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SOCRA CCRP EXAM ACTUAL EXAM QUESTIONS WITH
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Significant risk device - ANSWER - >A significant risk device is one that is intended as an implant and presents a potential for serious risk to health, safety, or the well-being of the subject. It is also purported or represented to be for a use in supporting or sustaining human life, which also presents a potential risk to health, safety, or well-being. Additionally, it is used for the substantial importance of diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health, which again presents potential risk to health, safety, or well-being.The correct answer is a combination of all three options. 45CFR46 - ANSWER - >HHS - Protection of Human Subjects The FDA form 483 is used for ... - ANSWER - >documenting inspectional observations made during an inspection of a regulated facility. What is the federal department responsible for helping people of Canada maintain and improve their health? - ANSWER -
Health Canada
What is the FDA form 3455? - ANSWER - >Disclosure - Financial Interests and Agreements of Clinical Investigators What do the HHS stand for? - ANSWER - >department of health and human services 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. Comparator - ANSWER - >an investigational or marketed product, or placebo, used as a reference in a clinical trial. What are the three fundamental ethical principals for human subjects research? - ANSWER - >Respect for persons, beneficence and justice BASIC elements of informed consent under section 21CFR50. Subpart B - ANSWER - >These elements include: a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; a description of any reasonably foreseeable risks or discomforts to the subject; a description of any benefits to the subject or to others which may reasonably be expected from the research; a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; a statement describing the extent,
potential therapeutic window based on scientific evidence, and the investigator, has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent, Obtaining informed consent not feasible - as described in 21CFR50.24 (a) FDA form 3454 - ANSWER - >Certification - Financial Interests and Arrangements of Clinical Investigators direct access - ANSWER - >permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial FDA form 482 - ANSWER - >Notice of Inspection Exception from General Requirements - ANSWER - >The necessary conditions to satisfy 21CFR50.23 Subpart B include: the absence of alternative therapies with a higher likelihood of saving the subject's life, insufficient time to obtain consent from the subject's legal representative, inability to obtain informed consent from the subject due to communication barriers or legal constraints, and the presence of a life- threatening situation that requires the use of the test article. Doctors Trial - ANSWER - >refers to the Nuremberg Trials, which were a series of military tribunals held after World War II to prosecute prominent leaders of Nazi Germany
The Belmont Report - ANSWER - >a response to the unethical experiments conducted by the U.S. Public Health Service on African American men in the Tuskegee Study. The ICH GCP Guideline aims to - ANSWER - >establish a common standard for clinical data acceptance among the EU, Japan, and the US regulatory authorities. FDA Form 3500 - ANSWER - >For Voluntary Reporting of Adverse Events and Product Problems Who monitors the progress of all clinical trial investigations being conducted under its IND? - ANSWER - >The Sponsor Good Clinical Practice (GCP) - ANSWER - >The international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects Adverse Event (AE) - ANSWER - >any undesirable experience associated with the use of a medical product in a patient Under 21CFR312, this form is the statement of the investigator of a clinical trial - ANSWER - > 1572 FDA form 3500A - ANSWER - >This form is used for the mandatory reporting of serious adverse events
CBER stands for - ANSWER - >Center for Biologics Evaluation and Research The sponsor shall notify the FDA by telephone or fax of any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible but no later than _____ after the sponsor's initial receipt of the information. - ANSWER
7 calendar days IDE stands for - ANSWER - >Investigational device exemption 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 - ANSWER - >adverse drug reaction What phase of a drug trial usually includes hundreds to thousands of volunteers? - ANSWER - >phase 3 source document - ANSWER - >any document where the data is first recorded Biometrics - ANSWER - >A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions
Closed System - ANSWER - >An environment in which system access is controlled by persons who are responsible for the content that are on the system Open System - ANSWER - >An environment in which system access is NOT controlled by persons who are responsible for the content that are on the system When is a short form ICF needed? - ANSWER - >For subjects whose first language is not English What are the 10 points of the Nuremberg Code? - ANSWER - >- Required voluntary, informed consent
- Experiment aims at positive results for society
- Based on previous knowledge that justifies the experiment
- Study design avoids unnecessary physical and mental suffering and injuries
- Not conducted if there is any reason to believe it implies a risk of death or disabling injury
- Risks < Benefits
- Preparations and facilities must be provided to protect subjects against risks
- Staff must be fully trained and qualified
- Subject must be free to quit at any time
- Medical staff stop the experiment at any time if they observe continuation would be dangerous. When can an investigational product be used without a signed consent? - ANSWER - >in a life threatening situation, inability to
What is considered a significant payment made from the sponsor to the investigator? - ANSWER - >$25, What is the main purpose of the IRB? - ANSWER - >Assure protection of rights, safety, and welfare of human subjects. Who provides the final approval of a study? - ANSWER - >IRB IRB must find when approving a study: - ANSWER - >- risks are minimized
- risks are reasonable for the anticipated benefits
- selection of subjects is equitable
- ICF follows guidelines
- ICF documented appropriately
- Adequate provisions for monitoring data collected to ensure the safety of subjects
- privacy and confidentiality is protected
- additional safeguards in place to protect vulnerable populations What is documented at IRB meetings? - ANSWER - >-copies of research proposals reviewed
- Minutes of IRB meetings
- records of continuing reviews
- copies of correspondence between IRB and investigator
- list of IRB members
- written procedures for the IRB
- statement of significant findings provided to subjects
What kind of investigational devices are exempt from Premarket approval requirements? (IDE) - ANSWER - >- diagnostic devices that are non-invasive
- for vet or lab use
- custom device not intended for commercial distribution Who must be part of the IRB members? - ANSWER - >- males and females
- varied background
- at least 5 members
- 1 scientific background
- 1 non-scientific background
- 1 no institutional affiliation
- diverse With respect to IRB/IEC membership, both the FDA and the ICH require that ... - ANSWER - >At least one member's primary area of interest is in a nonscientific area In an non-emergency situation, under which of the following conditions, if any, may subjects been rolled into a study prior to IRB/IEC approval? - ANSWER - >Subjects cannot be enrolled until IRB/IEC approval has been obtained A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. What is true about this subject? - ANSWER - >The subject should undergo all study procedures as outlines in the protocol
animals/humans. Summary of safety and efficacy, risks and side effects (to the extent known) How soon after an IND is submitted can investigators begin their studies? - ANSWER - >30 days What is a clinical hold in regard to an IND? - ANSWER - >Issued by the FDA to delay a proposed clinical investigation or to suspend an ongoing investigation. This means no new subjects can be recruited. When is an IND deemed inactive? - ANSWER - >If no subjects are entered for 2 years or more or if on a clinical hold for 1 year How long does a sponsor need to keep records after a marketing application for a drug is approved? - ANSWER - > 2 years What are the applications for the Belmont Report? - ANSWER -
- Informed Consent
- Assessment of Risk and Benefits
- Selection of Subjects What is a drug as defined by the FDA? - ANSWER - >A drug is an product that is intended for use in the diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to affect the structure or any function of the body.
