Regulations

Question 1

Electronic Signatures and Electronic Records

Answer 1

21 CFR Part 11

Question 2

Regulatory Hearing Before the FDA

Answer 2

21 CFR Part 16

Question 3

Protection of Human Subjects

Answer 3

21 CFR Part 50

Question 4

Financial Disclosure by Clinical Investigators

Answer 4

21 CFR Part 54

Question 5

IRBs

Answer 5

21 CFR Part 56

Question 6

IND Applications

Answer 6

21 CFR Part 312

Question 7

GLP

Answer 7

21 CFR Part 58

Question 8

IDE

Answer 8

21 CFR Part 812

Question 9

Premarket Approval of Medical Devices

Answer 9

21 CFR Part 814

Question 10

Human Subjects DHHS

Answer 10

45 CFR 45

Question 11

ICH Harmonised Guideline for Good Clinical Practice

Answer 11

E6R2

Question 12

ICH Clinical Safety Data Management

Answer 12

E2A

Question 13

FDA Form 482

Answer 13

Notice of Inspection

Question 14

FDA Form 483

Answer 14

Inspectional Observations

Question 15

FDA Form 1572

Answer 15

Statement of the Investigator

Question 16

FDA Form 3454

Answer 16

Certification - Financial Interests and Arrangements of Clinical Investigators

Question 17

FDA Form 3455

Answer 17

Disclosure – Financial Interests and Arrangements of Clinical Investigators

Question 18

FDA Form 3500

Answer 18

For Voluntary Reporting of AEs and Product Problems

Question 19

FDA Form 3500A

Answer 19

For Use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting

Question 20

Subparts of 21CFR Part 50

Answer 20

B - Informed Consent
D - Safeguards for Children

Question 21

Investigator has X many days to report exception from informed consent after use of the article

Answer 21

5 working days

Question 22

IRB Record Retention length requirement

Answer 22

3 years after study completion

Question 23

8 Required Elements per 21CFR Part 50 of an ICF

Answer 23

1) Statement of purpose and procedures
2) Risks or discomforts
3) Benefits
4) Alternative procedures
5) Confidentiality of records
6) Compensation and injury statement
7) Contact info
8) Statement of voluntary participation

Question 24

When using a short form consent, who signs what?

Answer 24

Subject signs the short form, but receives copies of short form and the summary. Witness signs BOTH documents

Question 25

When is one parent signature of consent needed versus both

Answer 25

One parent may sign only when there is minimal risk, or if there is > than minimal but direct benefit to subject. BOTH must sign if there is > than minimal or for studies unotherwise approvable (rare case studies)

Question 26

Ward Children Studies

Answer 26

Studies either must be related to their ward status, or enrolling where the majority of children involved as subjects ar NOT wards

Must be appointed an advocate that is not related to the investigation, investigators, or guardian organization

Question 27

Financial disclosure: Equity interest and Significant payments of other sorts reportable values

Answer 27

$50k equity and $25k exclusive of costs to run study, both during the time of the study and for one year after

Question 28

Length of financial record retention

Answer 28

2 years after approval of product application

Question 29

How often does the IRB need to renew its registration?

Answer 29

Every 3 years

Question 30

Requirements for Expedited Review

Answer 30

Be of subject on the Federal Register and of no more than minimal risk

Question 32

Reporting time of 3500A for IND Safety Reports

Answer 32

15 CALENDAR days

Question 33

Reporting time of 3500A for unexpected fatal or life threatening event

Answer 33

7 CALENDAR days