Practice Questions Flashcards
Sponsor is conducting a post-approval study for a new drug and is mandated to perform a post-approval study to monitor late AEs; what approval is needed?
a. OHRP
b.DSMB
c. IRB
d. QA team
IRB (need to approve all studies to ensure protection of human subjects)
Which of the following, if any, must provide approval before an investigator may enroll subjects in a quality of life research questionnaire study?
a. HHS
b. FDA or Regulatory Auth
c. IRB/IEC
d. No approvals if no pharmaceutical drugs are involved
IRB/IEC (need to approve all studies to ensure protection of human subjects)
What documents are reviewed during a sponsor audit?
a. SOPs
b. Personnel records
c. Financial reports
d. Audit reports
SOPs (per ICH HCP 5.19 Audit; the purpose of a sponsor’s audit, which is separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP and the applicable regulatory requirements
According to ICH, a monitoring plan should have what?
a. Recruitment procedures
b. the rationale for monitoring needs
c. monitoring cost
d. site close-out visit
the rationale for monitoring needs (1.64 Monitoring plan; a document that describes the strategy, methods, responsibilities and requirements for monitoring the trial
Which of the following is one of the responsibilities of the investigator?
a.maintaining accurate and current case histories of study subjects
b. updating investigator brochure (IB) with new safety info
maintaining accurate and current case histories of study subjects (ICH GCP)
Site violation of informed consent regarding?
a. subject’s signature missing on the copy of the short form consent
b. a copy of consent documents not provided to the subject
c. only the signature of the person obtaining consent and witness appear on the copy of the short form consent
d. the sponsor generated informed consent template is missing the required elements
subject’s signature missing on the copy of the short form consent (per 21CFR50.27)
FDA inspection of Phase 3 randomized trial. What is to be provided to the FDA investigator?
a.Patient’s insurance coverage form
b. subject’s data from the controlled arm
c. patient’s pre-screening logs
d. draft protocol amendment
subject’s data from the controlled arm (312.58) inspection of sponsor’s records and reports is an FDA inspection. (The sponsor shall discontinue shipments of the drug to any investigator who has failed to maintain or make available records or reports of the investigation as required by this part)
Why would a Phase 4 study be conducted?
Studying in a different off-label patient population or different doses, different schedule of administration that were used in phase 2 studies, drug in other patient populations, other stages of disease or use drug for longer time
(312.85) phase 4 studies. concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain post-marketing (phase 4) studies to delineate additional information about the drug’s risks, benefits and optimal use. -
When a sponsor transfers trial-related duties to a CRO , who is responsible for data integrity and quality?
a. investigator
b. IRB
c. CRO
d. sponsor
sponsor
To recruit participants for a new study, a CRC would like to access CRFs for a study they were not involved in. Which of the following, if anything, is required for access.
a. approval from the investigator
b. consent from the subject
c. IRB approval
d. nothing further is required
approval from the investigator (via DOA log sign off)
An IND application to the FDA should contain each of the following except:
A. IB
B. Financial disclosures for all participating investigators
B. Financial disclosures for all participating investigators (312.23) IND content and format
A company is starting an IDE study. CEO plans to commercially promote the device. Should be advised that the plan:
a. Would violate FDA regulations
b. Needs IRB approval
c. Needs IDE approval
Would violate FDA regulations (promotion of investigational new drug, a sponsor or investigator shall not represent promotional context of new drug that it is safe or effective for purposes for which the drug is under investigation for.
What is the purpose of an investigator’s meeting?
a. to review protocol
b. recruit investigators
c. to evaluate a site
d. to select PIs
to review protocol
Who is a suspension of IRB approval reported to?
a. Scientific review committee
b. Institutional officials
institutional officials (reported to investigator, appropriate institutional officials and the FDA
After IP is no longer investigated, how long until the site can destroy records?
a. 2 years
b. 3 years
c. 5 years
2 years (sponsor shall retain records/reports 2 years after marketing application is approved for the drug or if not approved, 2 years after shipment and delivery is discontinued for drug and FDA has been notified
Life-threatening/unexpected sponsor to reg authority: (sponsor to FDA; for IND, serious unexpected life-threatening safety events reporting)
a. 7 calendar days
b. 10 calendar days
c. 15 calendar days
7 calendar days (unexpected fatal or life-threatening suspected adverse reaction reports. Sponsor must notify FDA of any unexpected life threatening suspected adverse reaction asap but no later than 7 calendar days after sponsor’s initial awareness.
