ACRP-CP Certification Exam (Latest Update 2024/2025) Verified Solutions 100%, Exams of Law

Download ACRP-CP Certification Exam (Latest Update 2024/2025) Verified Solutions 100% and more Exams Law in PDF only on Docsity! What would be the first priority for an inves6gator when a subject wishes to withdraw prematurely from the trial? Try to obtain the subject's reason for withdrawal. Cro recently switched from paper crf to an edc system. The edc system must conform to the established requirements for Valida6on accuracy reliability completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to Maintain an audit trail, data trail, and edit trail. A research subject's responsibili6es for study par6cipa6on should be described in the Icf What document would an inves6gator reference to learn more about the previous clinical and nonclinical results of studies of the ip? Inves6gators brochure During a mul6 site clinical study: whose responsibility is it to report subject recruitment rate? ACRP-CP CERTIFICATION EXAM (LATESTST UPDATE 2024/2025) VERIFIED SOLUTIONS 100% The cra An unconscious adult subject was enrolled in a study aIer obtaining consent from an lar: and protocol therapy was ini6ated. The subject showed significant improvement in his clinical condi6on: and regained consciousness. The inves6gator should inform the subject about the study and Obtain consent from the subject for the study A site is in the start up phase of an industry sponsored phase 3 trial: and has received irb approval. The site can begin enrolling subjects aIer... A signed clinical trial agreement between the site and sponsor is in place. A site is screening poten6al subjects for a study looking at mild cogni6ve impairment. One of the inclusion criteria is a score of 25 or less on a psychometric test: a research specific tool which measures cogni6ve ability. Which of the following individuals can administer the psychometric test to the poten6al subjects? A research assistant who is cer6fied to administer the psychometric test A research study: in which there is no intended clinical benefit to the subject: is being submiOed to the irb. What benefit informa6on should be included in the icf? Wording indica6ng that there is no expected benefit should be included A cra no6ces during an onsite visit that the date on irb approval leOer for a protocol is prior to the effec6ve date indicated on the cover page of the protocol and the signatures of the inves6gator and sponsor. What should the cra do first? Confirm dates of ini6al receipt of the sponsor protocol and the irb submission dates. What event resulted in the nuremburg cod of 1949 Nazi medical experiments Prior to archiving a study: documenta6on of ip destruc6on at the site should be filed in the study files of the Pi and sponsor In the case of an incapacitated subject: who should receive a copy of the signed and dated icf? The subject's legally acceptable representa6ve Which of the following required elements should be included in a clinical trial protocol? The subject inclusion and exclusion criteria During a mul6-site clinical study: whose responsibility is it to report subject recruitment rate? The cra A study which seeks to determine the ideal dose and regimen of a new ip to treat hypothyroidism is considered to be Phase ii What document would an inves6gator reference to learn more about the previous clinical and nonclinical results of studies of the ip? Ib When considering par6cipa6on in a study: the inves6gator should determine if he/she Sees enough pa6ents who would qualify for the study When would an impar6al witness be needed during the consent process for an illiterate subject? To observe the consent process During a monitoring visit: what records would a cra reference to verify a subject's compliance to the study visit schedule and assessments? Electronic medical record A site is screening poten6al subjects for a study looking at mild cogni6ve impairment. One of the inclusion criteria is a score of 25 or less on a psychometric test: a research-specific tool which measures cogni6ve ability. Which of the following individuals can administer the psychometric test to the poten6al subjects? A research assistant who is cer6fied to administer the psychometric test A research study: in which there is no intended clinical benefit to the subject: is being submiOed to the irb/iec. What benefit informa6on should be included in the icf? Wording indica6ng that there is no expected benefit should be included. A research subject's responsibili6es for study par6cipa6on should be described in the Icf New safety informa6on has become available from the sponsor about the ip being used in a clinical trial. The inves6gator must Submit a revised icf to the irb/iec no6ng the new safety informa6on. A medical student is approached by a faculty member for possible par6cipa6on in a cricothyroidotomy simula6on research study. Which of the following increases risk to the subject? Consen6ng in the presence of figure of authority What would be the first priority for an inves6gator when a subject wishes to withdraw prematurely from the trial? Try to obtain the subject's reason for withdrawal. A blood sample collec6on is required to screen for bloodborne pathogens before subject could be enrolled in a study. Where will subjects find informa6on of the procedures and any foreseeable risks or inconveniences? Icf Per ich: an irb/iec must keep correspondence for at least how long aIer the comple6on of a clinical trial? 