Who is responsible? Flashcards
Who is responsible for monitoring the study?
The sponsor
Which party submits the completed, signed Form FDA 1572 to the FDA?
The sponsor submits the FDA Form 1572 to the FDA.
Who is required to report promptly “to the IRB…all unanticipated problems involving risks to human subjects or others,” including adverse events that should be considered unanticipated problems?
The investigator
Who is required to report serious adverse events (SAEs) promptly to the sponsor organization?
The investigator
If the investigator deviates from the protocol without IRB/IEC approval to eliminate an immediate hazard to subjects, the investigator should report the deviation as soon as possible to?
The sponsor AND the IRB
Once the study has been terminated, who is required to notify the IRB/IEC and provide a summary (final) report?
the investigator
Which party reviews and signs Form FDA 1572?
the investigator
Who is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data in the CRFs and in all required reports?
The investigator
What are the investigator’s commitments to the sponsor?
-Perform study procedures according to the protocol
-Complete and submit required regulatory documents (Form FDA 1572, disclosure forms, etc.)
-Notify the sponsor of any facility changes or changes that call for a revised Form FDA 1572
-Maintain study site records (Form FDA 1572, disclosure forms, etc.)
-Maintain subject source documents and study records
-Notify sponsor of serious AEs
What are the investigator’s commitments to the IRB?
-Submit study documents for initial and ongoing approval
-Notify IRB/IEC of SAEs (per IRB/IEC requirements)
-Notify IRB/IEC of unanticipated problems involving risks to subjects or others
-Provide periodic updates (as required by IRB/IEC)
-Provide notice of study completion/termination and summary of the study
What are the investigator’s commitments to the participants?
-Ensure that informed consent is obtained before starting study procedures
-Ensure that study procedures are explained adequately and performed appropriately
-Ensure that the rights and welfare of study subjects are protected
-Ensure the medical safety of the subject to the extent possible
What are the investigator’s commitments to the FDA?
-Allow inspections of the facilities and records
-Retain study records
-Comply with GCP standards
Who reports AEs to the sponsor?
the investigator
Who does the investigator report AEs to?
the sponsor
Which party is responsible for reporting directly to the FDA the investigator’s financial interests with the sponsor?
the sponsor
Under ICH, who is responsible for product accountability at the study site and maintenance of the clinical and research records?
the investigator
The ultimate responsibility for the disposition of the investigational product lies with?
The investigator
Who should document an explanation of any premature unblinding and promptly report it to the sponsor?
The investigator
What is an investigator responsible for in an IDE?
-Protecting the rights, safety, and welfare of research subjects
-Obtaining informed consent from each subject
-Controlling the distribution of the device being investigated
-Maintaining proper research records and making them available as required
-Reporting research progress, safety information, final results, financial disclosures
-Ensuring IRB/IEC review of study information for initial and continuing approval of the study
-Supervising the use of the investigational device (SR devices only)
Who is responsible for ensuring IRB/IEC review of study information for initial and continuing approval of the study in a device trial?
The investigator
Who is responsible for maintaining proper research records and making them available as required in a device trial?
The investigator
Is the IRB responsible for verifying risk category in an abbreviated IDE procedure?
Yes
Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the:
Sponsor
The investigator reports UADEs to the sponsor and the local IRB. The sponsor transmits evaluations of these reports to the FDA.
Who submits Unanticipated Adverse Device Effects (UADEs) to the sponsor?
The investigator
Who submits Unanticipated Adverse Device Effects (UADEs) to the IRB?
The investigator
Who submits AEs to the sponsor and why?
The investigator, so the sponsor can accumulate data in the effect of the drug
Who submits AEs to the IRB and why?
The investigator, so the IRB can evaluate the safety of the study
Who requires that investigators report unanticipated problems to the IRB?
FDA regulations
The FDA requires that investigators report unanticipated problems to whom?
The IRB
Who does FDA regulations require report unanticipated problems to the IRB?
The investigator
Who conducts audits?
Sponsor or CRO
Who conducts monitoring visits?
Sponsor or CRO. Under ICH the sponsor is ultimately responsible.
Who conducts inspections?
Regulatory Agency
Who do US regulations require to monitor the conduct of clinical trials performed under and IND or IDE?
The sponsor
A Clinical Hold is an order by FDA to whom to suspend or stop ongoing investigations?
The sponsor
Who obtains a statement from the IRB that they are organized and operate according to GCP?
the sponsor, but the sponsor can request the investigator do it instead
Who do FDA regulations and IBCH agree is responsible for conducting the clinical trial?
The investigator
Who does ICH say should implement a risk-based quality management system?
The sponsor
