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2025 SOCRA CCRP Exam with Answers (ANS) Graded: A+ _______ may request to review documentation and reports from ________ - ANS FDA request from investigator (who should permit the request) ________ can transfer responsibilities to CRO - ANS sponsor __________ must notify ________ and ________________ of safety risks regarding an IND within _____ days - ANS sponsor must notify FDA and investigators within 15 calendar days ___________ must report study endpoints to __________ - ANS sponsor to FDA ___________ reports emergency use to __________ within ______ days - ANS investigator to IRB in 5 working days _____________ is responsible for providing Investigators brochure to ______________ and then they provide it to __________________ - ANS sponsor to PI and then PI to IRB _____________ of a treatment IDE shall submit progress reports on a ____________ basis to ____________ until filing marketing application - ANS sponsor must submit on a semi-annual basis to reviewing IRBs and FDA (after submitting marketing app reports become annual) ___________________ was created after the Tuskegee trial - ANS Belmont Report "active protocol" - ANS initial review and continuing review every 12 months 2 methods to reduce/avoid bias - ANS randomization and blinding 2 reasons for inactive status - ANS 1) IND is under clinical hold for 1+ year
- no subjects enrolled for 2+ years 2 specialized regulatory organizations - ANS 1) Center for Drug Evaluation and Research (CDER)
- Center for Biologics Evaluation and Research (CBER) 21 CFR Part 314 - ANS Applications for FDA Approval to Market a New Drug 21 CFR Part 814 - ANS Premarket Approval of Medical Devices 3 elements of ICF according to Belmont Report - ANS 1) information (benefits and risks)
- comprehension (may include comprehension tests)
- voluntariness
45 Code of Federal Regulations part 46 Subpart B - ANS additional protections for pregnant woman, human fetuses, and neonates involved in research conducted or supported by Department of Health and Human Services (DHHS) 45 Code of Federal Regulations part 46 Subpart C - ANS additional protections pertaining to research conducted or supported by Department of Health and Human Services (DHHS) involving prisoners as subjects 45 Code of Federal Regulations part 46 Subpart D - ANS additional protections pertaining to research conducted or supported by Department of Health and Human Services (DHHS) involving children as subjects acceptable risk level for mother and fetus - ANS no greater than minimal risk and consent of both parents required According to _________ how long should IRB records be retained? - ANS 45 Code of Federal Regulations Part 46: Public Welfare, 3 years According to the Declaration of Helsinki, while the primary purpose of medical research is to ____________________, this goal can never take precedence over the ___________________ - ANS generate new knowledge; rights and interests of individual research subjects adverse drug reaction (ADR) - ANS all noxious and unintended responses to a medicinal product, causal relationship is at least a possibility adverse event - ANS any untoward medical occurrence associated with the use of a drug (whether or not it is related to drug) All ADRs that are ___________ and ___________ are subject to expedited reporting - ANS serious and unexpected (Does not need to be reported if serious but expected) An IRB may waive the requirement for an investigator to obtain signed consent for some or all subjects if?? - ANS 1) that the consent would be the only linking document resulting in potential harm from breach of patient confidentiality
- research presents no more than minimal risk and involves no procedures for which consent is normally required outside of research assent - ANS child's affirmative agreement to participate in research, parental permission is still required assessment of risk and benefits: What are the 3 factors? - ANS 1) determination of validity of presuppositions of research
- nature, probability and magnitude of risk
