Abstention: An abstention is neither a "yes" nor a "no" vote and is cast when a member is not comfortable in voting either way. Any member is free to abstain at any time. An abstention counts toward quorum but does not count toward a super majority.
Adverse drug reaction (ADR): In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase "responses to a medicinal 2 product" means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketed medicinal products: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
Adverse Event/Effect (AE): Any untoward physical or psychological occurrence in a subject participating in research. An AE can be any unfavorable or unintended event including an abnormal laboratory finding, or a symptom or disease associated with the research. Adverse events may or may not have a causal relationship with the research.
In the context of multicenter clinical trials, Adverse Events can be characterized as either internal adverse events or external adverse events. From the perspective of one particular institution engaged in a multicenter clinical trial, internal adverse events are those adverse events experienced by subjects enrolled by the investigator(s) at that institution, whereas external adverse events are those adverse events experienced by subjects enrolled by investigators at other institutions engaged in the clinical trial. In the context of a single-center clinical trial, all Adverse Events would be considered internal adverse events
Approved Drug / Device: An approved drug/device means the drug/device being studied has been cleared by the U.S. Food and Drug Administration (FDA) for marketing.
Assent: Agreement to participate in research obtained from an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person). An assent form is like an informed consent form but is tailored to the status/age of the individual not competent to give consent. It is only binding in conjunction with parent/guardian consent.
Audit: A systematic and independent examination of research activities and documents, to verify that the activities were conducted according to the protocol, sponsor's expectations, institutional procedures, good clinical practice (GCP), and applicable regulatory requirement(s).
Audit certificate: A declaration of confirmation by the auditor that an audit has taken place.
Audit report: A written evaluation by the sponsor's auditor of the results of the audit.
Audit trail: Documentation that allows reconstruction of the course of events.
Autonomy: Personal capacity to consider alternatives, make choices, comprehend information, and act without undue influence or interference of others.
Belmont Report: The National Commission for the Protection of Human Subjects in 1978 authored the Belmont report. It establishes the basic ethical principles for conducting human subjects research: autonomy, beneficence, and justice.
Beneficence: Beneficence is an ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
Benefit: A benefit is a valued or desired outcome; an advantage.
Bias: When objectivity is impaired by personal gain or personal judgment. In clinical studies, bias is minimized by blinding and randomization.
Biologics: Biologics, as regulated by the U.S. Food and Drug Administration, include therapeutic serum, toxin, anti-toxin or microbials used for the prevention, treatment, or cure of diseases or injuries.
Blinded Study Design: Study designs comparing two or more interventions in which the investigators, subjects, or some combination thereof do not know group assignments.
Case Report Form (CRF): A printed, optical, or electronic document designed to record regulatory and protocol-required data from each individual enrolled in the study. The CRF is reported to the sponsor for each subject and also provides documentation for quality assurance and monitoring.
Clinical Trial: A clinical trial is a research study to evaluate the safety and efficacy of vaccines, new therapies, or new ways of using known treatments. Clinical trials are often staged (e.g., phase I, II, III) to learn essential information putting fewest subjects at risk.
Clinical Trial/Research Agreement: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.
Coded Information: Coded means replacing identifiable information (such as name or social security number) with a number, letter, symbol, or combination thereof (i.e., the code).
Cognitively Impaired: Having a disorder (psychiatric or developmental) that affects cognitive or emotional functions that impair the capacity for sound judgment and reasoning. Other conditions that may impair judgment and reasoning are: being under the influence of drugs or alcohol, having a degenerative disease, having a terminal illness or having disabling handicaps.
Cohort: In epidemiology, a group of individuals selected for common characteristics.
Community Based Clinical Trial (CBCT): A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.
Community Member/ Non-Affiliated Member: A member of an Institutional Review Board who has no ties to an institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker, etc.).
Comparator (Product): An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
Compassionate Use: A method of providing experimental therapeutics prior to the final FDA approval. This allows treatment for sick individuals who have no other options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug, therapy or device.
Compensation: Payment for participation in research.
Competence (Capacity to consent): A legal term used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice.
Compliance: Adherence, in this case, to federal regulations, state laws, institutional policies and sponsor requirements.
Confidentiality: Pertains to the handling of information/data that an individual has disclosed in a relationship of trust. The expectation is that the information/data will not be divulged to others without permission, or in ways that are inconsistent with the original disclosure.
