Adverse Event: An unfavorable change in the health of a participant, including abnormal laboratory
findings, that happens during a clinical study or within a certain time period after the study has ended;
this change may or may not be caused by the intervention being studied
Adverse Event Reporting Plan: A description of how adverse events will be defined, identified,
documented, reported, reviewed, and resolved during the conduct of a study (guided by the Office of
Human Research Protections (HHS) recommendations on adverse event reporting)
Assent: Child's agreement to participate in research, which is not just a failure to object
Bias: Any tendency which prevents unprejudiced consideration of a question
Breach: An impermissible use or disclosure under the Privacy Rule that compromises the security or
privacy of the protected health information
Certificates of Confidentiality: Document that protects investigators and institutions from being forced
to release information that would identify research participants; Certificates protect against legal
demands for information such as court orders and subpoenas
Clinical Protocol (also Research Protocol, Protocol): A complete written description of, and scientific
rationale for, clinical study activities; protocol documents provide the framework by which the clinical
trials will be conducted and include, among other information, the study objectives, study design,
population to be studied, study intervention, study procedures, safety assessment, clinical management,
statistical considerations, data handling, and informed consent document(s) (Excerpts and SBR
adaptations from NIAID, Division of AIDS policy on protocol documents)
Clinical Research: Medical research that involves people to test new treatments and therapies
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
Coercion: An overt or implicit threat of harm intentionally presented by one person to another in order
to obtain compliance; for example, an investigator might tell a prospective subject that he or she will
lose access to needed health services if he or she does not participate in the research (From OHRP, HHS
guidance on informed consent)
Co-Investigator: Partners with a principal investigator on studies requiring scientific or methodological
expertise
Confidentiality: Refers to the duty of anyone entrusted with health information to keep that
information private
Consolidated Standard of Reporting Trials or CONSORT: Guideline that is intended to improve the
reporting of parallel-group randomized controlled trial (RCT), enabling readers to understand a trial's
design, conduct, analysis and interpretation, and to assess the validity of its results
Coordinator: Ensures day-to-day study tasks are completed and study team is trained; communicates
regularly with the PI about the study
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Data Management Plan: A description of how study data will be collected, stored, protected, and
validated so that the clinical database accurately reflects the data collected and is able to be used for
purposes of analyzing study data (Adapted from NIDCR’s Data Management Considerations guidance)
Data Manager: Oversees all data collection; ensures data are recorded and managed as specified in the
protocol document; prepares data for analysis
Data Safety Monitoring Boards or DSMB: Independent committee that reviews a clinical trial's progress
and safety and advises whether to continue, modify, or terminate it
Data Safety Monitoring Plan: Plan to assure safety of participants and validity of the data
Double Data Entry: Strategy to ensure data quality in which the same data is entered by two separate
individuals and then compared to ensure they match; helps control for errors due to mistakes in data
entry
Expectedness: Previously unobserved or undocumented are referred to as “unexpected,” in that their
nature and severity are not consistent with information provided in the relevant product information
(e.g., approved professional package insert or product label)
Fabrication: Making up data or results and recording or reporting them
Falsification: Manipulating research materials, equipment, or processes, or changing or omitting data or
results such that research is not accurately represented in the research record
Focus Groups: A demographically diverse group of people assembled to participate in a guided
discussion about a particular product before it is launched, or to provide ongoing feedback on a political
campaign, television series, etc.
Food and Drug Administration (FDA): HHS agency that reviews clinical research to regulate the
marketing of foods, drugs, devices, and cosmetics
Good Clinical Practice (GCP): An international ethical and scientific quality standard for the design,
conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials
Grant Proposal: A formal proposal submitted to a government or civilian entity that outlines
a proposed project and shows budgetary requirements and requests monetary assistance in the form of
a grant
HIPAA: Law from 1996 that sets privacy standards to protect patients' medical records and other health
information provided to health plans, doctors, hospitals, and other health care providers; developed by
HHS, HIPAA gives patients access to medical records and improves their control over the use and
disclosure of personal health information
Informed Assent: When children or minors (<18 years of age) are involved in research, the regulations
require the assent of the child or minor and the permission of the parent(s), in place of the consent of
the subjects
Informed Consent: A voluntary agreement based on adequate knowledge and understanding to
participate in human subjects research or undergo a medical procedure
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Institutional Review Board (IRB): An administrative body established to protect the rights and welfare
of human research subjects recruited to participate in research activities conducted under the auspices
of the organization with which it is affiliated; the Institutional Review Board has the authority to
approve, require modifications in, or disapprove all research activities that fall within its jurisdiction
International Conference on Harmonisation: “The International Council for Harmonisation of Technical
Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory
authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.
Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug
development. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe,
effective, and high quality medicines are developed and registered in the most resource-efficient
manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful
harmonisation.”
Interventionist: Administers study intervention, requiring special expertise and training (clinical
psychologist, therapist, educator, etc.)
Interventions: Physical procedures and other manipulations of human subjects or their environment for
gathering research data
IRB Protocol: A term used to describe a concise version of the clinical protocol with required elements
for review by a human subjects review board or IRB; it generally includes a description of the study,
research design, sample recruitment, study procedures, questionnaires or measures to be used in the
study, and data analysis plan
Legally Acceptable Representative (LAR): An individual or juridical or other body authorized under
applicable law to consent, on behalf of a prospective participant, to the participant's participation in the
clinical trial
Measurement Error: Observational error (or measurement error) is the difference between
a measured value of quantity and its true value. In statistics, an error is not a "mistake"; variability is an
inherent part of things being measured and of the measurement process
Monitor/Auditor: Ensures proper study procedures are being followed and that the study protocol is
being carried out consistently between study sites; usually involved in more complex studies
National Institutes of Health (NIH): Federal government agency that conducts and supports biomedical
and behavioral research to create fundamental knowledge of living systems and reduce the burden of
illness and disability
Office of Human Research Protection: 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)
Office of Research Integrity (ORI): HHS office that promotes integrity in biomedical and behavioral
research supported by the Public Health Service by monitoring institutional investigations of research
misconduct and facilitating the responsible conduct of research
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Plagiarism: The appropriation of another person's ideas, processes, results, or words without giving
appropriate credit
Portable Storage Device (PSD): A small hard drive designed to hold any kind of digital data. This is
slightly different from a portable media player, which stores and plays music and movies. Some are fixed
size hard drives of 256GB, 320GB, etc.
Principal Investigator (PI): The study lead; responsible for overseeing all aspects of the study; generate
ideas, writes grant proposals to obtain funding, and manages all scientific aspects of the study
Privacy: Refers to the right of an individual to keep his or her health information private
Procedures Manual: Provides instructions for consistent study procedure implementation and data
collection across participants and clinical sites. Details the study’s organization, operations, study
procedures, data management, and quality control (From NIDCR’s Clinical research toolkit)
Protocol Amendments: A written description of a change(s) to or formal clarification of a protocol
Protocol Deviation: A protocol deviation occurs when, without significant consequences, the activities
on a study diverge from the Institutional Review Board-approved protocol
Quality Assurance: All those planned and systematic actions that are established to ensure that the trial
is performed and the data are generated, documented ad reported in compliance with Good Clinical
Practice and the applicable regulatory requirements
Quality Control: The operational techniques and activities undertaken within the quality assurance
system, to verify that the requirement for quality of the trial-related activities have been fulfilled
Random Error: Fluctuations in the measured data due to the precision limitations of the measurement
device; random errors usually result from the experimenter's inability to take the same measurement in
exactly the same way to get exact the same number
Relatedness: A term intended to indicate that a determination has been made that the event had a
reasonable possibility of being related to exposure to the product
Reproducibility: The ability to replicate the results of a study
Research Assistant (RA): Responsible for recruiting participants and collecting data from participants
Research Bias (also Experimenter Bias): Process where the scientists performing the research influence
the results, in order to portray a certain outcome
Research Misconduct: The fabrication, falsification, or plagiarism in proposing, performing, or reviewing
research, or in reporting research results
Research Nurse: Carries out medical procedures requiring a licensed practitioner during a study
Rigor: Scientific rigor is the strict application of the scientific method to ensure robust and unbiased
experimental design, methodology, analysis, interpretation, and reporting of results (From NIH website
on Rigor and Reproducibility)
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Risk: Probability of harm or physical, psychological, social, or economic injury resulting from
participation in a research study
