45 CFR 46 Subpart A
"Basic HHS Policy for Protection of Human Research Subjects": (46.100)
Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review of ...
45 CFR 46 Subpart A - ANSWER-"Basic HHS Policy for Protection of Human Research Subjects": (46.100)
Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and
documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations,
review of research, and record keeping.
45 CFR 46 Subpart B - ANSWER-Additional protections for pregnant women, human fetuses, and
neonates (46.200)
45 CFR 46 Subpart C - ANSWER-Additional protection for prisoners (46.300
45 CFR 46 Subpart D - ANSWER-Additional protection for children
FDA Form 482 - ANSWER-Notice of Inspection
FDA Form 483 - ANSWER-Inspectional Onbservations
FDA Form 1572 - ANSWER-Statement of Investigator
FDA Form 3454 - ANSWER-Certification - Financial Interests and Arrangements of Clinical Investigators
FDA Form 3455 - ANSWER-Disclosure - Financial Interests and Arrangements of Clinical Investigators
FDA Form 3500 - ANSWER-For Voluntary Reporting of Adverse Events and Product Problems
FDA Form 3500A - ANSWER-For Use by User-Facilities, Distributors, and Manufacturers for Mandatory
Reporting
, CFR Title 45 - ANSWER-Public Welfare
CFR Part 46 - ANSWER-Protection of Human Subjects
45 CFR 46 Subpart E - ANSWER-Registration of Institutional Review Boards
When must IRB registration information be renewed? (46.505) - ANSWER-Every 3 years
This is the assurance where an institution agrees to comply with 45 CFR 46 - ANSWER-FWA (Federalwide
Assurance); it is filed with the OHRP
45 CFR 46 is regulated by which governing body - ANSWER-OHRP (Office of Human Research Protection)
HIPAA is regulated by which governing body - ANSWER-Office of Civil Rights
21 CFR Part 11 - ANSWER-Electronic Records, Electronic Signatures (trustworthy, reliable and equivalent
to paper records)
21 CFR Part 11 Subpart B - ANSWER-Electronic Records - controls for closed systems, controls for open
systems, signature manifestations, signature/record linking
21 CFR Part 11 Subpart C - ANSWER-Electronic Signature - General requirements, Electronic signature
components and controls, controls for identification codes/passwords
21 CFR Part 11 is regulated by which governing body - ANSWER-FDA
What is the Nuremburg code? - ANSWER-A set of 10 ethical principles for human experimentation
developed in 1947
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller Bensuda. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $7.99. You're not tied to anything after your purchase.
