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CCRP QUESTIONS WITH 100% EXACT ANSWERS 2024-2025 LATEST UPDATED., Exams of Nursing

CCRP QUESTIONS WITH 100% EXACT ANSWERS 2024-2025 LATEST UPDATED. CCRP QUESTIONS WITH 100% EXACT ANSWERS 2024-2025 LATEST UPDATED.

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2023/2024

Available from 11/25/2024

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Download CCRP QUESTIONS WITH 100% EXACT ANSWERS 2024-2025 LATEST UPDATED. and more Exams Nursing in PDF only on Docsity!

CCRP QUESTIONS WITH 100% EXACT

ANSWERS 2024-2025 LATEST UPDATED.

report outcome of trial w/in ____ yr(s) of ending - Exact answer 1 Disclosure of Financial Interest - Exact answer 3455 No Financial interest - Exact answer 3454 NDA (New Drug Application) - Exact answer When a drug is in the process of being made or discovered, this application must be filed with the FDA to prove efficacy and safety before being commercially available. T/F: A medical monitor can help with assessing severity of AEs? - Exact answer True FDA Form 3455 - Exact answer Disclosure - Financial Interests and Arrangements of Clinical Investigators FDA Form 483 - Exact answer Letter of investigational observations/citation of noncompliance that specifies how long you have to respond. FDA Form 3500A is used for A. Financial Disclosures B. Inspections C. Voluntary reporting D. Mandatory reporting - Exact answer C Sp. reporting time for non-fatal SAEs - Exact answer ASAP, but no later than 15 calendar days Sp. reporting time for unexpected fatal or life-threatening suspected [to attributed to the drug] AE - Exact answer ASAP, but no later than 7 calendar days Sponsor (definition) - Exact answer person who initiates a clinical investigation but does not actually conduct the investigation. A corporation

or agency (other than an individual) that uses it's employee or employees to conduct a clinical investigation it has initiated is considered the sponsor and the employees the investigator. Investigator Responsibilities - Exact answer - protect rights, safety and welfare of subjects

  • follow 1572 and regulations
  • conduct investigation
  • required to submit all reports to the sponsor in accordance with the protocol unless there is evidence of drug causality, then immediate reporting to Sp.
  • must provide Sp. with final report after study completion
  • reports unanticipated events to IRB
  • controls IP when to report financial disclosures to Sp. - Exact answer update as needed over the course of the study and for 1 yr following study completion Quality Data Acronym (ALCOA) - Exact answer Attributable, Legible, Contemporaneous, Original, Accurate (complete?) What are the financial conflicts? - Exact answer - significant equity interest in the Sp.
  • any monetary amount of stock in a non-publicly traded corp.
  • 50k or more in a publicly traded corp. who do financial disclosures apply to? - Exact answer PIs, sub-Is + their spouses and dependent children what are Sp. responsibilities? - Exact answer - selecting qualified investigators and monitors
  • providing investigators w proper info to conduct the trial
  • ensuring proper monitoring of the investigation
  • ensuring that investigation is conducted in accordance w general investigational plan
  • maintain an effective IND (w/in 60 days of IND anniversary, must submit brief progress report of investigation)
  • informing/updating FDA and all participating investigators of significant new AEs or risks

How long does the PI have to respond to FDA Form 483? - Exact answer 15 business days FDA Form 482 - Exact answer Notice of inspection What things must be included in ICFs? - Exact answer - an explanation of the purpose of the investigation

