Good Clinical Practice Course (Medical Clinical Research)
Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development? a. Preclinical b. Phase III c. Phase I d. Phase II
a. Preclinical
In the United States, following the ICH E6 guideline is: a. Mandatory for investigational device studies. b. Mandatory for drug studies. c. Voluntary for FDA-regulated drug studies. d. Mandatory for studies conducted outside the United States.
c. Voluntary for FDA-regulated drug studies.
When the FDA conducts an inspection, the inspectors will: a. Review regulatory records. b. Recommend protocol changes. c. Issue a warning letter. d. Determine if the Assurance should be restricted.
a. Review regulatory records.
What is the status of ICH in U.S.? a. It has no status. b. It is a FDA guidance. c. It is a regulation codified at 21 CFR. d. It is a federal statute (law).
b. It is a FDA guidance.
Which of the following is an important component of drug accountability? a. Manufacturer's compounding procedures b. Patent expiration date c. Drug shipping and disposition records d. Environmental controls
c. Drug shipping and disposition records
Who is responsible for making the initial risk determination for a device being used in a study? a. The IRB. b. The manufacturer of the device. c. The sponsor-investigator. d. The FDA.
c. The sponsor-investigator.
The overall goal of monitoring, audits, and inspection activities is to: a. Review research related publications. b. Resolve disputes between the sponsor and the investigators. c. Manage conflict of interest. d. Ensure the protection of human research subjects and data integrity.
d. Ensure the protection of human research subjects and data integrity.
When evaluating the causality of an adverse event, which of the following should be a consideration? a. The method used to randomize subjects b. The number of planned interventions in the protocol c. Whether or not the adverse event qualifies as a serious adverse event. d. The timing of the event in relation to administration of the investigational agent
d. The timing of the event in relation to administration of the investigational agent
ICH E6 describes standards that apply to: a. Investigators, sponsors, and IRBs b. IRBs only c. Research sponsors only d. Investigators only
a. Investigators, sponsors, and IRBs
Identify which party is responsible for reporting directly to the FDA the investigator's financial interests with the sponsor: a. The sponsor b. The IRB c. The investigator's institution d. The investigator
a. The sponsor
In terms of explaining the probability of assignment to trial arms in consent forms, which is true? a. Neither FDA nor ICH require statements about the probability for random assignment to each treatment arm or the use of a placebo arm. b. ICH notes that it should be included, but does not specify how the information should be presented. c. The probability of assignment should always be stated as being "like the flip of a coin" because subjects can understand that example. d. FDA requires the probability to be expressed as a percentage chance.
b. ICH notes that it should be included, but does not specify how the information should be presented.
Where is information on storage requirements for the investigational product usually found? a. In the drug accountability log b. In the study protocol c. In the case report form directions d. On the product code-breaker label
b. In the study protocol
Which of the following best describes the principle of Respect for Persons as described in the Belmont Report? a. Voluntariness, risk/benefit assessment, selection of subjects. b. Information, comprehension, voluntariness. c. Comprehension, conflicts of interest, risk/benefit ratio. d. Risk/benefit assessment, justification of research, comprehension.
b. Information, comprehension, voluntariness.
A primary purpose of the ICH is to: a. Require FDA registration of worldwide clinical trials. b. Minimize the need for redundant research. c. Require publication of negative trial results. d. Develop mandatory worldwide regulations for drug development.
b. Minimize the need for redundant research
For a Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure? a. Clinical trials b. Preclinical data c. FDA files d. Postapproval surveillance studies
b. Preclinical data
The ICH GCP guidelines: a. Require certification of clinical research sites and investigators b. Set standards for the design, conduct, monitoring and reporting of clinical research. c. Guarantee that a submission in any ICH region will be approved for marketing. d. Replace FDA regulations for internationally conducted studies of drugs that will be marketed in the U.S.
b. Set standards for the design, conduct, monitoring and reporting of clinical research.
The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following? a. Use of the PDA cycle (Plan, Do, Act) during the annual continuing review. b. Mandatory use of ICH E6 template Case Report Forms for all drug studies to be submitted to regulatory authorities c. Complete on-site documentation audits every 3-6 months. d. Identification of study risks to determine which may safely be omitted from continual monitoring.
d. Identification of study risks to determine which may safely be omitted from continual monitoring.
Investigational product dispensing or administration information for the sponsor is recorded on the: a. Case report form b. Form FDA 1572 c. Informed consent form d. Insurance claim form
a. Case report form
Form FDA 1572, Statement of Investigator, is legally binding between the investigator and the: a. FDA b. Subjects c. IRB d. Sponsor
a. FDA
The packaging of investigational drugs should ideally: a. Be attractive so the study coordinators will use it b. Be designed to help with subject compliance c. Allow subjects to identify placebo pills d. Look like a marketed product
b. Be designed to help with subject compliance
Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? a. Ensuring that confidentiality is maintained. b. Determining that the study has maximized benefits and minimized risks. c. Insuring that the selection of subjects includes people from all segments of the population. d. Providing detailed information about the study and obtaining the subject's consent to participate.
b. Determining that the study has maximized benefits and minimized risks.
