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CCRP Exam Prep Questions and
Answers Latest 202 5
Who was tried in the Nuremburg Military Tribunals and why? - ✔Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? - ✔After 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seven were sentenced to death and executed 6/2/1948. What historical document was born from the Nuremberg Military Tribunals? - ✔The Nuremberg Code (1947) According to the Nuremberg Code (1947), all unnecessary physical and mental suffering and injury... - ✔should be avoided According to the Nuremberg Code (1947), voluntary consent of the human subject is... - ✔absolutely essential According to the Nuremberg Code (1947), the experiment must yield.... - ✔generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in nature According to the Nuremberg Code (1947), animal experimentation should... - ✔precede human experimentation According to the Nuremberg Code (1947), no experiment should be conducted if there is reason to believe... - ✔death of disabling injury will occur According to the Nuremberg Code (1947), the degree of risk to subject should... - ✔never exceed the humanitarian importance of the problem According to the Nuremberg Code (1947), risk to subjects should be minimized through... - ✔proper preparations According to the Nuremberg Code (1947), experiments should only be conducted by... - ✔scientifically qualified investigators
According to the Nuremberg Code (1947), subjects should always be at liberty to... - ✔withdraw from experiments According to the Nuremberg Code (1947), investigators must be ready to end an experiment at any stage if... - ✔there is cause to believe that continuing the experiment is likely to result in injury, disability, or death to the subject The Declaration of Helsinki (1964) emphasized what? - ✔Brought about by the need for human research as opposed to human experimentation and better defined the criteria for consent What organization originally adopted the Declaration of Helsinki? - ✔The World Medical Association General Assembly What did the Declaration of Helsinki (1964) provide recommendations for? - ✔Recommendations guiding physicians in biomedical research involving human subjects The Declaration of Helsinki (1964) reiterated the basic ethical principles from what document? - ✔The Nuremberg Code According to the Declaration of Helsinki (1964), informed consent must be obtained from who? - ✔The subject or legal guardian According to the Declaration of Helsinki (1964), design and performance of experimental procedure must be... - ✔formulated in a clear protocol According to the Declaration of Helsinki (1964), research protocols should be transmitted to... - ✔a specially appointed independent committee for consideration, comment and guidance Who ran the Tuskegee Study of Untreated Syphilis in the Negro Male? - ✔The US Public Health Service and the Tuskegee Institute What was the purpose of the Tuskegee Experiments? - ✔To justify treatment programs for black Americans When were the Tuskegee Experiments intiated? - ✔ 1932
According to the Belmont Report (1979), treating people as independence is an example of what foundation of ethical research? - ✔Respect for persons According to the Belmont Report (1979), respect for persons means that those with diminished authority are entitled to... - ✔Protection According to the Belmont Report (1979), subjects entering into research voluntarily and with adequate information is an example of what foundation of ethical research? - ✔Respect for persons According to the Belmont Report (1979), concerns for privacy and confidentiality are an example of what foundation of ethical research? - ✔Respect for persons According to the Belmont Report (1979), respecting decisions, protecting from harm, and securing well-being are examples of what foundation of ethical research? - ✔Beneficence According to the Belmont Report (1979), beneficence is defined as... - ✔Doing no harm and maximizing benefits while minimizing possible risks What is the opposite of malfeasance as described in the Belmont Report (1979)? - ✔Beneficence According to the Belmont Report (1979), justice implies... - ✔fairness and is manifested in equitable selection of subjects for research According to the Belmont Report (1979), justice means that selection of subjects for research should be based on... - ✔reasons directly related to the problem being studied, not systematic selection of a class of individuals due to compromised position, manipulability, etc. What does the Belmont Report (1979) say about who should receive benefits of research? - ✔Benefits should not be restricted to those who can afford it, and research should not involve persons from groups not likely to benefit from application of the research What did the Henry K Beecher Paper reveal - ✔22 published medical studies where patients had been experimented on with no expected benefit to them, showing that unethical studies were widespread and represented a systemic problem in medical research rather than exceptions Human Radiation Experiments (1945-1957) -
✔The Atomic Energy Commission conducted secret and classified radiation experiments and releases on unknowning Americans to assess how the human body metabolizes radioactive material. What are the three foundations ethical research as outlined the Belmont Report (1979)?
