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Terms Abbrv. Definition Remarks
Qualified Person QP Qualified person responsible for final dispatch of trial drug
Quality Assurance QA All those 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 Good Clinical Practice (GCP) and the 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.
Quality of Life Trials (or Supportive care trial) Refers to trials that explore ways to improve comfort and quality of life for individuals with a chronic illness.
Randomization The process of assigning trial subjects to treatment or control groups using element of chance to determine the assignments in order to reduce bias. Randomization allows for researchers to comparably test different treatments in similar groups.
Randomized Controlled Trial RCT Randomized controlled trial is a study in which people are allocated at random to receive one of several clinical interventions
Randomized trial A study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. Occasionally placebos are utilized.
Recall The requirement to return an investigational drug to the manufacturer due to safety hazards, procedural problems, or when requested by regulatory authorities.
Recruitment Act of enrolling subjects with the proper inclusion criteria
Recruitment Period Time allowed to recruit all subjects for a study.
Recruitment Status Indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:
–       Not yet recruiting: participants are not yet being recruited or enrolled
–       Recruiting: participants are currently being recruited and enrolled
–       Enrolling by invitation: participants are being (or will be) selected from a predetermined population
–       Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
–       Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient’s last visit has occurred)
–       Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
–       Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
–       Withdrawn: study halted prematurely, prior to enrollment of first participant
Regulatory Affairs In clinical trials, the department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. Each drug sponsor has a regulatory affairs department that manages the entire drug approval process. centrewatch
Regulatory Authorities/ Competent Authority CA Bodies having the power to regulate. In the ICH GCP guideline 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 Files A standard file system that organizes the administrative research study records and documents. Sometimes referred to as the study file, project notebook, essential documents binder, study management document, or investigator file.
Rescue Medication A quick-relief or fast-acting medication patients in clinical trials may be given besides the investigational drug or control that can alleviate symptoms due to disease or lack of efficacy of the study treatment. It acts quickly to stop symptoms, but the effects are not long lasting.
Research Systematic investigation designed to develop or contribute to generalizable knowledge. Includes Clinical Research.
Research Misconduct Falsification, fabrication, or plagiarism in proposing, conducting, or reporting research.
Research Team Investigator, subinvestigator and clinical research coordinator involved with study.
Retrospective Study A study in which investigators select groups of patients that have already been treated and analyze data from the events experienced by these patients. These studies are subject to bias because investigators can select patient groups with known outcomes Acrohealth
Risk-benefit Ratio The risk a treatment places on individual participants versus the potential benefits of the treatment. The risk/benefit ratio may differ depending on the condition being treated.
Safety Reports FDA report required by investigator for any serious and unexpected adverse experience.
Screening trials Refers to trials which test the best way to detect certain diseases or health conditions.
Serious Adverse Event/ Serious Adverse Drug Reaction SAE/ ADR Any untoward medical occurrence that at any dose:
– result in death
– is life-threatening
– requires in-patient hospitalization or prolongation of existing hospitalization
– results in persistent or significant disability/ incapacity, or
– is a congenital anomaly/ birth defect (See the ICH Guideline for Clinical Safety Data Management)
Side-effects Any undesired actions or effects of a drug or treatment. Experimental drugs must be evaluated for both immediate and long-term side effects.
Single Point Use SPU The use of an investigational drug for the treatment of a serious or life-threatening condition for a specific individual. Requires prospective IRB approval and compliance with federal regulations.
Single Project Assurance Permit given to institution for single grant in compliance with government standards. See “assurance.”
Site Specific Assessment SSA assessment on the suitability of the site and local Principal Investigator (PI) to conduct a specific trial. SSA is a trial specific procedure based on review of documentation for each trial
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/ data verification SDV 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 copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, laboratories, and medico-technical departments involved in clinical trial)
Sponsor An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
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 A treatment currently in wide use by the medical community and approved by a country’s regulatory agency considered to be effective in the treatment of a specific disease or condition.
Standards of Care Treatment regimen or management based on state of the art medical care.
Statistical Significance The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.
Statistician One versed in or engaged in compiling statistics.
Strata Subgroup of participants selected by certain variables.
Study Endpoint An outcome used to judge the safety or effectiveness of a treatment
Subinvestigator 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 Identification Code a unique identifier assigned by the investigator to each trial subject to protect the subject’s identity and used in lieu of the subjects’ name when the investigator reports adverse events and/or other trial related data
Subject/Trial Subject/ Participant An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. GCP
Summary of Product Characteristics SPC The SPC is the basis of information for health professionals on how to use the medicinal product safely and effectively. The SPC sets out the agreed position of the medicinal product as distilled during the course of the assessment process. As such the content cannot be changed except with the approval of the originating competent authority. It must be included for application of marketing authorization
Surrogate Endpoint A biomarker or endpoint that is intended to substitute for a clinical endpoint. A surrogate endpoint is expected to predict a clinical endpoint or lack thereof
Toxicity A treatment-related adverse effect that may be detrimental to the recipient’s health. The level of toxicity associated with a treatment will vary depending on the attributes of the treatment itself and the condition the drug is being used to treat.
Treatment Investigational New Drug Treatment IND It makes promising new drugs available to desperately ill participants as early in the drug development process as possible. Treatment INDs are made available to participants before general marketing begins, typically during Phase 3 studies. To be considered for a treatment IND a participant cannot be eligible to be in the definitive clinical trials. A method through which allows seriously ill patients with no acceptable therapeutic alternative to access promising investigational drugs still in clinical development. The drug must show “sufficient evidence of safety and effectiveness.”
Treatment Trials Refers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Trial Site The location(s) where trial-related activities are actually conducted.
Suspected Unexpected Serious Adverse Reaction SUSAR A suspected adverse reaction related to the treatment that is both unexpected (i.e. not consistent with the expected outcomes of the treatment being offered) and serious.
Serious Unexpected Event SUE An unexpected serious adverse event is one which is not anticipated and is not known to be related to the condition being studied or the treatment being offered.