If IRB exempt, is a continuing review submitted, and if so, how often?
does not need a review
Upon study completion, what does the investigator do:
a. provide IRB with final report
b. compile data, public results, submit publication and final report
provide IRB with final report
The patient is not age eligible. Investigator enrolls patient if:
a. directly benefits the patient
b. after receiving the sponsor agreement and IRB approval of a protocol amendment
b. after receiving the sponsor agreement and IRB approval of a protocol amendment
Short form signatures according to CFR:
a. Subject/LAR and witness
b. Subject
Subject/LAR and witness
Definition of Q.A:
All those planned/systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the appropriate regulatory requirements
Documents located at sponsor and site:
CRFs
The investigator breaks the blind according to protocol and finds out the patient is on a placebo. Who does the investigator inform?
Sponsor only
What documents are included in the initial IND submission?
a. Lab ranges
b. CRFs
c. Recruitment materials
d. Investigator’s CV
Investigator’s CV
Sponsor submits IND to FDA. Which is included about the IND?
a. Application to export the drug
b. The rationale for human testing and drug plan
c. Sell for profit
d. Disclosure of financial interests of investigators
The rationale for human testing and drug plan
Which is included in a protocol? check
a. SOP for data collection
b. Summary of findings of nonclinical studies with possibly significant to the study
Summary of findings of nonclinical studies with possibly significant to the study
Additional protections taken for child consent:
a. Assent
b. Parents are present for all protocol activities
Assent
What is a source doc?
a. Subject instruction sheet
b. SOPs
c. Protocol
d. Pharmacy dispensing records
Pharmacy dispensing records (something with patient data)
The document from Nuremberg Code (NC) for the protection of human subjects’ basic ethical principles:
Belmont Report
IB contents requirements:
a. Lab draw requirements
b. Results of nude mouse study
c. Dispensing instructions
d. Schedule of events
Results of nude mouse study
Minimum number of IRB members:
five (to ensure diversity)
Sponsor to FDA, emergency usage reporting time:
a. 1 day
b. 5 working days
c. 10 working days
d. 30 days
5 working days
Monitor familiarity except:
a. Information to subjects
b. Storage of IP
c. Sponsor SOP
d. IRB requirements for reporting
IRB requirements for reporting
An approved IDE means:
a. An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device
b. Marketed as a humanitarian device
a. An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device
Who signs the protocol?
Sponsor and investigator
Sponsor required to:
Inform FDA and investigators of new risks
Who is present during consent if patient is unable to read:
Witness
According to ICH, which is the acceptable protocol review frequency for an IRB?
a. 6 months
b. 18 months
c. 24 months
d. 36 months
6 months
IND safety reporting by sponsor:
If the results of a sponsor’s investigation show that an adverse event not initially determined to be reportable under paragraph (c) of this section is so reportable, the sponsor must report such suspected adverse reaction in an IND safety report as soon as possible, but in no case later than 15 calendar days after the determination is made.
The investigator, that is not the sponsor, is responsible for:
a. Reporting SAEs to the regulatory authority
b. Maintaining control of the drug
Maintaining control of the drug
Sponsor submits a protocol amendment to the FDA for:
a. Addition of new test to improve monitoring for AEs
b. New investigator to conduct an investigation
New investigator to conduct an investigation
(not unexpected) IND safety reporting timeline for serious risks: ASAP but no later than:
a. 3 days
b. 5 days
c. 10 days
d. 15 days
15 days
After study completion, who submits closure report to IRB:
a. Final report
b. Monitoring close-out visit
c. Sponsor to IRB
sponsor to IRB
When determining the risks of IDE, what must be considered:
a. Number of patients
b. Use of the device in the study
use of the device in the study
If IRB has 12 members and 10 members are present, how many votes are needed to approve a study?
a. 5
b. 6
c. 7
d. 10
6
IRB expiration reporting timeline is?