Conflict of Interest (COI) Management Plan: Management plans are issued by Einstein's COI committee and describe the limits of a researcher's ability to serve as PI or a member of a study team. Management plans define a relationship between a researcher and a company. The management plan also describes the disclosures required in consent forms and publications that result from the study. One researcher may have multiple management plans.
Continuing Review: Periodic review of a research study by an IRB to evaluate whether risks to participants remain reasonable in relation to potential benefits and to verify the study continues to meet regulatory and institutional requirements. Continuing review shall be conducted at intervals appropriate to the degree of risk but not less than once per year. (45 CFR 46.109(e); 21 CFR 56.109(f))
Contract: An agreement that a specific research activity will be performed under the direction of an entity providing funds. Research performed under a contract is more closely controlled by the entity than research performed under a grant.
Contract Research Organization (CRO): A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.
Contraindication: A specific circumstance when the use of certain treatments is not recommended.
Control/Normal Subject(s): Subject(s) who do not receive the treatment being studied, who are then used for comparison to subjects who do receive the treatment. Or, subjects who do not have a given condition, background, or risk factor that is being studied.
Controlled Study: Research that involves at least two groups: one that receives the study intervention and the other that receives a placebo or another intervention. These studies are also referred to as “blind” / “masked” (i.e. the subjects do not know which treatment they are receiving) or “double blind” / “double-masked” (i.e. neither the subjects nor the researchers know the treatment assignments).
Cross-Over Design: A type of clinical trial in which each subject experiences, at different times, both the experimental and control therapy. For example, half of the subjects might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.
Data Analysis: The process of applying statistical techniques to describe, summarize, and compare data to extract useful information and facilitate conclusions.
Data and Safety Monitoring Board (DSMB): An independent committee that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends that would warrant changes or early closure of the trial.
Debriefing: Providing subjects with previously undisclosed information about the research project or the study’s real purpose.
Deception: Deception, when referring to studies, is the intentional misleading of subjects or the withholding of full information about the nature of the study. Deception increases ethical concerns because it interferes with the ability of the subject to give fully informed consent. However, deception is arguably necessary for certain types of behavioral research to prevent biased behavior or answers.
Deferral: Submissions to the IRB that: (1) require substantial revisions (e.g., specific wording cannot be provided by the convened IRB); or (2) prompt questions that cannot be answered within the context of the IRB meeting, will be deferred for further review by the convened IRB at a later date.
Design: A research design is a plan or analytical approach for answering research questions. Some examples of research designs are experimental, correlational, observational, and single case. The selection of a particular study design depends on the information sought.
Device/Medical Device: A diagnostic or therapeutic article that does not achieve any of its principal intended purpose through chemical action within or on the body (which would be considered medicine). Such devices include diagnostic test kits, crutches, electrodes, pacemakers, arterial grafts, intraocular lenses, and orthopedic pins or other orthopedic equipment.
Diagnostic Trials: Trials that are conducted to find better diagnostic tests/procedures for identifying a particular disease or condition. Diagnostic trials enroll people who have signs or symptoms of a disease or condition being studied.
Direct Access: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsors, monitors, and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.
Documentation: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
Double Blind Study: A clinical trial design in which neither the participating individuals nor the study staff knows which trial regimen participants are receiving. Double blind trials are used to increase objectivity so expectations do not influence outcome.
Drug/Pharmaceutical: Any chemical compound that may be administered to humans for the diagnosis, treatment, cure, mitigation, or prevention of disease or of benefit to other conditions.
Efficacy: The ability of a drug or treatment to produce the expected result.
Eligibility criteria: These are defined requirements for subject inclusion/exclusion in a given experiment. Eligibility criteria examples are age, sex, state of health, a defined range for a biologic measure (e.g. glucose level or cholesterol), blood cell counts, etc.
Empirical: Based on experimental data; not theory.
Endpoint: A target outcome of a trial. Endpoints are chosen because they are measurable.
Engagement of Institutions in Research: An institution becomes "engaged" in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes.
Equitable: The fair or just selection of study subjects (principle of justice) to assure that the benefits and burdens of research are equally distributed.
Ethnographic/Fieldwork/Anthropology Research: Ethnography is the study of people and culture. Ethnographic research involves observation of a person or group studied in their own environment, often for long periods of time.
Exempt Research: Exempt research is Human Subjects Research that meets one of the minimal risk categories in the federal regulations.
