The following is a glossary of acronyms and terms found within the Funding Opportunity Announcements issued by NIAID in connection with its clinical trials restructuring process.
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 Clinical Quality Management Plan is a formal written document that defines the processes and procedures that guide quality management activities (including Quality Assurance and Quality Control) in the clinical setting and details the responsibility, scope, and frequency of these activities.
A Clinical Research Site (CRS) is a component of a Clinical Trial Unit (CTU) and is defined as a discrete location (e.g., hospital, outpatient clinic, community health center, private practice, local health department clinic) with appropriate identified and characterized potential trial participants (e.g., demographics, incidence, and prevalence of HIV/AIDS) where participant recruitment and retention, protocol management, and other clinical research activities are conducted. The CRS must be staffed by qualified professionals capable of conducting clinical research for one or more clinical research networks in accordance with Good Clinical Practice (GCP) guidelines, local regulatory requirements, and other applicable NIH requirements. In addition, each CRS must participate in one or more HIV/AIDS clinical research network(s). The activities of each CRS will be directed by a CRS Leader with the experience and qualifications to oversee clinical activities and the day-to-day clinic operations will be overseen by a CRS Coordinator with relevant clinical research experience and qualifications.
The internal scientific review committee within NIAID’s Division of AIDS (DAIDS) responsible for the programmatic review of HIV/AIDS therapeutic protocols sponsored by NIAID. The review will include careful assessment of the scientific objectives, design, safety, ethics, and feasibility of proposed research protocols. Scientific representatives from collaborating National Institutes of Health (NIH) Institutes and Centers participate as appropriate.
The group delegated by NIAID’s Division of AIDS (DAIDS) to conduct periodic on-site monitoring visits to NIAID-supported 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.
An agreement negotiated between NIAID’S Division of AIDS (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, and includes investigational new drug (IND) sponsorship, safety and data monitoring, and access to data.
A Clinical Trials Unit (CTU) is an organization/institution responsible for the coordination and execution of clinical trials in accordance with the clinical research network, NIAID, and other applicable policies. The CTU provides the scientific and administrative expertise, as well as the infrastructure, to participate in NIAID clinical research networks.
The CTU PD(s)/PI(s) is/are responsible for all CTU/clinical research site (CRS) activities and performance, and also serve(s) as scientific and administrative representative(s) to the CTU’s affiliated network(s). The CTU is composed of multiple components, including:
The codification of the general and permanent rules published in the U.S. Federal Register by the executive departments and agencies of the U.S. federal government. It is divided into 50 titles that represent broad areas subject to U.S. federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.
A Community Advisory Board (CAB) is an active group of individuals representing the local population(s) impacted by HIV/AIDS from which clinical study participants will be drawn. The group promotes community engagement and provides local perspective(s) on the implementation of NIAID clinical resarch plans.
The Community Partners (CP) is a group established to promote effective representation of and timely communication among the many communities, in the United States and internationally, that work with and participate in the HIV/AIDS Clinical Trials Networks. The CP is comprised of representatives from each of the NIAID clinical trials networks community groups and is responsible for enhancing intra- and inter-network community input at all levels; identifying and developing programs to meet the training and support requirements of local Community Advisory Boards; increasing the representation and participation of community representatives from resource-limited settings; and identifying and addressing challenges and concerns to participation in clinical trials.
For the Leadership Group (LG), core funds cover the expenses needed for the LG to carry out its clinical research agenda. NIAID will provide core funds to the Leadership and Operations Center (LOC), Laboratory Center (LC), and the Statistical and Data Management Center (SDMC). LG application budgets should ONLY request core funds for the LOC, LC, and SDMC. Examples include salary (including fringe benefits) for senior/key personnel and critical contributors, consultant costs, supplies, travel, equipment and consortium costs.
For the CTUs, core funds provide financial support to maintain minimal infrastructure and staff. Core funds do not include expenses directly attributable to the development, approval, or conduct of specific clinical trials. Core funds may include (but are not limited to):
The NIAID Division of AIDS (DAIDS) Clinical Laboratory Oversight Team (DCLOT) is comprised of DAIDS staff members who serve as laboratory points-of-contact to the DAIDS-funded Networks. DCLOT’s mission is to: harmonize lab-related guidelines and requirements for establishing new laboratories; ensure that protocols are conducted in accordance with good clinical laboratory practices; provide central guidance in clinical laboratory matters to various DAIDS entities; review laboratory-related budgetary requests from sites; and optimize the contribution of DAIDS laboratory-related support contracts to network labs.