IRB membership expiration is 3 years
Per ICH, who allocates duties?
a. Institutional admin
b. Sponsor
c. Study coordinator
d. IRB
sponsor
New information of a SAE, when does the PI notify sponsor and the IRB?
a. Immediately
b. 5 days
c. 7 days
d. Just the IRB
Immediately
Per ICH GCP, who is responsible for continuing review:
a. Sponsor
b. Monitor
c. Investigator
d. Study coordinator
Investigator
Clinicaltrials.gov reporting timeline after data collection final:
a. Study results do not need to be reported
b. 1 year
c. 2 years
d. 3 years
1 year
Countries that adopted ICH GCP are Australia, Europe, Japan, US, Canada, and: a. China
b. Switzerland
c. Brazil
d. India
Switzerland
Who does a sponsor elect to perform a QA audit:
a. Member from another site
b. Monitor
c. Someone independent of the study
d. Study team member
Someone independent of the study
What qualifies an investigator?
Education, training, and experience
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?
a. This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm
b. This subject should undergo all study procedures as outlined in the protocol
c. This subject only needs to undergo the study procedures that pertain specifically to the subject
d. This subject can undergo the study procedures whenever it is convenient
This subject should undergo all study procedures as outlined in the protocol
Informed consent documents must contain which of the following?
a. A description of the scientific background for conducting the investigation
b. An explanation of the purpose of the investigation
c. Contact information for the sponsor of the investigational drug/device
d. A description of the investigator’s responsibilities
An explanation of the purpose of the investigation
With respect to IRB/IEC membership, both the FDA and the ICH require that a. A majority of the members’ primary area of interest is in a scientific area
b. At least one member hold a Ph.D. degree or equivalent
c. At least one member’s primary area of interest is in a nonscientific area
d. A majority of the members are from or have ties to the institution of record
At least one member’s primary area of interest is in a nonscientific area
Which of the following is the proper way to make a correction to a CRF?
a. Completely blacken the incorrect entry and then enter the correct information
b. Back date the corrected entry with the date of the original entry
c. Initial using the initials of the sponsor’s representative who reviewed the change
d. Add the initials of the person making the change, the date of the change, and if, necessary, a brief explanation of the change
d. Add the initials of the person making the change, the date of the change, and if, necessary, a brief explanation of the change
A purpose of monitoring clinical trials is to verify that:
a. The rights, safety, and well-being of human subjected are protected
b. Investigators receive adequate payment for their participation in the clinical trial
c. The investigator has received annual reports from the sponsor
d. The regulatory agency has received all case history information of subjects enrolled on the clinical trial
a. The rights, safety, and well-being of human subjected are protected
What happens in phase III of Trial Assess?
a. Establishment of some efficacy and safety
b. Safely profile of a compound is expanded upon and efficacy is further explored
c. Aftermarket trials
d. Dose escalation and optimization, first in human
a. Establishment of some efficacy and safety (the focus is on establishing some efficacy and safety of a compound. This means that the trial aims to gather more data on the effectiveness and safety profile of the compound, building upon the information collected in earlier phases. Phase III trials are typically larger and involve a larger number of participants to provide more robust evidence on the compound’s efficacy and safety. This phase is crucial in determining whether the compound is effective and safe enough to be considered for regulatory approval and subsequent use in the market)
When should serious Adverse Events be reported to the sponsor?
a. Less than an hour
b. Within 48hrs
c. Within the hour
d. Within 24hrs
d. Within 24hrs
How many types of clinical research professions are there?
a. 2
b. 3
c. 4
d. 1
2
Which FDA form is used for Investigational New Drugs?
a. IND1548
b. 1571
c. 12EIND
d. 1865IND
b. 1571 (This form is required by the Food and Drug Administration (FDA) for sponsors who wish to conduct clinical trials on new drugs. It provides detailed information about the drug, its manufacturing process, proposed clinical trials, and the qualifications of the investigators involved. The form helps the FDA evaluate the safety and effectiveness of the new drug before it can be approved for wider use.)
