| A | | |
| Adverse Drug Reaction (ADR) | In the pre-approval 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 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. (ICH) |
| Adverse Event (AE) | Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (ICH) |
| Amendment | TBD |
| Anonymous (Information) | Anonymous data and samples are never labelled with personal identifiers when originally collected, neither is a coding key generated. (ICH) |
| Arm | A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol. (clinicaltrials.gov) |
| Assent | Affirmative agreement of a minor to participate in clinical trial. The absence of expression of agreement or disagreement should not be interpreted as assent. (ICH) |
| Audit | A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). (ICH) |
| Audit trail | Documentation that allows reconstruction of the course of events. (ICH) |
| B | | |
| Bias | Bias is an error that distorts the objectivity of a study. It can arise if a researcher doesn't adhere to rigorous standards in designing the study, selecting the participants, administering the treatments, analyzing the data, or reporting and interpreting the study results. It can also result from circumstances beyond a researcher's control, as when there is an uneven distribution of some characteristic between groups as a result of randomization. (CIHR) |
| Biobank | An organized collection of searchable human biological materials stored for one or more specific or future unspecified research purposes. It may also include associated information about individuals from whom biological materials were collected. (TCPS2) |
| Biologic / Biological Drugs | Drugs that are made by living organisms or cells (e.g., therapeutic proteins). |
| Biomarker | A defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Molecular, histologic, radiographic, or physiologic characteristics are types of biomarkers. Blood pressure is one example of a biomarker. (FDA) |
| Biospecimen | A quantity of tissue, blood, urine, or other biologically derived material used for diagnosis and analysis. Sometimes biospecimens/specimens are called tissue samples. A single biopsy or surgical procedure may generate several specimens, including multiple paraffin blocks or frozen specimens. A specimen can include everything from subcellular structures (DNA) to cells, tissue (bone, muscle, connective tissue, and skin), organs (e.g., liver, bladder, heart, kidney), blood, gametes (sperm and ova), embryos, fetal tissue, and waste (urine, feces, sweat, hair and nail clippings, shed epithelial cells, and placenta). (NIH, NCI) |
| Blinding/Masking | A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). (ICH) |
| C | | |
| Calibration | The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements. (ICH) |
| Capacity | The ability of prospective or actual participants to understand relevant information presented (e.g. purpose of the research, foreseeable risks, and potential benefits), and to appreciate the potential consequences of any decision they make based upon this information. (TCPS2) |
| Case Report Form (CRF) | A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. (ICH) |
| Case study/ Case report /Case series | Case Reports describe a unique patient, group, or event that may be of interest to others. (CIHR) |
| Case-control studies | Case-Control Studies examine a disease in an attempt to identify risk factors. Two groups are identified. Everyone in one group has a particular condition and no one in the other group has that condition (e.g., heart disease). Both groups are studied to see if more people in one group have a particular event or behaviour in their history that could be associated with either causing the disease or protecting against it (e.g., smoking, exercise). (CIHR) |
| Causality / Relatedness/ Attributability assessment | Many terms and scales are in use to describe the degree of causality (attributability) between a medicinal product and an event, such as certainly, definitely, probably, possibly or likely related or not related. Phrases such as "plausible relationship," "suspected causality," or "causal relationship cannot be ruled out" are also invoked to describe cause and effect. However, there is currently no standard international nomenclature. The expression "reasonable causal relationship" is meant to convey in general that there are facts (evidence) or arguments to suggest a causal relationship. (ICH) |
| Certified copy | A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. (ICH) |
| Clinical equipoise | The existence of a genuine uncertainty on the part of the relevant expert community about which interventions are most effective for a given condition. (TCPS2) |
| Clinical significance/ Relevance | Clinical relevance refers to the ability of a therapy to improve how the patient feels, functions, and/or survives. More specifically, a therapy is clinically relevant if it provides a positive benefit from a patient’s perspective and the benefit is statistically significant and outweighs any potential harm or risk of harm. For an endpoint in a clinical trial to be clinically relevant, it must be able to capture and measure the potential benefit. (FDA) |