Expanded Access: Increasing the inclusion criteria in an experimental drug study to allow for enrollment of participants who are failing on currently available treatments, and/or are unable to participate in any other ongoing clinical trials.
Expedited Review: A review undertaken per federal regulations by the IRB chair or a designated voting member, rather than the entire IRB.
Experimental Drug: A drug that has an Investigational New Drug (IND) application filed with the FDA, but has yet to be licensed.
Federal Wide Assurance (FWA): An agreement between a federally funded entity and the HHS Office of Human Research Protections (OHRP) that stipulates methods by which the entity will protect research participants (66 Fed Reg 19139, 19141 April 13, 2001.). Non-HHS federal agencies also use the assurance process for their funded entities.
Fetus: A developing human from two months after conception to birth. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "embryo" is usually used for earlier phases of development.
Food and Drug Administration (FDA): Along with the Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA) is the other regulatory body with oversight authority over research with human subjects. FDA oversight extends to all research with human subjects involving investigational drugs, devices and biologics, regardless of funding source. The FDA is a division of the U.S. Department of Health and Human Services (DHHS), and FDA auditors can inspect the Einstein IRB’s records involving FDA regulated studies at any time. (http://www.fda.gov/).
Full Board Review: Review of proposed or continuing research (primarily greater than minimal risk research) by a convened IRB meeting, at which a majority of the voting membership is present.
Gene Therapy: The treatment of certain disorders, especially those caused by genetic anomalies or deficiencies, by introducing specific engineered genes into a patient's cells.
Genetic Screening: Genetic tests or methods to identify persons who have a gene that is thought to be linked to a certain phenotype or who are at risk of inherited diseases or disorders.
Good Clinical Practice (GCP): 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.
Guardian: An individual who is authorized under applicable state or local law to give permission on behalf of a child or make decisions for an incompetent adult [45 CFR 46.402(c)].
Grant: Financial support provided for a research study. Fund givers typically do not exercise strict control over the grants they have awarded.
Health Insurance Portability and Accountability Act (HIPAA): HIPAA’s Privacy Rule of 2003 prohibits health care providers such as health care practitioners, hospitals, nursing facilities and clinics from disclosing protected health information without written authorization from the individual (HIPAA Authorization).
Human In Vitro Fertilization: Fertilization involving human sperm and ova that occurs outside the human body (e.g. a test tube).
Human Research Protection Program (:HRPP): The Human Research Protection Program (HRPP) is the total of all departments and individuals responsible for the protection of human research subjects. At Einstein, the HRPP consists not only of the Office of Human Research Affairs and the IRB, but also the OCT, OSRP, IBC, ICTR, and the entire research community. The HRPP is headed by the Institutional Official (IO).
Human Subjects: Under the federal regulations (45 CFR 46), human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.
Identifiable Personal Information: Data containing enough information to reveal the identity of the subject.
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 acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
Inclusion/Exclusion Criteria: The pre-determined conditions of a clinical trial that allow or exclude participation. These criteria are factors such as age, gender, type and stage of a disease, previous treatment history, and/or other medical conditions.
Informed Consent: A person's voluntary agreement – based upon adequate knowledge and understanding of relevant information – to participate in research or undergo a diagnostic, therapeutic, or preventive procedure.
Informed Consent Document: A document that provides prospective participants with the purpose, procedures, potential risks and benefits of involvement in a research study, as well as alternatives to participating. This document is also what participants sign to demonstrate their consent to participate in research.
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’s (CROs) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
Institution (medical): Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
Institutional Official (IO): An officer of an organization who has the authority to speak for and legally commit the entity to comply with federal regulations regarding the involvement of human subjects in research.
Institutional Review Board (IRB): To protect the welfare of human subjects participating in research, a specially constituted review body designated by an entity to review human subject research protocols.
Interim Clinical Trial/Study Report: A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
International Studies: Procedures and policies that apply to research taking place outside the U.S. often differ from those set forth in the U.S. federal policies. U.S. federally funded research activities in a foreign country may be approved only if the ethical protections are equivalent to those in the U.S. This is also true for FDA approval of drugs/devices/biologics tested outside the United States.
Investigational Device Exemptions (IDE): Investigational devices that are exempt from regulations found in the FDA Medical Device Amendments because of their low risk profile. This allows such unapproved devices to be used in clinical investigations such as IDE.
Investigational New Drug or Device (IND): A drug or device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.
Investigator, a.k.a. Principal Investigator: A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. See also Sub-Investigator.
