MEGA SOCRA CCRP EXAM CONTENT QUESTIONS WITH CORRECT ANSWERS!!

5 - ANSWERThe minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained - ANSWERIn a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor - ANSWERThe responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? - ANSWERThis subject should undergo all study procedures as outlined in the protocol A significant risk device is defined as an investigational device that is: - ANSWERa. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject. b. Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject. c. For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject. With respect to IRB/IEC membership, both the FDA and the ICH require that - ANSWERAt least one member's primary area of interest is in a nonscientific area The rights, safety, and well-being of human subjects are protected - ANSWERA purpose of monitoring clinical trials is to verify that: Which of the following is the proper way to make a correction to a CRF? - ANSWERAdd the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change. What details need to be documented in the subject source documentation when an Adverse Event (AE) occurs? Select all that apply - ANSWERA. The severity of the event B. When the event occurred C. Setting in which the event occurred What is an Unexpected Adverse drug reaction? - ANSWERA reaction that is not consistent with the applicable product information The terms "serious" and "severe" are synonymous according to ICH. - ANSWERFALSE A serious adverse event is any untoward medical occurrence which at any dose is best described by which of the following statements? Select all that apply - ANSWERA. Results in death B. Is life-threatening C. Is a congenital anomaly . Which of the following options describes the term "severe" in regards to ICH? - ANSWERThe Intensity of a specific event 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. Which of the following options best describes this situation? - ANSWERSerious Adverse Drug Reaction 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. Is this a true or false statement? - ANSWERFALSE In pre-market approval studies, all noxious and unintended responses to a medicinal product, even possibly related to any dose, should be considered which of the following options? - ANSWERAdverse Drug Reaction A subject has a suspected serious adverse drug reaction with the outcome of death. Per the ICH E2A guideline, which are items that should be submitted to the Sponsor? - ANSWER1. A de-identified autopsy report, if available 2. Cause of death, and a comment on its possible relationship to the suspected drug reaction Two weeks after starting an investigational therapy, a subject is rushed to the hospital after experiencing a heart attack. The subject is currently being treated in the Intensive Care Unit (ICU). The ICU doctor has noticed that the subject was enrolled in the trial and has contacted the trial Principal Investigator. Heart attack is not described in the Investigator's Brochure. What actions must be taken by the Principal Investigator? - ANSWER1. Report to the Sponsor per the protocol timelines for serious, unexpected events. 2. Report to the IRB/IEC per their event reporting requirements for serious, unexpected events. What is the timeframe for "expedited" reporting of serious, fatal or life-threatening, unexpected adverse drug reactions to regulatory authorities? - ANSWERAs soon as possible, but no later than seven calendar days after first knowledge of the event Adverse Drug Reaction (ADR) Example - ANSWERYour third subject in a Phase III drug trial calls to report that she has developed a rash on her chest 12 hours after taking her second dose of the investigational study drug. She states that it itches and is slightly uncomfortable. She tells you that she has never had a rash and this is totally unexpected. You know from the Investigator Drug Brochure that only 12% of the patients get a rash from this drug. Which of the following options best describes this situation? What is the purpose of the IRB/IEC? - ANSWERSafeguard the rights, safety, and well-being of all trial subjects Who is responsible for designing the clinical trial protocol? - ANSWERSponsor Informed Consent Process - ANSWERThe process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is best described as which of the following options? The Monitor - ANSWERWho is ultimately responsible for Source Data Verification or SDV? A. At least five members B. At least one member whose primary interest is non-scientific C. At least one member who is independent from the Institution/trial site - ANSWERThe 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 which of the following options? Which of the following is NOT one of the required elements of an informed consent form? - ANSWERA listing of all site personnel who will be involved in the research Name 3 of several required elements of an informed consent form - ANSWER1. The purpose of the research 2. A description of benefits that may be reasonably expected from the research 3. A contact person for questions about the research According to ICH E6, who must sign the Informed Consent Form or ICF? - ANSWERThe person who conducted the informed consent