Outlines the process for creation of Independent Data-Monitoring Committee (IDMC) data reports, including content, distribution schedules, and recipients for the following purposes:
1. To help ensure the safety of the study participants;
2. To verify that the appropriate data are collected to monitor safety and address the protocol objectives;
3. To ensure that the reports are made available in a timely manner.
For DAIDS' network trials, the SPDSMP is created by the respective Statistical Data Analysis Center (SDAC) or Data Management Center (DMC). (DAIDS)
Summary Reports
The synopsis of the observations and recommendations of the designated Independent Data-Monitoring Committees (IDMCS). (DAIDS)
Suspected Unexpected Serious Adverse Reaction (SUSAR)
An AE that is:
1. Serious (i.e., an SAE),
2. Related (i.e., there is a reasonable possibility that the AE may be related to the study product), and
3. Unexpected (i.e., an AE whose nature or severity [intensity] is not consistent with the applicable product information found in an investigator’s brochure, a package insert or a summary of agent characteristics). (DAIDS)
T
U
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)
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. (HHS)
Unblinding
Process of revealing previously blinded treatment assignment. (DAIDS)
Unexpected Adverse Event
An Adverse Event whose nature, severity (intensity), or frequency is not consistent with the applicable study product information (e.g., investigator’s brochure, package insert, or summary of product characteristics).
Any adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is not consistent with either:
- the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the protocol–related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent document, and (b) other relevant sources of information, such as product labeling and package inserts; or
- the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event. (DAIDS EAE Manual; HHS)
User Acceptance Test (UAT)
A testing protocol to verify the system performs as required. (DAIDS)
V
W
Ward
A child who is placed in the legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law. (FDA)
X
Y