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SOCRA CCRP ACTUAL EXAM QUESTIONS AND ANSWERS 2025, Exams of Nursing

SOCRA CCRP ACTUAL EXAM QUESTIONS AND ANSWERS 2025

Typology: Exams

2024/2025

Available from 11/22/2024

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SOCRA CCRP EXAM QUESTIONS

WITH COMPLETE SOLUTIONS 2025

5 Correct Answer: The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained Correct Answer: 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? The Sponsor Correct Answer: The 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? Correct Answer: This subject should undergo all study procedures as outlined in the protocol A significant risk device is defined as an investigational device that is: Correct Answer: a. 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 Correct Answer: At least one member's primary area of interest is in a nonscientific area The rights, safety, and well-being of human subjects are protected Correct Answer: A purpose of monitoring clinical trials is to verify that: Which of the following is the proper way to make a correction to a CRF? Correct Answer: 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 Correct Answer: 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? Correct Answer: A reaction that is not consistent with the applicable product information The terms "serious" and "severe" are synonymous according to ICH. Correct Answer: FALSE 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 Correct Answer: 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? Correct Answer: 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. 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? Correct Answer: 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? Correct Answer: FALSE 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? Correct Answer: 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? Correct Answer: 1. A de-identified autopsy report, if available

  1. 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? Correct Answer: 1. 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? Correct Answer: As soon as possible, but no later than seven calendar days after first knowledge of the event

Adverse Drug Reaction (ADR) Example Correct Answer: Your 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? Correct Answer: Safeguard the rights, safety, and well- being of all trial subjects Who is responsible for designing the clinical trial protocol? Correct Answer: Sponsor Informed Consent Process Correct Answer: The 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 Correct Answer: Who 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 Correct Answer: 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 which of the following options? Which of the following is NOT one of the required elements of an informed consent form? Correct Answer: A listing of all site personnel who will be involved in the research Name 3 of several required elements of an informed consent form Correct Answer: 1. The purpose of the research

  1. A description of benefits that may be reasonably expected from the research
  2. A contact person for questions about the research According to ICH E6, who must sign the Informed Consent Form or ICF? Correct Answer: The 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"? Correct Answer: Members 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"? Correct Answer: False 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? Correct Answer: 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. 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? Correct Answer: Adverse 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? Correct Answer: Root 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? Correct Answer: Promptly 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? Correct Answer: Phase 3 Which phase of clinical research is often called "Therapeutic Use." It begins after drug approval. Correct Answer: Phase 4 The type of study that investigates human pharmacology and is the initial administration of the investigational new drug in humans. Correct Answer: Phase 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. Correct Answer: Phase 2 Characterization of a drug's absorption, distribution, metabolism, and excretion that continues throughout the development plan is defined as what? Correct Answer: Pharmacokinetics Which of the following is not a special population mentioned in ICH E8? Correct Answer: Prisoners