- Beneficence
- Justice Wichita Jury Study (1953) - ✔Social scientists covertly recorded discussions of 6 Wichita federal district court civil juries, without the consent of the jurors. Willowbrook Hepatitis Study (1955) - ✔Gave children with mental retardation hepatitis in order to track the progression of the disease and to test treatments Milgram's Obedience Study (1963) - ✔study of the phenomenon of obedience to an authority figure, examinfed the effects of punishment on learning (shock treatment for mistakes, 65% shocked dangerous amounts when ordered Jewish Hospital Cancer Study (1963) - ✔Elderly hospitalized patients were injected with live cancer cells to study the mechanism of immune reaction without true informed consent. Tearoom Trade Study (1970) - ✔Analysis of male-male sexual behavior in public toilets by Laud Humphreys. He observed acts masquerading as a voyeur rather than a researcher, tracked participants without their consent by using their license plate numbers, and interviewed them in disguise without disclosing his true intent (research) Stanford Prison Experiment (1970) - ✔Volunteers in a mock prison took on the roles of guards and inmates. The experiment was discontinued due to ongoing physical and psychological abuse inflicted on many prisoners. San Antonio Contraceptive Study (1971) - ✔Poor Mexican-American women given placebos instead of contraceptives without knowing they were subject to such research. There were high numbers of unplanned pregnancy in the placebo group University of Rochester Death of Healthy Subject (1996) -
✔Other clinical investigations that may have an impact on the safety and well-being of human subjects What are the categories of International Committee on Harmonization (ICH)? - ✔Quality guidelines Efficacy guidelines Safety guidelines Multidisciplinary guidelines ICH Quality Guidelines - ✔Conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management ICH Safety Guidelines - ✔Uncover potential risks like carcinogenicity, genotoxicity, and reprotoxicity What have ICH safety guidelines accomplished recently? - ✔A non-clinical testing strategy for assessing the QT interval prolongation liability, the single most important cause of drug withdrawals in recent years ICH Efficacy Guidelines - ✔Concerned with the design, conduct, safety, and reporting of clinical trials, covering novel trypes of medicines derived from biotechnological processes and the use of pharmacogentics/genomics techniques to produce better targeted medicines ICH Multidisciplinary Guidelines - ✔Including medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI) Clinical Safety constitutes what ICH efficacy guidelines? - ✔E1-E2F Good Clinical Practice constitutes what ICH efficacy guidelines? - ✔E (ICH E6 GCP 1.21) What is the legal status of the International Committee on Harmonization? - ✔While several countries have adopted ICH guidelines as laws, the US FDA adopted ICH only as guidance. They do not have the force of law in the US and are not regulations Compliance is _______, but compliance with ICH is considered part of __________ - ✔Voluntary, Good Clinical Practice
When were FDA regulations first published? - ✔ 1980 When did HHS and FDA revise regulations? - ✔ 1981 When was the Common Rule published? - ✔ 1991 When did GCP and HIPAA come into play? - ✔ 1996 What is the difference between a law and regulation? - ✔A law is passed by legislature and establishes the authority of a regulatory body. Regulations are passed by regulatory authorities and have the effect of law, meaning that there are civil and criminal penalties for noncompliance Define guidance - ✔Current thinking of regulatory bodies Are guidance documents binding? - ✔No, they represent the current thinking on good clinical practices. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of applicable statutes, regulations, or both Where are FDA regulations published and when? - ✔The Code of Federal Regulations is issued annually in the Federal Register Decipher the following regulation title: 21 CFR 312.28 (b) - ✔Title 21 Part 312 Section 28 Paragraph b In a regulation title, 21 corresponds to what regulatory authority? - ✔Food and Drug Administration (FDA) In a regulation title, 45 corresponds to what regulatory authority? - ✔Health & Human Services (HHS) The 300 series of parts apply to... - ✔Drug regulations The 600 series of parts apply to... - ✔Biologics regulations
21 CFR 50 -