  • description of risks and benefits
  • confidentiality of records (statement that FDA may inspect the records)
  • statement that participation is voluntary
  • who to contact for questions
  • compensation for injury/medical treatment -subject rights
  • treatment alternatives Short form consent - Exact answer In the context of human subjects' research, a written document stating that the elements of informed consent required by the Common Rule have been orally presented to and understood by the subject or the subject's legally authorized representative Who signs the short form? - Exact answer the subj./LAR and the witness who signs the summary of the short form consent? - Exact answer the witness and the person obtaining the consent Electronic signature - Exact answer must employ at least 2 distinct ID components such as ID code + password How often do IRBs have to renew registration with HHS? - Exact answer every 3 years How long do IRBs retain records after study completion? - Exact answer 3 years Sp. responsibilities - Exact answer - selecting investigators as appropriate experts to investigate the IP
  • maintaining control of IP
  • obtaining info (1572) from investigator
  • selecting qualified monitors
  • the sponsor must notify the FDA if the IRB cannot approve the research due to ethical concerns How do Sps. keep PIs informed? - Exact answer - providing PI with the IB -keep PI informed of new observations discovered by or reported to the sponsor about the drug (i.e. new safety/AE developments) Sps. responsibilities for ongoing monitoring - Exact answer - must monitor progress of all investigations under it IND
  • If Sp. discovers PI not complying w/ 1572, etc. promptly secure complaint or discontinue shipments of IP and end PIs participations. Sp. shall require that investigator dispose or return the IP and notify FDA
  • Sp. must provide annual safety and effectiveness progress reports to the FDA -if Sp. determines IP presents unreasonable risk to subjects: discontinue investigation, notify FDA, all IRBs and all investigators, dispose of all stocks of IP and FDA full report of Sp. actions. Must d/c investigation w/in 5 working days Records of IP must include: - Exact answer name of investigator/who the drug was shipped to How long are IP records retained for after marketing application approval? - Exact answer 2 years How long are IP records retained for after drug shipment discontinued + FDA notification? - Exact answer 2 years T/F: Sp. must provide FDA w access to any records related to the investigation upon written request - Exact answer T Does IP have to be returned to Sp.? - Exact answer YES - the Sp. must assure return of all unused supplies from each investigator Investigator recording keeping and retention - Exact answer - disposition of IP, dates, quantity, return unused supply
  • maintain accurate case histories (CRFs + supporting data)
  • doc. that informed consent was obtained prior to study participation
  • shall retain recs. for 2 years after completion

Investigator report responsibilities - Exact answer - provide Sp. with final report after completion -must report any SAE to Sp. regardless of causality; must be reported in accordance w/ the protocol unless casual relationship, then report immediately to the Sp.

  • must provide all reports to Sp. who submits annual reports to FDA Investigator IRB assurance responsibilities - Exact answer - must assure IRB will be responsible for initial and continuing review + approval of study
  • promptly report to IRB all changes in research activity, any unanticipated problems/risks to subj. or others
  • will not implement change in research w/o IRB approval except to eliminate immediate hazards to human subj What must electronic signatures contain? - Exact answer - printed name of the signer -date and time that sig was executed
  • the meaning (such as review, approval, responsible, or authorship) what do Ph1 investigations include on 1572? - Exact answer general outline of planned in investigation including est. study duration and max # of subjects what do Ph2 and 3 investigations include on 1572? - Exact answer outline of the protocol with # of subjects to be treated w drug or placebo (if any), clinical uses to be investigated, subject demographics, types of observations and lab tests, study duration, copies of CRFs to be used what's included on 1572? - Exact answer - name + address of investigator
  • name + code # of protocols in the IND
  • name and address of hospital/research facility
  • name + address of clinical laboratory
  • investigators agreement to conduct study according to protocol, will not make changes w/out IRB approval, follow informed consent
  • list of subis
  • CV of investigator
  • clinical protocol (general outline w/ study duration, ma # of subj)
  • Sp. shall select monitor

Phase 4 clinical trials - Exact answer FDA may seek agreement from Sp. to conduct post-marketing studies to look at diff. doses or schedules of admin., use of the drug for diff patient pops. or other stages of disease and use of drug from longer time period Are financial disclosures included in IND? - Exact answer No, Sp. keeps disclosures as separate docs. What is ICH GCP based on? - Exact answer The Declaration of Helsiniki Declaration of Helsinki - Exact answer An international standard providing physician guidelines for conducting biomedical research. World Medical Association's; 1964 What countries are involved with ICH GCP? - Exact answer EU, US, Switzerland Foreign investigators and INDs - Exact answer FDA will accept as support for an IND IF 1) the study was conducted under ICH-GCP or 2) foreign PI submits description of study, data, investigator qualifications, proof of informed consent, etc. -Records after agency decision must be kept for 2 years FDA Form 1571 - Exact answer Cover page for an IND application What does the FDA Form 1571 contain? - Exact answer 1. name and contact info. of sponsor, date of application, name of IP

