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ACRP CP FINAL EXAM LATEST 2024 REAL EXAM
150 QUESTIONS AND CORRECT
ANSWERS|AGRADE
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - ANSWER- 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: - ANSWER- Validation, accuracy, reliability, completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to - ANSWER- maintain an audit trail, data trail, and edit trail. A research subject's responsibilities for study participation should be described in the: - ANSWER- ICF What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - ANSWER- Investigators brochure During a multi site clinical study, whose responsibility is it to report subject recruitment rate? - ANSWER- The CRA An unconscious adult subject was enrolled in a study after obtaining consent from an LAR, and protocol therapy was initiated. The subject showed significant improvement in his clinical condition, and regained consciousness. The Investigator should inform the subject about the study and - ANSWER- Obtain consent from the subject for the study
included ICF? - ANSWER- Wording indicating that there is no expected benefit should be being submitted to the IRB. What benefit informatiom should be included in the A research study, in which there is no intended clinical benefit to the subject, is A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - ANSWER- Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates. When considering participation in a study, the investigator should determine if he... 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 after... - ANSWER- A signed clinical trial agreement between the site and sponsor is in place A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion criteria is a score of 25 or less on a psychometric test, a research specific tool which measures cognitive ability. Which of the following individuals can administer the psychometric test to the potential subjects? - ANSWER- A research assistant who is certified to administer the psychometric test In a multi arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk of cancer in subjects. Who is responsible for providing a written report to the IRB? - ANSWER- PI Which of the following required elements should be included in a clinical trial protocol? - ANSWER- Subject inclusion and exclusion criteria Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the - ANSWER- PI and Sponsor During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? - ANSWER- Electronic medical record
When can IRB waive informed consent? - ANSWER- IRB has the ability to waive Who is ultimately responsible for all aspects of the research conducted at a site? - ANSWER- Principal investigator Define GCP - ANSWER- An international quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials and credibility of data What event resulted in the Nuremburg Cod of 1949 - ANSWER- Nazi Medical Experiments Which ICH Guideline is known as the GCP guideline? - ANSWER- E6(R2) What are the basic ethical principles of the Belmont Report? - ANSWER- Beneficence, Respect for persons, Justice Define CBER, and full title - ANSWER- Center for Biologics Evaluation and Research FDA center that regulates blood, vaccine, gene therapy and tissue What is the International Conference on Harmonization (ICH) Guidelines? - ANSWER- A unified standard to facilitate the mutual acceptance of clinical data by the regulatory authorities in the European Union, Japan and United States. To be a qualifying clinical trial, which three requirements must be met? - ANSWER- Therapeutic Intent Enrolls patients with diagnosed disease Evaluates an item/service that falls within a Medicare Benefit Category Define informed consent - ANSWER- A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subjects decision to participate. Primary purpose of IRB - ANSWER- To ensure the protection of the rights and welfare of the human subjects
the informed consent requirement if the research is no more than minimal risk and involves no procedures for which consent is required outside of the research context and in emergency research An investigational New Drug (IND) Application becomes effective days after receipt by the FDA (barring a hold, request for additional information, or rejection of an application); is valid one year; and must be updated within days of taking effect. - ANSWER- 30, 60 Phase II - ANSWER- Focuses primarily on safety and effectiveness, is dose- ranging and occurs in subjects with the disease or condition. Quality documentation practices ALCOAC stands for - ANSWER- Attributable, Legible, Contemporaneous, Original, Accurate, Complete After the New Drug Application is approved, the responsibility for reporting safety issues to the FDA rests with - ANSWER- The sponsor To whom may a sponsor transfer its responsibility for any or all of its clinical trial obligations? - ANSWER- Contract Research Organization Define role of CDRH and abbreviation - ANSWER- Center for Devices and Radiological Health FDA center that assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiationemitting products. Define Adverse Drug reaction - ANSWER- all noxious and unintended response to a medicinal product related to any dose. How many days does a sponsor have to report non-fatal IND safety report to the FDA - ANSWER- 15 calendar days