In completing Form FDA 1572, Statement of Investigator, the investigator agrees to a. Maintain records indefinitely b. Report to the FDA any adverse events that occur c. Conduct or supervise the investigation personally d. Maintain a contract with the sponsor
c. Conduct or supervise the investigation personally
Who is ultimately responsible for product accountability at the study site? a. Investigator b. Clinical research coordinator c. Subject d. Pharmacist
a. Investigator
When must the investigator update the IRB about the progress of a trial? a. During the conduct of the study only b. During the conduct of the study and at termination c. Never d. At study termination only
b. During the conduct of the study and at termination
The investigator must report adverse events to the: a. FDA b. Subject c. Sponsor d. IRB only
c. Sponsor
All unused investigational agents are expected to be returned to the sponsor at the: a. Prestudy site visit b. Periodic site visit c. Site initiation visit d. Termination site visit
d. Termination site visit
Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the: a. IRB only b. Sponsor c. IRB and investigator d. Investigator only
b. Sponsor
At which study visits can the site expect the sponsor to review subjects' signed informed consent forms? a. Periodic and termination site visits b. Periodic and site initiation visits c. Prestudy and periodic site visits d. Site initiation and termination visits
a. Periodic and termination site visits
A subject presents to the emergency department (ED) with complaints of chest pain and shortness of breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a Phase I study of a new lipid lowering agent. Which individual should determine causality of the serious adverse event? a. Principal Investigator b. ED nurse c. Pharmacist d. Study Coordinator
a. Principal Investigator
OHRP is an oversight body primarily concerned with: a. Protection of human research subjects b. Compliance with ICH guidelines c. Adherence to FDA regulations d. Approval of new drugs
a. Protection of human research subjects
Regarding subject receipt of a signed and dated copy of the consent forms, which is true about FDA regulations? a. The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy. b. The FDA regulations require that the subject or the legally acceptable representative (LAR) receive a copy of the signed and dated written informed consent form. c. The FDA regulations require a witness to document that the subject or the legally acceptable representative (LAR) received the signed and dated copy of the consent forms. c. The FDA regulations do not specify if the subject or the legally acceptable representative (LAR) must receive a signed and dated copy of the consent forms.
a. The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy.
Under which circumstance does the FDA allow verbal consent prior to participation in a research study? a. The study is minimal risk. b. The subject is illiterate. c. The study is greater than minimal risk. d. The subject has a legally authorized representative (LAR).
a. The study is minimal risk.
ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: a. Include a statement in the consent form that confidentiality of trial data cannot be guaranteed because of foreign involvement and the possibility of hacking b. Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records c. Obtain a non-disclosure form before notifying the subject's primary physician d. Provide a separate form that notes the possibility that the FDA may inspect the records
b. Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records
Which of the following statements in a consent form is an example of exculpatory language? a. Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with your doctor or your right to health care or other services that you may be eligible for. b. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research. c. In the event of any injury related to this research, you will be given medical treatment. d. The investigator may stop you from participating in this research without your consent if you experience side effects that make your condition worse. If you become ill during the research, you may have to drop out.
b. I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
A subject of a research study is a passenger in a car involved in a motor vehicle crash. The subject sustained a broken wrist and mild concussion. The subject was treated and released from the emergency department. What should the investigator do when learning of the crash? a. No report is needed because the subject was a passenger in the vehicle and not driving. b. Report adverse events of both a broken wrist and a mild concussion. c. Report only the concussion because it might become serious. d. No report is needed because these are not serious adverse events.
b. Report adverse events of both a broken wrist and a mild concussion.
During the course of administration of an investigational drug, the following events occurred: On Day 7, subject 603 had an unexpected stroke that requires hospitalization; On Day 15, subject 415 complained of nausea, vomiting, and headache relieved by aspirin; On Day 21, subject 20 has brief dizzy spells upon trying to stand. Which of these subject's events meets the FDA definition of "serious" and "unexpected" and would require the sponsor to file an IND Safety Report with the FDA? a. All three of the subjects b. Subject 603 only c. Subject 20 only d. Subject 415
b. Subject 603 only
A 510(k) Premarket Notification is submitted: a. When clinical trials of a Class III device are completed b. When the new device to be marketed is substantially similar (equivalent) to one already on the market c. Before any clinical trials of an investigational device can begin d. When no alternative treatment exists for a life-threatening condition
b. When the new device to be marketed is substantially similar (equivalent) to one already on the market
The sponsor must submit an IND Safety Report to the FDA if an adverse event is (1) serious; (2) unexpected; and: a. (3) resolves quickly. b. (3) is life-threatening but listed in the Investigator's Brochure. c. (3) there is a reasonable possibility that the drug caused the event. d. (3) can reasonably be expected to recur.
c. (3) there is a reasonable possibility that the drug caused the event.