According to ICH E8, which of the following are response variables that are chosen to assess the drug's effects? Correct Answer: Study 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. Correct Answer: True Per ICH E8, methods used to evaluate patient usage of the test drug should be what? Correct Answer: Specified 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? Correct Answer: When 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? Correct Answer: Data 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)? Correct Answer: True What is the purpose of the "Data and Safety Monitoring Board (DSMB)?" Correct Answer: To assess the progress of a clinical trial, the safety data, and the critical efficacy endpoints Parallel Group Design Correct Answer: A design in which subjects are randomized to one of two or more arms, each arm being allocated a different treatment Randomization Correct Answer: Introduces a deliberate element of chance into the assignment of treatments to subjects in a clinical trial factorial design Correct Answer: a 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? Correct Answer: the sponsor should continue the trial the sponsor should modify the trial the sponsor should stop the trial Primary Variable Correct Answer: Which variable in a study should be used to determine the sample size? crossover design Correct Answer: What 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? Correct Answer: The target population Carryover effect Correct Answer: 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. ICH E11 Correct Answer: Guidance pertains to the Pediatric Population True or False? Due to low blood volumes researchers should not do pharmacokinetic studies in the pediatric population. Correct Answer: False example of assent Correct Answer: when 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. Correct Answer: True According to ICH E11, what would the suggested age categorization for children be if you were planning a study in "children"? Correct Answer: 2 to 11 years What are the three ways to minimize the number of samples obtained from each pediatric patient? Correct Answer: Sparse 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. Correct Answer: False Tanner staging Correct Answer: The 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 Correct Answer: Recruitment 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? Correct Answer: Milligram (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? Correct Answer: 92 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: Correct Answer: PI, 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: Correct Answer: Notify the IRB/IEC of the change According to ICH Guidelines, the source document should contain which of the following information regarding informed consent? Correct Answer: A. 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? Correct Answer: Suggest 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: Correct Answer: Pharmacokinetic analysis Dose escalation the following are regulatory documents Correct Answer: A. Informed consent B. Protocol signature page C. Laboratory certification The Confidentiality agreement is considered a regulatory document? Correct Answer: False 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: Correct Answer: Individual 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? Correct Answer: Correct 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? Correct Answer: Have 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? Correct Answer: Confirm 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? Correct Answer: Episodes 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: Correct Answer: 102 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: Correct Answer: 167 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 Correct Answer: 2 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 initiating a trial
  4. Recommend stopping a trial Correct Answer: 1 and 3 only A CRC is screening subjects for an oral IP. All subjects must be stabilized on currently approved medication. Which of the following questions should be asked by the CRC?
  5. When was the last time your medication dose changed?
  6. Have you made any dietary changes in the last month?
  7. When was your last chest x-ray?
  8. Do you have any difficulty swallowing oral medications? Correct Answer: 1 and 4 only A CRC is screening subjects for an oral IP. All subjects must be stabilized on currently approved medication. Which of the following questions can the CRC skip?
  9. When was the last time your medication dose changed?
  10. Have you made any dietary changes in the last month?
  11. When was your last chest x-ray?
  12. Do you have any difficulty swallowing oral medications? Correct Answer: 2 and 3 only A competent adult subject signs a consent form with an "X" and indicates approval. Which of the following is the BEST action for the CRC to take? Correct Answer: Document why the subject signed with an "X" The DSMB has prematurely terminated a trial evaluating an investigational pain medication that is taken 1 caplet orally b.i.d. for chronic hip pain. Subjects are allowed to take one extra caplet per day. Subjects receive a sufficient quantity of IP for 14 days plus two additional doses. Which of the following represents a drug accountability issue? Correct Answer: Subject B returns 12 pills after 8 days on trial A CRA is conducting a close-out visit at a site to review the regulatory documents. The CRC has prepared the following documents to be filed and/or sent to the sponsor: treatment decoding documentation, drug accountability log, subject identification code list, documentation of IP destruction, and final report to the IRB/IEC. Which of the following actions should the CRC perform? Correct Answer: 1) Send the treatment decoding documentation to the sponsor
  13. Remove the subject identification code list from the material to be sent to the sponsor
  14. Send copies of the IP destruction forms to the sponsor A site has not received IRB/IEC approval for protocol submission. The PI instructs the CRC employed by the clinic to begin scheduling subjects for screening appointments. Which of the

following is the BEST action for the CRC to take? Correct Answer: Review the research database and collate a list of potential subjects A subject has signed the informed consent form for a hypertension trial. All screening procedures and the physical examination have been completed. The CRC is ready to dispense the single-blind placebo to the subject who asks, "Is that the sugar pill that I read about in the form I signed?" Which of the following should the CRC tell the subject? Correct Answer: "It might be placebo, but we will be checking your blood pressure every week." Which of the following scenarios are considered SAEs?

  1. Infection following surgery prolonging hospital stay
  2. Pregnancy resulting in normal delivery of twins
  3. Boating accident with overnight hospitalization
  4. Use of illicit drug during the trial Correct Answer: 1 and 3 only Which of the following scenarios are NOT considered SAEs?
  5. Infection following surgery prolonging hospital stay
  6. Pregnancy resulting in normal delivery of twins
  7. Boating accident with overnight hospitalization
  8. Use of illicit drug during the trial Correct Answer: 2 and 4 only A clinical trial is being conducted to determine the safety and tolerability of a new anti-emetic IP. The sponsor expects to enroll 20 subjects. This would be considered a: Correct Answer: Phase 1 trial Which of the following would require consent when screening a subject? A. Subject demographics B. Relevant medical history C. Washout from medication D. Routine diagnostic lab tests Correct Answer: C. Washout from medication Which of the following Might NOT require consent when screening a subject? A. Subject demographics B. Relevant medical history C. Washout from medication D. Routine diagnostic lab tests Correct Answer: A. Subject demographics

