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The ethical principles and regulations governing clinical trials, particularly those involving human subjects. It covers key topics such as the declaration of helsinki, post-market analysis, pediatric trials, the belmont report, institutional review boards, informed consent, genetic and genomic research, vulnerable populations, international research collaborations, and the responsibilities of investigators and sponsors. The document highlights the importance of protecting the rights, well-being, and confidentiality of trial subjects, as well as ensuring the credibility of trial data.
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What would be the first priority for an investigator 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 Validation 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 responsibilities for study participation should be described in the ICF What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? Investigators brochure During a multi site clinical study: whose responsibility is it to report subject recruitment rate? 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 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 after... 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? A research assistant who is certified to administer the psychometric test A research study: in which there is no intended clinical benefit to the subject: is being submitted to the IRB. What benefit information should be included in the ICF? Wording indicating that there is no expected benefit should be included 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? Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates. 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? PI Which of the following required elements should be included in a clinical trial protocol? Subject inclusion and exclusion criteria
When should a research study involving human subjects be registered in a publicly accessible database? Before recruiting 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 representative A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the study? Consenting 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 ultimately responsible for all aspects of the research conducted at a site? Principal investigator An international 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: documentation of IP destruction 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 representative Which of the following required elements should be included in a clinical trial protocol? The subject inclusion and exclusion criteria
During a multi-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 investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? IB When considering participation in a study: the investigator should determine if he/she sees enough patients who would qualify for the study When would an impartial 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 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? A research assistant who is certified to administer the psychometric test A research study: in which there is no intended clinical benefit to the subject: is being submitted to the IRB/IEC. What benefit information should be included in the ICF? Wording indicating that there is no expected benefit should be included.
When should a research study involving human subjects be registered in a publicly accessible database? Before recruiting the first subject 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 obtain consent from the subject for the study. After completion 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 after a signed clinical trial agreement between the site and sponsor is in place. In a multi-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 written 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 entity is primarily charged with considering subject rights and well-being during clinical trials? Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Which of the following would be considered a vulnerable population requiring special consideration by an IRB/IEC?
An Unexpected Adverse drug reaction is A reaction that is not consistent with the applicable product information ICH safety definitions can be found in ICH E2A An Adverse Event (AE) that is severe in intensity May not meet the definition of serious T or F- Information discovered during the course of a clinical investigation that might materially influence the benefit-risk assessment of the investigation/product may necessitate rapid communication to regulatory authorities. True Subject 3826 had to stay in the hospital for three extra days when his legs started swelling after participation in a cardiac drug study. Swelling of the legs was listed in the Investigator's Brochure as a possible side effect. This is considered a/an Serious Adverse Drug Reaction T or F- A subject in your diabetes research study developed colon cancer: which the Investigator has determined to be unrelated to the study. The subject is currently asymptomatic. This will be considered a serious adverse event because it is life threatening. False In pre-market approval studies: all noxious and unintended responses to a medicinal product even possibly related to any dose should be considered Adverse Drug Reaction You were just informed that you have a research patient that is receiving intensive treatment in an emergency room for allergic bronchospasm. This should be considered as A serious adverse event
The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as Informed Consent Process T or F- The IRB/IEC may request additional information be given to subjects when: in the judgment of the IRB/IEC: it would add meaningfully to the protection of the rights: safety and/or well-being of the subjects. True The IRB/IEC should consist of a reasonable number of members: who collectively have the qualifications 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
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 action you implement is that a __________ be conducted. Root Cause Analysis A subject: who has been 100% compliant thus far has forgotten to bring her medication 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 action for the investigator/clinical research coordinator to take? Document that the subject has forgotten to return her medication in the source document and ask her to bring the medication back to the clinic as soon as possible or during her next visit If sponsor's attempts to secure compliance have failed: and the monitoring/auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution: the sponsor should
The main goal of this phase of drug development is to explore therapeutic efficacy in patients. It is important during this phase to determine the dose(s) and regimens that will be used for later trials.
Generalization The Investigator at your site asked you to review a protocol. The investigational 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 potential source of bias in a clinical trial. (True or False) True What study variable takes in the consideration the decision making process of the treating physician: who must weigh benefit and risk in making product use decisions. Global Assessment Variable True or False- You are working on a Phase 1 clinical trial. The sponsor tells you that the study will be carried out in three different research centers. Multi-center trials can be carried out at any stage of clinical development. True You are helping your Investigator write a protocol for a new combination of drugs for treatment of Irritable Bowel Syndrome. Since this is an Investigator Initiated Study you know you will need to establish a/an Independent Data Monitoring Committee When writing an early phase clinical study plan which of the following do you want to pay attention to if you wish to maximize the chance of observing specific clinical effects of interest? The target population
True or False- All new medications should have generated data on the use in the pediatric population? False True or False- Medicinal products may affect physical and cognitive growth and development: and the adverse event profile may differ in pediatric patients. True What is it called when a child is given information about a trial and asked if he or she wishes to participate? Assent T or F- Although initial safety and tolerability data is usually obtained in adult trials: some products may reasonably be studied only in the pediatric population even in the initial phases (e.g.: when studies in adults would yield little useful information or expose them to inappropriate risk). True T or F- Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric subjects. False T or F- Pharmacokinetic studies in the pediatric population are generally conducted in patients with the disease. True The two ways to minimize the number of samples obtained from each pediatric patient are