Adherence (in relation to the trial): Act of strictly following all requirements relating to the trial, Good Clinical Practices and applicable regulatory standards.
Adverse Drug Reaction: A harmful and unintended response to a drug, related to any dose.
Adverse Event: Unfavorable medical occurrence suffered by a Research Subject and which does not necessarily have a causal relationship with the product under investigation.
Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency) - ANVISA: Created by Law 9,782/99, it is the largest regulatory agency in Brazil. It has administrative independence and financial autonomy (linked to the Ministry of Health), stability of its leaders (appointed for a fixed term), predominance of technical decision-making criteria and stability and predictability of the regulatory process. It operates in sectors related to products and services that involve the health of the Brazilian population.
Allocation: Process of assigning a treatment to a research subject.
Amendment to the Protocol: Written description of one or more changes to the original protocol or a formal clarification regarding this protocol, presented with the justification that motivated it, and must be approved by the Research Ethics Committee.
Applicable Regulatory Requirement: Any legislation and regulations that relate to the conduct of clinical trials with investigational products.
Audit Certificate: A statement of confirmation by the auditor that an audit has been performed.
Audit Report: Written assessment by the auditor, reporting the results of the audit carried out.
Audit: Systematic and independent review of the activities and documents related to a clinical trial, which serves to determine whether the related activities were properly conducted and whether the data were recorded, analyzed and reported with complete accuracy, in accordance with the protocol, the sponsor's standard operating procedures, Good Clinical Practices and applicable regulatory requirements.
Bias (bias, vice, tendency): Systematic error or deviation of the trial. It leads to biased conclusions, distorts the truth, and its effect is not diminished by increasing the sample size.
Bioavailability: Indicates the speed and extent of absorption of an active ingredient in a dosage form, based on its concentration/time curve in the systemic circulation or its excretion in the urine.
Bioequivalence: Comparative trial between the bioavailability of two drugs that have the same active ingredient and the same therapeutic indication, and are administered through the same vascular route, in the same dose.
Bioethics: Study of ethical problems caused by biological research and its applications. Basic references: autonomy, maleficiency, beneficiency and justice.
Biostatistics: Branch of statistics focused on the analysis of biological phenomena.
Blind Medications: Products that are identical in size, shape, color, taste and other attributes that make it difficult for individuals involved in the study (research subjects and investigators) to know which medication (investigational drug or control) is being administered.
Blind Study: When at least one of the parties involved (research physician or research subject) is not aware of which product or dose is being administered by each of the participants.
Clinical Record (CRF): Printed, optical, or electronic document designed to record all information about each research subject required in a protocol to be reported to the sponsor. The clinical record must be a TRANSCRIPTION of source documents.
Clinical Record: Document held by an institution or medical professional, containing demographic, clinical and therapeutic information about a patient.
Clinical Research Coordinator: Person who manages the research center and whose tasks are delegated by the researcher. Acts as a liaison between the research center and the sponsor, and reviews registration data prior to the monitor's visit. Although important in a Research Center, its formation and attributions are not defined by the GCP/ICH guide.
Clinical Research: Clinical trial.
Clinical Researcher: Members of a team responsible for conducting a clinical trial at a research center.
Clinical Trial: Any investigation in human beings, aiming to discover or verify the pharmacodynamic, pharmacological, clinical and/or other effects of product(s) and/or identify adverse reactions to the product(s) under investigation, with the aim of ascertaining their safety and/or effectiveness.
Cohort trials: Prospective observational trials in which the researcher identifies a sample of the population exposed to the phenomenon in question and compares it with another portion of the unexposed population, which would act as a control.
Co-investigator: Member of a Research Center, designated and supervised by the Principal Investigator, with authorization to perform critical procedures and/or make important decisions. Must have the same training as the Principal Investigator and be qualified to assist him/her in conducting the study. Also called sub-investigator.
Comparison Product: Registered drug or placebo, used as a reference or control in a clinical trial.
Compensation: Material coverage in reparation for immediate or delayed damage caused by research to human beings subjected to it.