| Clinical Trial (CIHR definition) | A clinical trial is a research study involving human participants that evaluates the safety and/or effects of one or more interventions on health outcomes. Interventions include, but are not limited to, drugs, vaccines, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products (NHPs), process-of-care changes, preventive care, manual therapies, and psychotherapies. (CIHR) |
| Clinical Trial Agreement | TBD |
| Clinical Trial Application (CTA) | The sponsor must file a CTA prior to the initiation of the trial. CTAs are required for human clinical trials using drugs not authorized for sale in Canada, including clinical trials in Phases I through III of drug development and comparative bioavailability studies; as well as trials involving marketed drugs, where the proposed use of the drug is outside the parameters of the NOC or DIN , e.g., one or more of the following is different: a) Indication(s) and clinical use; b) Target patient populations(s); c)Route(s) of administration; or d)Dosage regimen(s). (HC) |
| Clinical Trial Application Amendment (CTA-A) | CTA-As are applications in which a sponsor proposes information to support changes to a previously authorized application. (HC) |
| Clinical Trial Site Information (CTSI) form | A form detailing site information, required by Health Canada for all trials that are subject to Division 5 of the Food and Drug Regulations Amendment. This is a post-authorization requirement. (HC) |
| Coercion | An extreme form of undue influence, involving a threat of harm or punishment for failure to participate in research. See "Undue influence." (TCPS2) |
| Cohort studies | Cohort Studies examine risk factors in an attempt to identify a disease. These studies follow two or more groups of people, or cohorts, over time. The people in each group are as similar as possible, except each group has an event, condition, or behaviour in their past that the other doesn't (e.g., smoking, exercise). Cohort studies can be either prospective or retrospective. A prospective cohort study begins at a certain date and then follows the participants over time to see how the groups in the study differ in terms of developing certain diseases. A retrospective cohort study starts in the present when it is already apparent who has the condition being measured, and traces events backward in time to see if a particular behaviour or event that occurred previously that may have caused the condition. (CIHR) |
| Comparator (product) | When a treatment for a specific medical condition already exists, it would be unethical to do a randomized controlled trial that would require some participants to be given an ineffective substitute. In this case, new treatments are compared to the best existing treatment, known as the "gold standard". The existing treatment is considered a comparator, and the trial will test the new treatment against the comparator. (CIHR) |
| Compliance (in relation to trials) | Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. (ICH) |
| Confidentiality | Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity. (ICH) |
| Confidentiality disclosure agreement | A legal agreement used with an outside organization to enter into collaborations or have confidential discussions leading to collaborations. (FDA) |
| Conflict of interest | The incompatibility of two or more duties, responsibilities, or interests (personal or professional) of an individual or institution as they relate to the ethical conduct of research, such that one cannot be fulfilled without compromising another. (TCPS2) |
| 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. (NIH NIA) |
| Consent | An indication of agreement by an individual, or their authorized third party, to become a participant in a research project. Throughout this Policy, the term "consent" means "free (or voluntary), informed and ongoing consent." (TCPS2) |
| 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. (ICH) |
| Control | The goal of a clinical trial is to determine how a new treatment will affect the course of a patient's disease. To do so, researchers must design their study so that it "controls for" other factors that may influence the disease. Researchers address this problem by assembling a group of patients with similar characteristics and dividing them randomly into groups. If one group receives the treatment and another doesn't, any difference in the course of their disease can then be attributed to the treatment, since it is the only factor that is different between them. The untreated group, known as the control group, answers the question, "What would happen to the people in the intervention group if they had not received any treatment?" (CIHR) |
| Controlled clinical trial (study design) | A type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may be observations from a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a "historical control"). (clinicaltrials.gov) |
| Corrective and preventative actions (CAPA) | System that focuses on investigating, understanding, and correcting discrepancies while attempting to prevent their occurrence. (ICH) |
| Cross-sectional study (prospective or retrospective) | Observational study in which a group is chosen (sometimes as a random sample) from a certain larger population, and the exposures of people in the group to an intervention and outcomes of interest are determined for a specific point in time. (NIH) |