B. Relevant medical history D. Routine diagnostic lab tests Which of the following is MOST useful for scheduling trial procedures? Correct Answer: Trial Schedule of Events The CRC reviewed a new protocol to prepare the trial budget for submission to the sponsor. According to the protocol, each subject is required to return for follow-up visits at 30 days, 6 months and 1 year.

  • At 30 days, the protocol requires a physical exam, an electrocardiogram and a chest x-ray
  • At 6 months, the protocol requires a physical exam and an electrocardiogram
  • At 1 year, the protocol requires a physical exam, an electrocardiogram and a chest x-ray The hospital charges $75 for the physical exam, $50 for the electrocardiogram, and $100 for the chest x-ray. The 30 day and 1 year visits are considered standard of care for the subjects. How much should the CRC budget per subject for the non-standard of care visits? Correct Answer: $ The CRC reviewed a new protocol to prepare the trial budget for submission to the sponsor. According to the protocol, each subject is required to return for follow-up visits at 30 days, 6 months and 1 year.
  • At 30 days, the protocol requires a physical exam, an electrocardiogram and a chest x-ray
  • At 6 months, the protocol requires a physical exam and an electrocardiogram
  • At 1 year, the protocol requires a physical exam, an electrocardiogram and a chest x-ray The hospital charges $75 for the physical exam, $50 for the electrocardiogram, and $100 for the chest x-ray. The 30 day and 1 year visits are NOT considered standard of care for the subjects. How much should the CRC budget per subject for the non-standard of care visits? Correct Answer: $ A PI has an enrollment goal of 24 subjects. Ten potential subjects are seen each week. Twenty percent of the potential subjects will not be interested in participating. Fifty percent of the subjects who are interested will fail to meet one or more of the eligibility criteria. How long will it take the CRC to fulfill enrollment? Correct Answer: 6 weeks A PI has an enrollment goal of 20 subjects. Ten potential subjects are seen each week. Twenty percent of the potential subjects will not be interested in participating. Fifty percent of the subjects who are interested will fail to meet one or more of the eligibility criteria. How long will it take the CRC to fulfill enrollment? Correct Answer: 5 weeks

The day before a CRA is to conduct an initiation visit, the CRC realizes that the IRB/IEC approval letter has not yet been obtained. Which of the following should the CRC do FIRST? Correct Answer: Call the IRB/IEC to check the status of the letter A CRA calls to schedule a close-out visit. Per sponsor SOPs, the PI must be present. The CRC informs the CRA that the PI will be out of the country during the period when the CRA would like to visit. The CRC should do which of the following? Correct Answer: Reschedule the close- out visit for a later date A subject is admitted to the hospital for chest pain and suspected myocardial infarction. This subject gave informed consent for a trial of a new antihistamine 1 week before the onset of any chest pain. The subject took the first dose of test article 2 days ago. The PI determines that the event is probably related to the IP. Which of the following is the BEST course of action for the CRC to take? Correct Answer: Notify the sponsor that the PI believes the event is related to the IP A subject is participating in a lipid-lowering clinical trial. Before the 12- month visit, the CRC receives an amendment from the sponsor, which includes the addition of quality of life measures to be collected at the 12-month visit. To ensure appropriate collection of this additional data, the CRC should: Correct Answer: Obtain the appropriate signature on the revised, approved consent, then have the subject complete the questionnaires. A sponsor has supplied all sites with digital thermometers for a vaccine trial. At one site, the CRC notices that 10 of 30 subjects have recorded consistently low temperature readings in their diaries for the first 7 days of the trial. Upon review with the subjects, there were no related complaints. What should be the CRC's FIRST action? Correct Answer: Notify the sponsor A CRC is enrolling three subjects for a Phase III trial with restrictive eligibility criteria. The PI indicates that she must leave the office to teach a lecture in 30 minutes. The laboratory will be closing in 1 hour. Which of the following is the MOST appropriate action for the CRC? Correct Answer: Give each subject sufficient time to review the ICF At a trial site, CRCs perform quality assurance as needed throughout the progress of their trials. A CRC notes that five of the seven research nurses failed to document subject understanding of the trial. Which of the following actions should the CRC perform?

