Random Mix

Question 1

Who created the Belmont Report?

Answer 1

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Rsearch (at direction of National Research Act of 1974)

Question 2

Sponsor Must report what kind of serious events to the FDA

Answer 2

1) Serious and unexpected suspected adverse reactions
2) Findings from other studies that suggest a significant risk in humans
3) Findings from animal or in-vitro testing that suggest risks to humans
4) Increased rate of occurrence of serious suspected adverse reactions

Question 3

What 5 incidences must sponsors report to the FDA and/or investigators?

Answer 3

1) UADEs
2) Withdrawal of IRB approval
3) Withdrawal of FDA approval
4) Recall and device disposition
5) Significant risk device determination

Question 4

How are medical devices categorized to determine whether a 510(k) or PMA is needed?

Answer 4

Class I, II, III

Question 5

What is Source Data Review (SDR)

Answer 5

What is Source Data Review (SDR)

Question 6

What are the 7 options for exempt device studies?

Answer 6

1) In distribution before 5/1976
2) Device substantially equivalent to one meeting criteria 1 and is used following FDA labeling
3) Diagnostic device that meets 4 criteria (not invasive, introduce energy or used w/o confirmation by other diagnostic device)
4) Undergoing consumer testing, modification testing or combination testing if subjects not at risk
5) Veterinary use
6) Lab animal use
7) Custom device unless being tested for commercial distribution

Question 7

What criteria does the FDA require for Phase 1 protocols? (3)

Answer 7

1) General outline of planned investigation
2) Estimated duration of study
3) Maximum # of subjects involved

Question 8

How is QA done during a trial?

Answer 8

Clinical site’s internal reviews of current procedures, processes and their documentation (like SOPs)

Question 9

What are the phases of device trials?

Answer 9

1) Pilot
2) Pivotal

Question 10

How many days does a sponsor have to submit a report to FDA/investigators/IRB about returns, repairs or disposal of units of a device?

Answer 10

Notice to be provided within 30 days after request was made - to include rationale

Question 11

What is the FDA monitoring program?

Answer 11

Bioresearch Monitoring program (BIMO)

Question 12

What are the 3 types of control groups used in trials?

Answer 12

1) Placebo
2) Standard of Care
3) Historical control

Question 13

What criteria does the FDA require of Phase 2 and 3 protocols? (7)

Answer 13

1) Outline of study protocol
2) Approximation of subject # treated vs controls
3) Clinical uses of treatment to be investigated
4) Characteristics of subjects by age, sex, condition
5) Clinical observations and lab tests to be conducted
6) Duration of study
7) Copies or description of CRFs to be used

Question 14

For FDA regulated trials, when does an amendment need to be submitted to both IRB and FDA?

Answer 14

Phase 1 study: significantly affects the safety of subjects
Phase 2 or 3: protocol that significantly affects the safety of subjects, the scope of the investigation, or the scientific quality of the study,”

Question 15

45 CFR 46
1) What studies are exempt?

Answer 15

1) commonly accepted educational studies
2) beneign behavioral interventions
3) Taste and food quality

Question 16

45 CFR 46
What studies allow for waiver or alteration of consent?

Answer 16

public benefit and service programs

Question 17

How often does FDA audit IRB?

Answer 17

every 3-5 years

Question 18

Who implements computer system validations for study?

Answer 18

Sponsor

Question 19

When research is proposed that involves risks and does not include a therapeutic component…

Answer 19

less burdened classes of persons should be called upon first to accept these risks of research, except where the research is directly related to the specific conditions of the class involved

Question 20

What is a transitional device?

Answer 20

device the FDA considers to be a new drug or antibiotic before 5/28/76

Question 21

How does a investigator or sub investigator get banned from conducting FDA regulated studies?

Answer 21

Steps:
1) If investigator/sub-investigator repeatedly or deliberately fail to comply with 21 CFR 50 or 21 CFR 56, after formal inquiries, commisioner can disqualify their participation in any FDA regulated studies.