| Cross-sectional survey | Cross-Sectional Surveys examine a large group of people at a point in time to see what proportion has a particular condition. Researchers then attempt to correlate the condition with other information about the participants that was collected at the same time (e.g., diet, age). A census would be an example of a cross-sectional survey. (CIHR) |
| Crossover trial | A trial in which subjects receive a sequence of different treatments. (HC) |
| D | | |
| Data | The information reported about a participant in a study. (AHRQ) |
| Data dictionary | Data dictionaries are used to provide detailed information about the contents of a dataset or database, such as the names of measured variables, their data types or formats, and text descriptions. A data dictionary provides a concise guide to understanding and using the data. (USDA) |
| Data management plan (DMP) | Key elements of the data management process. They describe how data are collected, formatted, preserved and shared, as well as how existing datasets will be used and what new data will be created. They also assist researchers in determining the costs, benefits and challenges of managing data. They should be developed using standardized tools, where available. (Government of Canada) |
| Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) | An independent advisory committee who review accumulated safety and efficacy data in a clinical trial and advise the principal investigator and/or the trial steering committee on the future management of the trial. (CIHR) |
| Database lock | Action taken to prevent further changes to a clinical trial database. NOTE: Locking of a database is done after review, query resolution, and a determination has been made that the database is ready for analysis (CDISC) |
| De-identified | Removal of elements connected with data which might aid in associating those data with an individual. Examples include name, birth date, social security number, home address, telephone number, e-mail address, medical record numbers, health plan beneficiary numbers, full-face photographic images). (CDISC) |
| Delegation Log / Delegation of Authorities (DOA) / Delegation of Duties (DoD) / Delegation of Responsibilities (DoR) / Task Delegation Log | TBD |
| Double-blind trial | A trial where both the investigators and the trial subjects don't know which treatment is given. (HC) |
| Drug (investigational product) accountability | TBD |
| Drug (product) | The term "drug" should be considered synonymous with therapeutic, preventative, or diagnostic medicinal products. |
| E | | |
| Efficacy and effectiveness | One of the goals of interventional research is to find out if an intervention works. Two measures that describe how well an intervention works are efficacy and effectiveness. A study focused on efficacy tests the ability of an intervention to produce its specific beneficial effect under ideal circumstances. This includes the measurement of focused outcomes after application of the intervention by experts to study participants who meet strict inclusion and exclusion criteria and who fully receive the intervention as it was designed. A study focused on effectiveness tests the ability of an intervention to provide overall benefit under real-world circumstances. This includes application of the intervention by those who will ultimately apply it and recruitment of all the types of people who will ultimately receive it. The study may also try to ensure that participants receive the intervention the same way they would if it were adopted. It should be noted that efficacy and effectiveness lie at opposite ends of a continuum. The outcome measures of many studies may fall anywhere along the continuum, using a mix of efficacy and effectiveness criteria. (TCPS2) |
| Electronic data capture (EDC) | The process of collecting clinical trial data into a permanent electronic form. NOTE: Permanent in the context of these definitions implies that any changes made to the electronic data are recorded with an audit trail. EDC usually denotes manual entry of CRF data by transcription from source documents. The transcription is typically done by personnel at investigative sites. (CDISC) |
| Electronic signature | “a signature that consists of one or more letters, characters, numbers or other symbols in digital form incorporated in, attached to or associated with an electronic document” (GoC) |
| Eligibility criteria | List of criteria guiding enrollment of participants into a study. The criteria describe both inclusionary and exclusionary factors, (e.g. inclusion criterion - participants must be between 55 and 85 years old; exclusion criterion – must not take drug X three month prior to the study). (NIH NIA) |
| Endpoint | An endpoint is a targeted outcome of a clinical trial that is statistically analyzed to help determine the efficacy and safety of the therapy being studied. Endpoints for a clinical trial may include one or more clinical outcome assessment and/or surrogate endpoint. Clinical outcomes assessments measure direct clinical benefit to the participant where as surrogate endpoints, including biomarkers, predict clinical benefit. Endpoints may also be used to throughout a study to determine if a participant’s risk of continuing to be in a study is too great. (NIH) |