  1. Inform the sponsor of this practice
  2. Revise the delegation of responsibility
  3. Ensure the subjects have been well informed of the trial
  4. Review the informed consent process with the individual research nurses Correct Answer: 3 and 4 only

At a trial site, CRCs perform quality assurance as needed throughout the progress of their trials. A CRC notes that five of the seven research nurses failed to document subject understanding of the trial. Which of the following 2 of 4 actions should the CRC perform last if necessary?

  1. Inform the sponsor of this practice
  2. Revise the delegation of responsibility
  3. Ensure the subjects have been well informed of the trial
  4. Review the informed consent process with the individual research nurses Correct Answer: 1 and 2 only According to the Declaration of Helsinki, biomedical research involving human subjects:
  5. Should be based on adequately performed laboratory and animal experimentation
  6. Should be conducted by scientifically qualified persons and under the supervision of a clinically competent medical person
  7. Must evaluate the potential benefits to society as opposed to the potential risk to individual subjects
  8. Must be preceded by careful assessment of predictable risks in comparison with foreseeable benefits Correct Answer: 1, 2 and 4 only What is NOT part of Declaration of Helsinki, biomedical research involving human subjects:
  9. Should be based on adequately performed laboratory and animal experimentation
  10. Should be conducted by scientifically qualified persons and under the supervision of a clinically competent medical person
  11. Must evaluate the potential benefits to society as opposed to the potential risk to individual subjects
  12. Must be preceded by careful assessment of predictable risks in comparison with foreseeable benefits Correct Answer: 3) Must evaluate the potential benefits to society as opposed to the potential risk to individual subjects Which of the following is the proper way to make a correction to a CRF? Correct Answer: Add the initials of the person making the change, date the change, and, if necessary, a brief explanation of the change. What is NOT the proper way to make a correction to a CRF? Correct Answer: Completely blacken the incorrect entry and then enter the correct information Back date the corrected entry with the date of the original entry With respect to IRB/IEC membership, both the FDA and ICH require that... Correct Answer: At least one member's primary area of interest is in a nonscientific area.

Advertising for study subjects must... Correct Answer: Be approved by the IRB/IEC prior to use. All of the following statements regarding the study protocol are true, except: A. The protocol describes the objectives, design, and methodologies of the trial. B. The protocol should be designed to protect the rights, safety and welfare of subjects. C. The protocol must include sufficient justification and rationale for the conduct of the research. D. The protocol specifies how the clinical development of an investigational product will be conducted. Correct Answer: D. The protocol specifies how the clinical development of an investigational product will be conducted. Which of the following statements regarding the study protocol are true? A. The protocol describes the objectives, design, and methodologies of the trial. B. The protocol should be designed to protect the rights, safety and welfare of subjects. C. The protocol must include sufficient justification and rationale for the conduct of the research. D. The protocol specifies how the clinical development of an investigational product will be conducted. Correct Answer: A. The protocol describes the objectives, design, and methodologies of the trial. B. The protocol should be designed to protect the rights, safety and welfare of subjects. C. The protocol must include sufficient justification and rationale for the conduct of the research. An unconscious adult subject was enrolled in a study after obtaining consent from an LAR, and the protocol therapy initiated. The subject showed significant improvement in his clinical condition, and regained consciousness. The investigator should inform the subject about the study and: Correct Answer: Obtain consent from the subject for the study Documentation of IP destruction at a site should be maintained by the: Correct Answer: Sponsor and PI Prior to agreeing to participate in a study, the investigator should consider whether they: Correct Answer: See enough patients who meet eligibility requirements According to ICH GCP, an impartial witness be present during the informed consent discussion when: Correct Answer: The subject or LAR is unable to read According to ICH GCP, who should be informed about a subject's

