ICH GCP (CCRC) Exam Prep Questions and Answers | Latest 2023/2024 | Graded

ICH GCP (CCRC) Exam Prep Questions and Answers | Latest 2023/2024 | Graded. Institutional Review Board Approval Correct 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 Correct 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 Correct Answer: A declaration of confirmation by the auditor that an audit has taken place Audit Report Correct Answer: A written evaluation by the sponsor's auditor of the results of the audit Audit Trail Correct Answer: Documentation that allows reconstruction of the course of events Blinding/Masking Correct Answer: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Case Report Form (CRF) Correct 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 Correct 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 Correct 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) Correct Answer: An investigational or marketed product, or placebo, used as a reference in a clinical trial. Compliance to Trials Correct Answer: Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements Confidentiality Correct Answer: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. Contract Correct 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 Correct Answer: A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. Coordinating Ivestigator Correct Answer: An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial Contract Research Organization (CRO) Correct 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 Correct Answer: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial Documentation Correct Answer: All records, in any form that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken Essential Documents Correct 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) Correct 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) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) Correct Answer: An independent datamonitoring 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 Correct 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) Correct 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 favorable 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 Correct 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--documented by means of a written, signed and dated informed consent form Inspection Correct Answer: The act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authorities 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 authorities Institution (Medical) Correct Answer: Any public or private entity or agency or medical or dental facility where clinical trials are conducted Institutional Review Board (IRB) Correct 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 Correct Answer: A report of intermediate results and their evaluation based on analyses performed during the course of a trial Investigational Product Correct 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 Correct Answer: A person responsible for the conduct of the clinical trial at a trial site. Investigator's Brochure Correct 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 Correct 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 Correct 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 Correct 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. Multicenter Trial Correct 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 Correct Answer: Biomedical studies not performed on human subjects IEC Opinion Correct Answer: The judgement and/or the advice provided by an Independent Ethics Committee (IEC) Protocol Correct Answer: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. Protocol Amendment Correct Answer: A written description of a change to or formal clarification of a protocol. Quality Assurance (QA) Correct Answer: All those planned and systematic actions that are established to ensure that the trial is performed ad the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements Quality Control (QC) Correct 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 Correct 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 Correct Answer: Bodies having the power to regulate. Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) Correct 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 -is a congenital anomaly/birth defect Source Data Correct 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 Correct Answer: Original documents, data, and records. Sponsor Correct Answer: An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial Sponsor-Investigator Correct 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) Correct Answer: Detailed, written instructions to achieve uniformity of the performance of a specific function Subinvestigator Correct 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. Subject/Trial Subject Correct 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 Correct 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 Correct Answer: The location(s) where trial-related activities are actually conducted Unexpected Adverse Drug Reaction Correct Answer: An adverse reaction, the nature or severity of which is not consistent with the applicable product information. Vulnerable Subject Correct Answer: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, or 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) Correct Answer: The physical and mental integrity of the subjects participating in a clinical trial E6(R1) 2 Correct Answer: The Principles of ICH GCP E6(R1) 2.1 Correct Answer: Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s) E6(R1) 2.2 Correct Answer: Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. E6(R1) 2.3 Correct Answer: The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. E6(R1) 2.4 Correct Answer: The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. E6(R1) 2.5 Correct Answer: Clinical trials should be scientifically sound, and described in a clear detailed protocol. E6(R1) 2.6 Correct Answer: A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB) approval/favorable opinion. E6(R1) 2.7 Correct Answer: The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. E6(R1) 2.8 Correct Answer: Each individual involved in conducting a trial should be qualified by eduction, training, and experience to perform his or her respective task(s). E6(R1) 2.9 Correct Answer: Freely given informed consent should be obtained from every subject prior to clinical trial participation E6(R1) 2.10 Correct Answer: All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting interpretation and verification. E6(R1) 2.11 Correct Answer: The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). E6(R1) 2.12 Correct Answer: Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol. E6(R1) 2.13 Correct Answer: Systems with procedures that assure the quality of every aspect of the trial should be implemented. E6(R1) 3.1 Correct Answer: Institutional Review Board/Independent Ethics Committee (IRB/IEC)--Responsibilities E6(R1) 3.2 