| Essential documents | Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (see 8. Essential Documents for the Conduct of a Clinical Trial). (ICH) |
| F | | |
| 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. (NIH NIA) |
| G | | |
| 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. (ICH) |
| Good documentation practices (GDP) | |
| H | | |
| Health-related outcome | Any outcome that concerns the health status of an individual, group or population. (TCPS2) |
| Healthy volunteer | A Healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention. (NIH) |
| I | | |
| Identifiable data | One or more of the following should automatically qualify a patient as identifiable: age (or age category, e.g., adolescent, adult, elderly), gender, initials, date of birth, name, or patient identification number. (ICH) |
| 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. (ICH) |
| Inclusion/Exclusion criteria | Inclusion/Exclusion Criteria are factors that allow someone to participate in a clinical trial are inclusion criteria. Those that exclude or not allow participation are exclusion criteria. (NIH) |
| Independent Ethics Committee (IEC) | An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations and regulatory requirements pertaining to Independent Ethics Committees may differ among countries but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline. (ICH) |
| Informed consent | A process by which a subject 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 subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form. (ICH) |
| Informed consent form (ICF) | Informed consent is documented by means of a written, signed and dated informed consent form. (ICH) |
| 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 (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). (ICH) |
| Institutional Review Board (IRB) | An independent body constituted of medical, scientific, and non-scientific members, whose responsibility 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 trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (ICH) |
| Interventional trial | A trial in which the treatment assigned to the trial subject is predefined by the trial protocol. (HC) |
| Investigational product/Agent (IP) | A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. (ICH) |
| Investigational test authorization (ITA) | Documentation that is required to obtain an authorization for the sale of a device for investigational testing, under the Medical Devices Regulations. (HC) |
| Investigator (add co-i, sub-i) | 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 Subinvestigator. (ICH) |
| Investigator's Brochure (IB) | A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects. (ICH) |
| J | | |
| K | | |
| Knowledge translation | A dynamic and iterative process that includes synthesis, dissemination, exchange and ethically sound application of knowledge to improve the health of Canadians, provide more effective health services and products and strengthen the health care system. (CIHR) |
| L | | |
| Learning Management System | TBD |
| Legally Acceptable Representative | An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial. (ICH) |
| M | | |
| Medical device | A medical device refers to any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s). Specific medical purposes include diagnosis, prevention, monitoring, treatment, or alleviation of disease injury; investigation, replacement, modification, or support of the anatomy or of a physiological process including supporting or sustaining life and control of conception. A medical device does not achieve its primary intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Diagnostic ultrasound products, x-ray machines, and medical lasers are also medical devices. (NIH) |
| Medical Record | TBD |
| Medicinal product | Refers to any therapeutic, prophylactic, or diagnostic agent including pharmaceuticals, biologics, vaccines, cell or gene therapy products (when applicable), as well as drug-device combination products when registered as a drug. (ICH) |
| Monitoring (in research) | The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). (ICH) |
| Monitoring plan | A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. (ICH) |
| Multicentre 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. (ICH) |
| N | | |
| Natural Health Product (NHP) | A clinical trial testing the safety and/or efficacy of one or more natural health products. The term "natural health product" is used to describe substances such as vitamins and minerals, herbal medicines, homeopathic preparations, energy drinks, probiotics, and many alternative and traditional medicines. (TCPS2) |
| No Objection Letter (NOL) | If the Clinical Trial Application (CTA) or Clinical Trial Application Amendment (CTA-A) is deemed acceptable by Health Canada, a No Objection Letter (NOL) will be issued within the review period. (HC) |
| Note to file | Notes to the Study File are written to identify and record: a discrepancy or problem in the conduct of the clinical research study; the root cause of the identified problem; The corrective action taken to prevent recurrence of the problem; and the corrective action that has resolved the problem. (NIH NIA) |
| O | | |