participation in a trial? Correct Answer: The subject's primary care physician In which of the following scenarios is re-consent required? A. The research nurse leaves and a new one is added to the study. B. New information arises which affects the safety of study participants. C. The CT scanner breaks and you to reschedule the study visit. D. It's been more than 30 days since consent was last obtained. Correct Answer: B. New information arises which affects the safety of study participants. You've been informed that a batch of IP is being recalled and you've been asked to identify which subjects received medication from the recalled batch. Where will you find this information? Correct Answer: IP accountability log In which of the following scenarios is re-consent NOT required? A. The research nurse leaves and a new one is added to the study. B. New information arises which affects the safety of study participants. C. The CT scanner breaks and you to reschedule the study visit. D. It's been more than 30 days since consent was last obtained. Correct Answer: A. The research nurse leaves and a new one is added to the study. C. The CT scanner breaks and you to reschedule the study visit. D. It's been more than 30 days since consent was last obtained. An adverse event that is severe in intensity Correct Answer: May not meet the definition of serious An adverse event that is severe in intensity is considered serious. Correct Answer: False An adverse event that is severe in intensity may not be considered serious. True or False? Correct Answer: True An investigator intentionally removes data points on a graph in order to generate a deceptive conclusion. This is an example of: Correct Answer: Falsification What is indemnification? Correct Answer: Defines the duties and responsibilities of the involved parties in cases of loss or injury linked to a clinical trial A clinical trial protocol should include: Correct Answer: The subject's responsibilities Alternative treatments available to the subject Indemnification statement

Biometrics Correct Answer: A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System Correct Answer: An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. ( CFR, Sec. 11.3) Digital Signature Correct Answer: An electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. (21 CFR, Sec. 11.3) Electronic Record Correct Answer: Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system. (21 CFR, Sec. 11.3) Electronic Signature Correct Answer: A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the handwritten signature. (21 CFR, Sec. 11.3) Open system Correct Answer: An environment in which system access is not controlled by persons who are responsible for the content of the electronic records that are on the system. ( CFR, Sec. 11.3) Clinical Investigation Correct Answer: Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. (21 CFR, sec. 50.3) Investigator Correct Answer: An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. (21 CFR, sec. 50.3) Sponsor Correct Answer: A person who initiates a clinical investigation but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to, or used involving, a subject under the immediate direction of another individual. A person other than the individual (e.g., corporation or agency) that uses one or more of its own employees to conduct a clinical investigation it has initiated it has initiated is considered to be a sponsor (not a sponsor- investigator), and the employees are considered to be investigators. (21 CFR, sec. 50.3)

Sponsor-Investigator Correct Answer: An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any other person other than an individual, e.g. corporation or agency. (21 CFR, sec. 50.3) Handwritten Signature Correct Answer: The scripted name or legal mark of an individual handwritten by that individual. (21 CFR, Sec. 11.3) Act Correct Answer: The Food, Drug and Cosmetic Act, as amended. Human Subject Correct Answer: An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. (21 CFR, sec. 50.3) Institution Correct Answer: Any public or private entity or agency (including Federal, State or other agencies). The word facility as used in section 520(g) of the Act is deemed to by synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3) Institutional Review Board (IRB) Correct Answer: Any board, committee, or other group formally designated by an institution to review biomedical research involving humans as subjects, to approve the initiation of and conduct periodic review of such research. The term has the same meaning as the phrase institutional review committee as used in section 520(g) of the act. (21 CFR, sec. 50.3) Test Article Correct Answer: Any food or drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351, and 354-360F of the Public Health Services Act. (21 CFR, sec. 50.3) Minimal Risk Correct Answer: Means that the probability and magnitude of harm or discomfort anticipated in the research are no greater in an of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (21 CFR, sec. 50.3) Legally Authorized Representative Correct Answer: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved. (21 CFR, sec. 50.3) Family Member Correct Answer: Any one of the following legally competent persons: spouse; parents; children (including adopted children); brothers, sisters and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is equivalent of a family relationship. (21 CFR, sec. 50.3) Assent Correct Answer: A child's affirmative agreement to participate in a clinical investigation. Mere failure to object may not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)

