8/30/24, 5:06 PM SOCRA CERTIFICATION EXAM 2024 ACTUAL EXAM COMPREHENSIVE QUESTIONS WITH DETAILED VERIFIED ANSW…
SOCRA CERTIFICATION EXAM 2024 ACTUAL
EXAM COMPREHENSIVE QUESTIONS WITH
DETAILED VERIFIED ANSWERS (100% CORRECT
ANSWERS) / ALREADY GRADED A+
Terms in this set (154)
Does the FDA consider Yes (although permission to use such e-sigs has to be
electronic signatures to be approved by the FDA)
as trustworthy and reliable
as handwritten paper
signatures?
Does the FDA consider Yes
electronic records that
meet requirements to be
equivalent to handwritten
records ?
System access is NOT controlled by people who are
responsible for the content of the electronic records in
Open system (FDA term)
the system. (Like me putting data into CHOP -
controlled databases)
Environment in which SYSTEM ACCESS is controlled
by the same people responsible for the content of the
Closed system (FDA term)
system (I.E. I control the Robotic Database access
AND its contents)
, 8/30/24, 5:06 PM SOCRA CERTIFICATION EXAM 2024 ACTUAL EXAM COMPREHENSIVE QUESTIONS WITH DETAILED VERIFIED ANSW…
1. Must be able to tell if records have been altered or
invalid
2. Must be able to copy records for agency review
3. Protect records throughout retention period
4. Limit system to authorized individuals only
5. Use time-stamped audit trails of modification etc
What are some FDA
6. Use operational system checks and restrictions
Standards to meet when
7. Use authority checks to make sure only authorized
operating a closed record
individuals are using the system
system?
8. Use device checks to validate data input
9. Make sure those authorized to use system have
appropriate training, education, experience
10. Have written policies that deter data falsification
11. Audit and control the maintenance of the actual
system
What are some FDA All those mentioned for the closed system.
standards to meet when 1. Document encryption as appropriate
using an Open System?
1. Printed name of signer
What information should a
2. Date and Time when signature was executed
handwritten SIGNATURE
3. The MEANING associated with the signature
block contain?
(approval? responsibility? authorship?)
Signatures must be linked to their respective electronic
Signature and record
records to make sure they cannot be copied, falsified,
linking ?
transferred etc.
Do researchers need to Yes
request permission from
the FDA to use electronic
signatures in place of
regular signatures?
What controls should an E- Employ at least 2 identification components - such as
SIGNATURE contain? an identification code AND a password.
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 MEGAMINDS. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $15.99. You're not tied to anything after your purchase.