Investigator Initiated Research: Research that is initiated and conducted by an individual rather than a sponsor/pharmaceutical company. The investigator has the same responsibilities that a sponsor would have.
Investigator's Brochure: A compilation, created by the sponsor of all the clinical and nonclinical data on the investigational product(s).
In Vitro: Refers to processes occurring outside of a living organism.
In Vivo: Refers to processes carried out within a living organism.
IRB Records: IRB records include but are not limited to: minutes from IRB meetings, proposals reviewed, amendments, investigator brochures, and supplemental information including recruitment materials, consent forms, continuing reviews, correspondence, and IRB membership.
iRIS: The online system through which all Einstein and Montefiore IRB applications are submitted, reviewed, and approved.
Justice: An ethical principle discussed in the Belmont Report requiring fairness in the equitable distribution of burdens and benefits within the study population.
Key: Personnel Key Personnel are the individuals who have access to Protected Health Information (PHI) and generate data either through direct interactions with subjects or through access to their medical records. Key Personnel and their study roles must be listed on an IRB submission.
Legally Authorized Representative: An individual, judicial, or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.
Longitudinal Study: A study designed to follow groups of subjects for an extended period of time.
Minimal Risk: A risk is minimal when 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 [45 CFR 46.102(i)].
Minor: Persons who have not attained the legal age to consent to treatment or procedures in research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46.401(a)].
Monitoring: A systematic, ongoing process to evaluate or oversee the conduct of research procedures.
Monitoring Report: A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.
Multicenter Trial: A clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator.
New Drug Application (NDA): The New Drug Application (NDA) is the application drug sponsors submit to the FDA for approval of a new pharmaceutical for sale and marketing.
Nonclinical Study: Biomedical studies not performed on human subjects.
Non-Significant Risk Device: An investigational medical device that does not present significant risk to the research subject (e.g., tongue depressor, or swab).
Non-Viable Fetus: An expelled or delivered fetus, which although living, cannot possibly survive to the point of independently sustaining life, even with the support of available medical therapy [45 CFR 46 203(d)(e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975):33552], a specific determination as to viability must be made by a physician in each instance.
Off Label-Use: A drug used for conditions other than those approved by the FDA.
Office for Human Research Protections (OHRP): The U.S. Department of Health and Human Services office responsible for regulations [45 CFR Part 46] governing research involving human subjects.
Office of Human Research Affairs (OHRA) at Einstein: The Einstein office responsible for the oversight and direction of the Human Subjects Protection Program. This includes administrative oversight of the IRBs, maintenance of institutional Human Subjects Research policies, and setting educational requirements.
Open Label Design: An experimental drug trial in which both the investigator(s) and the subjects know the treatment group(s) to which subjects are assigned.
Orphan Drugs: An FDA category of medication used to treat rare diseases and conditions.
Peer Review: Experts with the same scholarly background as the person submitting a project, who review research for scientific merit, participant safety, and ethical acceptability.
Pharmacokinetics: The study of mechanisms of absorption, distribution, metabolism, and excretion of a drug or vaccine.
Placebo: A chemically inert substance used in controlled clinical trials to provide data that helps distinguish and determine whether improvement and side effects reflect imagination or anticipation rather than the actual power of a drug.
Placebo Controlled Study: A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective than the placebo in treating the condition.
Preclinical: Refers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before human trials.
Prevention Trials: Refers to trials that find improved ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle interventions.
Primary Data Collection: Primary data collection involves direct contact with, or observation of, one or more people for the purpose of collecting data from or about them.
Principal Investigator (PI): The scientist, scholar, or student with ultimate responsibility for the design and conduct of a research project.
Prisoner: An individual confined or detained in a penal entity.
Privacy: Control over the extent, timing, and circumstances of sharing oneself (physically or behaviorally) with the PI or other research staff.
Prospective Studies: A study designed to follow groups of subjects for an extended period of time with defined outcomes.
Protected Health Information (PHI): PHI is health information transmitted or maintained in any form or medium that includes ALL of the three following parts:
- identifies or could be used to identify an individual; and
- is created or received by a healthcare provider, health plan, or healthcare clearinghouse; and
- relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual.
Protocol: The formal design or plan of an experiment or research activity. 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. Throughout the ICH GCP Guidance, the term protocol refers to protocol and protocol amendments.
Protocol Amendment: A written description of a change(s) to or formal clarification of a protocol.
Protocol Deviation: Any change in the processes or procedures of research that were not approved by amendment of an IRB-approved protocol.
