Clinical Research Glossary
This glossary contains terms that research teams encounter most frequently in their work. All definitions are pulled from the IRB, NIH, or subject matter experts at Northwestern.
ACA: Affordable Care Act
- Sometimes referred by the general public as "Obamacare"
- The ACA has implications for clinical research involving genetic materials
- Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related (21 CFR Part 312.32).
- See: SAE, UPIRSO, Reportable New Information
Animal Care and Use Program
- The institution-specific policies and procedures surrounding animals in biomedical research.
- The program is managed and monitored by the IACUC (or their delegates) and is in compliance with the federal Animal Welfare Act (AWA).
- This individual (or team) oversees the health and day-to-day needs of animals involved in research activities.
- Also referred to as the "Quality Animal Care Attending Veterinarian" or "Attending Vet"
- A collection of biological material and the associated data and information stored in an organized system, for a population or a large subset of a population.
- When an individual's personal external interests and/or relationships may influence (or appear to influence) their obligations and responsibilities as they relate to their employer, employees, or others.
- Conflicts of Interest must be disclosed to the NU Conflict of Interest Office.
- Conflicts may be financial (FCOI) or non-financial.
- Having a COI does not automatically disqualify an investigator from participating in research. The COI office can implement a plan to manage any conflicts (or perceived conflicts).
CTSA: Clinical and Translational Science Award
- A NIH program that supports a national network of translational science hubs.
- NUCATS is Northwestern's CTSA hub.
- The Federal Policy for the Protection of Human Subjects shared by all federal agencies (with the exception of FDA regulated research).
- This "common rule" is in lieu of separate policies for each agency.
- In addition to the ICF, the process used to obtain informed consent must be documented. The person obtaining consent indicates he/she has explained the research to the participant, ensured that the participant understood the research and that the participant freely consents to participate.
- A Study/Research Coordinator is an individual who handles the day-to-day operations of a research study (or, in most cases, multiple research studies) as delegated by the PI.
- This person acts as a Liason between investigators, sponsors, and research subjects.
- This person is also responsible for data entry, record keeping, and study compliance documentation.
- In some cases, a Research Assistant could work with a coordinator to perform specific tasks (e.g. data entry, preparing equipment).
- Some departments may have specialized coordinators responsible for a specific area or study phase (e.g. Regulatory Coordinators or Start-Up Coordinators).
- Note: a Research Nurse may also serve as the Study Coordinator. (Definition adapted from NCI)
- See: Investigator, Sponsor
CRA: Clinical Research Associate
- See: Monitoring
- Note: CRA may also be a title for an internal specialist who oversees a group of research coordinators or clinical trial operations.
CRO: Contract Research Organization
- A 3rd party contractor of the Research Sponsor that operates either the entire study, or specific components (e.g. monitoring).
- A legally-binding contract between a sponsor, site, and researcher that outlines each party's responsibility, obligations for the clinical trial, and study budget.
- A Master CTA is a general contract between a sponsor and a site that frequently work together on multiple studies and protocol-specific items are approved as an addendum.
- All CTAs are authored and negotiated by multiple stakeholders prior to agreement.
dbGaP: Database of Genotypes and Phenotypes
- Database of Genotypes and Phenotypes
- Developed by the NIH Center for Biotechnology Information
- The general name of a software platform used to collect clinical research data (as opposed to EMR's which are used for clinical care).
- For industry sponsored trials, most study sponsors provide an EDC where study teams enter protocol-specified data from consented research subjects.
- See: REDCap
- The electronic system for all IRB submissions including initial approval, continuing reviews, and reportable new information.
- If time does not allow, prior IRB review and approval is not required for one emergency use of a test article for the treatment of a single patient, provided that such emergency use is reported to the IRB within five working days.
- Waivers of Informed Consent include categories for Emergency Use and Planned Emergency Research.
EMR: Electronic Medical Record
- The digital medical record used for clinical care.
- Also referred to as the patient chart or by a specific platform name (Epic, Powerchart, Cerner, etc).
- See: Electronic Data Capture
- An event, outcome, or metric that can be measured objectively to determine whether the intervention being studied is beneficial.
- The endpoints of a clinical trial are usually included in the study objectives.
- Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disease-group specific metrics.
- Some studies delineate between primary endpoint(s) and additional secondary endpoints. (Definition adapted from NCI)
- The Electronic Medical Record platform used by Northwestern Memorial HealthCare
- Making up data or results and recording or reporting them.
- See: Research Misconduct
- Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
- See: Research Misconduct
FCOI: Financial Conflict of Interest
- See: Conflict of Interest
FDA: Food and Drug Administration
- US federal government agency that oversees the approval process for drugs, medical devices, and biologics.