What is a phase 1 clinical trial? - ANSWER - > 20 - 80: Typical number of healthy volunteers used in Phase 1: this phase emphasizes SAFETY. What is a phase 2 clinical trial? - ANSWER - >100s: Typical number of patients used in Phase 2; this phase emphasizes EFFECTIVENESS What is phase 3 of clinical trials? - ANSWER - >Drug given to large groups of patients (sometimes thousands) in several geographical locations as part of controlled clinical trials; obtain data concerning drugs effectiveness compared to placebo; most studies are double blinded. What is a phase 4 clinical trial? - ANSWER - >Post Marketing: Because it's not possible to predict all of a drug's effects during clinical trials, monitoring safety issues after drugs get on the market is critical. The role of FDA's post-marketing safety system is to detect serious unexpected adverse events and take definitive action when needed. A Phase ____ protocol is more flexible and less detailed than the others - ANSWER - >Phase 1 This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER - >Investigational New Drug Application (1571)
A) expected B) serious C) would have implications for the conduct of the study D) B & C E) A, B & C - ANSWER - >B&C A request to export an investigational drug from the US must include - ANSWER - >The quantity of drug to be shipped per shipment and the frequency of expected shipments AND a statement that the drug will be used for investigational purposes only An investigational drug can be exported from the US if, - ANSWER - >approval is granted after a written request is submitted to the FDAs International Affairs Staff Associate Commissioner How long is IRB registration with HHS effective for? 45CFR46.502 - ANSWER - >3 years IRB must renew registration every ___ years (45CFR46.505) - ANSWER - > 3 IRB Registration info must be updated within ____ days after changes occur regarding the contact person who provided the IRB registration OR the IRB chairperson - ANSWER - >90 days
An institution or organizations decision to disband a registered IRB also must be reported to OHRP in writing within ___ days after permanent cessation of ORBs review of supported research (45cfr46.505) - ANSWER - >30 days For Fatal or life threatening Unexpected ADRs or adverse events regulatory agencies should be notified ____ but no later than ____ calendar days after first knowledge by sponsor, follow by a completed as possible report within ____ additional calendar days - ANSWER - >ASAP, 7, 8 Serious,unexpected ADRs that are not fatal or life threatening must be filed ASAP but no later than ____ calendar days after first knowledge by sponsor that case meets criteria - ANSWER -
15 If immediate use of test article is required (as determined by PI) where independent determination cannot be granted, a statement with exemption from but PI and independent clinician must be submitted to IRB within ___ working days after use of article - ANSWER - > 5 IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation - ANSWER - > 3 All IRB records need to be kept for ____ years follow completion of research - ANSWER - > 3
If no subject are enrolled within ___ years or if IND remains on hold for___ year, the IND can be out in inactive status - ANSWER - >2 years, 1 year A sponsor and investigator shall retain records for ____ years after marketing is approved OR investigation becomes inactive - ANSWER - > 2 The sponsor must provide notice to FDA within ______ working days when making a change to an IDE - ANSWER - > 5 The clinical investigator shall update FDF with any relevant changes that occur during the course of the study and for _____ year following its completion - ANSWER - > 1 A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect - ANSWER - >5; 15 Unanticipated device AE should be reported by investigator to sponsor and IRB within ____ working days of knowledge of effect - ANSWER - > 10 An investigator shall report to sponsor within _____ working days if there is a withdrawal from IRB approval - ANSWER - > 5
Deviation from protocol that are emergencies situations should be reported within ___ working days after emergency - ANSWER - > 5 If an investigator uses a device without consent, it needs to be reported to sponsor and IRB within ____ working days - ANSWER - > 5 Within _____ months after termination or completion of trial, submit a final report to sponsor and IRB - ANSWER - >3 months A sponsor shall notify all IRBs and investigators within ____ working days of there is withdrawal of FDA approval - ANSWER
5 A sponsor should submit to FDA a current list of names of investigators participating every ___ months - ANSWER - > 6 Sponsor will notify FDA, IRBS and Investigators within _____days after learning of a recall and device disposition - ANSWER - >30 working days In sig risk device, sponsor shall notify FDA within _____ days after completions of or investigation and shall submit a final report within _____ months - ANSWER - >30 working; 6 months What is another name for Expanded Access Use? - ANSWER - Compassionate use - is a way for patients to receive drug who