discussion The subject or the subject's legally acceptable representative As per ICH E6 GCP, which groups of potential subjects could be defined as "vulnerable subjects"? - ANSWERMembers of the armed forces Patients with incurable diseases Persons in nursing homes As per ICH E6 GCP, patients with heart conditions alone are defined as "vulnerable subjects"? - ANSWERFalse 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 or clinical research coordinator to take? - ANSWERDocument 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. A study subject reports that he has been having headaches for years but they seem to have become more frequent since starting the study drug. The principal investigator believes that the headaches are not related to the study medication. How should the event be reported? - ANSWERAdverse event, since the headaches have become more frequent You are in the role of Study Manager for the Sponsor. One of your monitors reports significant noncompliance at a site. Which of the following options would be the first course of action for you to implement? - ANSWERRoot Cause Analysis If a sponsor's attempts to secure compliance have failed, and the monitoring/auditing identifies serious and/or persistent noncompliance on the part of an investigator or institution, the sponsor should implement which of the following actions? - ANSWERPromptly notify the regulatory authority(ies) Terminate the investigator's/institution's participation in the trial Which phase of clinical research has a primary objective to demonstrate or confirm therapeutic benefit? - ANSWERPhase 3 Which phase of clinical research is often called "Therapeutic Use." It begins after drug approval. - ANSWERPhase 4 The type of study that investigates human pharmacology and is the initial administration of the investigational new drug in humans. - ANSWERPhase 1 The main goal of which phase of drug development is to explore therapeutic efficacy in patients? It is important during this phase to determine the dose and regimens that will be used for later trials. - ANSWERPhase 2 Characterization of a drug's absorption, distribution, metabolism, and excretion that continues throughout the development plan is defined as what? - ANSWERPharmacokinetics Which of the following is not a special population mentioned in ICH E8? - ANSWERPrisoners According to ICH E8, which of the following are response variables that are chosen to assess the drug's effects? - ANSWERStudy endpoints True or False? The intention of ICH E8 is to describe internationally accepted principles and practices in the conduct of both individual clinical trials and overall development strategy for new medicinal products. - ANSWERTrue Per ICH E8, methods used to evaluate patient usage of the test drug should be what? - ANSWERSpecified in the protocol and actual usage documented The study subject asks you why the study is called a double blind study. You explain double blind as what? - ANSWERWhen the subject and the Investigator and sponsor staff who are involved in the treatment or clinical evaluation of the subjects are unaware of the treatment assignments What does "DSMB" stand for? - ANSWERData Safety Monitoring Board True or False? The Data and Safety Monitoring Board (DSMB) is a separate entity from an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC)? - ANSWERTrue What is the purpose of the "Data and Safety Monitoring Board (DSMB)?" - ANSWERTo assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints Parallel Group Design - ANSWERA design in which subjects are randomized to one of two or more arms, each arm being allocated a different treatment Randomization - ANSWERIntroduces a deliberate element of chance into the assignment of treatments to subjects in a clinical trial factorial design - ANSWERa study in which there are two or more independent variables, or factors Data and Safety Monitoring Boards or DSMBs, have the power to recommend which of the following? - ANSWERthe sponsor should continue the trial the sponsor should modify the trial the sponsor should stop the trial Primary Variable - ANSWERWhich variable in a study should be used to determine the sample size? crossover design - ANSWERWhat do you call the clinical trial design in which each subject is randomized to a sequence of two or more treatments and hence acts as his or her own control for treatment comparisons. 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? - ANSWERThe target population Carryover effect - ANSWERYou 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. ICH E11 - ANSWERGuidance pertains to the Pediatric Population True or False? Due to low blood volumes researchers should not do pharmacokinetic studies in the pediatric population. - ANSWERFalse example of assent - ANSWERwhen a child is given information about a trial and asked if he or she wishes to participate? True or False? Medicinal products may affect physical and cognitive growth and development, and the adverse event profile may differ in pediatric patients. - ANSWERTrue According to ICH E11, what would the suggested age categorization for children be if you were planning a study in "children"? - ANSWER2 to 11 years What are the three ways to minimize the number of samples obtained from each pediatric patient? - ANSWERSparse sampling Population PK Use of indwelling catheters True or False? Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric subjects. - ANSWERFalse Tanner staging - ANSWERThe current protocol for a study in pediatrics is asking for all new patients to have stages of pubertal development assessed. What is this assessment called? The pediatric population represents a vulnerable subgroup. Therefore, special measures are needed to protect the rights of pediatric study participants and to shield them from undue risk. Which of the following should be taken into consideration? Select all that apply - ANSWERRecruitment Consent and assent Minimizing risk Minimizing distress What is the medicinal product dosing in the pediatric population usually based on when developing a pediatric heart disease study involving an adult approved drug? - ANSWERMilligram (mg)/kilogram (kg) body weight Twenty-six subjects were enrolled in a pneumonia trial. The site received 100 bottles of IP. Each subject receives 2 bottles. Four subjects did not return their trial bottles. How many bottles are available for the CRC to return to the sponsor at the end of the trial? - ANSWER92 At the month-3 visit of a Phase III double-blind trial, the subject informs the CRC that he was seen in the emergency department for an anaphylactic reaction. The subject states, "The doctor told me I was very lucky. I might have died." Having received this information, the MOST appropriate sequence of action is to inform the: - ANSWERPI, sponsor and IRB/IEC In an effort to increase enrollment in an ongoing trial, the sponsor has broadened inclusion/exclusion criteria to increase the allowable creatinine level. The next step the CRC should take is to: - ANSWERNotify the IRB/IEC of the change According to ICH Guidelines, the source document should contain which of the following information regarding informed consent? - ANSWERA. Evidence that the consent form was signed prior to trial-related procedures A CRC has received three subject complaints of localized infection at the venipuncture site. The CRC queries the phlebotomist and discovers that when the first stick is unsuccessful, any additional sticks are done with the same needle. This is in violation of the site's SOPs. Which of the following actions should the CRC take? - ANSWERSuggest review of proper specimen collection for the phlebotomist Document and report the findings A small biotech company is investigating the anti-tumoral potential of scorpion toxin in high grade recurrent brain tumors. After animal trials have been completed, the first trial in humans should MOST likely involve: - ANSWERPharmacokinetic analysis Dose escalation the following are regulatory documents - ANSWERA. Informed consent B. Protocol signature page C. Laboratory certification The Confidentiality agreement is considered a regulatory document? - ANSWERFalse A subject is upset and wants to know whom she should contact regarding her rights as a research subject. The CRC should tell her to contact the: - ANSWERIndividual listed in the ICF During the monitoring visit, a CRA discusses the following queries with the CRC: • Dates of the subject visits recorded as month/day/year instead of day/month/year • Subjects' identification numbers are missing lead-in zeros • Weights are recorded as pounds instead of kilograms • Discrepancies in the two subjects' visit dates between source data and CRF entries. Which of the following actions should the CRC take? - ANSWERCorrect errors on the CRFs as discovered During a respiratory trial, a subject calls the CRC 1 week before his next scheduled trial visit and reports upper respiratory symptoms and a pea-sized lump in his neck. Which of the following should the CRC do FIRST? - ANSWERHave the subject come to the site for an interim assessment A potential subject for a trial has been mailed an ICF prior to his screening visit. When the subject arrives at the research department for his screening visit, he states he read the ICF and is ready to do the trial. He does not have the copy of the ICF that was mailed to his home with him. According to ICH Guidelines, which of the following are the BEST actions for the CRC to take initially? - ANSWERConfirm the subject's understanding of the ICF Have the subject sign the ICF A clinical trial is being conducted for hormone replacement. The trial includes a diary. Which of the following would be considered an objective parameter? - ANSWEREpisodes of vaginal bleeding At a screening visit, a CRC takes the following sitting BPs: • 168/100 mmHg • 166/104 mmHg • 167/102 mmHg The patient's mean sitting diastolic BP is: - ANSWER102 mmHg At a screening visit, a CRC takes the following sitting BPs: • 168/100 mmHg • 166/104 mmHg • 167/102 mmHg The patient's mean sitting Systolic BP is: - ANSWER167 mmHg Which of the following are responsibilities of an IDMC/DSMB? 1) Assess the financial aspects of a trial 2) Assess the progress of a trial 3) Recommend initiating a trial 4) Recommend stopping a trial - ANSWER2 and 4 only Which of the following are NOT responsibilities of an IDMC/DSMB? 1) Assess the financial aspects of a trial 2) Assess the progress of a trial 3) Recommend initi