  1. identification of the trials phase(s) to be conducted
  2. commitment not to begin investigations until IND goes into effect
  3. commitment that IRB will review + approve the study
  4. conduct investigation in accordance w reg requirements
  5. Name and title of monitor
  6. name and title of person responsible for review + eval of drug safety
  7. name and address of CRO, if applicable
  8. sig of Sp. or the Sp.'s rep (if not from US, needs to be countersigned by US rep) 312.40 - Exact answer An IND goes into effect (the Sp. may ship the drug) 30 days after the FDA receives the IND ort if the FDA notifies the Sp. ion writing sooner

Who are financial disclosures required for? - Exact answer All who sign the 1572 What is the responsible for implementing quality assurance and quality control? - Exact answer the Sp. Quality Assurance/control meaning - Exact answer w/ written SOPs by Sp., ensuring that trials are conducted + data are generated, documented, and reported incompliant w the protocol, GCP, + regulation requirements Minimum info needed to report and unexpected SADE - Exact answer 1. identifiable patient

  1. name of suspect medicinal product
  2. an identifiable reporting source
  3. an event or outcome that can be identified as serious and unexpected for which there is a suspected casual relationship 21 CFR 50 - Exact answer Protection of Human Subjects/Informed Consent 21 CFR 50.24 - Exact answer Exception from Informed Consent Requirements for Emergency Research what is responsible for determining whether a clinical investigation can waive the informed consent requirement? - Exact answer the IRB with the concurrence of a licensed physician who is a member of the IRB but not part of the investigation requirements for IND/IDE w/ an ICF exception - Exact answer protocols with ICF exception must be conducted under a separate IND/IDE that clearly states that the protocol may include subjs who are unable to consent even if an IND/IDE exists for the same product already what happens if IRB does not approve ICF exemption? - Exact answer IRB must document findings in writing and send to investigators and Sp. Sp. must promptly disclose these findings to FDA 21 CFR 50.25 - Exact answer Lists the BASIC ELEMENTS of informed consent

What are the basic elements of informed consent? - Exact answer 1. statement that study involves research, purposes, duration, procedures, ID of which procedures are experimental

  1. description of risks or discomforts
  2. benefits to subjs or others
  3. alternative treatments/procedures
  4. statement of confidentiality of records, noting that FDA may insect the records
  5. research involving risk- compensation/medical treatments for injury from this research
  6. explanation for whom to contact about research, subj rights, injury related to research
  7. statement that participation is voluntary/ no loss of benefits or penalty/may d/c at anytime 21 CFR 50.27 - Exact answer Documentation of informed consent How is informed consent documented? - Exact answer by a written ICF that is approved by the IRB, signed and dated by subj/LAR at time of consent and a copy given to person signing the form consent short form - Exact answer states that basic elements of ICF have been presented orally to subj who is the short form signed by? - Exact answer the subj and the witness who is the short form summary signed by? - Exact answer the witness and person presenting consent the IRB approves the written summary 21 CFR 50 Subpart D - Exact answer Additional Safeguards for Children in Clinical Investigations requirements for investigations involving children with no greater than minimal risk - Exact answer they can involve children if there are adequate provisions for assent and consent of parent(s) requirements for investigations involving children with greater than minimal risk, but prospect of direct benefit - Exact answer they can involve children

if the IRB finds that risk is justified by benefit to subject, risk/benefit ratio is comparable to available alternatives, assent + parent(s) consent requirements for investigations involving children with greater than minimal risk and no prospect of direct benefit but yields knowledge of disorder/condition - Exact answer they can involve children if the IRB finds that the risk represents only minor increase over minimal risk, intervention likely to yield generalizable knowledge about disorder/condition, intervention comparable to actual or expected procedures, assent + BOTH parents' consent (unless one parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the custody of the minor) requirements for investigations involving children with greater than Minimal Risk, No Direct Benefit to Subject, but Results May Alleviate Serious Problems of Children's Health or Welfare - Exact answer - must present a reasonable opportunity to understand, prevent, or alleviate a serious problem affecting the health/welfare of children -IRB + Commissioner of the FDA along with a panel of experts determines this (sound ethical principles)