- This is a separate agency from Health and Human Services (HHS).
Form FDA 482
- Notice of a FDA Site Inspection.
- Investigators and study staff must comply with the terms dictated on the notice of inspection.
- The IRB should be notified upon receipt of an inspection notice.
Form FDA 483
- The initial report of observations from a FDA Site Inspection.
- The form, along with any response from the investigator, is considered Reportable New Information to the IRB.
- A form that must be filed by an investigator running a clinical trial to study a new drug or agent.
- The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial. The investigator verifies that he or she has the experience and background needed to conduct the trial and that it will be done in a way that is ethical and scientifically sound.
- Also called the 1572 form and "Statement of Investigator". (Definition: NCI)
GINA: Genetic Information and Non-Discrimination Act
- Genetic Information and Non-Discrimination Act
- Federal law passed in 2008
GWAS: Genome Wide Association Studies
- Genome Wide Association Studies
- This included the NIH guidance for genetic research data sharing.
HHS: US Department of Health and Human Services
- The US Department of Health and Human Services (US Federal Level)
- This office includes the US Public Health Service (PHS), National Institutes of Health (NIH), and The Office of Human Research Protections (OHRP).
- The Health Insurance Portability and Accountability Act (HIPAA) sets forth requirements to protect the privacy and security of health information.
- HIPAA protects patients from inappropriate disclosures of the patient’s protected health information (PHI) that could cause harm to their insurability, employability, and/or their privacy.
- HIPAA also sets standards for protecting the confidentiality, integrity, and availability of electronic protected health information.
Human Genetic Research
- Involves the study of inherited human traits, usually with the goals of identifying DNA mutations that can help cause specific health problems, developing methods of identifying those mutations in patients, and/or improving the interventions available to help patients address those problems.
- A living individual about whom a researcher obtains data through intervention or interaction with the individual and/or identifiable private information [45§46.102(e)].
- The IRB provides oversight of Human Subjects Research on the institutional level.
IACUC: Institutional Animal Care and Use Committee(s)
- Institutional Animal Care and Use Committee(s).
- An internal regulatory compliance group required by the Animal Welfare Act.
- Commonly referred to as the "IRB for animal research."
IEC: Institutional Ethics Committee
- See IRB
IND: Investigational New Drug Application
- The IND is the key document submitted to the FDA that allows the use of a non-approved drug for clinical research or emergency treatment purposes.
- There are three types of INDs outlined by the FDA:
- Investigator IND
- Emergency Use
- Learn more on the FDA IND Page.
IND Safety Report
- A report issued by a research sponsor to the FDA and all participating sites/investigators that identifies any new potential serious risks.
- Study teams that receive an IND Safety Report from their sponsor must report it to the IRB. (21 CFR Part 312.32)
- See: Reportable New Information
- The continual process of providing potential and current research subjects information about the study, so they can make an informed decision about whether or not they want to participate (or continue to participate).
- These conversations and documents include, but are not limited to, information on what subjects will be doing in the study, how the protocol works, what risks or discomforts a subject may experience, and that participation is completely voluntary.
- The Informed Consent Form (ICF) is the primary document that outlines the areas of consent and is subject to IRB approval. (Definition adapted from the FDA)
- See: Short Form Consent, Consent Process Documentation
ICF: Informed Consent Form
- See: Informed Consent
- The Principal Investigator is the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research (Northwestern IRB).
- The investigator may help prepare and carry out the protocol (plan) for the study, monitor the safety of the study, collect and analyze the data, and report the results of the study.
- Investigators are usually doctors but may also be scientists or experienced nurses.
- Sub-Investigators (Sub-I's) are qualified clinical personnel who perform protocol-specified procedures at the direction of the PI. (Definition adapted from the NCI).
- See: Coordinator, Sponsor
- An investigational drug, device, or biologic that is not FDA approved. In the case of drug studies, this is also referred to as the "Study Drug" or "Test Product"
- Institutional Review Board.
- An independent committee at each institution conducting research charged with ensuring subject safety, ethical compliance, and data integrity.
- May be referred to as an Institutional Ethics Committee (IEC) in other countries.
- The ongoing process of overseeing a clinical study.
- For industry studies, a monitor from either the sponsor or CRO will work with the study coordinator to adjudicate data entered into the EDC.
- In other cases, a designated coordinating center may be charged with monitoring responsibilities.
- The IRB also conducts Post Approval Monitoring responsibilities.
- Some studies may have more than one monitor and/or have specialized monitors (e.g. Offsite Data Monitor and a Visiting Site Monitor).
- Monitoring plans are usually outlined in the protocol or the Clinical Trial Agreement.
NIH: National Institutes of Health
- National Institutes of Health.
- Abides by US Health and Human Services (HHS) regulations.