| Observational study | An observational study, as distinguished from a randomized study, is usually undertaken when it is impossible, impractical, or unethical to have a control group. They are useful for generating hypotheses that can be more rigorously tested in randomized controlled trials. Their major disadvantage is that there is no assumption that participants are representative of others with that condition. The four most common forms of observational studies are case reports, case-control studies, cohort studies, and cross-sectional surveys. (CIHR) |
| OCAP Principles | The First Nations principles of ownership, control, access, and possession – more commonly known as OCAP® – assert that First Nations have control over data collection processes, and that they own and control how this information can be used. (FNIGC) |
| Off-label use | The term “off-label” refers to any use of a drug beyond what Health Canada has reviewed and authorized to be marketed in Canada and as indicated on the product label. (CADTH) |
| Open-label study | A trial in which participants and investigators know which product each participant is receiving; opposite of a blinded or double-blind study. (CDISC) |
| Operating manual | TBD |
| Outcome | A change (or absence of change) in the variable or attribute of interest and/or related variables or attributes affected by an intervention in the context of research. (TCPS2) |
| P | | |
| Participant identification code/number | 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. (ICH) |
| Patient engagement | Meaningful and active collaboration in governance, priority setting, conducting research and knowledge translation. Depending on the context, patient-oriented research may also engage people who bring the collective voice of specific, affected communities. (CIHR SPOR) |
| Patient-oriented research | Refers to a continuum of research that engages patients as partners, focusses on patient-identified priorities and improves patient outcomes. This research, conducted by multidisciplinary teams in partnership with relevant stakeholders, aims to apply the knowledge generated to improve healthcare systems and practices. (CIHR SPOR) |
| Personal Health Information (PHI) | Personal health information includes oral or written information about the individual, if the information: relates to the individual’s physical or mental health, including family health history; relates to the provision of health care, including the identification of persons providing care; is a plan of service for individuals requiring long-term care; relates to payment or eligibility for health care; relates to the donation of body parts or bodily substances or is derived from the testing or examination of such parts or substances; is the individual’s health number; or identifies an individual’s substitute decision-maker. Any other information about an individual that is included in a record containing personal health information is also included in the definition. (IPC Ontario) |
| Personal Information Protection and Electronic Documents Act (PIPEDA) | TBD |
| Pharmacokinetics (PK ) | Study of how genetic factors affect the response to drugs. (HC) |
| Placebo | A control treatment that does not contain the medicinal ingredient that is given to a group of trial subjects. (HC) |
| Pre-screening include both | TBD |
| Principal investigator | The researcher who is responsible for the ethical conduct of the research, and for the actions of any member of the research team at a local site. (TCPS2) |
| Privacy breach / confidentiality breach | Involves improper or unauthorized collection, use, disclosure, retention or disposal of personal information. (GoC) |
| Product monograph | A product monograph is a factual, scientific document on the drug product that, devoid of promotional material, describes the properties, claims, indications, and conditions of use for the drug, and that contains any other information that may be required for optimal, safe, and effective use of the drug. (GoC) |
| Prospective study | TBD |
| Protocol | 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 Guideline the term protocol refers to protocol and protocol amendments. (ICH) |
| Protocol amendment | A written description of a change(s) to or formal clarification of a protocol. (ICH) |
| Protocol deviation | A protocol deviation is any change, divergence, or departure from the study design or procedures defined in the protocol. (ICH) |
| Q | | |
| Qualified investigator (QI) | The person responsible for the conduct of the clinical trial at a clinical trial site, who is entitled to provide health care under the laws of the province where the clinical trial site is located, and who is: In the case of a clinical trial respecting a drug to be used for dental purposes only, a physician, dentist and a member in good standing of a professional medical or dental association; In any other case, a physician and a member in good standing of a professional medical association. (HC) |
| Qualitative analysis | The purpose of a qualitative analysis is to get a range of responses on an issue from a variety of perspectives, valuing unique responses as much as consistent ones. Qualitative analysis methods can include focus groups, individual observations, in-depth interviews, or documentary accounts. Qualitative assessments can often be used as a means of generating research questions and identifying themes that can later be used in a quantitative analysis. Qualitative analyses are subjective, meaning that they depend on the particular people included, and can be shaped by interactions with the researcher or other participants. (CIHR) |