  • assent + BOTH parents' consent (unless one parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the custody of the minor) 21 CFR 50.55 Subpart D - Exact answer Requirements for permission by parents or guardians and assent for children who is responsible for determining risk level for children research? - Exact answer the IRB who is responsible for determining whether children being studied in an investigation are capable of assenting and that there are adequate provisions made for obtaining assent? - Exact answer the IRB what factors to the IRB consider when determining assent? - Exact answer ages, maturity and psychological state of children; this judgement can be made for entire protocol or for each child When can assent of a child be waived? - Exact answer when the IRB determines:
  1. no more than minimal risk
  2. waiver will not adversely affect rights and welfare of subj
  3. subject will be provided w additional inform. after participation who decides how assent will be obtained and documented? - Exact answer the IRB How is parental consent documented? - Exact answer same as regular consent 21 CFR 50.56 Subpart D - Exact answer Wards can be involved in research if such investigation is:
  4. related to their status as a ward
  5. conducted in schools or similar settings where most children involved are not wards ward - Exact answer A 'ward' is a child who is has been placed under the care or protection of a guardian, court, or an agency that is legally responsible for the child. Foster children are wards; their care may be in the hands of a foster parent or a governmental agency such as Children's Social Services. Children who live in an orphanage or penal institution may be wards. What must the IRB appoint to a ward in research? - Exact answer an advocate for each child ward who is not associated with the investigation or guardian organization (expect as an IRB member) what does an advocate do (for wards)? - Exact answer servers in addition to a guardian acting in the best interest of the child during the study can an individual be an advocate for more than one child ward? - Exact answer yes 45 CFR 46 part B - Exact answer regulations re pregnant women regulations re pregnant women consent - Exact answer only the woman needs to consent when the research holds prospect of benefit to the pregnant women, prospect of direct benefit to both, or no benefit when the risk to the fetus is not greater than minimal

Both parents need to consent if the benefit is only to the fetus 21 CFR 50.55 Subpart D (children) exceptions from IRB review - Exact answer - research on normal educational practices that won't adversely affect students' opportunity to learn

  • research that only involves education/cognitive/diagnostic behavior (including recording) provided anonymity of subjects and protection from criminal/civil liability/reputation damage from survey responses
  • rsch with benign behavioral interventions + recording of responses provided anonymity of subjects and protection from criminal/civil liability/reputation damage from survey responses
  • secondary rsch for which consent is not required: uses identifiable private info (provided investigator de-identifies later) or biospecimens
  • rsch conducts or supported by Federal dept. or agency 21 CFR 812 (IDE) - Exact answer Covers procedures for the conduct and shipment of clinical studies with medical devices, including application, responsibilities of sponsors and investigators, labeling, records, and reports. Implant definition - Exact answer device intended to be placed into a surgically or naturally formed cavity of the body if it is to remain there for > 30days (FDA discretion may determine if shorter periods also qualify) non-invasive - Exact answer not involving penetration of the skin (but venipuncture is OK) invasive procedure - Exact answer requires entry of a body cavity or interruption of normal body function How many copies of the signed IDE are submitted? - Exact answer Sp. submits 3 copes of signed IDE app by registered mail or by hand what must a Sp. submit IDE app? - Exact answer Sp. submits an application to FDA if the Sp. intends to use a SR device, conduct an investigation w an expectation from informed consent or if the FDA notifies the SP. that an IDE is required

