ACRP CCRC EXAM PREP Q&A -2023

ACRP CCRC EXAM PREP WITH COMPLETE SOLUTIONS 2023 LATEST UPDATE Adverse Drug Reaction (ADR) - ANSWER 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. Adverse Event (AE) - ANSWER 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. Applicable Regulatory Requirement(s) - ANSWER Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products. Approval (in relation to Institutional Review Boards) - ANSWER The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. Audit - ANSWER 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). Audit Certificate - ANSWER A declaration of confirmation by the auditor that an audit has taken place. Audit Report - ANSWER A written evaluation by the sponsor's auditor of the results of the audit. Audit Trail - ANSWER Documentation that allows reconstruction of the course of events. Blinding/Masking - ANSWER A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding - ANSWER usually refers to the subject(s) being unaware Double- blinding - ANSWER usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). Case Report Form (CRF) - ANSWER 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. Clinical Trial/Study - ANSWER 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. Clinical Trial/Study Report - ANSWER A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report Comparator (Product) - ANSWER An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Compliance (in relation to trials) - ANSWER Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements. Confidentiality - ANSWER Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. Contract - ANSWER A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. Coordinating Committee - ANSWER A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. Coordinating Investigator - ANSWER An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial. Contract Research Organization (CRO) - ANSWER 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. Direct Access - ANSWER Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Documentation - ANSWER All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. Essential Documents - ANSWER Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced Good Clinical Practice (GCP) - ANSWER 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. Independent Data-Monitoring Committee (IDMC) - ANSWER An independent data- monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. Impartial Witness - ANSWER 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. Independent Ethics Committee (IEC) - ANSWER An independent body, 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. Informed Consent - ANSWER 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. Inspection - ANSWER 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). Institution (medical) - ANSWER Any public or private entity or agency or medical or dental facility where clinical trials are conducted. Institutional Review Board (IRB) - ANSWER 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. Interim Clinical Trial/Study Report - ANSWER A report of intermediate results and their evaluation based on analyses performed during the course of a trial. Investigational Product - ANSWER 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. Investigator - ANSWER 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. Investigator/Institution - ANSWER An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements". Investigator's Brochure - ANSWER 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 Legally Acceptable Representative - ANSWER 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. Monitoring - ANSWER 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). Monitoring Report - ANSWER A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. Multicentre Trial - ANSWER A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. Nonclinical Study - ANSWER Biomedical studies not performed on human subjects. Opinion (in relation to Independent Ethics Committee) - ANSWER The judgement and/or the advice provided by an Independent Ethics Committee (IEC). Protocol - ANSWER A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. Protocol Amendment - ANSWER A written description of a change(s) to or formal clarification of a protocol. Quality Assurance (QA) - ANSWER 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) - ANSWER 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. Randomization - ANSWER 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. Regulatory Authorities - ANSWER Bodies having the power to regulate. Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) - ANSWER 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 Source Data - ANSWER 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 Documents - ANSWER 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). Sponsor - ANSWER An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. Sponsor-Investigator - ANSWER 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. Standard Operating Procedures (SOPs) - ANSWER Detailed, written instructions to achieve uniformity of the performance of a specific function. Subinvestigator - ANSWER 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) Subject/Trial Subject - ANSWER An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control. Subject Identification Code - ANSWER 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. Trial Site - ANSWER The location(s) where trial-related activities are actually conducted. Unexpected Adverse Drug Reaction - ANSWER 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) Vulnerable Subjects - ANSWER 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. Well-being (of the trial subjects) - ANSWER The physical and mental integrity of the subjects participating in a clinical trial. Abbreviation: "ADR" - ANSWER Adverse Drug Reaction Abbreviation: "AE" - ANSWER Adverse Event Abbreviation: "ALCOAC" - ANSWER Accurate, legible, contempr Abbreviation: "GCP" - ANSWER Good Clinical Practices 1.1 elements of a protocol ICH 6 - ANSWER Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s). 