FDA practice test 1 .pdf

14/03/2024, 16:45 View and Edit Coaching Report Assessment Name RAC (Drugs) Practice Test Status Timed out User ID 10916440 Percentage Score 34% Date/Time Started Mar 06 2024 08:38:16 Assessment Outcome Fail Date/Time Finished Mar 06 2024 09:38:26 Questions Topic Email RAC Practice Test Results Ques...

14/03/2024, 16:45 View and Edit Coaching Report Assessment Name RAC (Drugs) Practice Test Status Timed out User ID 10916440 Percentage Score 34% Date/Time Started Mar 06 2024 08:38:16 Assessment Outcome Fail Date/Time Finished Mar 06 2024 09:38:26 Questions Topic Email RAC Practice Test Results Question wording You will receive your full practice test results after the completion of this test. If you would like a copy of your results delivered via email, please enter your email address below. Please verify your email address is correct before proceeding. Choices Unscored, Scored Answer given [email protected] Correct answer N/A Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording While a company's NDA submission is under review at FDA, the US Pharmacopeial Convention issues a revised monograph involving a minor change to the company's product. Which of the following actions is the regulatory professional's MOST appropriate response? Choices 0 Conducttesting and submit the change as an ame, 1 Obtainapproval for submission and submit the c, 2 Petitionthe FDA for a stay of action and recon, 3 Takeno action and leave the submission at the Answer given Conduct testing and submit the change as an amendment Correct answer Obtain approval for submission and submit the change in the next annual report Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording A company is developing an (unapproved) drug-device combination product but is not sure to which center it should submit its marketing application. The company should first submit: Choices 0 ARequest for Determination to the appropriate , 1 ARequest for Designation to the Office of Comb, 2 ARequest for Determination to the Office of Ph, 3 ARequest for Designation to the Office of New Answer given A Request for Determination to the appropriate review division based on the product’s primary mode of action Correct answer A Request for Designation to the Office of Combination Products https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e3… 1/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording FDA CDER encourages submission of a human factor’s validation protocol for review prior to the execution of the study. What is the most appropriate mechanism by which a sponsor should use to get FDA’s feedback on the protocol? Choices 0 Type C meeting., 1 Email the protocol to the FDA., 2 Type C written feedback request., 3 Submit the protocol to the IND. Answer given Submit the protocol to the IND. Correct answer Submit the protocol to the IND. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording The Centralized Registration procedure is compulsory for human medicines containing a new active substance to treat human immunodeficiency virus (HIV), acquired immune deficiency syndrome (AIDS), cancer, diabetes, neurodegenerative diseases, auto-immune and other immune dysfunctions, viral diseases. Choices 0 True, 1 False Answer given True Correct answer True Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following is not an investigator's responsibility? Choices 0 Submitting unanticipated adverse event reports t, 1 Submitting notices to the IRB of deviations from, 2 Maintaining records of receipt, use and disposit, 3 Reporting to the sponsor withdrawal of IRB appro Answer given Submitting unanticipated adverse event reports to FDA Correct answer Submitting unanticipated adverse event reports to FDA Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following is NOT a reason to file an OMOR? Choices 0 Add an ingredient to a monograph, 1 Make a product in a dosage form not included in , 2 Switch a product from prescription to over-the-c, 3 Add a new combination of ingredients to a monogr Answer given Add an ingredient to a monograph Correct answer Switch a product from prescription to over-the-counter https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e3… 2/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording A company has submitted an IND application to start clinical studies on a promising new compound and has passed the 30-day waiting period. While reviewing some internal files, a quality auditor informs the regulatory professional that the results of a required safety test for the product are invalid and must be repeated. Which of the following is the BEST first action for the regulatory professional? Choices 0 Immediatelyinform all project team members of , 1 Immediatelyinform the FDA and offer to volunta, 2 Immediatelyinform the companys management for , 3 Immediatelyrequest a test investigation to det Answer given Immediately inform the FDA and offer to voluntarily hold the study until the test can be completed. Correct answer Immediately inform all project team members of the finding and determine if patients have been dosed Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording In the EU, which type of documentation should NOT be included in Module 1 of a submitted dossier? Choices 0 SmPC, Labeling and Package Leaflet, 1 Environmental Risk Assessment, 2 Quality Overall Summary, 3 Risk Management Plan Answer given Quality Overall Summary Correct answer Quality Overall Summary Topic RAC (Drugs) Practice Test\US Based Questions\Pool 01: Domain I and II Question wording Which of the following variations can be included in a single ANDA for