If Sp. submits IDE w ICF exemption, how long before the FDA will provide written determination? - Exact answer 30 days after receipt of IDE or earlier 21 CFR 50.24 - Exact answer Exception from Informed Consent Requirements for Emergency Research; subj to exemption must be on cover sheet of application contents of IDE application - Exact answer - name + address of Sp

  • complete report of prior investigations + summary of investigational plan or a complete plan if no IRB has reviewed them or upon FDA request
  • descriptions of manufacturing, storage, packing/installation of device
  • agreements from all investigators to comply with invest. obligations + list of names/addresses for all who have signed
  • certification that all investigators have been added t + no more will be added until they have signed the agreement
  • list of that mane, address and chairperson of each IRB that has/will review
  • if device is to be sold, the amount to be charged and an explanation of why sale does not continue commercialization
  • copies of all labeling/forms/information materials/material provided to subj during consenting Investigation Plan Contents (in order for devices) - Exact answer 1. purpose: name + use of device, objective, duration of investigation
  1. protocol
  2. risk analysis to subjs., description of patient population (age, sex, condition)
  3. description of device (components, operation, and anticipated changes)
  4. monitoring procedures + name/address of monitor
  5. labeling (for device)
  6. consent materials
  7. IRB information (name, locations, chairpersons, actions taken w respect to investigation)
  8. other institutions (names + addresses)
  9. add'tl records + reports Re a SR IDE, how long does the Sp have to notify the FDA that they finished the trial and how long to submit the final report? - Exact answer 30 working days; w/in 6 mos

how often are progress reports for all IDEs required and submitted to who?

  • Exact answer at least yearly; IRB how often are progress reports for SR IDEs required and submitted to who? - Exact answer at least yearly; IRB and FDA Re a NSR IDE, how long does the Sp have to submit the final report to the FDA? - Exact answer w/in 6 mos when is unblinding due to an SAE not recommended? - Exact answer if a fatal or serious outcome is the primary efficacy endpoint, integrity of the investigation maybe compromised if the blind id broken who submits progress reports to IRB/FDA for IDE? - Exact answer investigator what must an investigator do if they use a test article for emergency use? - Exact answer must have an independent physician review the reason for use w/in 5 working days and submit documentation to IRB Addt'l recs but not required in ICF - Exact answer - no. of trial participants
  • possibility of unforeseeable risks to subj
  • cost to subj
  • you can be withdrawn from the study by investigator if the choose
  • what happens if the subj. withdraws
  • statement that new findings may affect willingness to participate in study IRB Expedited Review - Exact answer Minimal risk associated with study contains minor changes in previously approved rsch of 1 year or less IRB Exempt - Exact answer minimal risk freely available de-identified data how many members needed for expedited IRB review? - Exact answer only one member required to approve the rsch, if not approved, it must go through full IRB review in order for final disapproval or require changes Requirements for IRB approval for rsch - Exact answer - risks to subjs are minimized
  • risk are in reasonable proportion to benefits
  • selection of subjs is equitable
  • informed consent is properly documented
  • monitoring plan in place for subj data
  • privacy of subj data contents of IRB meeting (if vote was taken) - Exact answer 1. action taken
  1. no of members voting for/against/abstaining
  2. the basis for requiring changes or not approving rsch
  3. written summary of the discussion
  4. list of IRB members by name, degrees, experience, employment/institution documents obtained by IRB prior to study start up - Exact answer - trial protocols/amendments
  • written ICFs
  • subj. recruitment materials
  • investigators brochure
  • safety/compensation info
  • current CVs of investigators quality control related to error - Exact answer checking for errors quality assurance related to error - Exact answer actions to prevent errors according to ICH GCP, how often should the IB be reviewed? - Exact answer annually contents of IB - Exact answer Table of Contents Summary Introduction Physical, Chemical, and Pharm properties non-clinical studies clinical data summary of data investigator guidance Belmont Report (date and 3 main take aways) - Exact answer April 18, 1979
  1. Respect for persons
  2. Beneficence
  1. Justice primary applications of Belmont Report - Exact answer informed consent, assessment of risk/benefit, equitable selection of subjs what was the Belmont report prompted by? - Exact answer Tuskegee Syphilis study Nuremberg Code - Exact answer 1947- a set of ethical principles essential for a medical experiment to be "permissible" What are the 10 points of the Nuremberg Code? - Exact answer 1. voluntary consent
  2. yield results for this good of society, not random or unnecessary in nature
  3. should be based on results from animal studies
  4. avoid unnecessary suffering + injury
  5. no experiments where death or disabling injury is guaranteed
  6. benefits should outweigh risks
  7. proper preparation/adequate facilities provided to protect health + safety
  8. qualified persons performing the study
  9. subj can withdraw at any time
  10. investigator can terminate study at any time Declaration of Helsinki - Exact answer (June 1964) set of ethical principles for human research developed for the medical community by the World Medical Association *est. the need for a LAR how long after a Sp determines that drug present unreasonable + sig risk to subj must they d/c investigation? - Exact answer 5 working days what types of devices are considered IDE exempt? - Exact answer - in commercial distribution before 5/28/
  • diagnostic device that is noninvasive, does not require invasive sampling, doesn't introduce energy and requires the confirmation of another medically established diagnostic product
  • device undergoing consumer preference testing, testing a modification, or testing a combination of 2 marketed devices w no risk to patient

