Page 1 of 170 1 MEGA SOCRA CCRP Exam Content with complete solutions (Verified Answers) Latest 2023 -2024 The minimum number of IRB members 5 In a non -emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? Subje cts cannot be enrolled until IRB/IEC approval has been obtained The responsibility for ensuring that the investigator understands a clinical trial lies with: The Sponsor 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? This su bject should undergo all study procedures as outlined in the protocol A significant risk device is defined as an investigational device that is: a. Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subj ect. 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. Page 2 of 170 2 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 At least one member's primary area of interest is in a nonscientific area A purpose of monitoring clinical trials is to verify that: The rights, safety, and well -being of human subjects are protected Which of the following is the proper way to make a correction to a CRF? Add 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 A. The severity of the event B. When the event occurred C. Setting in which the event occurred What is an Unexpected Adverse drug reaction? A reaction that is not consistent with the applicable product information The terms "serious" and "severe" are synon ymous according to ICH. FALSE Page 3 of 170 3 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 A. 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? The 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. Swell ing of the legs was listed in the Investigator's Brochure as a possible side effect. Which of the following options best describes this situation? Serious 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? FALSE In pre -market approval studies, all noxio us and unintended responses to a medicinal product, even possibly related to any dose, should be considered which of the following options? Adverse 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? Page 4 of 170 4 1. A de -identified autopsy report, if available 2. Cause of death, and a comment on its p ossible 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? 1. Report to the Spon sor 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? As soon as possible, but no later than seven calendar days after first knowledge of the event Adverse Drug Reaction (ADR) Example Your third subject in a Phase III drug trial calls to report that she has d eveloped 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 Inv estigator 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? Safeguard the rights, safety, and well -being of all trial subjects Who is res ponsible for designing the clinical trial protocol?
threatening, unexpected adverse drug reactions to regulatory authorities? As soon as possible, but no later than seven calendar days after first knowledge of the event Adverse Drug Reaction (ADR) Example Your third subject in a Phase III drug trial calls to report that she has d eveloped 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 Inv estigator 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? Safeguard the rights, safety, and well -being of all trial subjects Who is res ponsible for designing the clinical trial protocol?