1.1 elements of a protocol ICH 6 - ANSWER Name and address of the sponsor and monitor (if other than the sponsor). 1.1 elements of a protocol ICH 6 - ANSWER Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the sponsor. 1.1 elements of a protocol ICH 6 - ANSWER Name, title, address, and telephone number(s) of the sponsor's medical expert (or dentist when appropriate) for the trial. 1.1 elements of a protocol ICH 6 - ANSWER Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s). 1.1 elements of a protocol ICH 6 - ANSWER Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is responsible for all trial-site related medical (or dental) decisions (if other than investigator). 1.1 elements of a protocol ICH 6 - ANSWER Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the trial. 1.1 elements of a protocol ICH 6 - ANSWER Name and description of the investigational product(s). 1.1 elements of a protocol ICH 6 - ANSWER A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial. 1.1 elements of a protocol ICH 6 - ANSWER Summary of the known and potential risks and benefits, if any, to human subjects. 1.1 elements of a protocol ICH 6 - ANSWER Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s). 1.1 elements of a protocol ICH 6 - ANSWER Description of the population to be studied. 1.1 elements of a protocol ICH 6 - ANSWER References to literature and data that are relevant to the trial, and that provide background for the trial. 1.1 elements of a protocol ICH 6 - ANSWER A detailed description of the objectives and the purpose of the trial. 1.1 elements of a protocol ICH 6 - ANSWER A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial. 1.1 elements of a protocol ICH 6 - ANSWER A description of the type/design of trial to be conducted (e.g., double- blind, placebo- controlled, parallel design) and a schematic diagram of trial design, procedures and stages. 1.1 elements of a protocol ICH 6 - ANSWER A description of the measures taken to minimize/avoid bias, including: (a) Randomization. (b) Blinding. 1.1 elements of a protocol ICH 6 - ANSWER A description of the trial treatment(s) and the dosage and dosage regimen of the investigational product(s). Also include a description of the dosage form, packaging, and labelling of the investigational product(s). 1.1 elements of a protocol ICH 6 - ANSWER The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any. 1.1 elements of a protocol ICH 6 - ANSWER A description of the "stopping rules" or "discontinuation criteria" for individual subjects, parts of trial and entire trial. 1.1 elements of a protocol ICH 6 - ANSWER Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any. 1.1 elements of a protocol ICH 6 - ANSWER Maintenance of trial treatment randomization codes and procedures for breaking codes. 1.1 elements of a protocol ICH 6 - ANSWER The identification of any data to be recorded directly on the CRFs (i.e., no prior written or electronic record of data), and to be considered to be source data. 1.1 elements of a protocol ICH 6 - ANSWER Subject inclusion criteria. 1.1 elements of a protocol ICH 6 - ANSWER Subject exclusion criteria. 1.1 elements of a protocol ICH 6 - ANSWER Subject withdrawal criteria (i.e., terminating investigational product treatment/trial treatment) and procedures specifying: (a) When and how to withdraw subjects from the trial/ investigational product treatment. (b) The type and timing of the data to be collected for withdrawn subjects. (c) Whether and how subjects are to be replaced. (d) The follow-up for subjects withdrawn from investigational product treatment/trial treatment. 1.1 elements of a protocol ICH 6 - ANSWER The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial. 1.1 elements of a protocol ICH 6 - ANSWER Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial. 1.1 elements of a protocol ICH 6 - ANSWER Procedures for monitoring subject compliance. 1.1 elements of a protocol ICH 6 - ANSWER Specification of the efficacy parameters. 1.1 elements of a protocol ICH 6 - ANSWER Methods and timing for assessing, recording, and analysing of efficacy parameters. 1.1 elements of a protocol ICH 6 - ANSWER Specification of safety parameters. 1.1 elements of a protocol ICH 6 - ANSWER The methods and timing for assessing, recording, and analysing safety parameters. 1.1 elements of a protocol ICH 6 - ANSWER Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses. 1.1 elements of a protocol ICH 6 - ANSWER The type and duration of the follow-up of subjects after adverse events. 1.1 elements of a protocol ICH 6 - ANSWER A description of the statistical methods to be employed, including timing of any planned interim analysis(ses). 