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.
Phase ii 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 sponsors files 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 When should a research study involving human subjects be registered in a publicly accessible database? Before recrui6ng the first subject In the case of an incapacitated subject: who should receive a copy of the signed and dated icf? The subjects legally acceptable representa6ve A medical student is approaches by a faculty member for possible par6cipa6on in a cricothyroidotomy simula6on research study. Which of the following increases risk to the study? Consen6ng in the presence of figure of authority The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers Phase i Who is ul6mately responsible for all aspects of the research conducted at a site? Principal inves6gator An interna6onal quality standard that is provided by ich e6(r2) describing safety: accuracy of trials and credibility of data Gcp
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
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
A site is in the start-up phase of an industry-sponsored phase 3 trial: and has received irb/iec approval. The site can begin enrolling subjects aIer A signed clinical trial agreement between the site and sponsor is in place. In a mul6-arm: randomized clinical trial: one arm of the protocol was terminated due to an increased risk of breast cancer in the subjects. Who is responsible for providing a wriOen report to the irb/iec? Pi Part of a sponsor's responsibility pertaining to electronic trial data handling is to maintain an audit trail: data trail: and edit trail. Which en6ty is primarily charged with considering subject rights and well-being during clinical trials? Ins6tu6onal review board (irb)/independent ethics commiOee (iec) Which of the following would be considered a vulnerable popula6on requiring special considera6on by an irb/iec?
- Medical, pharmacy, dental, and nursing students:
- Prisoners
- Serving military personnel T or f- the terms "serious" and "severe" are synonymous according to ich False An unexpected adverse drug reac6on is A reac6on that is not consistent with the applicable product informa6on Ich safety defini6ons can be found in Ich e2a An adverse event (ae) that is severe in intensity May not meet the defini6on of serious T or f- informa6on discovered during the course of a clinical inves6ga6on that might materially influence the benefit-risk assessment of the
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?
- A de-iden6fied autopsy report: if available
- Cause of death: and a comment on its possible rela6onship to the suspected drug reac6on What is the purpose of an ini6a6on visit?
- To review the protocol
- To review research site's sops
- 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
- At least five members
- At least one member whose primary interest is non-scien6fic
- 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
- Unobscured original entries
- Traceable source documents
- 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?
Inform the sponsor per protocol and regulatory requirements According to ich e6 who must sign the informed consent form (icf)?
- The person who conducted the informed consent interview
- The subject or the subject's legal representa6ve A non-english speaking subject has responded to a recruitment ad to par6cipate in a trial for treatment of her diabetes. She arrives at the site with her daughter who is fluent in english. The informed consent forms are only available in english. What ac6ons are compliant with gcp? Call the sponsor to request a transla6on of the informed consent Per ich gcp e6: the purpose/elements of trial monitoring differ from trial audi6ng. Which apply to trial audi6ng only?
- The sponsor should appoint individuals: who are independent of the clinical trials/systems
- Regulatory authority(ies) should not rou6nely request this type of reports* *(they may seek access to reports on a case by case basis when evidence of serious gcp non-compliance exists: or in the course of legal proceedings) As per ich e6 gcp: which groups of poten6al subjects could be defined as "vulnerable subjects?"
- Members of the armed forces
- Junior members of the medical profession
- Employees of the pharmaceu6cal industry Which phase determines therapeu6c benefit: usually in wider popula6ons? Phase 3 What phase of a clinical trial involves a heavy emphasis on safety and tolerability: pharmacokine6cs: pharmacodynamics and early measurement of drug ac6vity? Phase 1
The principles and prac6ces concerning protec6on of trial subjects are stated in the ich guideline on good clinical prac6ce (ich e6). These principles have their origins from Declara6on of helsinki The main goal of this phase of drug development is to explore therapeu6c efficacy in pa6ents. It is important during this phase to determine the dose(s) and regimens that will be used for later trials.
- Selec6on of the ini6al human dose
- Safe dura6on of drug exposure
- Physiological and toxicological effects of a new drug T or f- the inten6on of ich e8 is to describe interna6onally accepted principles and prac6ces in the conduct of both individual clinical trials and overall development strategy for new medicinal products. True Dose-tolerance studies: single and mul6ple dose pk and/or pd studies: and drug interac6on studies are examples of what phase of clinical research? Phase one Characteriza6on of a drug's absorp6on: distribu6on: metabolism: and excre6on that con6nues throughout the development plan is defined as Pharmacokine6cs According to ich e8: "formula6ons used in clinical trials should be well characterized: including informa6on on ___________ whenever feasible." Bioavailability The study subject asks you why the study is called a double blind study. You will explain double blind as
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
- The procedure to be followed: the necessary documenta6on: and the subsequent treatment and assessment of the subject should all be described in the protocol
- 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?
- That the sponsor should con6nue the trial 2.that the sponsor should modify the trial
- 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?
- Single-blind
- Masking
- 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.
T or f- pharmacokine6c phase 1 studies in the pediatric popula6on are generally conducted in healthy pediatric subjects. False T or f- pharmacokine6c studies in the pediatric popula6on are generally conducted in pa6ents with the disease. True The two ways to minimize the number of samples obtained from each pediatric pa6ent are
- Popula6on pk & sparse sampling
- Use of indwelling catheters T or f- it is common to extrapolate efficacy from studies in adults or even in older pediatric pa6ents to the preterm newborn infant to decrease the amount of blood taken. False The current protocol for a study in pediatrics is asking for all new pa6ents to have stages of pubertal development assessed. This assessment is called Tanner staging You are reading a phase 2 protocol: which uses pharmacokine6c sampling in a pediatric popula6on with sickle cell disease. Which of the following op6ons may be true in this scenario?
- The data may beOer reflect clinical use
- This may lead to higher inter subject variability Dosing recommenda6ons for most medicinal products used in the pediatric popula6on are usually based on ________________ due to frequency of calcula6on errors. Mg/kg body weight
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?
- Recruitment
- Consent and assent
- Minimize risk
- Minimize distress During clinical development: the 6ming of pediatric studies will depend on
- Medicinal produc
- Type of disease being treated
- Safety considera6ons
- 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