Children Correct Answer: Persons who have not attained the legal age for consent to treatment or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. (21 CFR, sec. 50.3) Parent Correct Answer: A child's biological or adoptive parent. (21 CFR, sec. 50.3) Ward Correct Answer: A child who is placed in legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3) Permission Correct Answer: The agreement of the parent(s) or guardian to the participation of their child or ward in a clinical investigation. Permission must be obtained in compliance with part 50 subpart B and must include all the elements of the informed consent. (21 CFR, sec. 50.3) Guardian Correct Answer: An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care when general medical care includes research. (21 CFR, sec. 50.3) Emergency Use Correct Answer: The use of a test article on a human subject in a life- threatening situation in which no standard acceptable treatment is available, and in which there is no sufficient time to obtain IRB approval. (21 CFR, sec. 56.102) IRB Approval Correct Answer: The determination of the IRB that the clinical investigation has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal Requirements. (21 CFR, sec. 56.102) Contract Research Organization Correct Answer: A person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the FDA. (21 CFR, sec. 312.3) IND Correct Answer: An investigational new drug application. Is synonymous with "Notice of Claimed Investigational Exemption for a New Drug". (21 CFR, sec. 312.3) Independent Ethics Committee (IEC) Correct Answer: A review panel the is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An IRB is one type of IEC. (21 CFR, sec. 312.3) Custom Device Correct Answer: A device that 1) necessarily deviates from devices generally available 2) is not generally available to Physicians/dentists 3) not generally available in finished form for purchase or dispensing 4) is not offered for commercial distribution through labeling/advertising 5) is intended for use by an individual patient named in the order of the physician or dentist and is made to be in a specific form for that patient. (21 CFR, sec. 812.3)

Implant Correct Answer: A device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. (21 CFR, sec. 812.3) Investigational Device Correct Answer: A device, including a transitional device that is the object of investigation. (21 CFR, sec. 812.3) Monitor Correct Answer: When used as a noun, means an individual designated by a sponsor or contract research organization to oversee the progress of and investigation. When used as a verb, means to oversee and investigation. (21 CFR, sec. 812.3) Noninvasive diagnostic device or procedure Correct Answer: One that does NOT 1) penetrate the skin or mucous membranes of the body, ocular cavity or the urethra 2) enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum or the vagina beyond the cervical os. (21 CFR, sec. 812.3) Significant Risk Device Correct Answer: An investigational device that 1) is intended as an implant and presents a potential for serious risk to the health, safety or welfare of the subject 2) is purposed or represented to be for a use in supporting or sustaining human life and presents a potential serious risk 3) is for a use of substantial importance in diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of human health. (21 CFR, sec. 812.3) Termination Correct Answer: A discontinuance, b a sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion. (21 CFR, sec. 812.3) Translational Device Correct Answer: A device that FDA considered to be a new drug or and antibiotic drug before May 28, 1976. (21 CFR, sec. 812.3) Unanticipated Adverse Device Event Correct Answer: Any serious adverse effect on the health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect or problem, or death was not previously identified in nature, severity or degree of incidence in the investigational plan or application. (21 CFR, sec. 812.3) Department of Agency Head Correct Answer: The head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated. (45 CFR, sec. 46.102) Legally Authorized Representative (LAR) Correct Answer: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research. (45 CFR, sec. 46.102) Viable Correct Answer: As it pertains to the neonate, means being able after delivery to survive. Human Subject Correct Answer: A living individual about whom an investigator conducting research obtains 1)Data through intervention or interaction with the individual 2) Identifiable private information. (45 CFR, sec. 46.102)

Certification Correct Answer: The official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (45 CFR, sec. 46.102) Adverse Drug Reaction (ADR) Correct Answer: All noxious and unintended responses to a medicinal product related to any dose. (ICH GCP E6 1.1) Adverse Event (AE) Correct Answer: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. (ICH GCP E6 1.2) Applicable Regulatory Requirements Correct Answer: Any laws and regulations addressing the conduct of clinical trials of investigational products (ICH GCP E6 1.4) Audit Correct 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, sponsors SOPs, GCP and the applicable regulatory requirements. (ICH GCP E6 1.6) Audit Certificate Correct Answer: A declaration of the confirmation by the auditor that an audit has taken place. (ICH GCP E6 1.7) Audit Report Correct Answer: A written evaluation by the sponsor's auditor of the results of the audit. (ICH GCP E6 1.8) Audit Trail Correct Answer: Documentation that allow reconstruction of the course of events. (ICH GCP E6 1.9) Blinding/Masking Correct Answer: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment. (ICH GCP E6 1.10) Case Report Form (CRF) Correct Answer: A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. (ICH GCP E6 1.11) Clinical Trial/Study Report Correct Answer: A written description of a trial/study of any therapeutic, prophylactic or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. (ICH GCP E6 1.13) Comparator (Product) Correct Answer: An investigational or marketed product (i.e. active control). or placebo, used as a reference in a clinical trial. (ICH GCP E6 1.14)