✔Protection of Human Subjects 21 CFR 50 Subpart A - ✔General Provisions for the Protection of Human Subjects 21 CFR 50 Subpart B - ✔Informed Consent of Human Subjects 21 CFR 50 Subpart C - ✔Reserved 21 CFR 50 Subpart D - ✔Additional Safeguards for Children in Clinical Investigations 21 CFR 56 - ✔Institutional Review Boards 21 CFR 56 - ✔IRB general provisions 21 CFR 56 Subpart B - ✔IRB organization and personnel 21 CFR 56 Subpart C - ✔IRB functions and operations 21 CFR 56 Subpart D - ✔Records and Reports 21 CFR 56 Subpart E - ✔Administrative Actions for Noncompliance Are there exemptions to 45 CFR 46.101? - ✔Exemptions do not apply to research involving prisoners, subpart C. Exemption for research involving survey or interview procedures or observation of public behavior does not apply to research with children, subpart D, except for research involving observations of public behavior when the investigators do not participate in the activities being observed What are the exemptions from IRB requirement (21 CFR 56.104)? - ✔Any investigation that commenced before July 27, 1981 Emergency use of a test article Taste and food quality evaluations and consumer acceptance studies
Emergency use of a test article is exempt from 21 CFR 56.104 (IRB requirement) provided that.... - ✔Such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review What is a legally authorized representative? - ✔An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure involved in the research What does minimal risk mean? - ✔The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves that those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests According to 45 CFR 46.102, research means... - ✔a systemic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge According to 21 CFR 50.3c, clinical investigation means... - ✔Any experiment that involves a test article and one or more human subjects and that their is subject to requirements for prior submission to the FDA under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit How does 45 CFR 46.102 define a human subject? - ✔A living individual about whom an investigator (professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information How does 21 CFR 50.3g define a human subject? - ✔An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be a healthy human or a patient How does 45 CFR 46.102 define an IRB? - ✔An institutional review board established in accord with and for the purposes expressed in this policy How does 21 CFR 50.3i define an IRB? - ✔Any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research. The term has the same meaning as the phrase institutional review committee as used in section of 520(g) of the act.
According to 45 CFR 46.107 and 21 CFR 56.107, an IRB must have at least _____ members - ✔ 5 According to 45 CFR 46.107 and 21 CFR 56.107, IRB members must have varying _______ - ✔backgrounds According to 45 CFR 46.107 and 21 CFR 56.107, an IRB must not be entirely of one ____ or _____ - ✔gender of profession According to 45 CFR 46.107 and 21 CFR 56.107, there must be at least one member meeting each of the following descriptions... - ✔-with primary concern in scientific areas
- with primary concern in non-scientific areas
- not affiliated with the institution (community member), with no conflict of interest According to 45 CFR 46.107 and 21 CFR 56.107, an IRB may invite individuals with competence in special areas of interest to assist in review of issues which require expertise beyond or in addition to that available on the IRB. Can these individuals vote - ✔No According to 45 CFR 46.107 and 21 CFR 56.107, should be qualified through what? - ✔The experience and expertise of its members, and diversity with consideration to race, gender, and cultural backgrounds, with sensitivity to such issues as community attitudes According to 45 CFR 46.107 and 21 CFR 56.107, the IRB should be able to ascertain what? - ✔The acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice According to 45 CFR 46.107 and 21 CFR 56.107, who should be included in an IRB that regularly reviews research involving vulnerable subjects (children, prisoners, pregnant women, handicapped/mentally disabled persons)? - ✔Individuals who are knowledgeable about and experience in working with these subjects According to 45 CFR 46.108 and 21 CFR 56.108, each IRB should follow... - ✔written procedures According to 45 CFR 46.108 and 21 CFR 56.108, what conditions must be met at convened meetings -
✔Majority of members are present, including at least one member whose primary concerns are in nonscientific areas. For research to be approved, it shall receive approval of a majority of those members present. The exception is when an expedited review procedure is used. According to 45 CFR 46.109 and 21 CFR 56.109, IRB shall review and have the authority to... - ✔Approve, require modifications, or disapprove of research activities According to 45 CFR 46.109 and 21 CFR 56.109, the IRB shall require that information given to subjects as part of informed consent is in accordance with... - ✔with 46.116 or 50. According to 45 CFR 46.109 and 21 CFR 56.109, the IRB may require that information in addition to that specifically mentioned in 46.116 or 50.25 be given to subjects when...