What does CAPA stand for? - Exact answer Corrective and Preventive Action treatment IDE - Exact answer - Sp can apply for treatment IDE where the device can be used on non-trial patients

  • done in serious/life threatening diseases/conditions w no other alternatives existing what records do investigators need to retain in device studies? - Exact answer - all correspondences w other investigators, sponsor, IRB, monitor or FDA
  • records of receipt, use, disposition of device
  • records of case histories + subj exposure to device (CRFs, consent forms, medical records, etc.)
  • the trial protocol what records do sponsors need to retain in device studies? - Exact answer
  • all correspondences w other sponsors, investigators, IRB, monitor or FDA
  • device shipment records w batch #s, dates, quantities
  • signed investigators agreements + FDFs
  • trial info, lift of investigators, IRBs, device risk designation, device use
  • AE records UADE- when does the investigator report? - Exact answer w/in 10 working days to Sp and IRB who determines whether injured participants are compensated? - Exact answer institutional policy (not FDA); MTM risk studies must inform subj. of any compensation + medical treatment available if injury occurs examples of non-scientific IRB members - Exact answer lawyers, clergy, ethicists verbal approval/telephone consent - Exact answer does NOT meet the requirement for signed consent document. A consent form can be sent to a subj/LAR and discussion can be conducted over the phone w subj/LAR but the ICF must be signed and sent back does a copy of the consent also have to have the subjects sig? - Exact answer no, but this is encouraged

FDA does not require a third person besides consenter/consentee Sp is not required to provide model consent when should subjects be informed of chages in the study? - Exact answer protocol amendments must be reviewed and approved IRB first unless immediate hazard to subjects presently enrolled subjects should be informed of the changes if it might affect willingness to continue reconsenting not required SAE reporting - Exact answer immediately report all SAEs to Sp regardless of attribution to drug who does 45 CFR 46 (the common rule) apply to? - Exact answer studies conducted or sponsored by DHHS DHHS - Exact answer U.S. Department of Health and Human Services who does the IRB report to? - Exact answer the investigator and the institution if an investigator wants to carry out an investigation in a foreign country, what do they need to do? - Exact answer - get a translated consent form

  • disclosure to US IRB
  • approval form foreign IRB OHRP - Exact answer Office for Human Research Protections does OHRP carry out routine IRB audits? - Exact answer No, the FDA audits the IRB every 3-5 yrs OHRP audit standards - Exact answer generally conducted in response to complaints, credible allegations, or indications of noncompliance with the Common Rule. define vulnerable study population - Exact answer those subject to undue influence or coersion is quality assurance ICH-GCP or DHHS? - Exact answer GCP