Compliance Correct Answer: Adherence to all the trial related requirements, GCP requirements and the applicable regulatory requirements. (ICH GCP E6 1.15) Confidentiality Correct Answer: Prevention or disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. (ICH GCP E6 1.16) Contract Correct Answer: A written, dated and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and if appropriate on financial matters. (ICH GCP E6 1.17) Coordinating Committee Correct Answer: A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. (ICH GCP E6 1.18) Coordinating Investigator Correct Answer: An investigator assigned the responsibility for the coordination of investogators at different centres participating in a multicentre trial. (ICH GCP E6 1.19) Contract Research Organization (CRO) Correct Answer: A person or an organization (commercial academic or otherwise) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. (ICH GCP E6 1.20) Direct Access Correct Answer: Permission to examine, analyze, verify, and reproduce any records and reports that are important to the evaluation of a clinical trial. (ICH GCP E6 1.21) Documentation Correct Answer: All records, in any form, that describe or record the methods, conduct and or results of a trial, the factors affecting the trial and the actions taken. (ICH GCP E6 1.22) Essential Documents Correct Answer: Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. (ICH GCP E6 1.23) Good Clinical Practice (GCP) Correct Answer: A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of the trial subjects are protected. (ICH GCP E6 1.24) Independent Data Monitoring Committee (IDMC) Correct Answer: May be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints. (ICH GCP E6 1.25) Impartial Witness Correct Answer: A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's LAR cannot read, and who reads the informaed consent for, and any other written information supplied to the subject. (ICH GCP E6 1.26)

Independent Ethics Committee (IEC) Correct Answer: An independent body (a review board or a committee, institutional, regional, national or supranational), constitutes fo medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among, other things, reviewing and approving/providing favourable opinion on, the trial protocol, the suitability of the investigators, facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (ICH GCP E6 1.27) Inspection Correct Answer: The act by a regulatory authority of conducting and official review of documents, facilities, records and any other resources that are deemed by the authorities 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 organizations (CROs) facilities, or at other establishments deemed appropriate by the regulatory authorities. (ICH GCP E6 1.29) Interim Clinical Trial/Study Report Correct Answer: A report of intermediate results and their evaluation based on analyses performed during the course of the trial. (ICH GCP E6 1.32) Investigational Product Correct Answer: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trail, including a product with a marketing authorization when used or assembled in a different way from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. (ICH GCP E6 1.33) Investigator's Brochure Correct Answer: A compilation of the clinical and nonclinical data on the investigational products which is relevant to the study of the investigational products in human subjects. (ICH GCP E6 1.36) Legally Acceptable Representative Correct Answer: An individual or juridicial or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subjects participation in the clinical trial. (ICH GCP E6 1.37) Monitoring Report Correct Answer: A written report from the monitor or sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. (ICH GCP E6 1.39) Multicentre Trial Correct Answer: A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator. (ICH GCP E6 1.40) Nonclinical Study Correct Answer: Biomedical studies not performed on human subjects. (ICH GCP E6 1.41) Protocol Amendment Correct Answer: A written description of changes to or formal clarification of a protocol. (ICH GCP E6 1.45)

Quality Assurance (QA) Correct Answer: All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with Good Clinical Practices and the applicable regulatory requirements. (ICH GCP E6 1.46) Quality Control (QC) Correct 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. (ICH GCP E6 1.47) Randomization Correct Answer: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (ICH GCP E6 1.48) Regulatory Authorities Correct Answer: Bodies having the power to regulate. In the ICH GCP guideline that guidelines the expression Regulatory Authorities includes the authorities that review submitted clinical data. Form 1572 Correct Answer: Statement of investigator for IND Form 1571 Correct Answer: Cover sheet for an IND application Private Information Correct Answer: - information about behavior which occurs in a context in which an individual can reasonably expect that no observation or recording is taking place

