Download ICH GCP FOR CCRC EXAM PREP WITH COMPLETE SOLUTIONS!! and more Exams Advanced Education in PDF only on Docsity!
ICH GCP FOR CCRC EXAM PREP WITH COMPLETE SOLUTIONS!!
Adverse Drug Reaction (ADR) - ANSWER All noxious and unintended responses to a medicinal product related to any dose
E6(R1) 1 - ANSWER Glossary of terms
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--any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product
Applicable Regulatory Requirements - ANSWER Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products
Institutional Review Board Approval - 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).
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, or placebo, used as a reference in a clinical trial.
Compliance 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.
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 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 - 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 - 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) - 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.
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.
Multicenter 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
IEC Opinion - ANSWER The judgement and/or the advice provided by an Independent
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.
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.
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.
Vulnerable Subject - 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) - ANSWER The physical and mental integrity of the subjects participating in a clinical trial
E6(R1) 2 - ANSWER The Principles of ICH GCP
E6(R1) 2.1 - 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 - 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 - 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 - ANSWER The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
E6(R1) 2.5 - ANSWER Clinical trials should be scientifically sound, and described in a clear detailed protocol.
E6(R1) 2.6 - 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 - 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
E6(R1) 3.4 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - ANSWER An IRB/IEC should make its decisions at announced meetings at
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 - 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 - 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 - ANSWER Investigator
E6(R1) 4.1 - ANSWER Investigator's Qualifications and Agreements
E6(R1) 4.1.1 - 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 - 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 - ANSWER The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.
E6(R1) 4.1.4 - ANSWER The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authorities
E6(R1) 4.1.5 - 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 - ANSWER Investigator-Adequate Resources
E6(R1) 4.2.1 - 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 - ANSWER The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.
E6(R1) 4.2.3 - 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 - ANSWER The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational products, and their trial-related duties and functions.
E6(R1) 4.3 - ANSWER Investigator-Medical Care of Trial Subjects
E6(R1) 4.5 - ANSWER Investigator--Compliance with Protocol
E6(R1) 4.5.1 - 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 - 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 - ANSWER The investigator, or person designated by the investigator, should document and explain any deviation froth approved protocol.
E6(R1) 4.5.4 - 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 - ANSWER Investigational Product(s)
E6(R1) 4.6.1 - ANSWER Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution
E6(R1) 4.6.2 - 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 - 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 - 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 - ANSWER The investigator should ensure that the investigational product(s) are used only in accordance with the approved protocol
E6(R1) 4.6.6 - 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 - ANSWER Randomization Procedures and Unblinding
Randomization Procedures and Unblinding - 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 - ANSWER Informed Consent of Trial Subjects
E6(R1) 4.8.1 - 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
acceptable representative
E6(R1) 4.8.8 - 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.
E6(R1) 4.8.9 - ANSWER If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion. After the written informed consent form and any other written information to be provided to subjects, is read and explained to the subject or the subject's legally acceptable representative, and after the subject or the subject's legally acceptable representative has orally consented to the subject's participation in th etrial and, if capapble of doing so, has signed adn personally dated the informed cosnent form, the witness should sign adn personally date the consent form. By signing the consent form, the witness attests that the information in th e consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptablerepresentative, and that informed consent was freely given by the subject or the subject's legally acceptable representative
E6(R1) 4.8.10 Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of.. .Part 1 - ANSWER a) That the trial involves research
b) The purpose of the trial
c) The trial treatment(s) and the probability for random assignment to each treatment
d) The trial procedures to be followed, including all invasive procedures
e) The subject's responsibilities
f) Those aspects of the trial that are experimental
g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable to an embryo, fetus, or nursing infant
h) the reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be made aware of this
E6(R1) 4.8.10 Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include
explanations of.. .Part 2 - ANSWER i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks
j) The compensation and/or treatment available to the subject in the event of trial-related injury
k) The anticipated prorated payment, if any, to the subject for participating in the trial
l) The anticipated expenses, if any, to the subject for participating in the trial
m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled
n) That the monitor(s), the auditor(s), the IRB/IEC, and the regulatory authority(ies) will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality fo the subject, to the extent permitted by applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing such access
E6(R1) 4.8.10 Both the informed consent discussion and the written informed consent form and any other written information to be provided to subjects should include explanations of.. .Part 3 - ANSWER o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject's identity will remain confidential
p) That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial
q) The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury
r) The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.
s) The expected duration of the subject's participation in the trial
t) The approximate number of subjects involved in the trial
E6(R1) 4.8.11 - ANSWER Prior to participation i the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written
