Electronic Records

Question 1

What is a closed vs open system?

Answer 1

A closed system is when the individuals that control the content of the electronic records also authorize who gets to access the system. An open system is an environment where anyone and everyone has access to the system

Question 2

What is a validated electronic system?

Answer 2

A validated system (e.g. redcap) is a system that has scripts/programming in place to ensure the system is working as it is supposed to, that it is consistent and accurate

Question 3

What is some criteria that a closed electronic system must have to be 21 CFR 11 compliant?

Answer 3

• audit trail that tracks all changes, signatures, etc
• SOPs & training
• only authorized individuals can make changes and access the platform
• validated system
• ability to create accurate copies of records
• protection of the content of records
• authentication checks to ensure identity authorized individuals
• source verification checks
• order of events checks to ensure that any applicable functionalities are working in sequential fashion
• controls of documentation

Question 4

What is an example of an open system? What are the key things that need to be prioritized if a study is using an open system per 21 CRF 11?

Answer 4

An example is email. One could send a participant a form to sign via email and they could send it back. A study needs to ensure that the authenticity, integrity and confidentiality of such records are protected and ensured.

Question 5

What information needs to accompany an electronic signature per 21 CRF 11?

Answer 5

The printed name, date and time of signature and purpose (e.g. consent)

Question 6

What are three general requirements for using electronic signatures? (Per 21 CRF 11)

Answer 6

1. Only one electronic signature per individual (they cannot be shared)
2. Before an individual uses their electronic signature, their identity needs to be verified
3. The person needs to agree and acknowledge that their electronic signature is legally binding like their hand written signature

Question 7

What is biometrics? What is an example?

Answer 7

Verifying and confirming someone’s identity through different metrics like physical features, thumb print, etc.

Thumb print, iris/eye scan. It has to be things that are unique to each individual.

Question 8

What should electronic signatures that are not based upon biometrics have? (Per 21 CRF 11)

Answer 8

1. At least a code and password associated with them
2. Only used by that person
3. Designed in a way that it is very difficult for someone to use the signature (i.e. you would need multiple people to forge it)

Question 9

A sponsor is hoping to adhere to the ICH GCP guidelines for their electronic trial data system and handling electronic data. What standards should they ensure when using these systems?

Answer 9

• audit trails
• SOPs e.g. on back up, record retention, data collection
• secure access by specific people and protect unauthorized people from accessing it
• protecting blinding
• ensure system meets sponsors requirements for completes, validation, accuracy, reliability
• list of people that are allowed to make changes
• ensuring back ups
• maintain integrity, especially during updates/transitions

Question 10

What are some of the shared electronic record criteria between 21 CRF 11 and GCP E6?

Answer 10

• audit trail of all changes, access, etc.
• authorized individuals are allowed to make changes and protections against unauthorized people from accessing it
• ensuring that the electronic platform has a system for validation
• Ensuring that everyone that uses the systems has the training (via SOPs, experience, etc)

Question 11

How does ICH E6 describe a certified copy? In what instance would this need to be used?

Answer 11

A certified copy is a copy of the original (electronic or paper) that has had all of its information verified (e.g. by a dated signature or a validation process). It might be used as a copy of an ICF, or a copy of a medical exam that fades over time, electronic medical chart

Question 12

According to the FDA and NIH, what studies need to be registered to clinical trials.gov? What information must be updated? Who is responsible for submitting this?

Answer 12

• Applicable clinical trials (drug, device and biological trials regulated by the FDA) + trials funded by the NIH
• AEs + results
• sponsor or their delegate (PI or other responsible party)