What Am I
The regulatory board asks that an investigational device is followed past the original time point of an approved device.
What is a post market trial
Subjects are being recruiting via social media and not being seen in the clinic.
This is a Virtual Trial
You receive a call from the FDA. What are the next 3 most important steps you should do?
What is:
Call the sponsor
Inform your institutional office of regulatory affairs
Notify the PI
That is the responsibility of a Principle Investigator
What is to follow the conduct of a clinical trial
An informed consent outlines the risks of a trial however an event occurs which was not indicated in the consent. What is this called?
an unanticipated adverse event?
An Investigator notices that some of their African American patients have a higher incidences of heart failure. What type of trial might be helpful in verifying his/her anecdotal findings?
What is a Retrospective Review
Mr. Smith is seeing his doctor for a heart valve problem. The doctor suggests that the patient needs a valve replacement. The doctor states that the newest valve is only offered in a clinical trial. This requires that the patients comes into the office for an annual visit. What type of trial is this?
What is a physical trial.
The FDA Inspector arrives at your site. What should you ask first from the inspector?
What is identification
The investigator delegates roles to certain study team to administer activities based on their trained skill sets, this is called?
What is the delegation of authority
An investigational device is being tested to see if a wearable device looking at blood sugar control is more accurate than finger sticks for diabetes. The protocol describes a serious adverse event as anything that is possibly or probably related to the device. The subject calls and states that he had an allergic reaction to a bee sting, the patient was not hospitalized and was treated with an over the counter medication, is this an serious adverse event?
No, according to FDA guidance an serious adverse event is:
Death
Life-threatening
hospitalization or prolonged hospitalization
DIsability or permanent damage
Congenital Anomaly or Birth Defect
Other serious Event
What are the 3 main trials used during the COVID pandemic?
What are Prevention, Screening and Vaccines
A patient in a clinical trial states that the cost of returning to the city for a visit is expensive and time consuming. The investigator states that you can do some of the studies with your local doctor and other visits can be done via telemedicine or with someone coming to the patient's home.
This is an example of a Hybrid trial
The FDA inspector will always issue this?
What is a 482
The investigator is investing a new clinical device and has receive more than $25,000.00 in payment for his scientific knowledge. This is considered what?
What is conflict of interest
Who should report an unanticipated adverse event to the FDA?
Who is the sponsor
A scientist wanted to understand the long-term effects of low birth weights of infants born to a low income family. What is a type of trial might he/she design?
What is a Registry
Name 3 limitations of a physical trial design?
Cost
Travel
Time
lack of follow up
The practice of ensuring quality standards is called?
Good Clinical Practices, GCPs
What is one of the major implementations of the 21st Century Cures Act in clinical trials?
What is real world data and real world evidence?
A subject enrolled in a trial for a new drug. The patient's history states that she has a history of hypertension. She is at her physician office an her blood pressure was recorded as 145/95. She has been on medication before her enrollment. Would this be an adverse event?
No, this is a pre-existing condition
Scientists have followed patients overtime looking at the effects of Sickle Cell Disease in black and brown populations. There observations are ready for populations. The type of investigation is an example of this type of obersation?
What is the Natural History of the disease.
Who was the first sponsor who offered a virtual trial?
Pfizer, looking at the safety and efficacy of Detrol LA for treatment of overactive bladder.
In 1964 these were established to protect the health of people in clinical trials
What is the Declaration o f Helsinki
In 2016 this program was initiated to accelerate the research against cancer.
What is the Moonshot
When a Principal Investigator assesses an AE, he/she will indicate these assessments.
What is;
Seriousness
relationship to the drug or device
relationship to the procedure if applicable