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Microbiology and Infectious Diseases Clinical Research Policies, Guidance, and Tools

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Glossary of Terms

Adverse event:  Any untoward medical occurrence in a volunteer receiving a study product or intervention whether it is related or not.
 
Agreement:  A general term for documents that delineates terms for responsibilities and obligations.  Agreements are signed by all participating parties and are legally binding.
 
Ancillary Laboratory Tests:  Tests not defined in the protocol.  Results of an ancillary laboratory test may be obtained as part of a panel of tests.
 
Anonymized Clinical Specimens:  Anonymized clinical specimens lack individually identifiable private information (IIPI) that would enable the investigator to readily ascertain the identity of the individual to whom the specimens pertain.  Anonymized specimens have no code or link to the IIPI.
 
Assignment:  The study group to which the volunteer is assigned to receive an. investigational product or control or other intervention.
 
Bias:  The systematic tendency of any factors associated with the design, conduct, analysis, and evaluation of the results of a clinical trial to make the estimate of a treatment effect deviate from its true value. 
 
Blinding:  A procedure in which one or more parties participating or involved in the study are kept unaware of the treatment assignment(s).
 
Certificate of Analysis (COA):  A summary of tests and results for manufactured drug and biological products demonstrating release of the lot, which includes tests of sterility, identity, strength, quality, and purity to ensure conformity with specifications.  The COA includes the lot/batch number, test method, date tested, specifications, results, and signature of the individual authorized to release the product. 
 
Clinical Hold:  A clinical hold is an order issued by the FDA to the IND/IDE sponsor to delay or to suspend a clinical investigation.  The clinical hold order may apply to one or more of the investigations covered by an IND/IDE.
 
Clinical Material Supply Agreement (CMSA):  An agreement used when a company has agreed to supply materials (drug, vaccine, placebo, equipment) for use in the conduct of a DMID-funded clinical trial but the company does not participate in the conduct of the trial.  A CMSA sets forth the terms and conditions under which the materials will be supplied and utilized and specifies what trial information will be provided to the company.  A CMSA may also be used when DMID provides materials for use in a non-DMID clinical trial.
 
Clinical Research:  NIAID human subjects term indicating research conducted on human subjects or on material of human origin that can be personally identified.  Policy covers large and small-scale, exploratory, and observational studies.  There are three types:  Patient-oriented research (investigators directly interact with study participants); epidemiologic and behavioral studies; outcomes and health services research.  This term applies to both clinical trials and clinical studies.
 
Clinical Study:  Clinical research that does not meet the definition of a clinical trial.
 
Clinical Study Report (CSR):  A written description of a trial/study conducted in human subjects, in which all clinical and statistical description, presentations, and analyses are fully integrated into a single report.
 
Clinical Trial:  A 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 those interventions on health-related biomedical or behavioral outcomes.
 
Clinical Trials Agreement (CTA):  An agreement negotiated between the Institute (Government) and outside entities (usually manufacturers of investigational products) who decide it is to their mutual benefit to cooperate in the conduct of a clinical research protocol.  The agreement addresses the responsibilities and obligations of the parties in the conduct of the study as well as the handling of intellectual property, proprietary information, and acquisition and disposition of the product.
 
Code Access Agreement:  An agreement between the investigators receiving encoded clinical specimens and the holder of the key to decipher the code, which prohibits the release of the key to the receiving investigators under any circumstances until the individuals from whom the specimens were collected are deceased.  According to the Office for Human Research Protections (OHRP), once a Code Access Agreement is in place, research with a encoded specimens is no longer considered human subjects research.
 
Coded (Linked) Clinical Specimens:   Coded clinical specimens are those specimens for which the individually identifiable private information (IIPI) has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and a key to decipher the code exists, enabling linkage of the identifying information to the specimen.    
 
Combination Products:   Combination products combine drugs, devices, and/or biological products.  They include: (1) a product comprised of two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity;  (2) two or more separate products packaged together in a single package or as a unit; (3) a product packaged separately that is intended for use only with a specified approved product and would cause a labeling change of the  approved product or; (4) any product packaged separately that according to its proposed labeling is to be used with another specified investigational product.
 
Cooperative Research and Development Agreement (CRADA):   CRADA’s permit PHS agencies to establish a cooperative agreement between government facilities, industry, and academia to facilitate the development of health-care products. The CRADA defines the scope and terms of the collaborative relationship and is a mechanism by which government laboratories or extramural NIH Program Divisions may receive outside funds, personnel, services, facilities, equipment, or other resources toward the conduct of specified research or development efforts consistent with the mission of the PHS entity. The company may be more involved in product development than with other types of agreements and the CRADA may contain specific language concerning Intellectual Property (IP) and licensing agreements.
 
 
Data:  A piece of information acquired by observation, measurement, or experiment and used as a basis for calculation or reference.
 
Data Management Center:   An entity dealing with tasks associated with the entry, transfer, and/or preparation of source data and derived items for entry into a clinical trial database. These activities may include database creation, data entry, review, coding, data editing, data QC, locking, or archiving.
 