Quality Assurance (QA): All 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 applicable regulatory requirement(s).
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.
Quorum: A majority of voting members (50% + 1) who must be present for a convened IRB meeting to proceed. Must be maintained and documented for all votes.
Random, Random Assignment, Randomization, Randomized: A method of assigning subjects to different treatment groups based on chance.
Recruitment/Recruitment Materials: Recruitment is the process by which potential subjects are informed about a study. Recruitment materials, such as fliers, email messages, newspaper ads, and phone calls, must be accurate, non-coercive, and must not emphasize monetary compensation. These materials must be approved by the IRB.
Regulatory Authorities: Bodies having the power to regulate. In the ICH GCP guidance, the expression "Regulatory Authorities" includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities.
Regulatory/Essential Documents: Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced.
Regulatory requirement(s): Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products of the jurisdiction where trial is conducted.
Reliance Agreement: An IRB Reliance Agreement is a written document between Einstein and an external site or individual. It allows the Einstein IRB to extend its IRB oversight to the site/individual for the conduct of a specific study.
Research: Systematic investigation, including research development, testing, and evaluation, designed to produce or contribute to generalizable knowledge [45 CFR 102(d)].
Research with Human Subjects: Research with human subjects is a systematic investigation using data or samples derived from identifiable living humans that is designed to contribute to generalizable knowledge. Research with human subjects requires IRB review and approval.
Respect for Persons: An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
Retrospective Studies: Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews, surveys or measurements.
Risk: The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations only define “minimal risk.”
Risk/Benefit Ratio: Comparing the potential benefits to the risks of participating in a research study.
Secondary Data: Secondary data collection involves accessing information that has already been obtained either individually or in aggregate form.
Serious Adverse Event (SAE): Defined by the FDA as an event that jeopardizes the research subjects and may require medical or surgical treatment (e.g., death, a life threatening experience, hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly and/or birth defects).
Side Effect: Any undesired action or effect of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects.
Significant Risk Device: An investigational medical device that presents a potential for serious risk to the health, safety, or welfare of the subject.
Single-Blind/Blind Study: A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking.
Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
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: A person, federal agency, corporation, or other entity that provides funds for a research project.
Sponsor-Investigator: An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator.
Standard Operating Procedures (SOPs): Detailed, written instructions to achieve uniformity of the performance of a specific function.
Standard Treatment / Standard of Care: A treatment or regimen in wide use and considered to be effective in the treatment of a specific disease or condition. (Often used as comparator for a new drug, device, biologic or treatment).
Stipulation: A condition or requirement that is specified or demanded as part of an agreement (in the case of the IRB, application).
Stratification: A statistical method used to categorize subjects into subgroups by specific characteristics. This enables researchers to look into separate subgroups.
Study Arm: Any of the treatment groups in a randomized trial. Most randomized trials have two “arms” but some have three or more.
Sub-Investigator: Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial- related decisions (e.g., associates, residents, research fellows). See also Investigator.
Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
Subject Identification Code (aka Subject ID): A unique identifier assigned by the Sponsor-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.
Suspension/Termination: IRB approval is suspended/terminated and all research activity is halted as the result of: unanticipated problems involving risks to subjects or others, serious or continuing noncompliance with 45 CFR Part 46, or the requirements/determinations of the IRB not being followed or met.
Survey: A means to obtain information from respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
Toxicity: A detrimental effect produced by a drug or condition.
Trial Site: The location(s) where trial-related activities are actually conducted.
Unanticipated Problem Involving Risks to Subjects or Others (UP): Any event that is unexpected, related or possibly related, and suggests that the research places subjects or others at a greater risk of physical or psychological harm than was previously known or recognized.
Unexpected Adverse Drug Reaction: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). (See the ICH Guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
Viable Infant: When referring to a delivered or expelled fetus, the term “viable infant” means likely to survive to the point of sustaining life independently, given the benefit of available medical therapy [45 CFR 46.203(d)]. In research, this judgment must be made by a physician unaffiliated with the research project.
Voluntary: Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's willingness to participate (or continue to participate) in a research activity.
Vulnerable Populations: When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Waiver: A waiver or alteration of consent and/or HIPAA authorization is a document approved by the IRB that allows an investigator to forego certain requirements for obtaining consent or HIPAA authorization. It is commonly used to ascertain (identify) potential research subjects by reviewing their private health information prior to their consent.