an oral solid dosage form, assuming other parameters are the same? Choices 0 Capsules and tablets, 1 Different disintegrants, 2 Different strengths, 3 Different pharmacy bulk packages Answer given Different strengths Correct answer Different strengths Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Within how many days after receipt MUST the FDA file, or refuse to file, an NDA? Choices 0 30, 1 45, 2 60, 3 90 Answer given 60 Correct answer 60 Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following is the purpose of an end-of-Phase 2 meeting between the IND sponsor and the FDA? Choices 0 Toagree on advisory committee questions, 1 Toapprove the proprietary name, 2 Todefine post-marketing commitments, 3 Toevaluate the pivotal study design Answer given To evaluate the pivotal study design Correct answer To evaluate the pivotal study design https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e3… 3/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording A firm received a raw material for one of its drug products. The raw material was placed in quarantine and sampled appropriately. Sample containers should be identified so the following information can be determined: Choices 0 Themanufacturer name, lot number, name of pers, 1 Themanufacturer name, lot number, the sample a, 2 Thematerial name, lot number, the container fr, 3 Thematerial name, lot number, sample attribute Answer given The manufacturer name, lot number, the sample attributes, name of person who collected the sample and the date on which the sample was taken Correct answer The material name, lot number, the container from which the sample was taken, name of person who collected the sample and the date on which the sample was taken Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording What statements would NOT be correct about an Authorized Generic Drug? Choices 0 It is a copy of a brand-name drug that is develo, 1 It is the same as the brand name drug in active , 2 It is the same as the brand-name drug but does n, 3 It is not listed in the Orange Book. Answer given It is not listed in the Orange Book. Correct answer It is the same as the brand name drug in active ingredient, conditions of use, dosage form, strength, route of administration, and (with certain permissible differences) labeling. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording Which of the following is false regarding meeting minutes for formal meetings relating to biological products regulated by CBER? Choices 0 The FDA will issue official meeting minutes to t, 1 The FDA meeting minutes are not intended to repr, 2 If it is necessary to revise the original FDA me, 3 For input on additional issues not addressed at Answer given For input on additional issues not addressed at the meeting, the requester should submit a response to the FDA meeting minutes. Correct answer For input on additional issues not addressed at the meeting, the requester should submit a response to the FDA meeting minutes. Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording During a review of the production records for Batch 1 of Drug Product X, it was discovered the theoretical yield exceeded the maximum percentage established in the master production and control records by 1.5%. The batch has not been distributed. As a regulatory professional, you should recommend the investigation: Choices 0 Beextended to only other batches of Drug Produ, 1 Beextended to other drug products that may hav, 2 Noimmediate action is needed but the discrepan, 3 Furtherproduction should be halted until the r Answer given Further production should be halted until the reason for the discrepancy is identified Correct answer Be extended to other drug products that may have been associated with the discrepancy https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e3… 4/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\US Based Questions\Pool 02: Domain III and IV Question wording For a marketed prescription product, how long should the company retain all production, labeling, and packaging records for each batch of product? Choices 0 Untilthe batch expiration date, 1 Oneyear after the batch expiration date, 2 Threeyears after the batch expiration date, 3 Fiveyears after the last distribution date for Answer given Five years after the last distribution date for the batch Correct answer One year after the batch expiration date Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A clinical investigator would like to use an investigational medicinal product to treat a gravely ill patient who does not meet the protocol inclusion criteria. However, in the expert opinion of the clinical investigator, the product would be the best option for that patient. What action is MOST appropriate for the clinical investigator to take? Choices 0 Askthe trial sponsor to obtain CA approval for, 1 Notifythe trial sponsor of the deviation to th, 2 Obtainapproval from the CA for compassionate u, 3 Treatthis particular patient with the product, Answer given Obtain approval from the CA for compassionate use of the product for this particular patient Correct answer Obtain approval from the CA for compassionate use of the product for this particular patient Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording Clinical studies for an Investigational Medicinal Product are nearing the end of Phase 2, and the development team is actively planning Phase 3. The team is interested in seeking feedback from the Committee for Medicinal Products for Human Use (CHMP) on the proposed Phase 3 study design. As the regulatory professional on this team, what information