1.1 elements of a protocol ICH 6 - ANSWER The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects projected for each trial site should be specified. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and clinical justification. 1.1 elements of a protocol ICH 6 - ANSWER The level of significance to be used. 1.1 elements of a protocol ICH 6 - ANSWER Criteria for the termination of the trial. 1.1 elements of a protocol ICH 6 - ANSWER Procedure for accounting for missing, unused, and spurious data. 1.1 elements of a protocol ICH 6 - ANSWER Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the original statistical plan should be described and justified in protocol and/or in the final report, as appropriate). 1.1 elements of a protocol ICH 6 - ANSWER The selection of subjects to be included in the analyses (e.g., all randomized subjects, all dosed subjects, all eligible subjects, evaluable subjects). 1.1 elements of a protocol ICH 6 - ANSWER The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing direct access to source data/documents. 1.1 elements of a protocol ICH 6 - ANSWER Quality Control and Quality Assurance 1.1 elements of a protocol ICH 6 - ANSWER Description of ethical considerations relating to the trial. 1.1 elements of a protocol ICH 6 - ANSWER Data Handling and Record Keeping 1.1 elements of a protocol ICH 6 - ANSWER Financing and insurance if not addressed in a separate agreement. 1.1 elements of a protocol ICH 6 - ANSWER Publication policy, if not addressed in a separate agreement. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Title Page* This should provide the sponsor's name, the identity of each investigational product (i.e., research number, chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor), and the release date. It is also suggested that an edition number, and a reference to the number and date of the edition it supersedes, be provided. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Confidentiality Statement* The sponsor may wish to include a statement instructing the investigator/recipients to treat the IB as a confidential document for the sole information and use of the investigator's team and the IRB/IEC. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Table of Contents* 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Summary* A brief summary (preferably not exceeding two pages) should be given, highlighting the significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information available that is relevant to the stage of clinical development of the investigational product. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Introduction* A brief introductory statement should be provided that contains the chemical name (and generic and trade name(s) when approved) of the investigational product(s), all active ingredients, the investigational product (s ) pharmacological class and its expected position within this class (e.g., advantages), the rationale for performing research with the investigational product(s), and the anticipated prophylactic, therapeutic, or diagnostic indication(s). Finally, the introductory statement should provide the general approach to be followed in evaluating the investigational product. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Physical, Chemical, and Pharmaceutical Properties and Formulation* A description should be provided of the investigational product substance(s) (including the chemical and/or structural formula(e)), and a brief summary should be given of the relevant physical, chemical, and pharmaceutical properties. Instructions for the storage and handling of the dosage form(s) should also be given. Any structural similarities to other known compounds should be mentioned. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Nonclinical Studies* a. Nonclinical Pharmacology b. Pharmacokinetics and Product Metabolism in Animals c. Toxicology 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Nonclinical Studies: Introduction* The results of all relevant nonclinical pharmacology, toxicology, pharmacokinetic, and investigational product metabolism studies should be provided in summary form. This summary should address the methodology used, the results, and a discussion of the relevance of the findings to the investigated therapeutic and the possible unfavourable and unintended effects in humans. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Effects in Humans Introduction:* A thorough discussion of the known effects of the investigational product(s) in humans should be provided, including information on pharmacokinetics, metabolism, pharmacodynamics, dose response, safety, efficacy, and other pharmacological activities. Where possible, a summary of each completed clinical trial should be provided. Information should also be provided regarding results of any use of the investigational product(s) other than from in clinical trials, such as from experience during marketing. 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER *Effects in Humans* a. Pharmacokinetics and Product Metabolism in Humans b. Safety and Efficacy c. Marketing Experience d. Summary of Data and Guidance for the Investigator 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) 1.2 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual) ICH 7 - ANSWER ICH 7 - ANSWER ICH 7 - ANSWER ICH 7 - ANSWER ICH 7 - ANSWER ICH 7 - ANSWER ICH 7 - ANSWER ICH 7 - ANSWER ICH 7 - ANSWER