QA will be presenting at the February 14th Education Meeting regarding frequently asked consent questions and how to address them. Please come with any consent questions or send them to us before the meeting!
If you have any questions on anything in the meantime, feel free to contact us at dsmc-quality@stanford.edu.
If you are unable to print a certified copy of patient demographics and resort to printing a screenshot instead, we may have a solution for you!
But we can’t take the credit for it. This was brought to our attention by Stefania and Roan of the Head and Neck team. Thank you!
Please note: This function may not be available for all EPIC Departments. If you have any questions, please email dsmc-quality@stanford.edu
Steps for printing demographics from EPIC
1. Find your patient in EPIC
2. Find and Click SnapShot on the menu to the left-hand side of the screen
3. In the search field, enter PATIENT DEMOGRAPHICS and press ENTER
4. Print!
Did you know screenshots are not automatically valid source documents?
The FDA recognizes source documents to be “original documents and records or certified copies.” In order to be a certified copy, it requires more than just the information that can be included in a screenshot according to FDA guidances and ICH GCP a certified copy is—“a copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all of the same attributes as the original.”
EPIC print outs meet this requirement because they have your sID and the date printed; typically located at the bottom of most documents printed directly from EPIC. However, screenshots (most commonly demographics or labs/scans from CareEverywhere) do not automatically include this information in the printed copy and do not meet the requirements of a certified copy or valid source document!
How can I make something a certified copy?
If a screenshot is the only available option to print a document to be placed in a shadow chart, when printing the screenshot, please sign and date the copy, thereby validating it is a copy of the original record in EPIC and making it a certified copy and valid source document.
Why is my signature important?
Your signature means you personally completed or verified the completion of a required procedure/ test/ assessment/ etc. in a clinical trial.
As with any signature, it is important to ensure you know what you’re signing and what your sign off means!
If you have any questions or concerns, please email dsmc-quality@stanford.edu
References: ICH GCP E6 1.51 and 1.52, FDA Guidance for Industry: Computerized Systems Used In Clinical Investigations, FDA Guidance for Industry: Electronic Source Data in Clinical Investigations
We have an obligation when submitting for protocol renewal to include information about any noncompliance that has occurred over the last year of research conduct. This includes regulatory noncompliance and deviations.
This is essential for the accountability, correction of non-compliance, prevention of reoccurrences, adherence to the ethical standards, and integrity of the clinical trial.
In eProtocol, where to enter noncompliance in the Continuing Review/Renewal submission?
Helpful Tip! Use OnCore as your deviation log to document ALL protocol deviations. When entered into OnCore you are able to run a PDF report of your study’s deviations that can be attached to the IRB renewal submission! Ensure you specify in 2g what section the PDF is attached.
If you have any questions or concerns, please email dsmc-quality@stanford.edu.
References: HRPP Policy Manual
Have you ever looked for a Delegation of Responsibility Log in Coordinator Corner and found that we have 2 different versions? Click on the Full Story to find out which one to use for your study.
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