Table of Contents
Purpose

This HOW TO presents an acceptable REDCap process for creation of electronic copies of source documentation (including consent documents) per PHRC Guidance for Electronic Storage of Research Documents.


Requirements

  • If you are new to REDCap and unfamiliar with the basic terminology and features, there are short tutorial videos provided on the REDCap site under the ‘Training Resources’ tab to help you.  “Detailed Overview”, “Data Entry Overview” and “Online Designer” are 3 videos that cover much of the basics you will need.

If you have a specific question about this process, please email edcsupport@partners.org for assistance.

Instructions

A.  Create a REDCap Project

 

  1. Request a new REDCap project using TEMPLATE: Electronic Storage of Research Documents
  2. The template consists of 1 electronic document example:
    1. Rename Electronic Document Name to your document; ex: Informed Consent

  3. Copy the instrument as needed for each new document to be scanned.
  4. The Instrument consists of 4 fields and the REDCap form status field (5). Replace "doc" in the variable names with your document name or abbreviation:
  5. The file upload field is doc_name and has the action tag: @PREVIEWPDF={viewer}  This can also be replaced with just @PREVIEWPDF depending on your view preference.

 

6. Each instrument has the eSignature feature enabled. You must have User Rights to access Record Locking Customization and E-signature and Locking Mgmt.

Lock Record Custom Text to include on each Data Collection Instrument to be certified:

 

B.  Scan and Save Documents to your REDCap Project

1. Scan your forms using a printer/scanner. In this example, documents scanned using a Partners Printer/Scanner is emailed to my personal email address. If you have a shared study account, you may want to designate that account as the scanner destination email:

2. Download the scanned PDF to a secure file area (e.g. SFA, DFA).

3. Log in to REDCap. Navigate to your REDCap project.

4. Create a new record or navigate to specific record. Upload documents.

5. Certify the copies checking "Lock" and "E-Signature" and Save.  You will be prompted to sign using your REDCap/Partners account.

 

 

C.  View or Print Certified Copies

The electronic record (combination of scanned document and certification process with eSignature) in REDCap is now the source document. All other electronic PDFs and copies can be deleted. You should store this data in REDCap according to data retention policies.

If you need to produce "readable copies" for review outside of REDCap (audit, inspection); a certified copy can be generated dynamically when you print the records to PDF.  Therefore, you can make changes to the record and generate up to date PDF/paper copies in real time as needed.

  • Download individual records by navigating to the record and selecting "Download PDF... > ...with saved data"

  • Download ALL Certified Records: Navigate to Data Exports, Reports, and Stats > Other Export Options > PDF of data collection instruments containing saved data (all records)

Tips & Warnings

 

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