- ✔in the IRB's judgement the information would meaningfully add to the protection of the rights and welfare of subjects According to 45 CFR 46.109 and 21 CFR 56.109, IRBs should notify investigators and the institution... - ✔in writing of its decision to approve, disapprove, or require modifications to the proposed research activity According to 45 CFR 46.109 and 21 CFR 56.109, continuing reviews should be conducted at intervals appropriate to... - ✔the degree of risk of the research According to 45 CFR 46.110 and 21 CFR 56.110, the IRB may use an expedited review procedure to review... - ✔-research found by the reviewers to involve no more than minimal risk AND/OR
- minor changes in previously approved research According to 45 CFR 46.110 and 21 CFR 56.110, expedited review may be carried out by... - ✔The IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. Reviewers may exercise all of the authorities of the IRB except that they may not disapprove the research According to 45 CFR 46.111 and 21 CFR 56.111, the IRB must determine that all of the following requirements are satisfied: - ✔-Risks to subjects are minimized
- Risks are reasonable in relation to anticipated benefits
- Selection of subjects is equitable
- can discontinue at any time
- use in future research
- compensation (greater than min risk)
- FDA may review
- unforeseeable risks as applicable
- repro risk
- when participation may be terminated
- costs
- new info may be shared with subject if affecting research
- approx number of participants
- commercial profit sharing
- whether results are disclosed to subject
- whether whole genome sequencing possible What do research subjects need to be told about ClinicalTrials.gov according to 21 CFR 50.25? - ✔Clinical trial information has or will be submitted for inclusion in the clinical trial registry databank under paragraph j of section 402 of the Public Health Service Act saying that a description of the trial will be available online as required by US law. It will not identify you, and at most will include a summary of results. You can search the site at any time According to 45 CFR 46.116, an IRB may approve a consent procedure that does not include or alters the general requirements of informed consent, or waive requirement to obtain it all together if... - ✔The research is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine public benefit or service programs, procedures for obtaining benefits or services under those programs, possible changes in alternative to those programs, or possible changes in the methods or levels of payment for benefits or service under those programs; and the research could not possibly be carried out without waiver or alteration. According to 45 CFR 46.116, an IRB may approve a consent procedure that does not include or alters the general requirements of informed consent, or waive requirement to obtain it all together if... - ✔The research involves no more than minimal risk, does not adversely affect the rights and welfare of subjects, the research could not be practicably carried out without the waiver or alteration, and whenever appropriate, the subjects will be provided with additional pertinent info after participation According to 45 CFR 46.117 and 21 CFR 50.27, how is informed consent to be documented? - ✔By the use of a written consent form approved by the IRB and signed and dated by the subject or LAR. A copy must be given to the person signing.