NSF: National Science Foundation
- National Science Foundation.
- An independent government agency (separate from HHS, NIH, and FDA) that provides research and education funding.
OHRP: The Office of Human Research Protections
- The Office of Human Research Protections.
- Part of Health and Human Services (HHS)
ORI: Office of Research Integrity
- Most universities have an institutional ORI.
- The US Department of Health and Human Services also has a national ORI that oversees and directs research integrity activities across all HHS programs.
PHI: Protected Health Information
- Any health information that includes any of the 18 elements identified by HIPAA and maintained by a covered entity or any information that can be reasonably used to identify a person.
PHS: US Public Health Service
- United States Public Health Service.
- Part of Health and Human Services (HHS).
- The appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
- See: Research Misconduct
PI: Principal Investigator
- See: Investigator
- A detailed document outlining the study’s objectives, procedures, risks, benefits, recruitment, consent processes, and procedures to maintain confidentiality (Northwestern IRB).
- The protocol must be strictly followed to ensure subject safety and data integrity. Any time where the protocol is not followed must be documented as a Protocol Deviation.
- When study activities diverge from the IRB approved protocol.
- Some common examples include an out-of-window visit due to the research subject traveling, a missed question on a survey, or a lost medication diary.
- Serious Protocol Deviations include investigational product dosing errors, improper consent process/documentation, or non-compliance that results in increased harm to participants. All protocol deviations should be documented either in the EDC and/or on a log.
- Serious Protocol Deviations (sometimes referred to as Protocol Violations) may be considered Reportable New Information to the IRB.
QOL: Quality of Life
- A type of patient-reported metric.
- QOL endpoints and measurements should be outlined in the study protocol.
- The statistical validation of QOL surveys can vary considerably and may differ across disease groups.
- The process of generating awareness for a research study to find potential research subjects.
- Study Recruitment is the beginning of the Informed Consent process and is subject to IRB Guidelines
- A specific Electronic Data Capture platform frequently used by investigator-initiated research studies.
- Northwestern Faculty are required to use REDCap, or another approved Electronic Data Capture platform, for all Human Subjects Research.
- A systematic investigation designed to develop or contribute to generalizable knowledge [45§46.102(d)]
- See: Coordinator
- The fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
- This does not include honest errors or differences of opinion. (45 CFR 93.103)
- Events or incidents that may occur during the duration of a research study that needs to be reported to the IRB.
- See: AE, SAE, UPIRSO
- Any Adverse Event that, in the opinion of the investigator, results in any of the following: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. (21 CFR Part 312.32)
- See: AE, UPIRSO, Reportable New Information
SFI: Significant Financial Interest
- A set of financial thresholds that require disclosure prior to submitting a proposal and/or within 30 days of receiving a new interest.
- See: Conflict of Interest
- The short form consent is typically used when an unexpected potential research participant does not speak English and there is not enough time to translate the English version of the approved consent document into a language the potential participant understands.
- There are specific parameters and restrictions of the use of Short Form consents outlined by the IRB.
- A person, company, institution, group, or organization that oversees or pays for a clinical trial and collects and analyzes the data. (Definition: NCI)
- Also called trial sponsor.
- See: Investigator, Coordinator
Statement of Investigator
- See: Form FDA 1572
- See: Investigator
- These events could be medical or non-medical and are considered Reportable New Information (RNI) to the IRB.
- UPIRSOs must be unexpected, related (or possibly related) to participation in the research, and suggest that participation in research places human subjects (or others) at greater risk of harm than was previously known or recognized.
- Note: UPIRSO is a Northwestern-specific term. Research Sponsors or other institutions may have a similar category of Reportable New Information under a different name.
- See: Reportable New Information, AE, SAE
USDA: United States Department of Agriculture
- The USDA established the Animal Welfare Act which outlines appropriate use of animals bred for research purposes.
- Groups who can be involved in research but may be easily susceptible to coercion and/or additional risk and, therefore, require enhanced protections.
- The US Code of Federal Regulations (CFR) outlines protections for three central vulnerable populations: pregnant individuals (and the associated fetus/neonate), children, and incarcerated individuals.
- Some IRB’s outline additional special populations who may require protections or additional considerations in a research protocol or recruitment plan. These groups may include, but are not limited to, students or employees of an institution where research is being conducted, terminally ill individuals, low-income populations, and individuals with cognitive impairments.
Waiver of Documentation of Consent
- In specified cases, potential participants, or the parents of children who are potential participants, are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the process (signing of the consent form) has been waived by the IRB.
- See: Waiver of Obtaining Informed Consent
- Special circumstances when the IRB determines that it is not necessary to obtain the participants’ consent to conduct research.
- See: Emergency Use