Common Research Terms

Adverse Event (AE) – Any untoward or unfavorable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.

Amendment - Any change to previously approved research. Investigators may not initiate any changes in research procedures or consent form(s) without prior IRB review and approval, except when necessary to eliminate immediate hazards to the subject.

Assent - Affirmative agreement by an individual who is not competent to give legally valid informed consent (e.g., child or person with limited mental capacity) to participate in a research project. Mere failure to object should not be construed as assent.

Baseline – The initial time point in a clinical trial during which data is obtained (physical exams, laboratory tests, questionnaires, etc.) for use as a reference point to assess changes in subsequent assessments or observations.

Bias – A point of view or preference which prevents impartial judgment in the way in which a measurement, assessment, procedure, or analysis is carried out or reported.

Certificate of Confidentiality -A legal document that protects the privacy of research study participants and the confidentiality of data obtained from them. It prevents the forced disclosure of identifiable research information in civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

Class I, II, and III Devices - Classification by the Food and Drug administration of medical devices according to potential risks or hazards

Study Coordinator (SC) – An individual who is responsible for the administration and day-to-day conduct of a clinical trial, and also acts as a liaison for the clinical site.

Clinical Trial – The NIH defines a clinical trial as a prospective biomedical or behavioral research study of human subjects that is designed to determine the safety, efficacy, and effectiveness of biomedical (drugs, nutritional supplements, surgical intervention, or devices) or behavioral (diet, physical activity, cognitive therapy, etc.) interventions.

Conflict of Interest – Situation in which financial, relational, or other personal considerations may compromise, or have the appearance of compromising, an individual’s professional judgment in directing, conducting, reporting, evaluating, or reviewing research or patient care, or carrying out other types of School programs.

Continuing Review - A request for continuation of the project (which includes an annual progress report) that is submitted by investigators to the IRB. The IRB will review and approve requests for continuation based on the progress to date. Failure to submit a continuing review will result in automatic administrative closure of the protocol.

Coordinating Center (CC) – A group organized to coordinate the planning and operational aspects of a multi-center clinical trial. CCs may also be referred to as Data Coordinating Centers (DCCs) or Data Management Centers (DMCs).

Contract Research Organization (CRO) - Person or organization contracted by the sponsor to perform one or more of a sponsor’s trial related duties and functions

Control Group – The group of individuals in a clinical trial that serve as the comparison group against which the safety and efficacy of an intervention is measured. Subjects in a control group may receive no intervention, a dummy intervention (placebo), or an alternative treatment.

Controlled Clinical Trial – A clinical trial in which at least one group of participants is given a test intervention, while at least one other group concurrently receives a control intervention.

Covered Entity - Health plans, health care clearinghouses and health care providers who transmit any health information in electronic form in connection with a transaction that is subject to federal HIPAA requirements, as those terms are defined and used in the HIPAA regulations 45 CFR Parts 160 and 164.

Data Management – The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.

Data Management Plan (DMP) – A plan that documents the processes for handling the flow of data from collection through analysis. Software and hardware systems along with quality control and validation of these systems, as relevant are described.

Data and Safety Monitoring Board (DSMB) –A group of individuals who are independent of the study investigators that is appointed to monitor participant safety, data quality, and the overall progress of the clinical trial.

Eligibility Criteria – List of criteria guiding enrollment of participants into a study, which includes criteria for both inclusion and exclusion (e.g., inclusion criterion: subjects must be between 55 and 85 years old; exclusion criterion: subjects must not have taken drug X three month prior to the study).

Enrolled Subject - Any subject who signs a consent form to be enrolled in a research study.

Enrollment Log – An essential document that records all subjects who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.

Expedited Review - Review of a research project by a designated reviewer, rather than by a full board of the IRB. Federal rules permit expedited review for certain types of low risk research.

Food and Drug Administration (FDA) – An agency within the U.S. Department of Health and Human Services (DHHS) responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation.

Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule – The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as protected health information (PHI).

Human Subject - Living individual about whom an investigator conducting research obtains data through direct intervention or interaction, or obtains identifiable private information by review of the individual's medical records.

Identifiers - Information collected for research purposes that may be connected to a participant’s identity.

Impartial Witness - A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally authorized representative cannot read, and who reads the consent form and any other written information supplied to the subject.

Informed Consent – A process by which a participant or legal guardian 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 participant’s decision to take part in the clinical trial.

Informed Consent Form – A document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explicitly explained in the informed consent document.

Institutional Review Board (IRB)/Independent Ethics Committee (IEC) – An independent body constituted of medical, scientific, and nonscientific members whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a research protocol. The IRB reviews, approves, and provides continuing review of trials, protocols and amendments, and of the methods and materials used to obtaining and documenting informed consent of the trial participant.

Intervention – A procedure, drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed on a human subject for clinical research purposes (45 CFR 46.102(f)).