Confidentiality: Prevention of disclosure or revelation to unauthorized individuals of the sponsor's proprietary information or the identity of the Research Subject.
Continuous Variable: It normally results from a measurement, and the numerical scale of its possible values corresponds to any value between two limits.
Control Group: Group of research subjects who participated in a clinical trial not using the drug under investigation, serving as a control for the group using the investigational drug. Individuals in this group may be using a drug that is already well-established and considered the best for the situation under study, or a placebo.
Coordination Center: Center that collects and organizes all information from all research centers involved in the same study.
CRF (Case Report Form): Medical record
CRO (Contract Research Organization): English acronym for contract research organization.
Cross-Over Trials: Clinical trials in which all research subjects receive, not simultaneously, both treatments (e.g., investigated drug and placebo). Research subjects serve as their own controls.
Damage associated with or resulting from: Immediate or delayed harm to the individual or the community, with a proven causal link, direct or indirect, resulting from scientific study.
Declaration of Helsinki: Set of recommendations or basic principles, reviewed periodically, that guide doctors in ethical conduct when conducting biomedical research involving human beings. It was adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964. The recommendations include the procedures required to ensure the safety and well-being of research subjects, such as informed consent and approval of protocols by an ethics committee.
Discrete or Discontinuous Variable: Values generally expressed using whole, non-negative numbers. It usually results from counting.
Dispensing: Act of supplying the consumer with drugs, medicines, pharmaceutical inputs and related products, whether paid or not.
Double-Blind Study: Neither party involved (research physician nor research subject) has knowledge of which product or dose is being administered by each participant.
Drug Reference: Innovative product registered with the federal agency responsible for health surveillance and marketed in the country, whose effectiveness, safety and quality were scientifically proven with the competent federal agency, at the time of registration.
Drug: Pharmaceutical product, technically obtained or prepared, for prophylactic, curative, palliative or diagnostic purposes.
Drug: Substance or raw material that has a medicinal or sanitary purpose.
Effectiveness: Ability of a product to produce beneficial effects on the course or duration of a disease. Effectiveness is measured by evaluating the clinical and statistical results of a clinical trial.
EMEA: European Medicines Evaluation Agency – regulatory agency operating in the European Community.
Essential Documents: Documents that, individually or collectively, allow the evaluation of the conduct of a study and the quality of the data produced.
Ethics: Human conduct susceptible to qualification from the point of view of good and evil.
Exclusion Criteria: Characteristics that, when present in a Research Subject, do not allow him or her to participate or continue participating in a clinical trial. They must be reviewed at every assessment visit. These characteristics must be specified in the research protocol.
Expanded Access: Sponsored process for making available a new, promising product, not yet registered with the National Health Surveillance Agency, which is in a phase III study under development in Brazil or in the country of origin and with an EXPANDED ACCESS program approved in the country of origin, or with product registration in the country of origin, for patients with serious and life-threatening diseases, in the absence of satisfactory therapeutic alternatives available in the country, without additional burden for the patient. sponsor's responsibilities.
FDA – Food and Drug Administration: North American regulatory authority responsible for authorizing the conduct of clinical trials and registering new drugs.
Free and informed consent: Process by which an individual – free from defects (simulations, fraud or error), dependence, subordination or intimidation – voluntarily confirms his/her willingness to participate in a clinical trial, after having been informed about all aspects that were relevant to his/her decision-making. This consent must be documented through an informed consent form (ICF) to be completed, signed and dated.
GCP (Good Clinical Practice): English acronym for Good Clinical Practice.
Generic Drug: A medicine similar to a reference or innovative product, which is intended to be interchangeable with it, generally produced after the expiration or waiver of patent protection or other exclusivity rights, with its efficacy, safety and quality proven, and designated by the DCB - Denominação Comum Brasileira (the Brazilian Nonproprietary Name) or, in its absence, by the INN (International Nonproprietary Name).