The NIAID Division of AIDS (DAIDS) ES supports multi-directional flow of information between DAIDS, its networks, and other collaborators to enhance the inter-operability of its clinical trials networks. This information system consists of a consistent user interface built from a sharable set of components that communicate with each other and with external systems located in network SDMCs and LCs, network-affiliated CTUs/CRSs, and other NIH systems using a common vocabulary. The DAIDS-ES is comprised of the following functional areas: DAIDS Portal, Protocol Management, Master Contact, Adverse Experience Reporting System, Adverse Experience Processing System, Clinical Site Monitoring, Protocol Registration and investigational new application (IND) Management. DAIDS clinical trial networks are required to interface, integrate or adapt their information system(s) to interact with these and future components of the DAIDS-ES as necessary.
NIAID Division of AIDS (DAIDS) Program Officers are responsible for overseeing and facilitating the work of the networks. NLGPOs will be in regular contact with network staff and will be responsible for the normal scientific and programmatic stewardship of the award. DAIDS Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship of awards, including, but not limited to, facilitating coordination with other NIAID-supported networks and research groups; fulfilling NIAID investigational new drug (IND) sponsor and regulatory responsibilities; providing contract resources, as appropriate; serving as liaison with pharmaceutical companies; reviewing and approving protocols; approving safety monitoring plans; and evaluating network operations and accomplishments. In addition, networks collaborate with DAIDS staff and contractors responsible for monitoring the conduct of clinical research protocols at network-affiliated CRSs, including clinic, pharmacy, laboratory, and data management activities.
The NIAID Division of AIDS (DAIDS) Clinical SRC (CSRC) and Prevention SRC (PSRC) evaluate and approve protocols sponsored or funded by DAIDS that involve greater than minimal risk. The SRCs review clinical research protocols to ensure that each is relevant to NIAID’s scientific priorities, operationally feasible, and compliant with Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations and guidelines.
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.
The Division within NIAID that has the primary responsibility for sponsoring extramural basic and clinical research on HIV/AIDS.
CTU PD(s)/PI(s) will have primary responsibility for the overall activities and performance of the CTU, including, but not limited to: compliance with all adverse event reporting requirements designated by the NIAID and clinical research network(s), including, but not limited to the current DAIDS Policy on Expedited Adverse Event Reporting. Instructions and additional information on the reporting process are described in the Manual for Expedited Reporting of Adverse Events to DAIDS.
Note: The Expedited Adverse Event Reporting Policy (PDF) can be found at: http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/eaereportpolicy.pdf.
The only type of assurance of compliance accepted and approved by the Office for Human Research Protections (OHRP) for institutions engaged in non-exempt human subjects research conducted or supported by the U.S. Department of Health and Human Services (HHS). Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in the HHS Protection of Human Subjects regulations at 45 CFR part 46, as well as the terms of assurance.
The “Statement of Investigator,” Form FDA 1572, is an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic. (Form FDA 1572)
Good Clinical Laboratory Practices (GCLPs) are the minimal requirements that NIAID clinical research laboratories should follow, as these encompass both the research/pre-clinical and clinical aspects of Good Laboratory Practices (GLP). Complying with GCLP is an ongoing process that is central to optimal clinical research laboratory operations. NIAID will monitor the progress toward GCLP compliance through annual audits and/or site visits. GCLP compliance will ensure that consistent, reproducible, auditable, and reliable laboratory results that support clinical trials will be produced in an environment conducive to study reconstruction.
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 E6)
Refers to the use of combinations of various antiretroviral drugs with different mechanisms of action to treat HIV.
The HIV/AIDS Network Coordination (HANC) works with NIAID and the HIV/AIDS Clinical Trials Networks to facilitate collaboration and coordination on priority areas of research and operations, increase communication, and streamline processes to improve research efficiency. In addition to coordinating the efforts of the leadership principal investigators, inter-network coordination encompasses, among other areas, statistical and data management, laboratory, training, evaluation, clinical trials logistics, and community participation and education.