According to 45 CFR 46.117 and 21 CFR 50.27, what must be done if a written consent document is read to the subject or LAR? - ✔They have to be given adequate opportunity to read it before it's signed According to 45 CFR 46.117 and 21 CFR 50.27, a short form consent document must state what? - ✔That the elements of an informed consent required by 46.116 or 50.25 have been presented orally to the subject or LAR. There must be a witness to the oral presentation, and the IRB shall approve a written summary of what is to be said to the subject or representative. According to 45 CFR 46.117 and 21 CFR 50.27, how should the short form be used? - ✔Only the short form itself is to be signed by the subject or the representative, however the witness shall sign both the sort form and a copy of the summary. The person actually obtaining consent shall sign a copy of the summary, and the copy of the summary shall be given to the subject or representative, in addition to a copy of the short form. According to 45 CFR 46.117, an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either - ✔The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research OR that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context According to 21 CFR 56.109(c), the IRB may waive written informed consent if the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required... - ✔outside the research context According to the principles of ICH GCP, 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 requirements According to the principles of ICH GCP, before a trial is initiated, foreseeable risks and inconveniences... - ✔Should be weighed against the anticipated benefit for the individual trial subject and society, and a trial should only be initiated and continued if the anticipated benefits justify the risks
According to the principles of ICH GCP, the IRB/IEC should obtain what documents? - ✔Protocols, amendments, written ICFs, proposed updates, recruitment procedures, written info provided to subjects, IBs, safety info, info about payment and compensation, CVs for investigators According to the principles of ICH GCP, when a non-therapeutic trial is to be carried out with consent of a subjects LAR, the IRB/IEC should... - ✔determine that the proposed protocol and/or other documents adequately address relevant ethical concerns and meets applicable regulatory requirements for such trials According to the principles of ICH GCP, the IRB should ensure info regarding payments to subjects is provided in the ICF, including... - ✔methods, amounts, and schedule According to the principles of ICH GCP, the language used in consent forms should be... - ✔non-technical as is practical and understandable to the subject, LAR, and witness as applicable According to the principles of ICH GCP, the ICF should be signed and dated by - ✔The subject/LAR and the person who conducted the informed consent discussion According to the principles of ICH GCP, if a subject or LAR is unable to read... - ✔An impartial witness should be present during the entire informed consent discussion to sign the consent form attesting that information was accurately explained and understood, and consent was freely given According to the principles of ICH GCP, a non therapeutic trial is... - ✔a trial in which there is no anticipated direct clinical benefit to the subject According to the principles of ICH GCP, when a clinical trial includes subjects who can only be enrolled in the trial with the consent of the subjects LAR, the subject... - ✔should be informed about the trial to the extent compatible with the subjects understanding and, if capable, the subject should sign and personally date the written informed consent According to the principles of ICH GCP, non-therapeutic trials may be conducted in subjects with consent of a LAR provided that... - ✔-the trial cannot be conducted in subjects who can give consent personally
- foreseeable risks are low
- negative impact on well-being is minimized and low
- the trial is not illegal
- IRB approval on inclusion of these subjects What does 21 CFR 11 cover? -
✔Electronic records and signatures. It sets for the criteria under which the agency considers electronic records, signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper According to 21 CFR 11.3, biometrics are... - ✔a method of verifying an individual's identity based on measurement of the individual's feature(s) or repeatable action(s) where those features and or actions are both unique to that individual and measurable According to 21 CFR 11.3, a closed system is... - ✔An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system According to 21 CFR 11.3, electronic records are - ✔any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system According to 21 CFR 11.3, an open system is... - ✔an environment in which system access is not controlled by persons who are responsible for the content of electronic records According to 21 CFR 11.3, digital signatures are... - ✔an electronic signature based on cryptographic methods of originator authentication, computed by using a set of rules and parameters such that the identity of the signed and the integrity of the data can be verified According to 21 CFR 11.3, an electronic signature is... - ✔a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature According to 21 CFR 11.3, a handwritten signature is - ✔the scripted name or legal mark of an individual handwritten by the individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark According to 21 CFR 11.10, what are controls for closed systems? - ✔-Validation
- generate accurate and complete copies
- protection of records
- limited system access