| 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). (ICH) |
| 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. (ICH) |
| Quantitative analysis | Quantitative analysis attempts to understand the world objectively, rather than as different individuals might perceive it. It relies on compiling numerical data from many individuals into a single value, such as an average, or mean, that can be assessed by statistical tests. The goal of quantitative analysis is to be unbiased, which is why control groups and blinding are important considerations in constructing quantitative research studies. Statistical analyses applied to quantitative data define exactly how likely a result is to have occurred by chance alone, which helps the user understand how representative the results are of the population as a whole. (CIHR) |
| R | | |
| Randomization | The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (ICH) |
| Randomized controlled trial (RCT) | An experiment in which investigators randomly assign eligible human research participants or other human units of study (e.g., classrooms, clinics, playgrounds) into groups to receive or not receive one or more interventions that are being compared. The results are analyzed by comparing outcomes in the groups. (CIHR ) |
| Recruitment | Recruitment in a clinical trial includes the following steps: Identifying or sourcing potential participants who may be eligible. Discussing all aspects of the trial with them, ensuring comprehension and voluntariness, and subsequently obtaining informed consent for participation. (NIH) |
| Regulatory authorities / agencies | 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 (see 1.29). These bodies are sometimes referred to as competent authorities. (ICH) |
| Research agreement | A document that serves as a primary means of clarifying and confirming mutual expectations and, where appropriate, commitments between researchers and communities. (TCPS2) |
| Research Ethics Board (REB) | A body of researchers, community members, and others with specific expertise (e.g., in ethics, in relevant research disciplines) established by an institution to review the ethical acceptability of all research involving humans conducted within the institution's jurisdiction or under its auspices. (TCPS2) |
| Research Proposal | TBD |
| Research Participant | An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. (ICH) |
| Research phases | Clinical trials are conducted in “phases.” The trials at each phase have a different purpose and help researchers answer different questions. Phase I trials — An experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects. Phase II trials — The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety. Phase III trials — The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments. Phase IV trials — After a drug is licensed and approved by the FDA researchers track its safety, seeking more information about its risks, benefits, and optimal use. |
| 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. (NICHSR) |
| Risk-based monitoring | An adaptive approach to clinical trial monitoring that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact subject safety and data quality. (TransCelerate) |
| S | | |
| Screening | 1. A process in which an investigator reviews patients for possible entry into a clinical study. If the patient is eligible for the study, he/she may be approached to participate in the study. 2. A method of secondary prevention. Screening programs check large numbers of individuals who are otherwise healthy for known symptoms before a disease is established. Screening is presently offered through programs such as mammography for breast cancer or skin examinations for melanoma. (CIHR) |
| Serious adverse drug reaction (SADR) | Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (ICH) |
| Serious adverse event (SAE) | Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, - results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. (ICH-GCP) |
| Single-blind | Indicates that trial subjects don't know the treatment they are taking [for example (e.g.), placebo Vs test drug) but the investigator of the trial does. (HC) |
| Site initiation visit (SIV) | TBD |
| Site qualification visit (SQV) PSV, SSV | TBD |
| 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). (ICH) |
| 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 copies, 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). (ICH) |
| Sponsor | An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. (ICH) |
| 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. (ICH) |
| Standard of care (SOC) | The treatment that medical professionals consider at the time of the study to be the most prevalent and best available treatment. (FDA) |
| Standard operating procedure (SOP) | Detailed, written instructions to achieve uniformity of the performance of a specific function. (ICH) |