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.
The board, committee, or other group formally designated by an institution to review, approve the initiation of, and 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 HHS-sponsored research must be registered with OHRP and identified on the institute FWA.
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.
A drug or biological product that is used in a clinical investigation.
A request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application. (FDA) Application required by FDA before clinical trials of an investigational drug or biological agent may be initiated. An IND is also required if FDA has not approved the route of administration, dosage level, or patient population for the drug or biological agent.
The individual at the clinical research site (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 Division of AIDS (DAIDS) Investigator of Record Agreement for non-IND studies. The IoR may or may not also be a Unit PI or an In-country PI. Note that DAIDS allows two IoRs to be named on the Form 1572 or IoR Agreement; however, at least one of these must be located on site.
A document required by NIAID’s Division of AIDS (DAIDS) for non-IND studies. The IoR is required to accept full responsibility for the conduct of the trial at their clinical research site(CRS). Documentation of the agreement requires the IoR signature and date.
The Joint United Nations Programme on HIV/AIDS is an innovative partnership that leads and inspires the world in achieving universal access to HIV prevention, treatment, care and support.
The LC contributes to the development of the network’s research agenda, and leads the laboratory activities that are required to carry out the research agenda. The LC is responsible for (i) managing, monitoring and evaluating all LG-supported laboratory services, any network specimen repositories, and laboratory quality management programs and (ii) fostering collaboration and harmonization of laboratory activities within the network, at network-affiliated CTU/CRS laboratories, and with other NIH-supported networks or other federal and private sector clinical trial programs engaged in similar research.
The LOC provides overall scientific and administrative leadership for the network and coordination of the Leadership Group and the network-affiliated CTUs/CRSs. The LOC is responsible for: (i) overseeing research concept prioritization, protocol development and implementation, and timely publication and communication of results; (ii) developing and implementing network governance and resource management policies and procedures; (iii) fostering and ensuring engagement and effective partnership with affected communities in strategic planning; protocol development and implementation and timely communication of results; (iv) evaluating and revising the network’s research agenda; (v) overseeing and evaluating the performance of each LG segment and network-affiliated CTUs/CRSs; and (vi) allocating network resources. The LOC has oversight for the LC and SDMC.
The LOC Principal Investigator is responsible for the leadership and coordination of all Network activities both scientifically and administratively and serves as the Principal Investigator for the LOC Award. The LOC PI may or may not be associated with a Clinical Trial Unit.
NIAID Division of AIDS (DAIDS) staff member or member from another sponsoring NIH Institute or Center that monitors the safety of the intervention(s) for ongoing studies and those in development.
A cooperative of institutions conducting clinical trials under a common research agenda. A Network is comprised of the LOC, SDMC, LC and the network-affiliated Clinical Trial Units and their network affiliated/associated clinical research sites.
The Strategic Working Group (SWG) provides expert advice on the scientific priorities of the NIAID-funded HIV/AIDS Clinical Trials Networks. Specifically, the SWG serves as a forum for discussion, resolution, and proactive planning of critical issues; provides guidance on scientific priorities for future high resource trials, provides input about budget allocation for future funding of the networks and sites, and facilitates communication among all stakeholders relevant to the NIAID-sponsored HIV/AIDS Clinical Trials Networks. The SWG meets two to three times a year, and members include the network principal investigators, NIAID-appointed external advisors, representatives from the Community Partners, and the Director of DAIDS.
The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: 1) notifies the recipient of the award of a grant; 2) contains or references all the terms and conditions of the grant and federal funding limits and obligations; and 3) provides the documentary basis for recording the obligation of federal funds in the NIH accounting system.
OCSO is an office within the Division of DAIDS Office of the Director. OCSO staff members facilitate the clinical research of the NIAID scientific programs by overseeing clinical research sites associated with the NIAID-sponsored HIV/AIDS clinical research networks.
Individuals who have committed to contribute to the scientific development or execution of the project, but are not committing any specified measurable effort (i.e., person months) to the project. These individuals are typically presented at "effort of zero person months" or "as needed." Individuals with measurable effort may not be listed as Other Significant Contributors (OSCs). Consultants should be included if they meet this definition.