3 years A cra no6ces during an onsite visit that the date on irb/iec approval leOer for a protocol is prior to the effec6ve date indicated on the cover page of the protocol and the signatures of the inves6gator and sponsor. What should the cra do first? Confirm dates of ini6al receipt of the sponsor protocol and the irb/iec submission dates. A cro recently switched from paper crf to an edc system. The edc system must conform to the established requirements for Valida6on, accuracy, reliability, and completeness. When should a research study involving human subjects be registered in a publicly accessible database? Before recrui6ng the first subject An unconscious adult subject was enrolled in a study aIer obtaining consent from an lar: and protocol therapy was ini6ated. The subject showed significant improvement in his clinical condi6on: and regained consciousness. The inves6gator should inform the subject about the study and Obtain consent from the subject for the study. AIer comple6on of a study: the final trial close-out monitoring report prepared by the cra should be filed in which of the following stakeholder files? The sponsor's files What is the 6meframe for "expedited" repor6ng of serious: fatal or life- threatening: unexpected adverse drug reac6ons to regulatory authori6es? As soon as possible, but no later than seven calendar days aIer first knowledge of the event The term "severe" in ich is used to describe The intensity of a specific event All cases judged by either the repor6ng health care professional or the sponsor as having a reasonable suspected causal rela6onship to the medicinal product qualify as Adverse drug reac6ons Which of the following criteria is described in ich-gcp as necessary for classifying an adverse event (ae) as an adverse drug reac6on (adr)? That a causal rela6onship is at least a reasonable possibility A subject has a suspected serious adverse drug reac6on with the outcome of death. Which are items that should be submiOed to the sponsor? 1. A de-iden6fied autopsy report: if available 2. Cause of death: and a comment on its possible rela6onship to the suspected drug reac6on What is the purpose of an ini6a6on visit? 1. To review the protocol 2. To review research site's sops 3. To review the blank crfs The process by which a subject voluntarily confirms his or her willingness to par6cipate in a clinical trial is known as Informed consent process T or f- the irb/iec may request addi6onal informa6on be given to subjects when: in the judgment of the irb/iec: it would add meaningfully to the protec6on of the rights: safety and/or well-being of the subjects. True The irb/iec should consist of a reasonable number of members: who collec6vely have the qualifica6ons and experience to review and evaluate the science: medical aspects: and ethics of the proposed trial. It is recommended that the irb/iec should include 1. At least five members 2. At least one member whose primary interest is non-scien6fic 3. At least one member who is independent from the ins6tu6on/trial site Which of the following is not one of the required elements of an informed consent form? A lis6ng of all site personnel who will be involved in the research How can an adverse drug reac6on (adr) be defined? As a noxious and unintended response to the inves6ga6onal drug Who is most responsible for the appropriate monitoring of clinical trials? Sponsor You are asked to monitor a study for another coordinator. In looking for the changes made in the source document you want to see which of the following 1. Unobscured original entries 2. Traceable source documents 3. An audit trail A clinical research coordinator (crc) adjusted the dose of the inves6ga6on product (ip) for a subject as the subject was suffering from adverse events (aes) like headaches and vomi6ng. When is a crc allowed to do this task? Only when the crc is a qualified physician and has been delegated this responsibility by the pi You are in the role of study manager for the sponsor. One of your monitors reports significant noncompliance at a site. The first course of ac6on you implement is that a __________ be conducted. Root cause analysis A subject: who has been 100% compliant thus far has forgoOen to bring her medica6on back to the clinic for her regular visit. She reports that she has not missed any doses and has been fully compliant with the protocol. What is the most appropriate ac6on for the inves6gator/clinical research coordinator to take? Document that the subject has forgoOen to return her medica6on in the source document and ask her to bring the medica6on back to the clinic as soon as possible or during her next visit If sponsor's aOempts to secure compliance have failed: and the monitoring/audi6ng iden6fies serious and/or persistent noncompliance on the part of an inves6gator/ins6tu6on: the sponsor should 1. Promptly no6fy the regulatory authority(ies) 2. Terminate the inves6gator's/ins6tu6on's par6cipa6on in the trial Essen6al documents should be retained at least ______ aIer the last approval of a marke6ng applica6on: or formal discon6nua6on of clinical development of the inves6ga6onal product. 