coercion - ANS when an overt threat of harm is intentionally presented in order to obtain compliance cooperative research - ANS projects involving one or more institution, each is responsible for safeguarding the rights and welfare of human subjects but must rely on approval of only ONE IRB Cooperative research projects with multiple institutions should enter into what? - ANS joint review agreement and rely on IRB of another institution coordinating committee - ANS A committee that a sponsor may organize to coordinate the conduct of a multicenter trial (with coordinating investigator) CRF 56.110 Subpart D - ANS FDA may restrict, suspend, or terminated institution's or IRB's use of expedited review to protect rights and wellbeing of subjects CRO - ANS Contract Research Organization, contacted by sponsor to perform one or more of sponsor's trial-related duties dead fetus - ANS no heartbeat, respiratory activity, muscle movement, or pulsation of umbilical cord Declaration of Geneva - ANS a declaration of physicians' dedication to the humanitarian goals of medicine, a declaration that was especially important in view of the medical crimes which had just been committed in Nazi Germany Declaration of Helsinki - ANS 32 principles regarding research compared to normal medical care and distinction of benefit to patients and/or research Declaration of Helsinki physician statement - ANS the health of my patient will be my first consideration and I shall act in the patient's best interest when providing medical care define immediately life-threatening/severely debilitating - ANS major irreversible morbidity (high likelihood of death) dissent - ANS when a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, legal rep must also approve distinction of expected vs unexpected AEs - ANS from perspective of previously observed, not on basis of what might be anticipated from pharmalogical properties unexpected=not consistent with info in relevant source docs
Do placebo reactions fall under ADR, for expedited reporting, or neither? - ANS Neither emergency use - ANS use of test article when the situation is life-threatening and there is no standard acceptable treatment available, with no time to obtain IRB approval Ethical principles from ICH GCP draw from which document? - ANS Declaration of Helsinki Examples of research that can utilize expedited review - ANS research involving no more than minimal risk, minor changes in approved research Fatal or life threatening ADRs should be reported within ___________ calendar days and complete report should be sent within ________ additional calendar days to regulatory agencies - ANS 7; 8 FDA 45 Code of Federal Regulations Part 46 - ANS public welfare/protection of human subjects (with general ICF requirements) FDA 50.5 Part D - ANS obtaining assent form children (cannot be greater than minimal risk) FDA 56.110 - ANS Expedited review procedures for research with no more than minimal risk and for minor changes in approved research FDA form 1572 - ANS investigator statement FDA form 312.64 - ANS Investigator reports:
- progress
- safety
- final
- financial disclosure FDA Form 3454 - ANS Certification - Financial Interests and Arrangements of Clinical Investigators FDA Form 3455 - ANS Disclosure - Financial Interests and Arrangements of Clinical Investigators FDA Form 3500 - ANS For Voluntary Reporting of Adverse Events and Product Problems FDA form 3500 vs 3500A - ANS 3500: voluntary reporting any AE to FDA 3500: mandatory reporting of drug or medical device AE to FDA
-unqualified PI -misleading investigator brochure -IND does not contain sufficient info to assess risks -reproductive toxicity risk -other major safety issues HHS - ANS Health and Human Services How and why to break blinding of a patient - ANS if a serious AE is judged to be reportable, only break blind for one patient and only to those who need to know (not statisticians) How long is IRB registration effective for? - ANS 3 years How long should investigator or sponsor maintain records? - ANS 2 years How often do IRB's have to renew registration? - ANS every 3 years How soon do sponsors have to report any fatal or life-threatening AEs? - ANS within 7 days of initial notification How soon should documentation be submitted to IRB after emergency use? - ANS within 5 days ICF should contain - ANS 1) explanation of purpose, duration of subject participation, etc.
- any possible risks
- any possible benefits
- alternative treatments
- confidentiality and possibility of FDA inspection
- contact info
- participation is voluntary
- removal of PHI from biospecimens and if they will include genome sequencing
- details of termination/option to withdraw ICF should not include _____________ - ANS exculpatory language in which subject waives legal rights or releases investigator/sponsor/institution from liability of negligence ICH - ANS international conference of harmonisation ICH GCP guidance is the current thinking/recommendation of whom? - ANS FDA (recommendation, not legally enforcable) ICH Harmonised Guideline for Good Clinical Practice E6 (R2) - ANS describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs.
cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator's Brochure which had been agreed earlier through the ICH process IDE approval - ANS permits the use of a device that would otherwise be required to comply with performance standards or have premarket approval to conduct investigation, cannot be significant risk device IDE cannot be ______________________ device - ANS significant risk device IDMC - ANS Independent Data Monitoring Committee IEC - ANS Independent Ethics Committee, includes IRBs If a device is recalled, ___________ should notify ____________ withing _________ days - ANS sponsor should notify FDA within 30 days If a patient chooses to withdraw, this should not affect ____________ - ANS patient- physician relationship If a sponsor transfers any or all of its duties or functions to a CRO who is ultimately responsible for the quality and integrity of the trial data? - ANS sponsor If a trial is single blind, who is blinded: patient or PI/treatment team? - ANS patient If an ADR is serious and expected appears to have an increase in the rate of occurrence that is clinically important, does it meet standards for expedited reporting? - ANS yes (affects the benefit/risk product assessment and use in the trial) If an auditor identifies noncompliance, what should they do? - ANS sponsor should take action and perform root cause analysis, then implement corrective and preventative measures If an IDE is approved, what is it exempt from? - ANS the requirements of the following sections of Federal Food, Drug, and Cosmetic Act: -Misbranding under section 514 -Premarket approval under section 515 -Banned device regulation under section 516 -Records and reports under section 519 -Restricted device and manufacturing practice requirements under section 520 If an IND is on a clinical hold for more than one year, ______________________________ - ANS it is place on inactive status by FDA If IRB terminates, who do they inform? - ANS PI, and PI informs sponsor
c. Contact information for the sponsor of the investigational drug/device d. A description of the investigator's responsibilities - ANS b. An explanation of the purpose of the investigation injustice - ANS when some benefit to which a person is entitled is denied without good reason or when burden is imposed unduly investigator vs. sponsor vs. sponsor-investigator - ANS I: conducts trial S: initiates trial (manages and finances) S-I: conducts and initiates trial Investigator's Brochure - ANS 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. IP must provide what in protocol? - ANS -drug substance and formula -effects on animals and humans -safety and effectiveness -possible risks and side effects -pharma and toxicology reports (any in vitro and effects on fetus) -radioactivity and absorption of dose IRB - ANS Institutional Review Board; designated to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects IRB 312 subpart E - ANS Drugs Intended to Treat Life-threatening and Severely- debilitating Illnesses IRB must register and comply with ________ and ___________ - ANS Office of Human Research Protection; and Health and Human Services IRB must send any info changes within ____ days of change - ANS 90 IRB requirements - ANS 1) at least 5 members
- 1 member whose primary concerns are in the scientific area
- 1 member whose primary concerns are in a nonscientific area
- 1 member not affiliated with the institution
- no IRB members can have conflicts of interest
- the IRB can invite individuals with expertise in complex areas IRBs when prisoners are involved - ANS majority should not be associated with the prison but one member of the board shall be a prisoner or prisoner rep Is centralized monitoring on or off site? - ANS remote evaluation of accumulating data performed in a timely manner, supported by appropriately qualified and trained people, can reduce time needed to monitor on-site
List 4 situations that must be reported by investigator to sponsor within 5 working days.
- ANS 1) withdrawal of IRB approval
- deviations
- not obtaining ICF
- significant risk device determinations minimal risk - ANS probability and magnitude of harm and discomfort are not greater than those encountered in day-to-day life minimum number of IRB members - ANS 5 multicenter trial has one ______ and multiple ______ - ANS one protocol and multiple sites neonate - ANS newborn noninvasive - ANS when applied to diagnostic device or procedure, device does not penetrate or pierce the skin or mucous membranes of the body or enter in any other location nontherapeutic trials - ANS trials with no anticipated direct clinical benefit to subject; subject should be able to consent without legal rep unless subject cannot consent and risk is low nonviable neonate - ANS a neonate after delivery that, although living is not viable Nuremberg Code - ANS ethical code of conduct of ten principles for research that uses human subjects OHRP - ANS Office for Human Research Protections Overall aim of Investigator's Brochure - ANS to provide investigators with clear understanding of possible risks and adverse reactions relative to the clinical study Phase 4 studies - ANS post market studies that may reveal additional side effects, adverse effects and drug interactions Primary purpose of trial monitoring - ANS 1) rights and well-being of human subjects
- accurate, complete, and verifiable data
- compliance with protocol and GCP Protocol deviation and/or protocol amendment must be submitted to: - ANS IRB, sponsor, and any other regulator authorities