The branch within the DAIDS Office of Clinical Site Oversight (OCSO) that provides expertise on all pharmaceutical aspects of protocol development and conduct as protocol team members; coordinates and oversees the supply, packaging, blinding and distribution of study products for all DAIDS-supported domestic and international clinical trials; establishes processes, oversees and monitors adherence to quality assurance standards and standard operating procedures for all pharmacy and product-related issues at the clinical research sites participating in DAIDS-supported clinical trials.
The NIAID Division of AIDS (DAIDS) 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.
The individual(s) designated by the applicant organization to have the appropriate level of authority and responsibility to direct the project or program to be supported by the award. The applicant organization may designate multiple individuals as program directors/principal investigators (PD/PIs) who share the authority and responsibility for leading and directing the project, intellectually and logistically. When multiple PD/PIs are named, each is responsible and accountable to the applicant organization, or as appropriate, to a collaborating organization for the proper conduct of the project or program including the submission of all required reports. The presence of more than one PD/PI on an application or award diminishes neither the responsibility nor the accountability of any individual PD/PI. Additional information on multiple PDs/PIs is found in Chapter 9 of the NIH Grants Policy Statement.
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.
A written description of a change(s) to or formal clarification of a protocol.
Protocol funds provide support (in addition to core funds) to cover protocol-related expenses attributable to protocol development, implementation or close-out of a clinical trial.
Protocol Funds for Network Leadership Groups, for example, may include salary for a statistician’s increased level of effort to meet the needs of a protocol (when their base salary may be met using core funds).
Protocol Funds for CTUs include, but are not limited to: salary for additional staff or expanded commitment of core staff; protocol development activities (e.g., translations, printing, etc.); participant recruitment and retention; protocol required tests and evaluations; participant reimbursement; equipment and supplies; community education and engagement structures and activities that are protocol-specific; and additional support for regulatory, pharmacy, data management, and laboratory activities.
Note: Protocol Funds are NOT to be requested in the Leadership Group or CTU application budgets. Protocol Funds will be determined post-award, in collaboration with NIAID.
The process established by NIAID’s Division of AIDS (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.
A site that is activated to conduct a specific NIAID network protocol, because the capacity or expertise to conduct the protocol is not immediately available through existing CRSs. Protocol-specific sites will be scheduled to close, and funding discontinued, upon completion of the specified protocol activities, unless the clinical research network requires the PS site to meet additional, identified, appropriate protocol needs.
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.
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.
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.
The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered senior/key personnel if their involvement meets this definition. Consultants and those with a postdoctoral role also may be considered senior/key personnel if they meet this definition. "Zero percent" effort or "as needed" is not an acceptable level of involvement for senior/key personnel. For the CTU grant application, only the following staff are considered senior/key personnel: CTU PD(s)/PI(s), CTU coordinator, CRS leader, CRS coordinator, and Pharmacist(s) of Record.
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).
The original documents, data, and records containing clinical findings, observations, or other activities in a clinical research study that allows the reconstruction and evaluation of the study. Examples of source documents include: 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.
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.
The SDMC is the component of the Leadership Group that is responsible for statistical leadership of the Network research agenda, the statistical aspects of study design and analysis, and management of the clinical and laboratory data. The SDMC assists with the development of the network’s clinical research agenda and provides biostatistical leadership in study design, analysis, interpretation and publication of results, along with state-of-the-art clinical and laboratory data management systems to ensure complete, high quality data. The SDMC is responsible for: (i) ensuring the integrity of study design, data management, data analyses and compliance with regulatory requirements, as appropriate; (ii) providing effective data communication systems for the network; (iii) providing data management training for network-affiliated CTUs/CRSs investigators and laboratory staff; (iv) standardizing and harmonizing statistical and data management activities both within the network and with other NIH-supported networks or other federal and private sector clinical trial programs when required; and (vi) collecting and storing data in accordance with standards of the Clinical Data Interchange Standards Consortium (C-DISC) requirements.
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.
NIH grant activity code to support large-scale cooperative agreements involving complex clinical trials with multiple components, e.g., clinical networks. The components represent a variety of supporting functions and are not independent of the research projects. Substantial federal programmatic staff involvement is intended to assist investigators during performance of the research activities, as defined in the terms and conditions of award.
Last Updated April 05, 2012
Last Reviewed February 16, 2012