IRB
What is the minimum number of Institutional Review board (IRB) members?
5
Which signatures are required by FDA regulation to be on the consent form?
the participant
FDA regs require only the participant’s (or LAR) signature on the consent. The signature indicates voluntary agreement to participate after receiving the necessary information. In practice, the investigator often signs as well, confirming they explained the study and obtained informed consent.
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 _________.
unexpected
would put participant or others at greater risk
Possibly related to the study
Only the principal investigator is allowed to transcribe data from the source document to the CRF? True or False
False
Other trained and authorized personnel, such as CRC or data managers, may also be involved in this process. The PI may oversee the data transcription, but is not exclusively their responsibility (delegation)
Per 21 CFR Part 312, who is required to sign a 1572 Statement of Investigator form?
The investigator
This form is a crucial document for clinical trials involving investigational new drugs or medical devices in the US. By signing Form 1572, the investigator commits to conducting the study according to the approved protocol, relevant regulations, and Good Clinical Practice (GCP) guidelines.
The IRB must determine that requirements for permission by parents or guardians and assent by children are met.
True
In accordance with regulations, before implementation, the informed consent document must be approved by the:
IRB
IRBs are responsible for reviewing research protocols and ensuring that the rights and welfare of study participants are protected. The sponsor and investigator may also be involved in the approval process, but the ultimate authority lies with the IRB.
Are any of these AEs?
1. Participant has normal BP before study drug, on C2D1 nurse finds BP high but subject has no symptoms.
2. Subject has DM since childhood and while on study they still have DM, not worse
3. Subject stumbles over rock and sprains ankle
BP and sprain
Which of the following is the proper way to make a correction to a CRF?
Add the initials of the person making the change, the date of the change, and, if necessary, a brief explanation of the change
This ensures that the correction is properly documented and attributed to the person responsible for making the change. It also provides clarity and transparency regarding the reason for the correction, if needed.
The World Medical Association (WMA) ethical principles for medical research involving human subjects is called...
The Declaration of Helsinki
a set of ethical principles for medical research involving human subjects, established by the WMA. It provides guidelines for researchers to ensure the protection and well-being of human participants in research studies. The Belmont Report, the National Research Act, and the Nuremberg Code are also important documents related to research ethics, but they are not specifically associated with the WMA or medical research involving human subjects.
FDA may waive any of the requirements contained in the regulations, including the requirements for IRB review.
True
The FDA can waive regulations, including IRB review, if it's in the public's best interest or necessary to protect subjects' rights and welfare. This might occur in emergencies where IRB review delays treatment for life-threatening conditions. The FDA considers various factors to ensure ethical principles are maintained and subjects' rights are safeguarded.
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?
Subjects cannot be enrolled until IRB/IEC approval has been obtained
This means that even if the investigator provides their written approval or if the study drug has an FDA approved marketing application, subjects still cannot be enrolled until the necessary IRB/IEC approval has been obtained. The FDA providing written approval of the IND also does not allow for subjects to be enrolled prior to IRB/IEC approval.
Per 21 CFR Part 312, the sponsor must notify FDA and all participating investigators in an IND safety report within ___ calendar days after the sponsor determines that the information qualifies for reporting.
15 days
The responsibility for ensuring that the investigator understands a clinical trial lies with:
The Sponsor
The sponsor is responsible for ensuring that the investigator understands a clinical trial. This includes providing the necessary information and training to the investigator, as well as ensuring that the investigator is aware of and follows all applicable regulations and guidelines. The sponsor also plays a role in monitoring the progress of the trial and addressing any issues or concerns that may arise.
The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation's course and for _______ following the study's completion.
1 year
This is important to ensure transparency and integrity in the research process and to identify any potential conflicts of interest that may arise. By updating the financial disclosure information for 1 year, it allows for a sufficient period of time to capture any changes that may occur after the study has ended.
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?
Subjects cannot be enrolled until IRB/IEC approval has been obtained
When a short form is used for Informed Consent, the witness must sign either the short form or the summary.
False
According to regulations and best practices, the witness must sign both the short form and the summary when a short form is used for informed consent. Here's a breakdown of the correct process:
A Clinical Hold is an order by FDA to the investigator to suspend or stop ongoing investigations
FALSE issued by the FDA to the sponsor, not the investigator, to suspend/stop ongoing trial. This occurs when the FDA has concerns about the safety or integrity of the study data. The sponsor must address the FDA's concerns and provide adequate information to resolve the issues before the clinical hold can be lifted and the study resumed.
What is A written description of the procedures for reviewing accumulated data in an ongoing research protocol to ensure the safety of research participants and the continuing validity and scientific merit of the protocol. (NIH)
Data and Safety Monitoring Plan
An IND is always required before using an investigational new drug.
FALSE Exceptions include using a marketed drug for an unapproved indication without a clinical investigation, specific Phase 1 studies with approved drugs, or emergencies when no alternative therapy exists. If the drug is used in a clinical investigation to gather data for FDA marketing approval or labeling changes, an IND application is required. This process ensures proper testing and monitoring, protecting safety and generating reliable data on the drug's safety and efficacy
With respect to IRB/IEC membership, both the FDA and the ICH require that
At least one member's primary area of interest is in a nonscientific area
When using the short form informed consent, the witness and the person actually obtaining the consent from the subject shall each sign the short form in addition to the summary.
False
Study 21 CFR 50.27 (2) -The witness shall sign BOTH the short form and summary. Person actually obtaining consent shall sign ONLY a copy of the summary. (Subject ONLY has to sign the short form).
Reporting participant AEs to the IRB is required if the AE meets ________________ requirements
Unanticipated Reporting Requirements
The main purpose of monitoring clinical trials is to verify that:
The rights, safety, and well-being of human subjects are protected
The Three Ethical Principles of the Belmont Report are:
Respect for Persons
Beneficence
Justice