Who is responsible?

Question 1

Who is responsible for monitoring the study?

Answer 1

The sponsor

Question 2

Which party submits the completed, signed Form FDA 1572 to the FDA?

Answer 2

The sponsor submits the FDA Form 1572 to the FDA.

Question 3

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?

Answer 3

The investigator

Question 4

Who is required to report serious adverse events (SAEs) promptly to the sponsor organization?

Answer 4

The investigator

Question 5

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?

Answer 5

The sponsor AND the IRB

Question 6

Once the study has been terminated, who is required to notify the IRB/IEC and provide a summary (final) report?

Answer 6

the investigator

Question 7

Which party reviews and signs Form FDA 1572?

Answer 7

the investigator

Question 8

Who is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data in the CRFs and in all required reports?

Answer 8

The investigator

Question 9

What are the investigator’s commitments to the sponsor?

Answer 9

-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

Question 10

What are the investigator’s commitments to the IRB?

Answer 10

-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

Question 11

What are the investigator’s commitments to the participants?

Answer 11

-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

Question 12

What are the investigator’s commitments to the FDA?

Answer 12

-Allow inspections of the facilities and records
-Retain study records
-Comply with GCP standards

Question 13

Who reports AEs to the sponsor?

Answer 13

the investigator

Question 14

Who does the investigator report AEs to?

Answer 14

the sponsor

Question 15

Which party is responsible for reporting directly to the FDA the investigator’s financial interests with the sponsor?

Answer 15

the sponsor

Question 16

Under ICH, who is responsible for product accountability at the study site and maintenance of the clinical and research records?

Answer 16

the investigator

Question 17

The ultimate responsibility for the disposition of the investigational product lies with?

Answer 17

The investigator

Question 18

Who should document an explanation of any premature unblinding and promptly report it to the sponsor?

Answer 18

The investigator

Question 19

What is an investigator responsible for in an IDE?

Answer 19

-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)

Question 20

Who is responsible for ensuring IRB/IEC review of study information for initial and continuing approval of the study in a device trial?

Answer 20

The investigator

Question 21

Who is responsible for maintaining proper research records and making them available as required in a device trial?

Answer 21

The investigator

Question 22

Is the IRB responsible for verifying risk category in an abbreviated IDE procedure?

Answer 22

Yes

Question 23

Evaluation of Unanticipated Adverse Device Effects (UADEs) must be reported to the FDA by the:

Answer 23

Sponsor

The investigator reports UADEs to the sponsor and the local IRB. The sponsor transmits evaluations of these reports to the FDA.

Question 24

Who submits Unanticipated Adverse Device Effects (UADEs) to the sponsor?

Answer 24

The investigator

Question 25

Who submits Unanticipated Adverse Device Effects (UADEs) to the IRB?

Answer 25

The investigator

Question 26

Who submits AEs to the sponsor and why?

Answer 26

The investigator, so the sponsor can accumulate data in the effect of the drug

Question 27

Who submits AEs to the IRB and why?

Answer 27

The investigator, so the IRB can evaluate the safety of the study

Question 28

Who requires that investigators report unanticipated problems to the IRB?

Answer 28

FDA regulations

Question 29

The FDA requires that investigators report unanticipated problems to whom?

Answer 29

The IRB

Question 30

Who does FDA regulations require report unanticipated problems to the IRB?

Answer 30

The investigator

Question 31

Who conducts audits?

Answer 31

Sponsor or CRO

Question 32

Who conducts monitoring visits?

Answer 32

Sponsor or CRO. Under ICH the sponsor is ultimately responsible.

Question 33

Who conducts inspections?

Answer 33

Regulatory Agency

Question 34

Who do US regulations require to monitor the conduct of clinical trials performed under and IND or IDE?

Answer 34

The sponsor

Question 35

A Clinical Hold is an order by FDA to whom to suspend or stop ongoing investigations?

Answer 35

The sponsor

Question 36

Who obtains a statement from the IRB that they are organized and operate according to GCP?

Answer 36

the sponsor, but the sponsor can request the investigator do it instead

Question 37

Who do FDA regulations and IBCH agree is responsible for conducting the clinical trial?

Answer 37

The investigator

Question 38

Who does ICH say should implement a risk-based quality management system?

Answer 38

The sponsor