Certified Copies
Flatiron offers an innovative implementation to store case report forms, informed consent, and supporting source data in one location. The Investigator (and its delegates) can upload “Source Documents” from their EMR 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 CRFs may be filled out and Source Document Verification (SDV) activities can occur from. As needed, the Sponsor can give access to appropriate authorities for audit and/or inspection activities.
Certified Copies in Source Upload are utilized for remote monitoring purposes. These documents include original medical records, study regulatory documents, CRFs, etc. that need to be reviewed by a CRA. In general, these copies are uploaded to their respective assessments, subject logs, or site logs as determined by the sponsor. The sponsor will provide guidance on where individual documents are expected to be uploaded. The system can also have built-in notices and guidance to provide further instruction for source uploading.
Uploading Source
To upload a source document, navigate to the appropriate visit and procedure. A Certified Copies section that allows for adding new documents as well as reviewing documents that have previously been uploaded is presented. When uploading certified copies, the user is prompted to verify authenticity of the document and to enter their name and signature. A full audit trail, including the original file, is stored and available in the system to the appropriate user roles.
Press choose file button to add the certified copy. Verify the certified copy with a signature. Press add certified copy button to complete the upload.
Once a certified copy has been uploaded, the green photo icon indicates which visits and procedures have uploads. Once inside a procedure, there will be an icon of the uploaded document visible.
Supported file types
PDF, JPG, and PNG files can be uploaded. Encrypted PDFs can also be uploaded by entering the password needed to open the file. When using a smartphone or tablet, the user can also directly capture a photo using the device’s built-in camera.
Certified Copies Comments
After a certified copy has been uploaded, the user can click on the certified copy icon to view the file. Clicking on the image again will bring up the signature details as well as a comment section. The comment box can be utilized to address errors related to the upload or give additional detail to the monitor when they are viewing the record. Monitors can only see certified copy comments, they cannot respond or add additional info. A monitor can comment regarding certified copies via the review workflow.
Searching Certified Copies
Site users have the ability to search Certified Copies at both the visit and procedure levels. PDFs and images are scanned for text to allow for the search of medical related terms including conditions, medications, procedures, labs, tests.
