Certified Copies

Overview

Certified Copies are copies (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. Investigators and Site Coordinators can upload “Source Documents” from their EHR and/or paper charts and create a “certified copy” within the Flatiron system. This data will serve as the “Original data” or “Source data” for which assessments may be filled out or Source Document Verification (SDV) activities can occur from. Certified Copies can be uploaded to any assessment, subject log, or site log if enabled for the assessment or log.

Access to Certified Copies

Access to Certified Copies within the Flatiron platform is limited to the following role types:

  • Primary Investigator
  • Site User
  • Clinical Monitor (CRA)

Uploading Certified Copies

To upload a certified copy, click “+Add” under the Certified Copies section of the associated procedure. Although there is no file size limit, file upload will take significantly more time if the file size is large. It is recommended to upload files with reasonable size to avoid timeout.

In procedures:


In subject logs:


Supported File Types

The following file types are supported for upload as certified copies:

  • pdf
  • png
  • jpg

Invalidating Certified Copies

Because Flatiron software is a regulated environment we don't allow deletion of files that have been uploaded. Instead, we allow for the marking of a document as not valid.

  • Documents can be invalidated when they are being viewed as thumbnails in subject logs or by clicking on the thumbnail images in the “Certified Copy” section of the individual CRFs. If the documents were opened by clicking on the “View All Certified Copies” button at the top of visit or log screen the invalidation option will not be available.
  • Documents can only be invalidated if the CRF or log entry is in the Open or Review Comment state. If the CRF/log entry has been marked as Submitted or Reviewed the invalidation option will not be available.

To mark a certified copy as invalid (or re-validate an invalid copy):

In procedures:

  1. Click a thumbnail image to view the document
  2. Right click anywhere on the document.
  3. A message will appear to confirm that the page should be marked as invalid:


4. After confirming, the document will then appear, marked with a red X:


In subject logs:

  1. For documents with multiple pages, check the pages to be invalidate then click Invalidate Selected Pages button. For documents with only one page, click Invalidate Document button. 


  2. A message will appear to confirm that the page should be marked as invalid


  3. After confirming, the document will then appear, marked with a red X:



Viewing and Adding Comments to Certified Copies

To view signature details or add a comment to a Certified Copy:

In procedures:

  1. Click a thumbnail image to view the document
  2. Left click anywhere on the document.

  3. A screen will appear displaying the date and time that the document was uploaded/signed and the name of the user that uploaded it. This date and time is in the timezone set up on the viewer's device and will be updated accordingly if the viewer changes their timezone setting.


  4. Any necessary comments can be added or modified in the Comment box.
  5. Click Update to save comments added to the document.

In subject logs:

  1. Click View Signature button on any document uploaded
  2. The Signature Details dialog box will be displayed with the date and time that the document was uploaded/signed and the name of the user that uploaded it. This date and time is in the timezone set up on the viewer's device and will be updated accordingly if the viewer changes their timezone setting.  
  3. Any necessary comments can be added or modified in the Comment box.
  4. Click Update to save comments added to the document.

Visit Level Certified Copies 

All uploaded Certified Copies can also be viewed at the visit level.  Site and Monitor user roles have a “View All Certified Copies” button available when opening a visit.  Clicking on this allows the user to view (and modify) all certified copies that have been uploaded to all procedures associated with this visit.  Clicking on an individual certified copy will display the signature details, including the procedure that the certified copy is associated too.


Subject Log Level Certified Copies 

All subject logs with at least one entry will have a button to allow all certified copies that have been uploaded to the selected log to be viewed together for all Site and CRA users.  

Timezones

In the Certified Copies workflow, timestamps are displayed in the following timezones:

  • When column in View All Certified Copies audit trail, accessible by clicking on the clock icon next to the View All Certified Copies button: timezone set up on the viewer's device and will be updated accordingly if the viewer changes their timezone setting.

  • Certified Copy Signature Details:
    • Sign date and time: timezone set up on the viewer's device and will be updated accordingly if the viewer changes their timezone setting.

    • Invalidation date and time: timezone set up on the viewer's device and will be updated accordingly if the viewer changes their timezone setting.

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