Development of most new drugs, from discovery to marketing approval, usually takes: a. Less than 5 months b. 5 years c. 9 years or more d. 1-3 years
c. 9 years or more
According to ICH E6, an "audit" is defined as: a. The act of overseeing the progress of a clinical trial. b. An official review of documents, facilities, records, and any other resources related to a clinical trial. c. A systematic and independent examination of trial-related activities and documents. d. An institutional self-assessment.
c. A systematic and independent examination of trial-related activities and documents.
The FDA requires retention of investigational drug study records for: a. At least three (3) years after the study has ended at the site b. Indefinitely c. At least two (2) years after the investigational drug's approval by the FDA d. At least one (1) year after the last subject completes all study interventions
c. At least two (2) years after the investigational drug's approval by the FDA
A double-blinded trial for a new indication is conducted under an IND comparing two (2) marketed drugs, at twice the approved prescribed doses. On Day 2, subject 603 had difficulty breathing. Although it was life-threatening initially, subject 603 was treated and discharged directly from the emergency department after complete recovery. On Day 5, subject 20 had a headache, which led to hospitalization and required blood pressure lowering medications. These episodes cannot be explained on the basis of the pharmacological property of either drug or the subjects' medical histories. The investigator would submit an SAE report for: a. Neither of the subjects b. Subject 603 only c. Both of the subjects d. Subject 20 only
c. Both of the subjects
Which of the following is required at a prestudy site visit? a. Review of regulatory document files b. Review of data from previous studies c. Evaluation of the site's capacity to conduct the study d. Evaluation of staff performance records
c. Evaluation of the site's capacity to conduct the study
When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA? a. IND renewal application b. Marketing plan (that is, annual updated projection of sales and profits) c. IND report d. Adverse Event Summary Report, but only from unblinded portions of studies ("open-label IND safety report")
c. IND report
Which of the following best describes when the majority of case report form (CRF) data are verified against source record information? a. Termination site visit b. Site initiation visit c. Periodic site visits d. Prestudy site visit
c. Periodic site visits
Adults with more than a twelve (12)-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was twelve-hundred (1200) subjects. Which of the following best describes the clinical phase of this study? a. Phase II b. Phase I c. Phase III d. Preclinical
c. Phase III
An investigator conducting a study of a medical device under an IDE is required to complete and sign which of the following? a. An interagency personnel agreement b. A memorandum of understanding c. A data use agreement d. An investigator's agreement
d. An investigator's agreement
According to ICH E6, an inspection is defined as: a. The act of overseeing the progress of a clinical trial. b. An institutional self assessment. c. A systematic and independent examination of trial-related activities and documents. d. An official review of documents, facilities, records, and any other resources related to a clinical trial.
d. An official review of documents, facilities, records, and any other resources related to a clinical trial.
A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following? a. Withhold this new information to avoid confusing the subject with other treatment options or alternatives b. Do not tell the subject about the new drug since physicians have the right to try out new treatments with their patients c. Tell the subject about the new drug but discourage him from switching treatments until the study is completed d. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
d. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
Accurate reporting of adverse events is most important for: a. Ensuring correct site reimbursement for work performed. b. Updating recruitment materials. c. Allowing rechallenge of subjects. d. Ensuring subject safety.
d. Ensuring subject safety.
Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans? a. Preclinical b. Phase II c. Phase III d. Phase I
d. Phase I
Subject 311 has had elevated white blood cell (WBC) counts for the past two (2) study visits, with no clinical signs or symptoms. "Increased WBC count" is not listed in the Investigator's Brochure (IB) as an adverse event. The investigator should: a. Hospitalize subject for transfusion b. Repeat the laboratory tests until they return to normal before reporting c. Immediately fax a handwritten SAE report to the FDA. d. Report the elevated WBC to the sponsor as an unexpected adverse event
d. Report the elevated WBC to the sponsor as an unexpected adverse event
Which of the following are the three principles included in the Belmont Report? a. IRB review, Federal regulations, Declaration of Helsinki. b. Informed Consent, Institutional Assurance, Researcher responsibility. c. Privacy, Confidentiality, Equitable selection of subjects. d. Respect for Persons, Beneficence, Justice.
d. Respect for Persons, Beneficence, Justice.
An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent for the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator: a. Do not use the test article until either the subject or the subject's legally authorized representative can give consent. b. Submit a research protocol to the IRB and justify an expedited review approval of the consent document so the test article can be used immediately. c. Sign the consent form on behalf of the subject and use the test article. d. The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.
d. The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.
Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND? a. The study intends to involve more than one hundred (100) patients in a study. b. The study involves a route of administration that significantly increases the risks to the patient. c. The study intends to invoke an exception from informed consent. d. The study is not intended to be reported to FDA to support a new indication or support a labeling change.
d. The study is not intended to be reported to FDA to support a new indication or support a labeling change.