- 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.
- Baseline : The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. At this reference point, measurable values such as physical exam, laboratory tests, and outcome assessments are recorded.
- 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.
- Case Report Form (CRF) : A printed, optical, or electronic (eCRF) document designed to capture all protocol-required information for a study.
- Clinical Research Coordinator or Study Coordinator (CRC) : An individual that handles the administrative and day-to-day responsibilities of a clinical trial and acts as a liaison for the clinical site. This person may collect the data or review it before it is entered into a study database.
- Clinical Research Definition: Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
- Clinical Trial definition: clinical trial as 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 are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral clinical trials involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fit this definition of a clinical trial.
- Concomitant Medication : Prescription and over-the-counter drugs and supplements a study participant has taken along with the study intervention. This information may be collected as a history item as well as during the study. Some studies may collect only those medications that may interact with the study or intervention or that may exclude an individual from participating in a study.
- Conflict of Interest : A conflict of interest occurs when individuals involved with the conduct, reporting, oversight, or review of research also have financial or other interests, from which they can benefit, depending on the results of the research.
- 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.
- 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 independent of the study investigators that is appointed by the NIA to monitor participant safety, data quality and to assess clinical trial progress.
- Data and Safety Monitoring Plan (DSMP) : Plan included with the grant application for clinical trials which establishes the overall framework for data and safety monitoring, how adverse events will be reported to the IRB and the NIH and, when appropriate, how the NIH Guidelines and FDA regulations for INDs and IDEs will be satisfied.
- Efficacy : Indication that the clinical trial intervention produces a desired therapeutic effect on the disease or condition under investigation.
- Eligibility Criteria : List of criteria guiding enrollment of participants into a study. The criteria describe both inclusionary and exclusionary factors.
- 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, nation’s food supply, cosmetics, and products that emit radiation.
- Good Clinical Practice : 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 participants are protected.
- 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 : A patient or healthy individual who is or becomes a participant in research, either as a recipient of the intervention or as a control.
- 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 is usually documented by means of a written, signed, and dated informed consent form, which has been approved by an IRB/IEC.
- 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 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 trial by, among other things, reviewing, approving, and providing continuing review of trials, protocols and amendments, and of the methods and material to be used to obtaining and documenting informed consent of the trial participant.
- Intervention : A procedure or treatment such as a drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed for clinical research purposes.
- Investigational New Drug Application (IND) : An IND is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application (21 CFR 312).
- Masking/Blinding : A procedure in which the investigator administering the assessments and intervention as well as the participants in a clinical trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the study participant(s) being unaware, and double blinding usually refers to the study participant(s) and any of the following being unaware of the treatment assignment(s): investigator(s), monitor, and data analyst(s).
- Manual of Procedures (MOP) : A set of procedures describing study conduct. A MOP is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites.
- New Drug Application (NDA) : An application submitted by the manufacturer of a drug to the FDA, after the clinical trial has been completed, for a license to market the drug for a specified indication.
- Observational Study Monitoring Board (OSMB) : The safety and data monitoring body for observational studies with large or vulnerable populations or risks associated with tests or standard of care.
- 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 investigators and participants know which intervention is being administered.
- Pharmacokinetics : The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.
- Phase I : clinical trials to test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects). It can include healthy participants or patients.
- Phase II : clinical trials to study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety. It is conducted in participants with the condition or disease under study and will determine common short-term side effects and risks.
- Phase III : studies to investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.
- Phase IV : studies conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.
- Placebo : A placebo is an inactive pill, liquid, powder, or other intervention that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness.
- Placebo Controlled Study : A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article 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 Amendments : A written description of a change(s) to or formal clarification of a protocol.
- Protocol Deviations : Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution’s commitments and policies, and standards of professional conduct and practice.
- Protocol Deviations Report : Internal document created as part of the ongoing quality control process summarizing compliance with the protocol and listing protocol deviations and/or violations.
- Prospectively Assigned : A pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.
- 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 participants to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
- Recruitment Plan : The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal.
- 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 Officer (SO) : An independent individual, often a clinician who is appointed by the NIA and performs data and safety monitoring activities in low-risk, single site clinical studies. The SO advises the NIA regarding participant safety, scientific integrity, and ethical conduct of a study. The SO is advisory to the Institute Director.
- Screening Log : An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.
- Screening Process : A process designed to determine individual’s eligibility for participation in a clinical research study.
- Source Document : Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a clinical trial.
- Standard Operating Procedure (SOP) : Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.
- Unanticipated Adverse Device Effects (UADEs) : Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in a nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application) or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
- Active comparator arm: An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.
- 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 amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied.
- Cross-over assignment: A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two-by-two cross-over assignment involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A. So during the trial, participants “cross over” to the other drug. All participants receive drug A and drug B at some point during the trial but in a different order, depending on the group to which they are assigned.
- Data Monitoring Committee (DMC)
- A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.
- Early Phase 1 (formerly listed as Phase 0): A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
- Experimental arm: An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial.