Which of these codes deals with electronic MRs, and electronic signatures?
a. 21CFR01
b. 21CFR99
c. 21CFR54
d. 21CFR11
d. 21CFR11
FDA requires that all study records be retained for how long after a marketing application is approved?
a. 8 months
b. 2 years
c. 3 years
d. 1 year
b. 2 years (To ensure data and information used in the application can be accessed and reviewed if needed, particularly for post-marketing surveillance and monitoring purposes. Also allows for ongoing evaluation of the safety and efficacy of the approved product, as well as compliance with regulatory requirements)
How long are investigators mandated to disclose their financial interests after a study is completed?
a. 1 year after study closure
b. 3 years after study closure
c. Immediately after research study ends
d. 6 months after study closure
a. 1 year after study closure (Required to report any financial interests they have related to the study for a period of one year after the study is completed. This disclosure is important to ensure transparency and to prevent any potential conflicts of interest that could compromise the integrity of the research).
Which of these has an outlined ethical principles of research, including: respect for persons, beneficence, and justice?
a. Belmont Code
b. Nuremberg Code
c. Nuremberg Trial
d. Belmont Report
d. Belmont Report (The three main points of the Belmont Reports are respect of persons, beneficence, and justice)
Whose role is it to protect the rights and welfare of human subjects participating in clinical trials?
a. CRC
b. ITD
c. IRB
d. CDM
c. IRB (The role of the IRB (Institutional Review Board) is to protect the rights and welfare of human subjects participating in clinical trials. The IRB is responsible for reviewing and approving research protocols, ensuring that the risks to participants are minimized, and that their rights and well-being are protected. They also monitor ongoing trials to ensure compliance with ethical standards and regulations. The other options (CRC, ITD, CDM) do not have specific roles in protecting the rights and welfare of human subjects in clinical trials.)
In general, an AE observed during the conduct of a study should be considered an unanticipated problem involving risk to human subjects, and reported to the IRB, only if it were _________.
a. Expected
b. Serious
c. Would have implications for the conduct of the study
d. B & C
e. A, B, & C
d. B & C (An AE observed during a study should be considered an unanticipated problem involving risk to human subjects and reported to the IRB if it is serious and would have implications for the conduct of the study)
In accordance with regulations, before implementation, the informed consent document must be approved by the:
a. Sponsor
b. Investigator
c. IRB or IEC
d. A, B, & C
e. B & C only
c. IRB or IEC (These bodies are responsible for reviewing research protocols and ensuring that the rights and welfare of study participants are protected.)
What is 45 CFR Part 46?
a. HHS - Protection of Human Subjects
b. FDA - Protection of Human Subjects
c. HHS - Protection of Children
d. HHS - Protection of Research Participants
a. HHS - Protection of Human Subjects (Also referred to as Public Welfare. The HHS regulations for the protection of human subjects in research at 45 CFR 46 include five subparts. Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration.)
This form is used for the voluntary reporting of adverse events and product problems:
a. 1571
b. 1572
c. 3500
d. 3500A
3500 (voluntary)
3500A (for mandatory reporting)
Level of risk for a trial researching a new life sustaining device?
Exempt
Minimal Risk
Non-significant Risk
Significant Risk
Significant Risk
Which document does the clinical investigator maintain after termination of the study?
Randomization list
Subject identification list
COV monitoring report
Audit certificate
Subject identification list (or randomization, subject identification list and audit report if available)
Frequency of continuing review of Phase I trial?
No less than every 3 years
No less than every 2 years
No less than once a year
No review required
No less than once a year
When is an IB addendum needed?
ICF risks revision
New SUSARs report
SAE
Product monograph updates
New SUSARs report
What is asked for during site selection visit?
# of site staff
Pharmacy storage temp ranges
Pharmacy available storage square feet
Pharmacy storage costs
Pharmacy available storage square feet…?
Investigator received new IB with no subject safety changes, who should be notified?
IRB
DSMB
Regulatory
No one
No one
Who keeps the COV report?
Investigator
Sponsor
CRC
IRB
sponsor
Who determines risk benefit ratio at site?
Investigator
IRB
Legal
Sponsor
IRB
When is FDA authorized to inspect IRB records?
a. Reasonable time but cannot make copies unless they have affidavit
b. Reasonable time and yes can make copies
c. No authority to review
d. Only if IRB formally requests
Reasonable time and yes can make copies
What to include in a phase 3 IRB submission?
Lab ranges
CRFs
Recruitment materials
Investigator CV
Investigator CV or recruitment materials…
Documents to share with CRA at COV?
Copy of final IRB report and IP shipping docs
ICFs and printed source docs
Printed source docs and remaining IP
ICFs and IP documents
ICFs and IP documents