Good Clinical Practices: The standard by which clinical trials are designed, implemented, conducted, recorded and reported so that there is confidence that the data are correct, complete and accurate and that the rights, welfare and confidentiality of Research Subjects have been protected. Good Clinical Practices represent the standards that govern the conduct of a trial in a correct, integral and ethical manner.
Health Surveillance: Set of actions capable of eliminating, reducing or preventing health risks and intervening in health problems arising from the environment, the production and circulation of goods and the provision of services of interest to health, including control of consumer goods and the provision of services directly or indirectly related to health.
ICH (International Conference on Harmonisation): Acronym in English that denotes International Conference on Harmonisation.
Import Licensing (IL): Act required for goods subject to non-automatic licensing and requested electronically by the importer or his legal representative, through SISCOMEX (Integrated Foreign Trade System). IL is a shipping authorization and must be requested before the product is shipped to the country of origin.
Inability: Refers to the potential research subject who does not have the civil capacity to give free and informed consent, and must be assisted or represented, in accordance with current Brazilian legislation.
Inclusion Criteria: Characteristics that must be present in all Research Subjects.
Informed Consent Form (ICF): Document containing all relevant information related to the research project, in accessible language, which will provide the research volunteer with the necessary support for their decision to participate in the trial. When agreed, the research volunteer must sign and date the document, which must be prepared in two copies, one of which must remain in the possession of the research subject (named after signing the ICF).
Inspection: Official act of a regulatory authority that will examine documents, facilities, records and any other resources deemed relevant to the practice of clinical trials, which may be at the research center, at the sponsor's facilities or at CROs.
Institution: Any medical or dental entity or facility, public or private, legitimately constituted and authorized, in which the research center where clinical trials are conducted is located.
International Conference on Harmonisation (ICH): Document agreed upon by several countries, led by the USA, Europe and Japan, which determines international rules for conducting scientific research involving human beings.
Masking: Implementation of blinding in a clinical trial.
Monitor: A person hired by the sponsor (or the CRO) who is responsible for ensuring that a study is conducted in accordance with the protocol, Good Clinical Practices, and the sponsor's Standard Operating Procedures at a given research center.
Monitoring Report: Written report prepared by the monitor and addressed to the sponsor, after each visit to the research center and/or other contacts related to the study, in accordance with the sponsor's SOPs.
Monitoring: Act of supervising the progress of a clinical trial, ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practices and applicable regulatory requirements.
Multi-Site Trials: Trials conducted according to a single protocol, concurrently in several national or international research centers.
National Research Ethics Committee (CONEP - Comissão Nacional de Ética em Pesquisa): Independent collegiate body, of a consultative, deliberative, normative and educational nature, linked to the National Health Council (CNS), created by CNS Resolution 196/96.
Nuremberg Code: As a result of medical experimentation conducted by the Nazis during World War II, the Military Tribunal held in the city of Nuremberg in 1947 defined a code of medical ethics for researchers conducting clinical trials, with the intention of protecting the safety and integrity of study participants. From then on, the requirement for “voluntary consent” on the part of the Research Subject was introduced.
Observational Trials: Trials in which the researcher observes and records his findings, then submitting them to statistical treatment.
Open Study: Study in which all parties involved (research subject, investigating physician and coordinator) are informed about which drug and dose was used by each participant. In an open study, placebo is not used.
Patient: Individual in need of medical care.
Petition Form for Clinical Research Consent (FPP1 and FPP2): Document sponsored by ANVISA in which the interested party requests consent to carry out clinical research and presents information about the product(s) to be used in the research. They are available on the Anvisa website with instructions for filling out the form.
Pharmacodynamics: Refers to the modifications that a biological system produces in an active principle. It is the study of the interaction between drug and living structure, including the processes of physical responses.
Pharmacokinetics: It refers to the changes that an active ingredient produces in a biological system, with regard to absorption, distribution, metabolism and excretion.
Phase 1 Trial: First of four phases of a clinical trial, when a human being receives a new drug product for the first time. It involves a small population of healthy research subjects, with the aim of understanding safety and toxicity data, absorption, distribution and metabolism of the new drug.