Investigational Product - Pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial.

Investigator - An individual who is involved in conducting human subjects research activities, and is responsible for the safe and ethical conduct of the trial.

Key personnel - Term used to describe any individual responsible for the design, conduct, and reporting of research for a given study. Key personnel contribute to the scientific development or execution of a study in a substantive, measurable way.

Legally Authorized Representative (LAR) - An individual, judicial, or other body authorized under applicable law to consent on behalf of a potential subject to the subject’s participation in the research.

Masking/Blinding – A procedure in which the investigator administering the assessments and interventions in a clinical trial and/or the subjects participating the trial are kept unaware of which treatment they are providing or receiving. Single blinding usually refers to only the study participant(s) being unaware. Double blinding usually refers to both the study participant(s) and the investigator(s), study monitors, and data analyst(s) any of the following being unaware of the treatment assignment(s).

Office for Human Research Protection (OHRP) – A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.

Open-Label Trial – A clinical trial in which both the investigators and the subjects know which intervention is being administered.

Phase I - A study in which an intervention is tested for the first time in a small group of people (e.g., 20-80) to evaluate its safety (e.g., to determine a safe dosage range; to identify possible side effects). A Phase I Trial can include healthy subjects or patients with the illness for which the intervention is designed to treat. Phase I Trials are typically of relatively short duration (weeks-months).

Phase II - A study of an intervention that is conducted with a larger group of subjects (100's) to determine its efficacy, to further evaluate safety, and to assess short-term side effects and risks. Subjects in a Phase II Trail usually have the condition or disease for which the intervention is designed to treat. Phase II may be of longer duration.

Phase III - A study of an intervention that is conducted with large groups of people (100's- 1000's) to compare its efficacy against other standard or experimental interventions, to monitor long-term adverse effects, and to collect information to allow safe use. Subjects in a Phase II Trail will have the condition or disease for which the intervention is designed to treat. Phase III Trials may be of long duration (years). An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation to evaluate an experimental intervention in comparison with a standard or controlled intervention, or to compare the efficacy of two or more existing treatments. These trials usually involve several hundred or more human subjects. Often, the aim of such investigations is to obtain evidence that provides a scientific basis for changing health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.

Phase IV - Studies conducted after an intervention has been marketed. Phase IV studies are designed to monitor effectiveness of the approved intervention in the general population and to gather data about adverse effects associated with widespread use.

Protected Health Information (PHI) - Individually identifiable health information

Placebo – A placebo is an inactive pill, liquid, powder, or other intervention that has no established activity or treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness.

Placebo Controlled Study – A type of study in which an inactive substance/treatment (the placebo) is given to one group of participants, while the experimental intervention is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.

Protocol – A document that describes the objective(s), design, methodology, statistical consideration, and organization of a trial.

Protocol Deviations – Failure to conduct a study as explicitly described in the protocol, whether by accident, on purpose, or due to negligence. In any case, protocol deviations must be documented. Protocol deviations also include failure to comply with federal laws and regulations; the institution's commitments and policies; and standards of professional conduct and practice.

Provisional Approval - A board decision that the research is potentially approvable, however, the investigators must respond to the board's queries, provide additional information, and/or make minor changes to the protocol or consent before final approval is granted. Provisional approval does not constitute permission to begin the research.

Quality Assurance (QA) – Systematic approach to ensure that the data are generated, documented (recorded), and reported in compliance with the protocol and good clinical practice (GCP) standards.

Quality Control (QC) – The internal operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial related activities have been fulfilled (e.g., data and form checks, monitoring by study staff, routine reports, correction actions, etc.).

Randomization – The process of assigning clinical trial subjects to treatment or control groups using the element of chance, so as to reduce possible bias.

Recruitment Plan – A description of the methods by which study investigators will identify, recruit, and retain subjects for the study, so as to reach the recruitment goal.

Research - A systematic investigation designed to develop or contribute to generalizable knowledge. In general, single case reports, reports of small series of patients, and internal quality assurance projects (if not published) are not research.

Retention Plan – The plan that details the methods in which the study will use in order to retain study participation in the clinical trial.

Safety Monitoring Plan – A plan that outlines the oversight of a clinical trial, with the specific goal of assuring the safety, rights, and welfare of the participating subjects.

Standard Operating Procedure (SOPs) – Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.

Stratification – Separation of a study cohort into subgroups according to specific characteristics, such as age, gender, etc., so that factors which might affect the outcome of the study, can be analyzed and taken into account.

Subject Identification - A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.

Tabled - A board decision that a proposed study may not go forward until major changes have been made to the protocol, consent, or application. After the investigators have responded to the board's concern in writing, the revised study will be reconsidered at a subsequent board meeting.

Unmasking/Unblinding – A procedure in which one or more parties to the trial are made aware of the treatment assignment(s).