2 years What is the purpose of the irb/iec? Safeguard the rights: safety: and well-being of all trial subjects Which of the following should the inves6gator do first if a serious adverse event (sae) occurs? When the inves6gator and sponsor staff who are involved in the treatment or clinical evalua6on of the subjects and analysis of data are unaware of the treatment assignments According to ich e8 what type of study would have the following elements? Adequate: and well controlled studies to establish efficacy 1. Randomized parallel dose response studies 2. Clinical safety studies 3. Studies of mortality/morbidity outcomes 4. Large simple trials -therapeu6c confirmatory Your inves6gator wants to par6cipate in a phase 3 pharmacokine6cs study. Pharmacokine6c studies are commonly conducted in later phases to answer what ques6ons? 1. Food effects on bioavailability 2. Informa6on in sub-popula6ons such as pa6ents with impaired elimina6on 3. Drug to drug interac6ons A trial where the treatment assignment is not known by the study par6cipant because of the use of placebo or other methods of masking the interven6on: but the study team knows Single blind A new study is inves6ga6ng a new ind "glue" that can be used to hold skin cuts together and decrease the chance of scaring. You know children should be included because ich e8 considers them a special popula6on. In designing the protocol you should expect to Include children in the general plan from the beginning Per ich e8: methods used to evaluate pa6ent usage of the test drug should be Specified in the protocol and actual usage documented Which trial design is used for the specific purpose of examining the interac6on of a and b? Factorial design T or f- the data and safety monitoring board (dsmb) is a separate en6ty from an ins6tu6onal review board (irb) or an independent ethics commiOee (iec)? True What is the purpose of the "data and safety monitoring board (dsmb)?" To assess the progress of a clinical trial: the safety data: and the cri6cal efficacy endpoints T or f- the focus of ich e9 is on sta6s6cal principles: however: it does not address the use of specific sta6s6cal procedures or methods. True For a randomized trial: the following is true 1. The procedure to be followed: the necessary documenta6on: and the subsequent treatment and assessment of the subject should all be described in the protocol 2. Helps to avoid possible bias in the selec6on and alloca6on of subjects arising from the predictability of treatment assignments Data and safety monitoring boards (dsmbs) have the power to recommend which of the following? 1. That the sponsor should con6nue the trial 2.that the sponsor should modify the trial 3. That the sponsor should stop the trial You need to maintain the blind in a clinical study. Which of the following op6ons might you use when administering supplies in the clinical trial? Double-dummy Which variable in a study should be used to determine the sample size? Primary variable You are wri6ng an inves6gator-ini6ated clinical research protocol and you need to limit the occurrence of conscious and unconscious bias. Which of the following methods may be used? 1. Single-blind 2. Masking 3. Double-blind You are reading the findings of a clinical trial on hair loss and use of shampoo. You note in the final analysis that data was extrapolated from the subjects who par6cipated in the trial to a broader pa6ent popula6on and a broader range of clinical seongs. This is known as Generaliza6on The inves6gator at your site asked you to review a protocol. The inves6ga6onal product listed in the protocol already has proven clinical benefits for the disease under study. This is considered what type of trial? Confirmatory trial You are designing a cross-over study. Cross-over designs have a number of problems that can invalidate their results. The chief difficulty concerns __________: that is: the residual influence of treatments in subsequent treatment periods. Carryover effect Missing data points (values) represent a poten6al source of bias in a clinical trial. (true or false) True What study variable takes in the considera6on the decision making process of the trea6ng physician: who must weigh benefit and risk in making product use decisions. You are evalua6ng a pediatric protocol for a new drug. When reviewing the drug clearance data it is important to know that hepa6c and renal func6ons are first mature in which of the following defined group? Children Non-compliance is a special problem in this age group. Adolescents The pediatric popula6on represents a vulnerable subgroup. Therefore: special measures are needed to protect the rights of pediatric study par6cipants and to shield them from undue risk. Which of the following should be taken into considera6on? 1. Recruitment 2. Consent and assent 3. Minimize risk 4. Minimize distress During clinical development: the 6ming of pediatric studies will depend on 1. Medicinal produc 2. Type of disease being treated 3. Safety considera6ons 4. Efficacy and safety of alterna6ve treatments What does ich e11 say about long-term surveillance of children in clinical trials? It may be needed to determine the possible effects on development When each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment comparisons Crossover When subjects are randomized to 1 of 2 or more arms: each arm being allocated a different treatment. Each treatment will include their inves6ga6onal product at one or more doses: and one or more control treatments: such as placebo and/or an ac6ve comparator Parallel A sponsor is developing an ip for treatment of a medical condi6on where there is one addi6onal marketed product approved for treatment of the condi6on. The sponsor believes their product works as well or beOer than the current treatment with fewer side effects. What is the most-likely study design they will use to test the efficacy of the ip? Non-inferiority What