- Extension request: In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing masked trial). All requests must be reviewed and granted by the National Institutes of Health. This process for review and granting of extension requests is being developed.
- Factorial assignment: A type of intervention model describing a clinical trial in which groups of participants receive one of several combinations of interventions. For example, two-by-two factorial assignment involves four groups of participants. Each group receives one of the following pairs of interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo and drug B, or (4) a placebo and a placebo. So during the trial, all possible combinations of the two drugs (A and B) and the placebos are given to different groups of participants.
- First submitted: The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record’s availability on ClinicalTrials.gov (the first posted date).
- First submitted that met QC criteria: The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM’s QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
- Gender-based eligibility: A type of eligibility criteria that indicates whether eligibility to participate in a clinical study is based on a person’s self-representation of gender identity. Gender identity refers to a person’s own sense of gender, which may or may not be the same as their biological sex.
- Group/cohort: A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
- Human subjects protection review board: A group of people who review, approve, and monitor the clinical study’s protocol. Their role is to protect the rights and welfare of people participating in a study (referred to as human research subjects), such as reviewing the informed consent form. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also called an institutional review board, or IRB, or an ethics committee.
- Intervention model: The general design of the strategy for assigning interventions to participants in a clinical study. Types of intervention models include: single group assignment, parallel assignment, cross-over assignment, and factorial assignment.
- Intervention/treatment: A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
- Interventional study (clinical trial): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study’s protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
- Investigator: A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
- Last update posted: The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study’s sponsor or investigator (the last update submitted date) and the last update posted date.
- Last update submitted: The most recent date on which the study sponsor or investigator submitted changes to a study record to ClinicalTrials.gov. There is typically a delay of a few days between the last update submitted date and when the date changes are posted on ClinicalTrials.gov (the last update posted date).
- Last verified: The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study’s recruitment status is shown as unknown.
- Location terms: In the search feature, the Location terms field is used to narrow a search by location-related terms other than Country, State, and City or distance. For example, you may enter a specific facility name (such as National Institutes of Health Clinical Center) or a part of a facility name (such as Veteran for studies listing Veterans Hospital or Veteran Affairs in the facility name). Note: Not all study records include this level of detail about locations.
- Masking: A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. Types of masking include: open label, single blind masking, and double-blind masking.
- NCT number: A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is “NCT” followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
- No intervention arm: An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial.
- Observational study: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment. A patient registry is a type of observational study.
- Observational study model: The general design of the strategy for identifying and following up with participants during an observational study. Types of observational study models include cohort, case-control, case-only, case-cross-over, ecologic or community studies, family-based, and other.
- Outcome measure: For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
- Parallel assignment: A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A “in parallel” to participants in the other group, who receive drug B.
- Participant flow: A summary of the progress of participants through each stage of a clinical study, by study arm or group/cohort. This includes the number of participants who started, completed, and dropped out of the study.
- Patient registry: A type of observational study that collects information about patients’ medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world.
- Placebo: An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
- Placebo comparator arm: An arm type in which a group of participants receives a placebo during a clinical trial.
- Primary completion date: The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The “estimated” primary completion date is the date that the researchers think will be the primary completion date for the study.
- Primary outcome measure: In a clinical study’s protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
- Primary purpose: The main reason for the clinical trial. The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.
- Protocol: The written description of a clinical study. It includes the study’s objectives, design, and methods. It may also include relevant scientific background and statistical information.
- Quality control (QC) review: National Library of Medicine (NLM) staff perform a limited review of submitted study records for apparent errors, deficiencies, or inconsistencies. NLM staff identify potential major and advisory issues and provide comments directly to the study sponsor or investigator. Major issues identified in QC review must be addressed or corrected (see First submitted that met QC criteria and Results first submitted that met QC criteria). Advisory issues are suggestions to help improve the clarity of the record. NLM staff do not verify the scientific validity or relevance of the submitted information. The study sponsor or investigator is responsible for ensuring that the studies follow all applicable laws and regulations.
- Randomized allocation: A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance.
- Not yet recruiting: The study has not started recruiting participants.
- Recruiting: The study is currently recruiting participants.
- Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
- Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
- Suspended: The study has stopped early but may start again.
- Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
- Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant’s last visit has occurred).
- Withdrawn: The study stopped early, before enrolling its first participant.
- Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.
- Registration: The process of submitting and updating summary information about a clinical study and its protocol, from its beginning to end, to a structured, public Web-based study registry that is accessible to the public, such as ClinicalTrials.gov.
- Removed location countries: Countries that appeared under listed location countries but were removed from the study record by the sponsor or investigator.
- Reporting group: A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different from a study arm or group.
- Responsible party: The person responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information. Usually the study sponsor or investigator.
- Results database: A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results information for completed or terminated clinical studies. A study with results available on ClinicalTrials.gov is described as having the results “posted.”
- Results delayed: Indicates that the sponsor or investigator submitted a certification or extension request.
© Oxygen Clinical Trial : 2024 All Rights Reserved designed by Digitalz Creations