Phase 2 Trial: After successfully completing the phase 1 trial, the drug is then tested for safety and effectiveness in a slightly larger population of research subjects, no longer healthy but affected by the disease or condition for which the new drug was developed. Here we seek to establish the dose-response relationship.
Phase 3 Trial: Third and final pre-approval phase of the new drug, it is conducted on a larger and varied number of research subjects, all suffering from the disease or condition for which the drug was developed, with the objective of determining the result of the risk/benefit in the short and long term, most frequent adverse reactions, special characteristics of the drug and/or medicinal specialty such as: clinically relevant interactions, main effect-modifying factors such as age, sex, race, etc.
Phase 4 Trial: Research carried out after the product and/or medicinal specialty has been marketed based on the characteristics with which it was authorized. These are post-marketing surveillance trials to establish the therapeutic value, the emergence of new adverse reactions and/or confirmation of the frequency of emergence of those already known, and treatment strategies in a larger population than that involved in the previous phases. In phase IV research, the same ethical and scientific standards applied to research in previous phases must be followed. Once a drug and/or medicinal specialty has been marketed, clinical research carried out to explore new indications, new methods of administration or new combinations (associations) etc. are considered as new drug research.
Pilot Trial: Preliminary trial, designed to indicate whether a larger trial is feasible. Also used to establish sample size.
Placebo: Inactive substance (without active ingredient), which has the same characteristics (shape, color, appearance, taste) as the drug to be tested in a clinical trial.
Population: Total set of elements carrying at least one common characteristic.
Pre-Clinical Phase Study = Non-clinical trial (ANVISA): Pre-clinical phase. Evaluation of the product under investigation in animals after identification in in vitro experiments as having therapeutic potential. Preliminary information on pharmacological activity and safety. With specific pharmacological activities and an acceptable toxicity profile, the study moves on to the clinical phases.
Principal Investigator: Researcher in Charge. Leader of a group of researchers at a given research center responsible for coordinating and carrying out the research. Its greatest responsibility is to guarantee the integrity and well-being of the Research Subjects after signing the ICF, with respect to maintaining ethical criteria for all procedures throughout the study.
Qualitative Variable: Values expressed by attributes: sex, skin color, etc.
Quality Assurance: All systematic and planned actions that are established to ensure that a trial is executed and that the data generated by it are documented and reported in accordance with Good Clinical Practice standards and applicable regulatory requirements.
Quantitative Variable: Values of a clearly quantitative nature and the set of results, have a numerical structure (variable statistics) and are divided into: Discrete or Continuous.
Random: When luck or chance defines in which study group the Research Subject will be included.
Randomization: Method used in controlled clinical trials to randomly distribute participants so that each research subject has the same probability of receiving one or another intervention (e.g. drug or placebo).
Recruitment Period: The time allotted for recruiting and including the anticipated number of research subjects in a given clinical trial.
Refund: Exclusive coverage, in compensation, of expenses arising from the participation of the research subject.
Regulatory Authorities (competent authorities): Organizations with regulatory powers.
Representative Organization for Clinical Research (ROC): Regulated company established in national territory hired by the sponsor to perform one or more of the tasks that are the sponsor's responsibility, in a clinical trial. The responsibilities of the ROCs must be set out in a written, dated and signed agreement between these entities and the sponsor(s). It may also be referred to as a Contract Research Organization (CRO).
Research Center: Place where activities related to the clinical trial are conducted. It is headed by the principal investigator, and his main responsibility is to ensure the safety of Research Subjects. By RDC Resolution No. 219 dated September 20, 2004, the term “Research Center” is used synonymously with “Research Institution”.
Research Contract: Written document, dated and signed between two or more parties involved, which establishes any agreements on delegation and distribution of tasks and obligations and, if applicable, on financial matters. The protocol can be used as the basis of a contract.