Correct Answer: Institutional Review Board/Independent Ethics Committee (IRB/IEC)--Composition, Functions and Operations E6(R1) 3.3 Correct Answer: Institutional Review Board/Independent Ethics Committee (IRB/IEC)--Procedures -The IRB/IEC should establish, document in writing, and follow its procedures E6(R1) 3.4 Correct Answer: Institutional Review Board/Independent Ethics Committee (IRB/IEC)--Records -The IRB/IEC should retain all relevant records for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authorities E6(R1) 3.1.1 Correct Answer: An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects E6(R1) 3.1.2 Correct Answer: The IRB/IEC should obtain the following documents: trial protocols/amendments, written informed consent forms and consent form updates that the investigator proposes for use in the trial, subject recruitment procedures, written information to be provided to subjects, Investigator's Brochure, available safety information, information about payments, and compensation available to subjects, the investigator's current curriculum vitae and/or other documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfill its responsibilities. E6(R1) 3.1.3 Correct Answer: The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests E6(R1) 3.1.4 Correct Answer: The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year E6(R1) 3.1.5 Correct Answer: The IRB/IEC may request more information than is outlined in paragraph 4.8.10 be given to subjects when, in the judgement of the IRB/IEC, the additional information would add meaningfully to the protection of the rights, safety and/or well-being of the subjects. E6(R1) 3.1.6 Correct Answer: When a non-therapeutic trial is to be carried out with the consent of the subject's legally acceptable representative, the IRB/IEC should determine that the proposed protocol and/or other documents adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials E6(R1) 3.1.7 Correct Answer: Where the protocol indicates that prior consent of the trial subject or the subject's legally acceptable representative is not possible, the IRB/IEC should determine that the proposed protocol and/or other documents adequately addresses relevant ethical concerns and meets applicable regulatory requirements for such trials E6(R1) 3.1.8 Correct Answer: The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly contingent on completion of the trial by the subject. E6(R1) 3.1.9 Correct Answer: The IRB/IEC should ensure that information regarding payment to subjects, including the methods, amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other written information to be provided to subjects. The way payment will be prorated should be specified. E6(R1) 3.2.1 Correct Answer: The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: a) at least five members b) at least one member whose primary area of interest is in a nonscientific area c) at least one member who is independent of the institution/trial site. Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should vote/provide opinion on a trial-related matter. A list of IRB/IEC members and their qualifications should be maintained. E6(R1) 3.2.2 Correct Answer: The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirements E6(R1) 3.2.3 Correct Answer: An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its written operating procedures, is present E6(R1) 3.2.4 Correct Answer: Only members who participate in the IRB/IEC review and discussion should vote/provide their opinion and/or advise E6(R1) 3.2.5 Correct Answer: The investigator may provide information on any aspect of the trial, but should not participate in the deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC E6(R1) 3.2.6 Correct Answer: An IRB/IEC may invite nonmembers with expertise in special areas for assistance E6(R1) 3.3.1 Correct Answer: Determining its composition(names and qualifications of the members) and the authority under which it is established E6(R1) 3.3.2 Correct Answer: Scheduling, notifying its members of, and conducting its meetings. E6(R1) 3.3.3 Correct Answer: Conducting initial and continuing review of trials. E6(R1) 3.3.4 Correct Answer: Determining the frequency of continuing review, as appropriate. E6(R1) 3.3.5 Correct Answer: Providing, according to the applicable regulatory requirements, expedited review and approval/favorable opinion of minor changes in ongoing trials that have the approval/favorable opinion of the IRB/IEC. E6(R1) 3.3.6 Correct Answer: Specifying that no subject should be admitted to a trial before the IRB/IEC issues its written approval/favorable opinion of the trial E6(R1) 3.3.7 Correct Answer: Specifying that no deviations from, or changes of, the protocol should be initiated without prior written IRB/IEC approval/favorable opinion of an appropriate amendment, except when necessary eliminate immediate hazards to the subjects or when the changes involves only logistical or administrative aspects to the trial. E6(R1) 3.3.8 Correct Answer: Specifying that the investigator should promptly repot to the IRB/IEC a) deviations from, or changes of, the protocol to eliminate immediate hazards to the trial subjects b) changes increasing the risk to subjects and/or affecting significantly the conduct of the trail c) all adverse drug reactions (ADRs) that are both serious ad unexpected d) new information that may affect adversely the safety of the subjects or the conduct of the trial. E6(R1) 3.3.9 Correct Answer: Ensuring that the IRB/IEC promptly notify in writing the investigator/institution concerning: a) its trial-related decisions/opinions b) the reasons for its decisions/opinions c) Procedures for appeal of its decisions/opinions. E6(R1) 4 Correct Answer: Investigator E6(R1) 4.1 Correct Answer: Investigator's Qualifications and Agreements E6(R1) 4.1.1 Correct Answer: The investigator(s) should be qualified by education, training, and experience to assume responsibility of the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authorities E6(R1) 4.1.2 Correct Answer: The investigator should be thoroughly familiar with the appropriate use of the investigational products, as described int he protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor. E6(R1) 4.1.3 Correct Answer: The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements. E6(R1) 4.1.4 Correct Answer: The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authorities E6(R1) 4.1.5 Correct Answer: The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties E6(R1) 4.2 Correct Answer: Investigator-Adequate Resources E6(R1) 4.2.1 Correct Answer: The investigator should be able to demonstrate a potential for recruiting the required number of suitable subjects within the agreed recruitment period. E6(R1) 4.2.2 Correct Answer: The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period. E6(R1) 4.2.3 Correct Answer: The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely. E6(R1) 4.2.4 Correct Answer: The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational products, and their trialrelated duties and functions. E6(R1) 4.3 Correct Answer: Investigator-Medical Care of Trial Subjects E6(R1) 4.3.1 Correct Answer: A qualified physician (or dentist when appropriate), who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions. E6(R1) 4.3.2 Correct Answer: During and following a subject's participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial. The investigator/institution should inform a subject when medical care is needed for intercurrent illness(es) of which the investigator becomes aware E6(R1) 4.3.3 Correct Answer: It is recommended that the investigator inform the subject's primary physician about the subjects participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed. E6(R1) 4.3.4 Correct Answer: Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a trial, the investigator should make a reasonable effort to ascertain the reasons, while fully respecting the subject's rights. E6(R1) 4.4 Correct Answer: Investigator--Communication with IRB/IEC E6(R1) 4.4.1 Correct Answer: Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures, and any other written information to be provided to subjects E6(R1) 4.4.2 Correct Answer: As part of the investigator's/institution's written application to the IRB/IEC, the investigator/institution should provide the IRB/IEC with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the trial, the investigator/institutions should supply a copy of the updated Investigator's Brochure to the IRB/IEC. E6(R1) 4.4.3 Correct Answer: During the trial the investigator/institution should provide to the IRB/IEC all documents subject to review. E6(R1) 4.5 Correct Answer: Investigator--Compliance with Protocol E6(R1) 4.5.1 Correct Answer: The investigator/institution should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, by th regulatory authorities and which was given approval/favorable opinion by the IRB/IEC. The investigator/institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement E6(R1) 4.5.2 Correct Answer: The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favorable opinion from eh IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the changes involves only logistical or administrative aspects of the trial. E6(R1) 4.5.3 Correct Answer: The investigator, or person designated by the investigator, should document and explain any deviation froth approved protocol. E6(R1) 4.5.4 Correct Answer: The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s) to trial subjects without prior IRB/IEC approval/favorable opinion. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted (a) to the IRB/IEC for review and approval/favorable opinion, (b) to the sponsor for agreement and, if required, (c) to the regulatory authority(ies) E6(R1) 4.6 Correct Answer: Investigational Product(s) E6(R1) 4.6.1 Correct Answer: Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution E6(R1) 4.6.2 Correct Answer: Where allowed/required, the investigator/institution may/should assign some or all of the investigator's/institution's duties for investigational product(s) accountability at the trial site(s) to an appropriate pharmacist or another appropriate individual who is under the supervision of the investigator/institution E6(R1) 4.6.3 Correct Answer: The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution, should maintain records of the product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s) and trial subjects. Investigators should maintain records that document adequately that the subjects were provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor E6(R1) 4.6.4 Correct Answer: The investigational product(s) should be stored as specified by the sponsor and in accordance with applicable regulatory requirement(s) E6(R1) 4.6.5 Correct Answer: The investigator should ensure that the investigational product(s) are used only in accordance with the approved protocol E6(R1) 4.6.6 Correct Answer: The investigator, or a person designated by the investigator/institution, should explain the correct use of the investigational product(s) to each subject and should check, at intervals appropriate for the trial, that each subject is following the instructions properly E6(R1) 4.7 Correct Answer: Randomization Procedures and Unblinding Randomization Procedures and Unblinding Correct Answer: The investigator should follow the trial's randomization procedures, if any, and should ensure that the code is broken only in accordance with the protocol. If the trial is blinded, the investigator should promptly document and explain to the sponsor any premature unblinding of the investigational product(s) E6(R1) 4.8 Correct Answer: Informed Consent of Trial Subjects E6(R1) 4.8.1 Correct Answer: In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirement(s), and should adhere to GCP and to the ethical principles that have their origin in the Declaration of Helsinki. Prior to the beginning of the trial, the investigator should have the IRB/IEC's written approval/favorable opinion of the written informed consent form and any other written information to be provided to subjects. E6(R1) 4.8.2 Correct Answer: The written informed consent form and any other written information to be provided to subjects should be revised whenever important new information becomes available that may be relevant to the subject's consent. Any revised written informed consent form, and written information should receive the IRB/IEC's approval/favorable opinion in advance of use. The subject or the subject's legally acceptable representative should be informed in a timely manner if new information becomes available that may be relevant to the subject's willingness to continue participation in the trial. The communication of this information should be documented E6(R1) 4.8.3 Correct Answer: Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial E6(R1) 4.8.4 Correct Answer: None of the oral and written information concerning the trial, including the written informed consent form, should contain any language that causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence E6(R1) 4.8.5 Correct Answer: The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the trial including the written information and the approval/favorable opinion by the IRB/IEC E6(R1) 4.8.6 Correct Answer: The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical adn should be understandable to the subject or the subject's legally acceptable representative adn the impartial witness, where applicable. E6(R1) 4.8.7 Correct Answer: Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the subject or the subject's legally acceptable representative E6(R1) 4.8.8 Correct Answer: Prior to a subject's participation in the trial, the written informed consent form should be signed and personally dated by the subject or by the subject's legally acceptable representative, and by the person who conducted the informed consent discussion.