Make the Switch to Electronic Data Capture (1/2)

27 August, 2014, by ClinCaptureTeam

Electronic Data Capture (EDC) collects clinical trial data electronically rather than on paper. It is becoming an increasingly popular solution for streamlining clinical data processing. Studies suggest that using EDC systems drastically reduces data errors and speeds up the overall trial process, therefore reducing clinical research costs by up to 20%. Clinical data quality is also dramatically improved when relying on EDC: According to the Regional Operations Manager at Eli Lilly in Canada, implementing an EDC system resulted in a 70 to 80% reduction in queries.

However, the adoption of EDC (Electronic Data Capture) systems has remained slow in some segments of clinical research. According to Datamonitor, the market intelligence and data analysis firm, only 40% of Phase I clinical trials had adopted EDC by the end of 2011. 60% of Phase 2 clinical trials, 80% of Phase 3, 70% of Phase 4, and 5% of “Others” (non-FDA regulated studies) are utilizing EDC systems.

A potential steep learning curve for clinical research teams, structural changes in organizations, and perceived high cost of EDC implementation are some of the legitimate reasons to hesitate before adopting EDC. However, considerable time- and cost-savings, along with drastic data quality improvements outweigh these difficulties. This paper aims at clarifying and facilitating the process of switching to Electronic Data Capture (EDC). We have listed below some of the essential points to consider before selecting and implementing an EDC system.

 1. Track Record

 The first thing to consider is the track record of the eClinical system vendor: How long have the vendor and its EDC system been on the market? On how many studies has the system been implemented? Can the vendor produce testimonials and case studies from past customers to substantiate its marketing claims? Was the system utilized for any FDA submissions?

2. Regulatory Compliance

Make sure the EDC system you’re evaluating is 21 CFR Part 11 Compliant. Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) is the United States Federal Regulation which applies to electronic records and electronic signatures in clinical systems. Also take EU regulations into consideration if you’re planning on running clinical trials in Europe.

1. EDC systems must track all data changes in audit trails in order to be 21 CFR Part 11 compliant. Any change to any record is captured in the audit trail and these entries are time stamped with additional information including operator name and why the record was changed.
2. The EDC system provides adequate security to prevent unauthorized modification by ensuring role-based access and preventing users from directly updating the database.
3. The software employs electronic signatures for any transaction into the system.
4. Vendors must also plan for disaster recovery and analyze and remedy potential risks.

We have found that some popular cost-efficient Electronic Data Capture (EDC) systems on the market are not 21 CFR Part 11 compliant, such as REDCap. These systems cannot be used for FDA-regulated clinical studies, but only for research and investigational purposes.

3. Data Security

Most EDC vendors offer a “secure hosting”, but we recommend to take a close look at where and how clinical data is being stored. Does the vendor provide disaster recovery? Is the data center SSAE-16 compliant? SSAE-16 (Statement on Standards for Attestation Engagements (SSAE) No. 16) defines the standards an auditor must employ in order to assess the contracted internal controls of a service organization, such as co-location service providers, including network and system management SOPs, security and business continuity.

4. Pricing model

The cost of implementing an EDC system can dramatically vary from a few thousand dollars to half a million dollars. Most EDC systems vendors charge customers a high upfront cost to cover heavy development and customization costs. The pricing model of most EDC systems is thus not transparent and varies depending on the project. Some systems will charge you depending on the number of users, which is well adapted to small clinical trials, but reportedly not scalable for longer and larger clinical trials.

Sophie McCallum

Director of Operations at Clinovo

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Extract of Clinovo’s White Paper “Make the Switch to Electronic Data Capture”

Read the full White Paper on clinovo.com/papers

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