SOCRA Certification Exam Questions and Answers

Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten records ? - Yes Open system (FDA term) - System access is NOT controlled by people who are responsible for the content of the electronic records in the system. (Like me putting data into CHOP - controlled databases) Closed system (FDA term) - Environment in which SYSTEM ACCESS is controlled by the same people responsible for the content of the system (I.E. I control the Robotic Database access AND its contents) What are some FDA Standards to meet when operating a closed record system? - 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 6. Use operational system checks and restrictions 7. Use authority checks to make sure only authorized individuals are using the 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 standards to meet when using an Open System? - All those mentioned for the closed system. 1. Document encryption as appropriate What information should a handwritten SIGNATURE block contain? - 1. Printed name of signer 2. Date and Time when signature was executed 3. The MEANING associated with the signature (approval? responsibility? authorship?) Signature and record linking ? - Signatures must be linked to their respective electronic records to make sure they cannot be copied, falsified, transferred etc. Do researchers need to request permission from the FDA to use electronic signatures in place of regular signatures? - Yes What controls should an E-SIGNATURE contain? - Employ at least 2 identification components - such as an identification code AND a password. Name some CONTROLS for the identification components (i.e. identification code and password) for e-signature? - 1. no 2 people should have the same identification controls (password... code) 2. Identification codes and passwords should be periodically checked, revised, etc. 3. Deauthorize lost, stolen, missing codes and passwords 4. Periodically test your devices that generate these codes Can an informed consent contain exculpatory language? - NO! Cannot say things like "you are waiving your right to damages" etc When may an experimental drug or device be used on a patient WITHOUT informed consent? ((EMERGENCY USE)) - 1. the investigator and an independent physician agree that the patient is -life threatening situation