All research involving humans collect regulatory documentation.  The collection of source documentation serves to reconstruct the study as it happened.  It enables an independent observer to confirm the results.  This process holds investigators accountable to the protocol and protects participants' rights and safety.  Good documentation described in the FDA's data integrity and compliance guidelines is obtained in the form of ALCOA (attributable, legible, contemporaneous, original and accurate).  The utilization of a regulatory binder and participant binder assists investigators and study personnel in the collection and maintenance of documentation required for the reconstruction of a study.  

Purposes of the eRegulatory Binder:

This eRegulatory Binder assists study sites to achieve and maintain regulatory compliance for research involving human subjects.

Each section outlines the regulatory documentation requirements, general guidance for organization and record keeping, and, when applicable, references to federal regulations and Good Clinical Practice guidelines.

Why collect records electronically?

There are many benefits to collecting records in an electronic format.  A few of those benifits include:

  • Quickly and easily track data over time.
  • Monitor and audit study protocol.
  • Improve overall quality of data collected. 
  • Efficient way to keep study records and requires less storage space.
  • Automatilly tallies participant records and provides easy reporting functions.
  • Allows backup of records and keep them in a safe place.
  • Consitant compliance and logging of data collection.

How to Use the REDCap eRegulatory Binder Template?

The REDCap eRegulatory Binder Template provides a structure for essential record collection and retention.  This template is intended for IRB approved research studies and should follow your organizations SOPs. 

Guidelines for use of the binder:

  • Title of the binder with the PI name, study short title, and IRB assigned number.
  • Tailor the binder to meet the needs of your specific protocol:
    • This eRegulatory Binder is a template. Include only sections pertinent to your protocol. Omit unused sections and add sections as needed.
    • Organize and order the sections to facilitate easy use and reference.
    • Add additional tabs and/or documents to each section as needed.
  • Keep the eRegulatory Binder current and up-to-date.
  • Identify an individual(s) responsible for maintaining the binder. Ensure that this person is on file with the IRB as an Additional Person to Contact to ensure that all IRB correspondence and documents are received/filed in a timely manner.
  • Participant-specific documentation and information, e.g., signed consent forms, test results, and completed case report forms should be maintained separately in participant-specific binder/file.
  • Let the binder work for you by linking the location of the source documents to the binder tabs. 
  • Set-up automated reminders for regular collection of information straight from the source.  For example, use the scheduling feature in REDCap to send an inivitation email directly to personnel for their updated signed CVs, licensure, etc. 
  • Use REDCap reports to assist users in quickly opening the binder doucments to the correct page.  Print PDF of the reports for mointor visits.   

For more eREG resources go to eREG at CCHMC.  For more information on general regulatory requirements, go to CCTST Regulatory Knowledge and Support or the FDA.

eREG Binder Connections

STEP 1: Access and customize the eRegulatory Binder database for your study

  1. Request REDCap database (https://cctst.uc.edu/research)
  2. Download regulatory binder template.csv
  3. In your project, locate the Data Dictionary tab, then upload the regulatory binder template.csv
  4. Tailor eRegulatory Binder to your study.  Look in instrument 1 (Instructions) for help.

    What sections apply to your research protocol?

    Depending on the nature of the research, some tabs may or may not be required. Use the below list to ensure that the applicable sections are maintained.

    1. Human Research
      • Protocol 
      • IRB 
      • Consent Forms 
      • Data Collection 
      • NIH 
      • Sponsor 
      • DSMB 
      • Training 
      • External IRB Documentation 
      • Ethics Committee/Community Advisory Board Documentation 
      • Scientific Review 
      • Data Protection 
      • Other
    2. FDA-regulated Human Research (e.g., IND, IDE). In addition to #1 above (Human Research), maintain the below tabs:
      • Logs 
      • Investigator's Brochure/Device Manual/Package Insert 
      • Drug/Device 
      • FDA
    3. Good Clinical Practice. In addition to #1 above (Human Research), maintain the below tabs: 
      • CVs 
      • Licensure 
      • Investigator's Brochure/Device Manual/Package Insert 
      • Laboratory Documents 
      • FDA
  5. Enable surveys
    1. In Project Setup, enable "Use surveys in this project?".
    2. In the "Online Designer, find the insturment you are enabling and click "enable".  A green checkmark will appear.
      1. Enable surveys 
  6. Custimize the fields to your study.
    1. Add/remove fields as needed
    2. Incorprate your IRB approved Consent documents.  
    3. Check hyperlinks are sending user to correct location.
  7. Review the pre-defined settings and set user rights Settings defined on the Project Setup page.
  8. When set-up and testing are done, move project to production status.

eREG workflow

STEP 2: Using the eRegulatory Binder

  1. The eRegulatory Binder pulls all study documents together into one source.  The key component to success is not to duplicate work, but inform the binder where to find the appropriate source documents.  Utilize notes and hyperlinks to send the user directly to your documents.
    1. Each Instrument is a Tab in your binder.
    2. Instruments that require scheduled document collection (i.e. CV, Licensure, etc.) have hyperlinks to another database.
  2. Each instance of a change to the regulatory binder becomes a new Record in REDCap.  This will allow a clear historical logging of what happened when inside the binder.  See the Example of a REDCap dashboard below.
  3. Information found in a binder tab is viewd through the use of REDCap reports.  See the Eample of a REDCap report list below.

Developed by Theresa Baker

  • No labels