should you offer related to Scientific Advice? Choices 0 ScientificAdvice is legally binding on the app, 1 ScientificAdvice is both retrospective and pro, 2 Itis always appropriate to request Scientific , 3 IfScientific Advice is not followed, the reaso Answer given If Scientific Advice is not followed, the reasons will need to be discussed in the subsequent submission documents Correct answer If Scientific Advice is not followed, the reasons will need to be discussed in the subsequent submission documents https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e3… 5/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording Your company is planning to place a generic, non-biologic product on the market. The original product manufacturer’s data exclusivity period is over. As a regulatory professional, how will you advise your company to obtain a faster Marketing Authorisation? Choices 0 Atthe outset, to commission a top rated clinic, 1 Toconduct bioavailability and bioequivalence s, 2 Nofresh documentation is required for a Market, 3 Toconduct all the studies and generate the req Answer given To conduct bioavailability and bioequivalence studies to prove equivalence to the original product and refer to the original product manufacturer’s file for the rest of the documentation Correct answer To conduct bioavailability and bioequivalence studies to prove equivalence to the original product and refer to the original product manufacturer’s file for the rest of the documentation Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording What advice should the regulatory professional give a clinical trial sponsor on the content required for the label on a study drug? Choices 0 Forsites in the EU, the labeling must specify , 1 Arandomisation code on the label is necessary , 2 Eitherthe sponsor, the Clinical Research Organ, 3 Thestatement “Keep out of reach of children” i Answer given The statement “Keep out of reach of children” is required to appear on the immediate container in all cases Correct answer For sites in the EU, the labeling must specify the period of use for the product Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A clinical trial for a medicinal product was conducted in several European countries and has been finalized. What is the MOST appropriate next regulatory step? Choices 0 Filea declaration on the end of the clinical t, 1 Informthe EMA that the study is finalized and , 2 Preparethe final clinical study report for the, 3 Submitscientific advice to the CA to receive f Answer given File a declaration on the end of the clinical trial to the CA and ethics committees of the participating countries Correct answer File a declaration on the end of the clinical trial to the CA and ethics committees of the participating countries Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording How many days after the start of the DCP Assessment Step I does the reference member state have to supply the draft labeling to the concerned member states and applicant? Choices 0 30, 1 70, 2 90, 3 120 Answer given 90 Correct answer 120 https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e3… 6/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording According to ICH Q10, implementing a Pharmaceutical Quality System (PQS) addresses all of the following EXCEPT: Choices 0 APQS can be certified through the ICH Q10 Cert, 1 Manufacturingprocess robustness and continuou, 2 APQS reduces the risk of product failure and i, 3 Providesan opportunity to increase understandi Answer given A PQS can be certified through the ICH Q10 Certification Programme, reducing the frequency of inspections Correct answer A PQS can be certified through the ICH Q10 Certification Programme, reducing the frequency of inspections Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording A manufacturer is sponsoring a pharmaceutical clinical trial. Before starting the trial, the clinical investigator MUST first obtain which of the following? Choices 0 Publicationcopyright statements, 1 Approvalfrom the ethics committee, 2 Signedinformed consent forms, 3 AppropriateICH forms Answer given Approval from the ethics committee Correct answer Approval from the ethics committee Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 01: Domain I and II Question wording Regulation EC 469/2009 provides which of the following? Choices 0 Thecontent and format of the SmPC, 1 Thepossibility to obtain protection from gener, 2 Theopportunity to obtain an SPC, 3 Theprocess for filing a European patent applic Answer given The opportunity to obtain an SPC Correct answer The opportunity to obtain an SPC Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording What could form part of the procedures for a non-interventional imposed PASS (Post Authorization Safety Study)? Choices 0 After study commencement, the MAH must submit an, 1 Final Assessment by Pharmacovigilance Risk Asses, 2 Upon study completion, a final study report with, 3 All of the above. Answer given All of the above. Correct answer All of the above. Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording What is the least likely action OPDP will take in response to this promotional communication? Choices 0 OPDP will consider whether the promotional mater, 1 OPDP will consider the REMS and boxed warnings i, 2 OPDP will consider whether the promotional claim, 3 OPDP will take no action as their role is purely Answer given OPDP will take no action as their role is purely advisory on promotional materials, especially on FDA-approved products. Correct answer OPDP will take no action as their role is purely advisory on promotional materials, especially on FDA-approved products. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e3… 7/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording Your company is planning to have a new drug product to be registered with local health authority and you have been tasked to prepare for pre-submission meeting. What are your courses of actions in sequence? Choices 0 Book a meeting with health authority., 1 Compile the documents required for meeting with , 2 Check with internal stakeholders on the readines, 3 Check on the list of attendees for the meeting. Answer given Check with internal stakeholders on the readiness of required documents. Correct answer Check on the list of attendees for the meeting. Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording When advertising, which type of information can be provided without limitations relative to medicinal products? Choices 0 Publicadvertising of reimbursable over-the-cou, 1 Direct-toconsumeradvertising of prescription , 2 Diseaseinformation with no reference to a medi, 3 Comparativeadvertising Answer given Correct answer Disease information with no reference to a medicinal product Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording A variation for a complex manufacturing change should include which of the following? Choices 0 Astatement and CV from an independent pharmace, 1 Anexpert statement and CV from a quality exper, 2 Anexpert statement and CV from a clinical expe, 3 Anexpert statement from the site quality head Answer given Correct answer An expert statement and CV from a quality expert Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording What is the least likely action OPDP will take in response to this promotional communication? Choices 0 OPDP will consider whether the promotional mater, 1 OPDP will consider the REMS and boxed warnings i, 2 OPDP will consider whether the promotional claim, 3 OPDP will take no action as their role is purely Answer given Correct answer OPDP will take no action as their role is purely advisory on promotional materials, especially on FDA-approved products. https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e3… 8/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\EU Based Questions\Pool 02: Domain III and IV Question wording Your company has received a Warning Letter from the FDA that your marketed drug product has been found to contain ingredients, which make it adulterated, and it has been linked to hundreds of reports of minor AEs. At the same time a related product has been reported in the press as involving a legal claim by a group of children whose mothers took the medication during pregnancy many years ago. You have successfully marketed this drug for over 20 years without incident. As a regulatory specialist what is your top priority to minimize your company’s legal liability? Choices 0 Gather all pertinent information for a risk-asse, 1 Respond to the FDA WL immediately., 2 Gather all pertinent information and use your 25, 3 Respond without delay to the press reports denyi Answer given Correct answer Gather all pertinent information for a risk-assessment and recommend to the Senior Leadership Team that preliminary legal advice is obtained without delay. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording According to ICH, what is the primary basis of assessment for the efficacy of antihypertensive drugs? Choices 0 Formalmortality and morbidity outcomes, 1 Highsystolic and diastolic blood pressures, 2 Organdamage secondary to hypertension, 3 Strokeand cardiovascular events Answer given Correct answer High systolic and diastolic blood pressures Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which of the following is BEST identified as a multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide assurance of quality? Choices 0 Designspace, 1 Manufacturingcontrols, 2 Operatingranges, 3 Specification Answer given Correct answer Design space Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II The safety database for an anti-hypertensive drug consists of the following: Question wording 461 patients exposed for threemonths 343 patients exposed for sixmonths 112 patients exposed for ninemonths 74 patients exposed for 12months Overall exposure is 2.000 patients. Which long-term ICH data requirement has NOT been met? Choices 0 100patients for 12 months, 1 200patients for nine months, 2 500patients for three months, 3 3.000total patient exposures Answer given Correct answer 100 patients for 12 months https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e3… 9/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording If you run clinical trials from a site at a medical center based in Maryland, USA what investigational drugs may be shipped and to what locations? Choices 0 Investigational drugs with an Investigational Ne, 1 Investigational drugs without an IND (non-IND) c, 2 Investigational drugs (with or without an IND) c, 3 All of the above Answer given Correct answer All of the above Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which of the following documents outlines whether a serious adverse event occurring during a clinical trial is considered expected or unexpected? Choices 0 Clinicaltrial application, 1 Clinicaltrial report, 2 Ethicscommittee document, 3 IB Answer given Correct answer IB Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording During an ongoing clinical trial, an investigator deviates from the protocol for the second time, without harm to a patient. Which of the following actions should be taken? Choices 0 Thesponsor reports the protocol deviation to t, 1 