Data Safety Monitoring Board (DSMB):  A committee of experts, independent of the trial investigators, pharmaceutical partners (if any), and funding agency, which periodically reviews the conduct and results of the trial and recommends continuation without change, continuation with change, or termination of the trial.  These recommendations are made to DMID.
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Database Freeze:  Action taken to take a “snapshot in time” of current data and archive them to ensure that an analysis, report or publication that uses the data can be reproduced at a later date.  As multiple data freezes can be conducted over the course of the study for different reporting purposes, the database freeze does not imply that data are in their final state.
 
Database Lock:  Action taken to prevent further changes to a clinical trial database.  NOTE: Locking of a database is done after review, query resolution, and a determination has been made that the database is ready for analysis.
 
Dataset:  A collection of structured data. Clinical data are typically stored in relational databases that contain multiple datasets or tables.
 
Device Certification:  A certification from the manufacturer that the device was manufactured and processed in accordance to product specifications and 21 CFR 820, Quality System Regulation
 
DMID-Sponsored Research:  Clinical research for which DMID is responsible for reporting to the regulatory agency.
 
Drug:  The FD&C Act defines drugs as articles recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; articles (other than food) intended to affect the structure or any function of the body of man or other animals; and articles intended for use as a component of any article specified above.
 
Endpoint:  Variable that pertains to research evaluations such as safety, immunogenicity, pharmacokinetics, and efficacy.
 
Engagement:  An institution is considered engaged in a particular non-exempt human subjects research project if the institution received federal funds for the research, whether the research is carried out by its employees or by agents of another institution, and the following information is obtained for the purposes of the research project: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.
 
Essential Documents:  Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
 
Federal Wide Assurance (FWA):   An assurance of compliance issued by the Office for Human Research Protections (OHRP) for institutions engaged in human subjects research conducted or supported by the U.S. Department of Health and Human Services (DHHS).  Under an FWA, an institution commits to DHHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the OHRP Terms of Assurance. 
 
Financial Conflict of Interest:  A financial interest that could directly and significantly affect the design, conduct, or reporting of clinical research.
 
Freedom of Information Act (FOIA):   The Freedom of Information Act (FOIA) is a federal statute (5 U.S.C. 552) that allows for the full or partial disclosure of previously unreleased information and documents controlled by the United States Government, except to the extent records are protected from disclosure by the Act.  The Act defines agency records subject to disclosure, outlines mandatory disclosure procedures, and grants specific exemptions to the statute.
 
Good Clinical Practice (GCP):  A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, 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.
 
Human Subjects:  Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information.
 
Human Subjects Research:  A systematic investigation designed to develop or contribute to generalizable knowledge that involves a living individual(s) about whom an investigator obtains data through intervention or interaction with the individual; or identifiable private information.
 
Identifiable Specimens:   Identifiable specimens are those that are linked to Individually Identifiable Private Information (IIPI) in such a way that the person from whom the material was collected could be identified by information such as name, initials, patient number, or clear pedigree location (i.e., his or her relationship to a family member whose identity is known).
 
Individually Identifiable Private Information (IIPI):  Private information (such as name, initials, exact date of birth, or social security number) from which the identity of the individual to whom it pertains is or may readily be ascertained. 
 
Independent Ethics Committee (IEC):  Committee designation frequently used by non-US institutions for the body that performs the functions of an IRB.
 
Independent Safety Monitor (ISM):  A physician identified prior to the study who is independent of the study and is readily available to review and recommend actions on adverse events and other safety issues pertinent to the study.
 
Individually Identifiable Private Information (IIPI):  Private information (such as name, initials, exact date of birth, or social security number) from which the identity of the individual to whom it pertains is or may readily be ascertained. 
 
Informed Consent (IC):  A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.  Informed consent is usually documented by means of a written, signed, and dated informed consent form (ICF). 
 
Inspection:  The act by a regulatory authority (ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority (ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority (ies).
 
Institutional Animal Care and Use Committee (IACUC):  An IACUC is a self-regulating entity that, according to U.S. federal law, must be established by institutions that use laboratory animals for research or instructional purposes to oversee and evaluate all aspects of the institution's animal care and use program.
 
Institutional Review Board (IRB):  An independent body comprising medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of the human subjects involved in clinical research.
 
International Equivalent (IE):  A regulatory submission/application is considered an international equivalent of a U.S. Investigational New Drug Application (IND) if the submission is under a regulatory authority in another country with a review process that is similar to and as rigorous as that of the U.S. Food and Drug Administration.
 
Investigational Device Exemption (IDE):   An IDE allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. 
 
Investigational New Drug Application (IND):  An IND is a mechanism for securing an exemption from the premarketing approval process that allows the use of an agent in clinical trial investigations in humans.  It is also used for marketed products for prospective clinical investigations of off label use, or as legal authority for investigations that involve a change in the route of administration, dosage, or patient population or other factors that significantly increase the risks associated with the product. 
 