knowledge. conclusions to be drawn and, thereby, to develop or contribute to general Research - ANSWER- An activity designed to test a hypothesis, permit Clinical practice - ANSWER- intereventions that are designed solely to enhance the well-being of the individual and that have a reasonable expectation of success. Patient-oriented research - ANSWER- IND/IDE What is the primary difference between an AE and an ADR(advanced drug reaction) - ANSWER- An ADR is always related to the study drug and an AE may or may not be related to the study drug. Define CDER and abbreviation - ANSWER- Center for Drug Evaluation and Research FDA center responsible for regulating over-the-counter and prescription drugs, including generic drugs At what frequency does an RIB need to conduct continuing review of each clinical trial? - ANSWER- Intervals appropriate to the degree of risk to human subjects, but at least once per year. The purpose of is to document qualifications and eligibility to conduct a trial and/or provide medical supervision of subjects - ANSWER- Curriculum vitae What are the requirements for conducting a study in the USA - ANSWER- A study conducted in the USA needs to be compliant with both ICH GCP guidelines and FDA regulations What documentation does the monitor provide the investigator and site staff for a monitoring visit? - ANSWER- Pre-visit letter, initiation monitoring report, postvisit letter. Clinical Trial - ANSWER- Any investigation in human subjectes intended to discover or veryf the clinical, pharmacological and or other pharmacodynamic effects of an IP or to identify adverse reactions to an IP, or absorption, distribution, metabolism and excretion of an IP.
that FDA and all participating investigators are promptly informed. responsibility it is to ensure the protection of the rights, safety and well-being of body constituted of medical professionals and non-medical member, whose IEC - ANSWER- Independent Ethics Committee (AKA IRB): An independent Investment in new drug, biologics, ie vaccines. IND/ IDE: Invest Device Exemption IND - ANSWER- Investigational New Drug, any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. Any use of drug except for the marketed intention of the drug. IDE - ANSWER- Investigational Device Exemtpion: A clinical investigation or research involving the safety or effectiveness of a device. General Responsibilities of Sponsors: 21 CFR 312.50-.59 - ANSWER- Sponsors are responsible for selecting qualified investagors, providin gthem witht he information they need to conduct an investigation properly, ensuring proper monitoring of the investigations, ensuring that the investigation is conducted in accordance with the general investigational plan and protocols contained in the IND, maintianing an effective IND with respect to the investigations, and ensuring human subjects involved in a trial CFR - ANSWER- Code of Federal Regulations: ------ ICH - ANSWER- International Council for Harmonization E6(R2) = GCP Need to standardize regulations Europe, Japan, US Safety, quality, efficacy ICH E8 - ANSWER- General Considerations for Clinical Trials ICH E6 - ANSWER- Guideline for Good Clinical Practice ICH E9 - ANSWER- Statistical Principles for Clinical Trials ICH E2A - ANSWER- Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
trial (humane endpoint). disease or sign that strongly motivates the withdrawal of that individual from the constitutes one of the target outcomes of the trial, but may also refer to any such Study Endpoint - ANSWER- Occurrence of a disease, symptom, or sign that Selection of Subjects - ANSWER- The stage of development and the indication to be studied should be taken into account in selecting the subject population, as should prior non-clinical or clinical knowledge. The variability of groups of patients or healthy volunteers studied in early trials may be limited to a narrow range by strict selection criteria, but as drug development proceeds, the populations tested should be broadened to reflect the target population. Selection of Subjects - ANSWER- Trial subjects should not participate concurrently in more than one clinical trial. Selection of Subjects - ANSWER- Women of childbearing potential should be using highly effective contraception. For male subjects, potential hazards of drug exposure in the trial to their sexual partners or resulting progeny should be considered. Selection of Control Group - ANSWER- Trials should have an adequate control group. Comparisons may be made with placebo, no treatment, active controls, or of different doses of the drug under investigation. Historical controls can be justified in some cases. Primary Endpoint - ANSWER- Endpoint for which subjects are randomized and for which the trial is powered. Secondary Endpoint - ANSWER- Endpoints that are analyzed post hoc, for which the trial may not be powered or randomized. Surrogate Endpoint - ANSWER- Endpoint that is intended to relate to a clinically important outcome but does not in itself measure a clinical benefit. Randomization - ANSWER- In conducting a controlled trial, randomized allocation is the preferred means of assuring comparability of test groups and minimizing the possibility of selection bias. Introduces a deliberate element of
treatment, and a placebo of the other treatment. treatments cannot be made identical. Both treatment groups take one form of Double-Dummy - ANSWER- A technique for retaining the blind when two chance into the assignment of treatments. In multi-center trials, randomization should be organized centrally. Blinding - ANSWER- Intended to limit the occurrence of conscious and unconscious bias in the conduct and interpretation of a clinical trial. (masking) Single Blind Study - ANSWER- Type of masking in which one party involved in the trial (usually the subject) does not know which subjects have been assigned which interventions. Double Blind Study - ANSWER- Type of masking in which two or more parties involved with the clinical trial do not know which participants have been assigned which interventions - typically, the investigator and the subject. Bias - ANSWER- Systematic tendency of any factors associated with the design, conduct, analysis, and interpretation of the results to make the estimate of a treatment effect deviate from its true value. Operational Bias - ANSWER- Bias introduced through deviations in conduct. Parallel Design - ANSWER- Two or more subject groups receive different treatments Crossover Design - ANSWER- Subject groups receive two or more treatments in a particular order. All subjects receive the same treatments, but in different order. Factorial Design - ANSWER- Subject groups receive one of several combinations of interventions Cohort - ANSWER- Group of subjects sharing a common characteristic or experience Control - ANSWER- Standard for comparison