Sponsor responsibilities if FDA approval is withdrawn - ANS sponsor shall notify IRBs and investigator within 5 working days Sponsor responsibilities if IRB approval is withdrawn - ANS sponsor shall notify FDA, IRBs, and investigator within 5 working days sponsor should keep IP records for how long? - ANS 2 years suspected AE - ANS reasonable possibility drug caused AE, causal relationship T or F: Adverse events must have a causal relationship with IP. - ANS False, AE is any untoward medical occurrence while a patient is in a trial- may or may not be causal T or F: both sponsor and PI need IRB approval documents, even though PI is in direct communications - ANS True both need approval from IRB The Common Rule - ANS 1980s: HHS protection of human subjects 2018: updated to include biospecimen and data The investigator should give the final report to ________________ within ______________________ following study completion. - ANS to sponsor within 3 months to socially balance justice and benefits/risks, ...? - ANS research should specify who and should not participate based on the buren to bear Tor F: Countries are not to stockpile investigational drug as this prevents access of the drug to other countries. - ANS False: IND may be stockpiled in anticipation of national emergency with approval from FDA and HHS Tor F: injustice specifically pertains to the study in question - ANS false, it goes beyond the study and is societal True of False: if a device is IDE and IRB has been notified, it can be marketed - ANS false, and it must be labeled with "Caution" True or False: As long as there is a potential for benefit, extremity of risk does not matter - ANS risk must be reasonable in relation to anticipated benefits True or false: if sponsor terminates, they should inform the PI and IRB. - ANS False, then inform PI and PI informs IRB True or False: Since the PI is primary in communicating with the IRB, it is not necessary for any contact between sponsor and IRB. - ANS False, sponsor should obtain contact info about IRB from the PI or institution
True or False: Sponsor is not required to submit annual reports for INDs of inactive status. - ANS True, and they must submit an amendment if they wish to become active again Tuskegee Syphilis study - ANS 600 low income Black men not told they had syphilis but were given free medical care. Denied treatment for trial unanticipated AE must be reported by ___________to _______________in ________ business days - ANS investigator to sponsor in 10 days and then sponsor to FDA within 10 working days Undue Influence - ANS offer of excessive, unwarranted, inappropriate, or improper reward in order to obtain compliance (often occurs when one person is in position of authority) unexpected ADR - ANS an adverse event that is not consistent with Investigator's Brochure unexpected AE - ANS if not listed in investigator brochure, not specifically observed, or not consistent with risk info Unjustifiable pressures - ANS often occur when people are in positions of authority or have commanding power Upon trial completion, who informs IRB? - ANS investigator viability and research - ANS research will have no part in determining viability. viability must be determined prior to participation Vulnerable people - ANS children, prisoners, pregnant women, physically or mentally disabled people, economically or educationally disadvantaged people What are exceptions to ICF general requirements? (for emergency use with IRB approval) - ANS 1) life-threatening situation necessitating use of test article
- patient cannot communicate
- insufficient time to communicate with legal representative
- no alternative treatment with equal or greater likelihood of saving subject's life What countries recognize ICH GCP? - ANS EU countries, Japan, and US (guidance was developed using GCP from US, EU, Japan, Canada, Australia, and WHO) What is MedWatch? - ANS a voluntary FDA adverse event reporting system, should include reporting person, AE details, product details, affected person demographics, manufacturer info
When obtaining informed consent, the PI should adhere to _____________ and the ethical principles that have their origin in ________________. - ANS GCP and Declaration of Helsinki When to protocol, content, investigator, etc. Changes need to be submitted as amendments? - ANS 30-day intervals prior to implementation Where is the Common Rule? - ANS 45 CFR Part 46; protects human subjects under HHS Who conducts audit? - ANS sponsor selects people who are independent of trial and qualified Who has the power to disqualify an IRB? - ANS the Commissioner, notice is then sent to FDA Who is responsible for making sure IRB complies with part 56? - ANS investigator Who is responsible for the protection of research subjects? - ANS medical physicians and professionals, not the subject Who must review safety info of investigational drug? - ANS sponsor Who provides annual reports and when? - ANS sponsor, within 60 days of IND anniversary Who selects monitors? - ANS sponsor Who should report protocol deviations to IRB? - ANS investigator Who signs short form? - ANS patient and witness; PI and witness also sign summary Who wrote the Belmont Report? - ANS National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Why should an individual be given ample time and sufficient opportunity to consider whether or not to participate? (2 reasons) - ANS 1) minimize coercion
- understandable language With respect to IRB/IEC membership, both the FDA and the ICH require that a. A majority of the members' primary area of interest is in a scientific area b. At least one member holds a Ph.D. degree or equivalent c. At least one member's primary area of interest is in a nonscientific area d. A majority of the members are from or have ties to the institution of record - ANS c. At least one member's primary area of interest is in a nonscientific area