  • information which has been provided for a specified purpose by an individual and which the individual can reasonably expect will not be made public (e.g. medical record) IRB membership requirements according to 45 CFR 46 Correct Answer: - minimum of 5 members
  • IRB must be qualified through experience, expertise, diversity
  • diversity with respect to race, gender, cultural background
  • cannot consist of members of one profession
  • at least one member must have a primary concern in a scientific area and one in a non-scientific area
  • at least one member not affiliated with the institution Circumstances/conditions required for informed consent Correct Answer: - subject has had sufficient opportunity to consider whether to participate
  • the possibility of coercion or undue influence is minimized Informed Consent MUST Contain: Correct Answer: - explanation of purpose of research
  • duration of participation
  • description of procedures to be followed
  • identification of any procedures which are experimental
  • any foreseeable risks or discomfort
  • statement about potential benefits to subjects
  • statement if no reasonable alternative procedures or treatments are available to subjects
  • for > minimal risk, a statement about compensation and if medical treatment is available for injuries
  • statement of who to contact in the event of research-related injury Informed Consent ADDITIONAL Elements: Correct Answer: - risk to embyro or fetus
  • termination procedures
  • costs to study subjects
  • approximate number of study subjects
  • a statement of new findings when they may impact a subject's willingness to participate Oral consent Correct Answer: - requires a witness
  • subject must sign short form only
  • witness must sign both short form and summary of what was said Waiver of Signed Informed Consent Correct Answer: - if the only record linking the subject to the research would be the consent document and the principal risk would result from breach in confidentiality
  • the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the context of research Types of federally-funded research that may be done using prisoners as subjects Correct Answer:
  • possible causes, effects, and processes of incarceration and criminal behavior
  • prisons as institutional structures or prisoners as incarcerated persons
  • conditions particularly affecting prisoners
  • practices aimed at improving the health or well-being of prisoners 3 regulatory agency sponsors of ICH Correct Answer: European Union, Japan, United States What ethical standards are the ICH document based on? Correct Answer: Declaration of Helsinki What special population must the IRB pay special attention to? Correct Answer: Vulnerable subjects What 5 classes of products do the informed consent regulations apply? (test articles) Correct Answer: - drugs
  • medical devices
  • biological products
  • electronic products
  • food (including dietary supplements and infant formulas)
  • color additives Minimum risk Correct Answer: the probability and magnitude of anticipated harm or discomfort are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Form 3454 Correct Answer: Certification of financial interest and arrangements of clinical investigators Form 482 Correct Answer: Notice of inspection Form 483 Correct Answer: Inspectional observations Form 3500 Correct Answer: Voluntary safety reporting of adverse events and product problems Form 3500A Correct Answer: Mandatory safety reporting by user facilities, distributors, and manufacturers Form 3455 Correct Answer: Disclosure of financial interest and arrangements of clinical investigators 21 CFR 312 Correct Answer: IND 21 CFR 812 Correct Answer: IDE Who is responsible for the safety and well-being of all trial subjects? Correct Answer: the IRB When does an SAE have to be reported to the FDA within 15 calendar days? Correct Answer: When it fits all SAE criteria but is not life-threatening and does not result in death. 21 CFR 50 Correct Answer: Protection of Human Subjets/Informed Consent 21 CFR 11 Correct Answer: Electronic Records/Signatures Where would you look to find official government information regarding GCP? Correct Answer: US Code of Federal Regulations According to ICH guidelines, how many members should an IRB have? Correct Answer: at least 5 How many calendar days does a sponsor have to report a fatal or life-threatening unexpected adverse drug reaction? Correct Answer: 7 calendar days According to ICH guidelines, IRB must retain records for... Correct Answer: 3 years Phase I Clinical Trial Correct Answer: Small trials with healthy subjects, purpose is to determine pharmacokinetics and maximum tolerated dose 21 CFR 56 Correct Answer: IRB 45 CFR Correct Answer: The Common Rule