primary responsibility of IRB members - Exact answer prepare and maintain adequate documentation of IRB activities what indicated a certified copy? - Exact answer date + sig DSMB (Data Safety Monitoring Board) - Exact answer reviews safety + Efficacy at defined intervals, can stop a trial, reports sent to Sp 510(k) - Exact answer section of the Food, Drug, and Cosmetic Act that deals with premarket notification (devices) 510(k) requirements - Exact answer requires manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance reports required by PI - Exact answer progress reports annually safety reports (all AEs w assessment of causality) final report when finished financial disclosures sent to Sp clinical trials conducted/supported by Feds and ICFs - Exact answer IRB approved ICF must be posted on a publicly available federal website must be posted no later than 60 days after the last study visit by any sunject decision to disband an IRB - Exact answer written report to OHRP w/in 30 days after review T/F: all adverse drug reactions are subject to expediated reporting? - Exact answer true PI keeps: - Exact answer - source docs

  • signed ICFs
  • subj. recruitment material
  • copies of CRFs
  • subj ID code list
  • subj enrollment log
  • final report to IRB/reg authorities Sponsor keeps: - Exact answer monitoring reports FDFs

samples of IP labels original CRFs audit certificate final close our report responsible for ongoing safety evals of IP CIOMS-I - Exact answer Council for International Organizations of Medical Sciences form for AE reporting; widely accepted as standard cooperative research and IRB - Exact answer single IRB oversees Limited IRB Review - Exact answer Limited IRB review is a process that is required only for certain exemptions and does not require an IRB to consider all of the IRB approval criteria in §46.111. In limited IRB review, the IRB must determine that certain conditions, which are specified in the regulations, are met. things that are subject to limited IRB review - Exact answer - broad consent for storage, secondary research use of info, privacy protections, whether subjs are vulnerable/coercion/undue influence 21 CFR Part 11 - Exact answer Electronic Records; Electronic Signatures 21 CFR Part 50 - Exact answer Protection of Human Subjects 21 CFR Part 56 - Exact answer IRB regulations 21 Part 312 - Exact answer Investigational new drug application 21 CFR Part 812 - Exact answer Investigational Device Exemptions (IDE) 21 Part 50 sub part B - Exact answer Informed consent of human subjects The principle of justice in the Belmont report relates to... - Exact answer Distribution of burdens and benefits Respect for persons and the Belmont report relates to... - Exact answer Decision on the part of subjects to voluntarily participate or not in the research

Which of the following is cited as an influence in the Belmont report? A. The Milgram study B. The tea room trade study C. Nuremberg war crimes trial involving Nazi medical experiments - Exact answer c Which of the following is cited in the principle of justice as exemplifying an injustice in the Belmont report? - Exact answer Tuskegee study If an investigator does not obtain consent from his subjects, the principle in the Belmont that is violated is? - Exact answer Respect for persons The IRB should refer to the principle of beneficence in the Belmont report when it is evaluating what? - Exact answer Risk benefit ratio The Belmont report addresses? A. Compensation for medical injury B. Guidelines for conflict of interest C. Differences between practice and research D. Disclosure of incidental findings - Exact answer C The Belmont report was formulated by what body and for what? - Exact answer The national commission for the protection of human subjects in biomedical and behavioral research The commission that formulated the Belmont report was created as a part of? - Exact answer The national commission of 1979 Withdrawal of subjects from a research study implies that a) Activities involving interaction or intervention must cease b) Accessing identifiable private information about the subject be discontinued c) Observation or recording of private behavior must be stopped d) All of the above - Exact answer d) All of the above A subject withdrawing from a primary intervention component may still opt to continue secondary interventions which can include a) Activities that involve interventions other than those of the primary student interaction, including radiography and venipuncture

