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90 questions and answers related to clinical trials and pharmacology. It covers topics such as adverse drug reactions, blinding/masking, case report forms, clinical trials/studies, informed consent, inspections, and more. The document also includes definitions and explanations of various terms and concepts related to clinical trials and pharmacology.
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All noxious and unintended responses to a medicinal product related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function
A procedure in which one or more parties to the trial are kept unaware of the treatment assignment. 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 GCP E6 1.10) - Correct Answer ✅Blinding/Masking 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. - Correct Answer ✅Case Report Form (CRF) Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. - Correct Answer ✅Clinical Trial/Study A written description of a trial/study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and
Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. - Correct Answer ✅Essential Documents 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. - Correct Answer ✅Good Clinical Practice (GCP) 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. - Correct Answer ✅Impartial Witness 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. - Correct Answer ✅Informed Consent 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). - Correct Answer ✅Inspection 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. - Correct Answer ✅Institutional Review Board (IRB) 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
Biomedical studies not performed on human subjects. - Correct Answer ✅Nonclinical Study A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. Usually also gives the background and rationale for the trial, but these could be provided in other documents. - Correct Answer ✅Protocol 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). - Correct Answer ✅Quality Assurance (QA) 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. - Correct Answer ✅Quality Control (QC)
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.
members of a hierarchy in case of refusal to participate. - Correct Answer ✅Vulnerable Subjects
All adverse drug reactions (ADRs) that are both ____________ and _____________ are subject to expedited reporting. - Correct Answer ✅Serious and Unexpected 7, 8 - Correct Answer ✅Regulatory agencies should be notified (e.g., by phone, fax transmission, or in writing) of fatal or life-threatening unexpected ADRs in clinical investigations as soon as possible but no later than ___ calendar days after first knowledge by the sponsor that a case qualifies, followed by as complete a report as possible within ___ additional calendar days. 15 - Correct Answer ✅Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be filed as soon as possible but no later than ___ calendar days after first knowledge by the sponsor that the case meets the minimum criteria for expedited reporting.
Although human pharmacology studies are typically identified with Phase ___, they may also be indicated at other points in the development sequence. - Correct Answer ✅Phase I Studies in this phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteer subjects or certain types of patients, e.g. patients with mild hypertension. - Correct Answer ✅Phase I
Studies in Phase ___ are typically conducted in a group of patients who are selected by relatively narrow criteria, leading to a relatively homogeneous population and are closely monitored. - Correct Answer ✅Phase II Phase ___ usually is considered to begin with the initiation of studies in which the primary objective is to demonstrate, or confirm therapeutic benefit. - Correct Answer ✅Phase III Studies in Phase ___ are designed to confirm the preliminary evidence accumulated in Phase ___ that a drug is safe and effective for use in the intended indication and recipient population. - Correct Answer ✅Phase III, Phase II Studies in Phase ___ are all studies (other than routine surveillance) performed after drug approval and related to the approved indication. - Correct Answer ✅Phase IV The _______________ of the study should be clearly stated and may include exploratory or confirmatory characterization of safety and/or efficacy and/or assessment of pharmacokinetic parameters and pharmacological, physiological, biochemical effects. - Correct Answer ✅Objective(s)
trials are necessary to provide firm evidence of efficacy or safety. - Correct Answer ✅Confirmatory trial _______________ trials may sometimes require a more flexible approach to design so that changes can be made in response to accumulating results. - Correct Answer ✅Exploratory trials To avoid multiplicity concerns arising from post hoc definitions, it is critical to specify in the protocol the precise definition of the ____________ ___________ as it will be used in the statistical analysis. - Correct Answer ✅Primary variable ____________ ____________ are either supportive measurements related to the primary objective or measurements of effects related to the secondary objectives. - Correct Answer ✅Secondary variables If a single primary variable cannot be selected from multiple measurements associated with the primary objective, another useful strategy is to integrate or combine the multiple measurements into a single or '___________' variable, using a pre-defined algorithm. - Correct Answer ✅Composite variable
In some cases, '__________ ___________' variables are developed to measure the overall safety, overall efficacy, and/or overall usefulness of a treatment. This type of variable integrates objective variables and the investigator's overall impression about the state or change in the state of the subject, and is usually a scale of ordered categorical ratings. - Correct Answer ✅Global assessment variables The most important design techniques for avoiding bias in clinical trials are ____________ and _______________. - Correct Answer ✅Blinding, Randomization In a(n) _________________ trial, the identity of treatment is known to all. - Correct Answer ✅Open-label A technique for retaining the blind when administering supplies in a clinical trial, when the two treatments cannot be made identical. Supplies are prepared for Treatment A (active and indistinguishable placebo) and for Treatment B (active and indistinguishable placebo). Subjects then take two sets of treatment; either A (active) and B (placebo), or A (placebo) and B (active). - Correct Answer ✅Double-dummy