Breaking the Blind - ANSWER- Should be considered for a single subject only when knowledge of the treatment assignment is deemed essential by the subject's physician for the subject's care. Any intentional or unintentional breaking of the blind should be reported and explained at the end of the trial, irrespective of the reason for its occurrence. Multi-Center Trial - ANSWER- An accepted way to evaluating a new medication or device more efficiently. May present the only practical means of accruing sufficient subjects to satisfy the trial objective within a reasonable time frame by recruiting subjects from a wider population and administering treatment in a broader range of clinical settings, thus presenting an experimental situation that is more typical of future use. Full Analysis Set - ANSWER- The set of subjects that is as close as possible to the ideal implied by the intention-to-treat principle. It is derived from the set of all randomized subjects by minimal and justified elimination of subjects. Per-Protocol Set - ANSWER- A subset of the subjects in the full analysis set who are more compliant with the protocol. This data would be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements, and absence of major protocol deviations. Missing Values - ANSWER- A potential source of bias. (outliers) Blind Review - ANSWER- The checking and assessment of data during the period of time between trial completion (last observation of the last subject) and the breaking of the blind, for the purpose of finalizing the planned analysis. Content Validity - ANSWER- The extent to which a variable measures what it is supposed to measure. Composite Variables - ANSWER- If a single primary variable cannot be selected from multiple measurements associated with the primary objective, another useful strategy is to integrate or combine the multiple measurements into a single or composite variable, using a pre-defined algorithm.
Generalization/Generalizability - ANSWER- The extent to which the findings of a clinical trial can be reliably extrapolated from the subjects who participated in the experimental situation. certain outcomes occurring in hypothetical repeated realizations of the same and confidence intervals, which can be interpreted in terms of the frequency of Frequentist Methods - ANSWER- Statistical methods, such as significance tests Interaction - ANSWER- The situation in which a treatment contrast (e.g. difference between investigational product and control) is dependent on another factor (e.g. center). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor, whereas for a qualitative interaction the direction of the contrast differs for at least one level of the factor. Equivalence Trial - ANSWER- A trial with the primary objective of showing that the response to two or more treatments differs by an amount which is clinically unimportant. This is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence margin of clinically acceptable differences. trial to a broader patient population and a broader range of clinical settings. Global Assessment Variable - ANSWER- A single variable, usually a scale of ordered categorical ratings, which integrates objective variables and the investigator's overall impression about the state or change in state of a subject. Intention-to-Treat Principle - ANSWER- Asserts that the effect of a treatment policy can be best assessed by evaluation on the basis of the intention to treat a subject rather than the actual treatment given. It has the consequence that subjects treatment. Inter-Rater Reliability - ANSWER- The property of yielding equivalent results when used by different raters on different occasions. Intra-Rater Reliability - ANSWER- The property of yielding equivalent results when used by the same rater on different occasions. allocated to a treatment group should be followed up, assessed and analyzed as members of the group irrespective of their compliance to the planned course of
Treatment Effect - ANSWER- An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state. Adverse Event (AE) - ANSWER- Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) - ANSWER- All noxious and unintended responses to an investigational medicinal product related to any dose should be considered adverse drug reactions, as dose and usage may not be established. Unexpected Adverse Drug Reaction - ANSWER- An adverse reaction, the nature or severity of which is not consistent with the applicable product information (IB). Severe - ANSWER- Often used to describe the intensity of a specific event. The event itself, however, may be of relatively minor medical significance. Not the same as serious. Serious - ANSWER- Based on patient/event outcome or action criteria usually associated with events that post a threat to a patient's life or functioning. Serious Adverse Event - ANSWER- Any untoward medical event occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Other Observations Necessitating Expedited Reporting - ANSWER- Increase in the rate of occurrence of "expected" serious ADRs, a significant hazard to the patient population - such as lack of efficacy with a medicinal product used in treating life- threatening disease, a major safety finding from a newly completed animal study (such as carcinogenicity). Reporting Fatal or Life-Threatening Unexpected ADRs - ANSWER- ASAP, but no later than 7 days. Reporting All Other Serious, Unexpected ADRs - ANSWER- ASAP, but no later than 15 days.