Serious: Serious adverse events (SAEs) include events that result in death, are life threatening (an event
in which the patient was at risk of death at the time of the event), require or prolong inpatient
hospitalization, result in persistent or significant disability or incapacity, or result in a congenital
anomaly; important medical events may also be considered serious when, based on medical judgment,
they may jeopardize the person exposed and may require medical or surgical intervention to prevent
one of the outcomes listed above (e.g., death or prolonged hospitalization)
Social and Behavioral Research: Social behavioral research applies the behavioral and social sciences to
the study of people's or animals' responses to certain stimuli (both external and internal);
such research is conducted by the following academic disciplines: sociology, psychology, anthropology,
economics, political science, and history
Source Documents: Original documents, data, and records (e.g., hospital records, clinical and office
charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing
records, recorded data from automated instruments, copies or transcriptions certified after verification
as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-
rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical
departments involved in the clinical trial)
Sponsor: Federal funding agency, industry or foundation that reviews grant applications submitted by
principal investigators and selects studies for funding; typically monitors progress of a study to ensure
study objectives are met and study findings are disseminated
Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity of the
performance of a specific function; individual SOPs are often organized into a Procedures
Manual/Manual of Operations (MOP)
Statistician: Works with the principal investigator and co-investigator to help design the data analysis
plan, analyze the data, and interpret study findings; possibly a co-investigator or consultant
Systematic Error: Reproducible inaccuracies that are consistently in the same direction; systematic
errors are often due to a problem which persists throughout the entire experiment
Transparency: The clear and accurate reporting of study scientific and operational details so that others
may reproduce and extend the findings; transparency is an essential element of scientific rigor
Treatment Fidelity: The methodological strategies used to monitor and enhance the reliability and
validity of behavioral interventions
Vulnerable Populations: Participants belonging to or identifying with a group that may need special
protections when participating in research; federal agency definitions of vulnerable populations vary,
but tend to include children, prisoners, pregnant women, handicapped or mentally disabled persons,
and the economically or educationally disadvantaged (From 45 CFR 46; NIH; CDC; WHO)
Waiver of Consent: A circumstance in research where a signed informed consent form is not required;
according to the governing federal regulations for documentation of informed consent (45 CFR 46.117),
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a waiver of consent may be used when the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is normally required outside of the
research context OR the only record linking the subject and the research would be the consent
document and the principal risk would be potential harm resulting from a breach of confidentiality; each
subject will be asked whether the subject wants documentation linking the subject with the research,
and the subject's wishes will govern
Sources Used:
http://grants.nih.gov/grants/glossary.htm#B
http://grants.nih.gov/reproducibility/index.htm
http://oprs.usc.edu/education/social-behavioral/
http://www.cc.nih.gov/ccc/clinicalresearch/guidance.pdf
http://www.cdc.gov/aging/emergency/legal/privacy.htm
http://www.consort-statement.org/consort-2010
http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073122.pdf
http://www.hhs.gov/hipaa/for-professionals/breach-notification/index.html
http://www.hhs.gov/ohrp/
http://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/
http://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/#
http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#46.117
http://www.ich.org/home.html
http://www.ncbi.nlm.nih.gov/books/NBK208615/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917255/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3097692/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3487227/
http://www.ncbi.nlm.nih.gov/pubmed/15778656
http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/protocolPolicy.pdf)
http://www.nidcr.nih.gov/Research/toolkit/#startup4
https://clinicaltrials.gov/ct2/about-studies/glossary#A
https://en.wikipedia.org/wiki/Observational_error
https://en.wikipedia.org/wiki/Portable_storage_device
https://www.entrepreneur.com/encyclopedia/grant-proposals
https://www.niaid.nih.gov/researchfunding/glossary/Pages/default.aspx
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https://www.nih.gov/health-information/nih-clinical-research-trials-you/glossary-common-terms
https://www.nlm.nih.gov/ep/dsm.html
https://www2.southeastern.edu/Academics/Faculty/rallain/plab193/labinfo/Error_Analysis/05_Rando
m_vs_Systematic.html