Investigator’s Brochure (IB):  An IB is a compilation of the clinical and non-clinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.  Its purpose is to provide the investigators and others involved with the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration, safety monitoring procedures, and possible adverse events.  For marketed products, the package insert (also known as product label) can be used for the IB.
 
Manual of Procedures (MOP):  MOPs are the study specific procedures or manual that may include the Laboratory Procedures Manual, Laboratory Specimen Handling instructions, test article handling and/or preparation, and Protocol-specific instructions.
 
Minimal risk:  An event in which the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
 
Minority Group:  Any readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, and/or cultural heritage.
 
Non-Exempt Human Subjects Research:  Research activities involving human subjects that are exempt from IRB review under 45 CFR 46.101(b). 
 
Non-Significant Risk (NSR) Device:   A device that does not present a potential for serious risk to the health, safety, or welfare of a subject.  IRB approval is required with an IRB risk determination of NSR.  The FDA considers an NSR device study to have an approved IDE after IRB approval and must meet the abbreviated IDE requirements under 21 CFR 812.2(b).
 
Office of Animal Welfare Laboratory (OLAW) Assurance:  An OLAW Assurance is a written Assurance provided to institutions approved by OLAW for research involving laboratory animals.  The Assurance provides commitment from the institution and its personnel to comply with U.S. Public Health Service (PHS) Policy on the humane care and use of laboratory animals in PHS-supported research, testing, and training.
 
Pharmacovigilance:   The process of collecting, monitoring, and evaluating adverse events in clinical trials for safety signals. 
 
Pre-Investigational New Drug Application (Pre-IND):  Pre-IND refers to briefing materials, including background information and sufficient data for the FDA to respond to the sponsor’s questions.  The pre-IND is submitted to the appropriate FDA review division prior to filing an IND.
 
Protected Health Information (PHI):  A Health Insurance Portability and Accountability Act (HIPAA) term for information that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual.
 
Protocol:  A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial as well as provides the background and rationale for the trial.
 
Protocol Amendment:  A written description of a change(s) to or formal clarification of a protocol.
 
Protocol-Defined Parameters:  Protocol-defined values, including laboratory tests, clinical assessment, specialized testing, and/or diagnosis specified in the protocol.
 
Protocol Team:  A group of individuals comprised of internal representatives from DMID and external members as appropriate, including investigators and other protocol support people, who are responsible for managing the development and review of a protocol.  The team assesses the protocol design, data integrity, and the protection of human subjects, as well as ascertaining that the protocol execution follows good clinical practice (GCP), DMID’s current policies and requirements, and appropriate laws and regulations.
 
Quality Assurance (QA):  All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s). These are periodic activities.
 
Quality Control (QC):  The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. These are real-time activities.
 
Safety Committee:  A term that refers collectively to Data and Safety Monitoring Boards (DSMB) and Safety Monitoring Committees (SMC).
 
Safety Monitoring Committee (SMC):  A committee of experts, independent of the trial investigators, pharmaceutical partners (if any), and funding agency, which periodically reviews the conduct and safety of the trial and recommends continuation without change, continuation with change, or termination of the trial.  These recommendations are made to DMID.
 
Safety Oversight:  Generally speaking, safety oversight is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and subjects on the adverse effects of medications, biological products, and investigational devices with a view to identifying new information about hazards associated with medicines and preventing harm to patients. 
 
Safety Oversight Committee (SOC):  An SOC refers to a committee of experts, independent of the trial investigators, pharmaceutical sponsor (if any) and funding agency, that periodically reviews the conduct and results of the clinical trial.  Following review the SOC makes recommendations to: continue without change, continue with change, or terminate the trial.  An SOC refers to either a Data and Safety Monitoring Board (DSMB) or a Safety Monitoring Committees (SMC).
 
Serious Adverse Event (SAE):   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 many 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 one of the outcomes listed in this definition. 
 
Significant Risk (SR) Device:   A device that presents a potential for serious risk to the health, safety, or welfare of a subject.   Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health.
 
Sponsor:  A sponsor takes responsibility for executing a clinical investigation.  The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.
 
Statistical Analysis Plan:  An SAP is a document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data.
 
Study Conduct:  All protocol-related activities from volunteer recruitment and screening through site close-out and database lock.  
 
Study Product:  A study product is defined by DMID as any drug, biologic, device, or combination product that is provided for the study or identified in the protocol as a study product, including any diluents or placebos provided for use during the study.
 
Study Subject Identification Number (SSIN) or Patient Identification Number (PIN or PID):  A unique identifier assigned by the investigator to each trial volunteer to protect the volunteer’s identity and used in lieu of the volunteer’s name when the investigator reports adverse events or other trial-related data.  
 
Volunteer:  A person who, by his/her own free will, undertakes or expresses a willingness to undertake a service without obligation.  In human subject research, this individual presents for consideration and/or consents to participate in human subjects research. 
 
Vulnerable Populations:  Populations are considered vulnerable if there are legitimate concerns about their competency to understand the information presented to them and make reasoned choices; or because they are relatively incapable of protecting their own interest and/or may be subject to undue influence or coercion. 

Last Updated December 04, 2014