| Statistical significance and probability | Statistical significance is about the likelihood of findings being due to chance. Probability, or p-value, is a statistical calculation that is used to determine how likely a result could have occurred just by chance. Any statistical analysis begins with the assumption that there is no difference between the two groups being compared (e.g., the intervention and control groups in a clinical trial). This assumption is known as the null hypothesis. Researchers select a p-value in advance of conducting the study to represent how much of a difference they would expect between the intervention and control group results in order to be confident that the results represent a true, or statistically significant, difference. Although it is possible to set this value at any level, for most analyses the p-value is set at 0.05, or 5%. This means that such a result could have occurred by chance only 5 times out of 100. Probability and confidence are influenced by a number of factors including the size and consistency of a sample. A study with a large sample size and highly consistent results is much more likely to produce statistically significant results with 95% confidence than a study with a small sample size and variable results. A statistically significant result technically applies only to the sample measured, and may not generalize to other populations. (CIHR) |
| Study population | Characteristics of subjects that are eligible to participate in the clinical trial, e.g., adult males and females, children, etc. (HC) |
| Study site / Investigator Site | The location(s) at or from where trial-related activities are conducted under the investigator’s/institution’s supervision. (ICH) |
| 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. See also Investigator. (ICH) |
| Survey | Surveys can be either quantitative or qualitative. A quantitative survey provides a series of questions where the answers can be recorded as numerical answers on a scale. Results are combined for each question, and percentages of responses can be calculated. A qualitative survey can involve personal interviews, participation in a focus group, or answers written on a questionnaire. These may be analyzed by identifying themes and consistencies, but individual perspectives make important contributions as well. (CIHR) |
| T | | |
| Therapeutic misconception | A misunderstanding, on the part of participants, of the purpose, benefits, and/or risks of clinical trials. Often participants do not understand that research is aimed primarily at producing knowledge and may not provide any therapeutic benefit to them. (TCPS2) |
| Tri-Council Policy Statement: Ethical Conduct For Research Involving Humans (TCPS2) | TBD |
| Trial Site | The location(s) where trial-related activities are actually conducted. (ICH) |
| U | | |
| Unanticipated problems/issues | Issues that: occur during the conduct of research; may increase the level of risk to participants or have other ethical implications that may affect participants' welfare; and were not anticipated by the researcher in the research proposal submitted for research ethics review. (TCPS2) |
| Unblinding | Unblinding refers to the process by which the identifying information for a patient or group of outcomes from a clinical trial is revealed to the subject and/or investigators conducting the clinical study. In other words, the procedure in which one or more parties involved in a blinded clinical trial are made aware of the therapy assignment(s). (NIH) |
| Undue influence | The impact of an unequal power relationship on the voluntariness of consent. This may occur when prospective participants are recruited by individuals in a position of authority over them (e.g., doctor/patient, teacher/student, employer/employee). See "Coercion." (TCPS2) |
| 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). (ICH) |
| V | | |
| Validation of computerized systems | A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results. (ICH) |
| Vulnerable Participants | Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. (ICH) |
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| ACRONYMS | | |
| PI | Principal Investigator |
| IRB | Institutional Review Board |
| IEC | Institutional Ethics Committee |
| IB | Investigator's Brochure |
| ICF | Informed Consent Form |
| REB | Research Ethics Board |
| ICH | International Council for Harmonization |
| GCP | Good Clinical Practice |
| GLP | Good Laboratory Practice |
| GMP | Good Manufacturing Practice |
| IP | Investigational Product |
| CRF | Case Report Form |
| SOP | Standard Operating Procedure |
| IRT | Interactive Response Technology |
| CRO | Contract Research Organization |
| SRSD | Single Reference Safety Document |
| ALCOACCEA | Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available |
| LSFV | Last Subject First Visit |
| LSLV | Last Subject Last Visit |
| EMR | Electronic Medical Record |
| EDC | Electronic Data Capture |
| SDV | Source Document Verification |
| AE | Adverse Event |
| SAE | Serious Adverse Event |
| ADR | Adverse Drug Reaction |
| ADL | Activities of Daily Living |
| DSMB | Data Safety Monitoring Board |
| SUSAR | Suspected Unexpected Serious Adverse Reaction |
| HC | Health Canada |
| DIN | Drug Identification Number |
| NOC | Notice of Compliance |
| CTA | Clinical Trial Application |
| NOL | No Objection Letter |
| CMC | Chemistry, Manufacturing and Controls |
| QI | Qualified Investigator |
| QIU | Qualified Investigator Undertaking |
| REBA | Research Ethics Board Attestation |
| CTSIF | Clinical Trial Site Information Form |