Thesponsor informs the ethics committee and st, 2 Themonitor reports the protocol deviation to t, 3 Themonitor reviews the protocol deviation agai Answer given Correct answer The monitor reviews the protocol deviation against the trial monitoring plan and takes appropriate corrective action Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which of the following BEST describes the purpose of the ICH? Choices 0 Toprovide scientific evaluation of application, 1 Toprotect and promote public health through th, 2 Tolobby for improved industry standards for th, 3 Todiscuss and establish common guidelines for Answer given Correct answer To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording Which of the following agencies initiated a pilot program “PARALLEL SCIENTIFIC ADVICE (HUMAN MEDICINAL PRODUCTS)” to exchange their views on scientific issues during the development phase of new medicinal products? Choices 0 PMDA (Pharmaceuticals and Medical Devices Agency, 1 EMA (European Medicine Agency), EU and MHRA (Med, 2 USFDA (United States Food and Drug Administratio, 3 All ICH (International Council for Harmonization Answer given Correct answer USFDA (United States Food and Drug Administration) and EMA (European Medicine Agency) https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e… 10/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 01: Domain I and II Question wording In what module of the CTD is information on the quality of a medicinal product noted? Choices 0 1, 1 2, 2 4, 3 5 Answer given Correct answer 2 Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following claims would classify an apple as a drug? Choices 0 Itwill make you look younger., 1 Itwill satisfy hunger., 2 Itwill whiten teeth., 3 Itwill prevent colds. Answer given Correct answer "It will prevent colds." Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following would FDA consider to be obstructing an inspection? Choices 0 Scheduling an inspection at a date later than re, 1 A facility does not provide an FDA investigator , 2 The facility fails to produce requested records , 3 A facility does not allow the investigator to en Answer given Correct answer The facility fails to produce requested records in a timely manner, without a reasonable explanation. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording According to ICH, within how many months of the DLP should an MAH submit a PSUR? Choices 0 1, 1 2, 2 6, 3 12 Answer given Correct answer 2 Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording A regulatory professional is preparing a clinical trial application for the company's new product. During the review of the clinical protocol, operational difficulties in the execution of the protocol were discovered. What is the BEST action for the regulatory professional to take? Choices 0 Askfor a consultation with the regulatory agen, 1 Askfor pre-inspection from the regulatory agen, 2 Consultthe advisory committee of the regulator, 3 Consultthe IRB Answer given Correct answer Ask for a consultation with the regulatory agency https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e… 11/13 14/03/2024, 16:45 View and Edit Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following is directly related to the stability of a product? Choices 0 Contraindications, 1 Dosinginformation, 2 Expirationdate, 3 Sealinginstructions Answer given Correct answer Expiration date Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following is FALSE regarding regulatory meetings between CBER and sponsors of biological products? Choices 0 Meetings may be electronically recorded., 1 The questions submitted to CBER within a single , 2 The meeting package should generally not contain, 3 The meeting requester or other meeting participa Answer given Correct answer Meetings may be electronically recorded. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following terms is defined as reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously? Choices 0 Index, 1 Sign, 2 Signal, 3 Symptom Answer given Correct answer Signal Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording Which of the following is false regarding meeting minutes for formal meetings relating to biological products regulated by CBER? Choices 0 The FDA will issue official meeting minutes to t, 1 The FDA meeting minutes are not intended to repr, 2 If it is necessary to revise the original FDA me, 3 For input on additional issues not addressed at Answer given Correct answer For input on additional issues not addressed at the meeting, the requester should submit a response to the FDA meeting minutes. Topic RAC (Drugs) Practice Test\Global Based Questions\Pool 02: Domain III and IV Question wording In an advisory committee meeting organized by the regulatory authority, which of the following is the LEAST likely to be involved? Choices 0 Biostatisticsdepartment, 1 Keyopinion leaders, 2 Manufacturingdepartment, 3 Patientadvocates Answer given Correct answer Manufacturing department Topics Topic description https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e… 12/13 14/03/2024, 16:45 View and Edit EU Based Questions: Domain I and II Topic Detail Score % 78% EU Based Questions: Domain III and IV Topic Detail Score % 29% Global Based Questions: Domain I and II Topic Detail Score % 0% Global Based Questions: Domain III and IV Topic Detail Score % 0% US Based Questions: Domain I and II Topic Detail Score % 56% US Based Questions: Domain III and IV Topic Detail Score % 43% https://ondemand.questionmark.com/em/modules/ERC/CRPreview.aspx?From=ASP&ResultID=418246038&TemplateID=2&da=1&digest=6ae30804a8e02e… 13/13