Minimum Criteria for Reporting - ANSWER- An identifiable patient, a suspect medicinal product, an identifiable reporting source, and an event or outcome that can be identified as serious and unexpected, and for which, in clinical investigation cases, there is a reasonable suspected causal relationship. Follow-up information should be actively sought and submitted as it becomes available. Key Patient Data in Expedited Reporting - ANSWER- Initials, study ID number, gender, age/DOB, weight, height. Key Medicinal Data in Expedited Reporting - ANSWER- Brand name, International Non-Proprietary Name (INN), batch number, dosage form and strength, daily dose and regimen, route of administration, starting date and time of day, stopping date and time, or duration of treatment. Also any other treatments. Key Reaction Data in Expedited Reporting - ANSWER- Full description of reaction, start date and time of onset of reaction, stop date and time or duration of reaction, dechallenge and rechallenge information, setting, and outcome. Key Reporter Data in Expedited Reporting - ANSWER- Name, address, telephone number, medical specialty. Key Administrative Data in Expedited Reporting - ANSWER- Source of report, date reported, country in which event occurred, type of report, name and contact info for sponsor, identifying regulatory code or number for clinical investigation, sponsor's identification number. Good Clinical Practice (GCP) - ANSWER- International ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Audit - ANSWER- A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures, Good Clinical Practice, and applicable regulatory requirements.
Protocol - ANSWER- A document that describes the objectives, design, methodology, statistical considerations, and organization of a trial. The protocol Informed consent is documented by means of a written, signed, and dated informed consent form. Inspection - ANSWER- The act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's facilities, or at other establishments deemed appropriate by the regulatory authority. Interim Clinical Trial Report - ANSWER- A report of intermediate results and their evaluation based on analyses performed during the course of a trial. Investigational Product - ANSWER- A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Investigator's Brochure - ANSWER- A compilation of the clinical and nonclinical data on the investigational product which is relevant to the study of the investigational product in human subjects. Legally Acceptable Representative - ANSWER- An individual of juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial. Monitoring - ANSWER- The act of overseeing the progress of a clinical trial, and ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirements. Monitoring Report - ANSWER- A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs.
refugees, minors, and those incapable of giving consent. in emergency situations, ethnic minority groups, homeless persons, nomads, diseases, persons in nursing homes, unemployed or impoverished persons, patients persons kept in detention. Other vulnerable subjects include patients with incurable usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Protocol Amendment - ANSWER- A written description of a change to or formal clarification of a protocol. Quality Assurance (QA) - ANSWER- All those planned and systematic actions that requirements. Quality Control - ANSWER- The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled. of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Sponsor - ANSWER- An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. Vulnerable Subjects - ANSWER- Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. e.g. medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and Every 4 years - ANSWER- How often is the Declaration o Helsinki reviewed and updated? 9 - ANSWER- How many times has the Declaration of Helsinki been revised? are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance, with GCP, and the applicable regulatory Source Data - ANSWER- All information in original records and certified copies
