Cost reduction of human error in EDC business processes with electronic Data Change Requests

Data change requests processing is a standard workflow where EDC & IWRS systems are in use. We made it really user-friendly and still compliant with applicable regulations (Title 21 CFR Part 11, ICH GCP E6). 

Where investigators access or current state of the data does not allow editing them directly, the user initiates a DCR to trigger actions by other stakeholders based on their roles in the study. 

Blinded and Unblinded DCRs have separate workflows. 

The process is configured flexibly and may include several steps:

1. Request from Site to change the data they entered initially;
2. Approval for the data change;
3. DCR execution;
4. Control of the result.

Things to remember:

• full audit trail of the DCR processed
• a record for Investigator Site File
• a tracker of all the DCRs for Trial Master File

Paper DCR has its known weaknesses:

• demands much effort from all parties
• is prone to human errors
• often lacks reference between the database edit and paper request as it requires handwritten annotation
• delays execution control and feedback
• accumulates backlog with a snowball effect

Automated workflow with user access permissions control and instant notifications diminishes these difficulties.

• MainEDC™ will pre-populate a part of DCR and form a link to the related eCRF page as indicated by user
• The system is validated
  • electronic records, electronic signatures
• Data, metadata and their updates are
  • attributable to users, 
  • traceable, 
  • exportable.

By using the automated tracking incorporated into MainEDC™, you ensure the following:

• the DCR process becomes less resource-consuming
• its quality increases
• you gain competitive advantages and
• more time for new deeds

The eDCR function has been available since January 2021 – we welcome users to familiarize themselves with the Release Note build 20210113 before starting.