b) Accessing private information including medical, educational or social service agency records c) Participation in studies required to monitor the long term safety of the subject. d) All of the above - Exact answer D If an investigator terminates a subjects participation in a clinical trial, according to OHRP guidance, the investigator should: - Exact answer Ask the subject if participation and secondary interventional component should continue A subject who has withdrawn from a research study requests that all of their data be destroyed. According to OHRP guidance the investigator should: - Exact answer Choose to honor the request after consultation with NIH, FDA and the appropriate regulatory agency When a subject withdraws from the research study, the investigator should according to OHRP guidance: a) Document whether the withdrawal was a decision of the subject or the investigator b) Document whether the withdrawal applied to both the primary and secondary components of the research c) Report the matter to the IRB depending on the prevailing institutional policy d) All of the above - Exact answer D According to the FDA, when a subject withdraws from a clinical trial: - Exact answer All data collected up to the time of withdraw must remain in the clinical trial database in order for the study to be scientifically valid The ability of the investigator to retain and analyze the data of a withdrawn subject even if the data includes identifiable information is permitted in which governing body regulations? - Exact answer The FDA regulations but not in DHHS regulations According to HIPAA if the research subject revokes an HIPAA authorization

  • Exact answer The revocation has to be in writing and the revocation does not affect use or disclosure of data prior to the revocation

According to OHRP guidance the informed consent element that the subject may discontinue participation at any time: A. Can be stated without any reservations B. Must be explained with regard to data retention in light of the prevailing FDA, DHHS & HIPAA regulations C. Will be honored by destroying all data D. Can be overruled by the investigator even if the subject requests it - Exact answer b) Must be explained with regard to data retention in light of the prevailing FDA, DHHS and HIPAA regulations Exemptions for IRB review - Exact answer Before July 27, 1981 or if emergency use What IRBs must register? - Exact answer HIV in the US that reviews clinical investigations regulated by FDA must register at a site maintained by the department of health and human services (HHS). All other IRB's may register voluntarily What information must an IRB register? - Exact answer 1. The name, mailing address, and street address of the institution operating the IRB and the name, mailing address, phone number, fax number and email of the senior officer of that the institution is responsible for overseeing

  1. The IRB's name, mailing address, street address, phone number, fax number, email address each IRB chair persons name, phone number, email address and the name, mailing address, phone number, fax number, email address of the contact person providing their registration info
  2. The approximate number of active protocols involving FDA regulation
  3. A description of the types of FDA regulated products involved in the protocols How often must each IRB renew its registration with HHS? - Exact answer Every three years How does an IRB revise its contact information? - Exact answer If an IRB's contact or chairperson information changes, the IRB must revise its registration info by submitting any changes within 90 days of the change. How does an IRB revise its review information? - Exact answer An IRB's decision to review new types of FDA regulated products, or to discontinue reviewing investigations regulated by FDA must be reported within 30 days

of the change. Decision to disband is a change that must be reported within 30 days of permanent cessation all other info changes may be reported when the IRB renews its registration If an IRB invites an individual with competence in a special area to assist and a review of complex issues which require expertise beyond or an addition to the available on the IRB can these individuals vote with the IRB? - Exact answer No How many votes does the research need for the IRB to approve? - Exact answer The majority at the meeting If an IRB decides to disprove a research activity, how is the notification going about? - Exact answer The IRB should provide written notification that includes a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. Who reviews IRB expedited research? - Exact answer The IRB chair person or by one or more experienced reviewers designated by the IRB chair person from among the members of the IRB Can research be disapproved during an expedited IRB review procedure? - Exact answer No, research activity may be disapproved only after review in accordance with the non-expedited review procedure When may the FDA restrict, suspend, or terminate in institutions or IRB's use of expedited review? - Exact answer When necessary to protect the rights and welfare of subjects Criteria for IRB approval of research (seven) - Exact answer 1. Risk to subjects or minimized

  1. Risks to subjects are reasonable in relation to anticipated benefits (the IRB should not consider long-term range effects of applying knowledge gained in the research)
  2. Selection of subjects is equitable
  3. Informed consent will be sought from each subject or it's LAR
  4. Informed consent will be appropriately documented
  5. Research plan makes adequate provision for monitoring data collected to ensure safety of subjects
  1. There are adequate provisions to protect the privacy of subjects in maintain confidentiality of data What should the central focus of the initial IND submission be? - Exact answer The general investigational plan and the protocols for specific human studies