type of clinical trial most likely requires enrollment of the largest number of research subjects? Therapeu6c confirmatory (aka pivotal trial: ph iii: or compara6ve efficacy) Minimum number of membors on an irb/iec 5 (... Lay people and medical professionals can be part of the irb/iec) Who is responsible for providing the protocol The sponsor The purpose of the siv is to 1. Review standard procedures 2. Review the protocol 3. Review the blank ecrfs: minimum sae repor6ng requirements 4. Subject details (id not name) 5. Ip 6. Interven6ons for the event that is being reported 7. Details of the event 8. Details on the reporter of the event 9. Admin and sponsor or company details Vulnerable subjects 1. Junior members of the medical profession 2. Employees of a pharmaceu6cal company 3. Military personnel 4. Pregnant women 5. Prisoners Irb/iec evaluates 1. The rights: safety: and well-being of the subjects par6cipa6ng in the trial 2. The subject selec6on procedure 3. The scien6fic tenability of the trial Serious adverse event (sae) 1. Results in death: is life threatening 2. Requires inpa6ent admission 3. Prolonged admission 4. Congenital anomaly 5. Persistent incapacity 6. Death itself is not neccessarily an sae* 7. Must be reported by sponsor to authori6es within 15 calendars days from sponsors first knowledge of the event *seriousness does not equal severity in that serious requires repor6ng while severe may not.. Severe may just be used to describe an ae Adverse drug reac6on (adr) 1. All noxious and unintended response that is related to any dose 2. If the reac6on is possibly: probably: or definitely related to the drug: it is considered an adr 3. All adrs must be documented 4. Adrs are not always aes When should research studies involving human subjects be registered in a publicly accessible database Before recrui6ng the first subject Any changes to safety language in an ib should be submiOed to the irb/iec (t/f) True All sae's must be life-threatening to be considered an sae opposed to ae (t/f) True AIer comple6on of a study: where should the final trial close-out monitoring report prepared by the cra be filed? In the sponsor's files During a mul6-site clinical study: whose responsibility is it to report subject recruitment rate? Cra (monitor) What is the inves6gator's first priority when a subject wishes to withdraw prematurely from the trial? To obtain the subject's reason for withdrawal Crc's can't adjust ip dose: even if they are a qualified physician (t/f) False. If a crc is a qualified physician they can adjust ip dose Following unblinding in the case of a suspected serious unexpected adverse drug reac6on: the treatment assigned to the subject turns out to be the comparator product. Who should the sponsor inform? The manufacturer of the product and/or the regulatory authori6es If there is a a serious unexpected adverse drug reac6on in a blinded trial: when should the inves6gator unblind the subject? The inves6gator unblinds before repor6ng the suadr: in order to determine a safe treatment If a subject experiences a heart aOack or other unexpected sae that wasn't documented in the ib: who must the event be immediately reported to? The sponsor and the irb/iec The study protocol does not need to include sta6s6cal analysis methods (t/f) False Subjects can be enrolled using lab results preda6ng when the icf was signed (t/f) True What must be done: at the site level: if the protocol is altered during the trial? The subjects must be reconsented and the irb/iec should be informed and approve the changes if the trial is to con6nue If a person is in a life threatening situa6on that necessitates the test ar6cle: and they/their lar cannot provide consent... What must the pi do to properly enroll the subj per required measures described in the protocol? Receive documented approval/favorable opinion by the irb/iec prior to enrollment. Then ensure the subjs lar is informed asap to con6nue the consent Pre-trial mee6ngs discuss 1. Subject availability 2. Compe6ng studies 3. Lab requirements 4. Sponsor expecta6ons Dsmb (data and safety monitoring board) 1. Assesses the progress of a clinical trial: the safety data: and the cri6cal efficacy endpoints 2. Can recommend that sponsors modify: end: or con6nue a trial. But cannot recommend they start a new trial Incapacitated subjects can provide consent as soon as capacity is regained (t/f) True The signature page is a required sec6on of the ib False All trial phases assess safety (t/f) True Focuses on safety and dose in healthy subjects determine metabolic and pharmacologic ac6on of the drug in humans inves6gates human pharmacology the most typical study ini6al administra6on or ind into humans Phase i Focuses on efficacy and side effects in subjects of that specific indica6on a study which seeks to determine the ideal dose and regimen of a new ip to treat the indicated condi6on Phase ii Compares new tx to exis6ng tx for that indica6on a study which seeks to evaluate the ip to similar treatment op6ons or placebo if there are no current tx's for the indica6on determines therapeu6c benefit and is done in a larger: specific popula6on. Can be reffered to as a therapeu6c confirmatory trial: pivotol trial: or compara6ve efficacy trial Phase iii * *phase iii trials usually have fewer subjects than phase iv trials Therapeu6c use: begins aIer drug approval tx is approved and available: but s6ll evalua6ng for long term effects phase iv trials usually require more subjects and data collec6on than phase iii trials