Research Ethics Committee (CEP - Comitê de Ética em Pesquisa): Independent, interdisciplinary group with “public munus” (public duty) that must exist in institutions that carry out research involving human beings in Brazil, created to defend the interests of Research Subjects in their integrity and dignity and to contribute to the development of research within ethical standards (Regulatory Norms and Guidelines for Research Involving Human Beings – CNS Res. 196/96, II.4).
Research Institution: Research Center
Research Protocol: Document describing the objectives, design, methodology, statistical considerations and organization of a clinical trial. It presents information regarding the research subject, the qualifications of the researchers and all responsible bodies.
Research Risk: Possibility of damage to the physical, psychological, moral, intellectual, social, cultural or spiritual dimension of the human being, at any stage of research and resulting from it.
Research Subject Identification Code: Unique identification code, assigned by the researcher to each Research Subject, in order to protect their identity, being used as a substitute for their name in situations where confidentiality must be maintained.
Research Subject: Individual who, voluntarily, after being informed about the objectives, methodology and risks and benefits, decides to participate in a clinical trial.
Research: Class of activities whose objective is to develop or contribute to generalizable knowledge. Generalizable knowledge consists of theories, relationships, or principles, or the accumulation of information on which they are based, that can be corroborated by accepted scientific methods of observation and inference.
Researcher's Brochure: Gathering of clinical and non-clinical data already known about the product under investigation, which are relevant to the safe use of that product, in a clinical trial involving human beings. Provides information to researchers that enables decision-making regarding study proposals.
Sample: Representative portion (subset) of a population that is examined for the purpose of drawing conclusions about that population.
Serious Adverse Event: Unfavorable medical event suffered by a Research Subject using an investigational product, which at any dose administered results in death, represents a risk to life, results in significant or persistent disability, anomaly or congenital malformation, requires hospitalization or prolongation of a scheduled hospitalization.
Similar Drug: The one that contains the same active ingredient(s), has the same concentration, pharmaceutical form, route of administration, dosage and therapeutic, preventive or diagnostic indication, as the reference medicine registered with the federal agency responsible for health surveillance, and may differ only in characteristics related to the size and shape of the product, expiration date, packaging, labeling, excipients and vehicles, and must always be identified by commercial name or brand.
Source Document: Original record (first note) that serves as the basis for filling out the clinical form. A source document can be: medical records, nursing records, subsidiary examination reports, study agenda, informed consent form, research subject's diary, among others.
Special Announcement (CE): Authorizing document issued by the Management of New Medicines, Research and Clinical Trials – GEPEC, which allows the execution of the research protocol in a given Research Center and, when applicable, the import of the product(s) involved in the protocol.
Sponsor: Individual, company, institution or organization responsible for implementing, managing and/or financing a clinical trial.
Standard Operating Procedure (SOP): Detailed instructions, with all the steps for carrying out a specific function, regardless of the area of action. It must be written in such a way as to achieve uniformity in the production or provision of a service. It is not possible to talk about Good Clinical Practices without SOPs being followed in a research center.
Statistical data: Numerical data, considered the raw material on which we will apply statistical methods.
Statistical Parameters: Unique values that exist in the population and serve to characterize it. To define a parameter we must examine the entire population.
Statistics: Exact science that aims to provide support to the analyst to collect, organize, summarize, analyze and present data.
Trial Extension: Proposal to extend or continue the research with the same recruited subjects, without essential changes to the objectives and methodology of the original project. If there are important changes to objectives and/or methods, another research protocol must be presented.
Unexpected Adverse Drug Reaction: Adverse reaction of a nature or severity not consistent with the information applicable to the product in question (or with the information contained in the investigator's brochure).
Variable: Set of possible results of a phenomenon.
Vulnerability: It refers to the state of people or groups who, for whatever reason or motive, have their capacity for self-determination reduced, especially with regard to the informed consent.
Vulnerable Subjects: Individuals who are unable to make decisions on their own or who may be influenced when deciding whether or not to be research subjects, i.e., to participate in a clinical trial voluntarily. In these cases, the legal guardians of these people must sign the Free and Informed Consent Form.
Well-Being: In the context of clinical trials, it is the physical and mental integrity of Research Subjects.
