Significant risk device is defined as an investigational device that is:
- Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.
- Purported or represented to be for a use in supporting or sustaining human life and presents a potential risk to the health, safety, or welfare of a subject.
- For a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.
A purpose of monitoring clinical trials is to verify that:
The rights, safety, and well-being of human subjects are protected
The initial drug dose is 110mg/m2. Due to toxicity, the drug needs to be decreased by 30%. The new dosage would be?
77 mg/m2
Within how many days must a sponsor report unanticipated adverse device effects to the FDA, all reviewing IRBs and participating investigators?
Ten working days after sponsor first received notice of effect.
A medical device investigation may begin:
Thirty days after the date the FDA received IDE application, unless FDA notifies sponsor may not begin.
FDA classifies medical devices based on the risks associated with the device. Devices are classified into ___________________ categories.
Three
Class I - deemed to be low risk and are therefore subject to the least regulatory controls. For example, dental floss is classified as Class I device.
Class II - higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. For example, condoms are classified as Class II devices.
Class III devices - highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed. For example, replacement heart valves are classified as Class III devices.
The responsibility for ensuring that the investigator understands a clinical trial lies with:
the sponsor
Once an agreement with a CRO has been finalized, all responsibilities transfer from the sponsor to the CRO.
false
What must the sponsor obtain from the investigator/institution to confirm IRB/IEC review?
Name and address of investigator/institution’s IRB/IEC
- Statement from the IRB/IEC that it uses GCP and
adheres to applicable laws and regulations - Documented IRB/IEC approval and copies of IRB/IEC
reviewed documents
An IRB/IEC should have its own written SOPs for both initial and continuing review of trial.
true
What must the investigator/institution agree to do when conducting the study?
- Comply with GCP, applicable regulatory requirements,
and protocol - Adhere to data recording/reporting procedures, and retain
essential documents until notified they are no longer needed - Permit monitoring, auditing, and inspection
Protocol Amendments should include?
- Protocol identification (title, version number) and date
- Nature of protocol changes
IRB should include at least 5 members, one of which should be in a nonscientific field. T or F
true
How many years must the IRB/IEC retain study-related records?
- Three years following study completion
The ICH is concerned with harmonization of technical requirements for registration of pharmaceutical products from what three regions?
European Union, Japan, and USA
- ______________ are those documents which individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.
essential documents
The pretrial monitoring report should be found in the files of the __________.
sponsor
If a marketed product is being studied for a new use, an IB specific to the new use does not need to be prepared? T or F
false
The signature sheet documents the signatures and initials of all persons authorized to make entries and/or corrections to the case report forms should be found in the files of the ________________.
- Sponsor
- Investigator/Institution
Dr. Smith wrote the protocol, submitted the IND, and is the only PI conducting the study. The drug was supplied by a private pharmaceutical company.
Dr. Smith is a(n):
Sponsor-Investigator
