In Clinical Research, we are all too familiar with the phrase, “If you didn’t document it, it didn’t happen.”

I’ve seen firsthand at busy clinical research sites the detrimental effects missing paper source has on data integrity and quality.

I’ve worked at facilities that are completely paperless and those that were not. In the fast-paced clinical research industry, time management is of the utmost importance. Maximizing the time you have to efficiently meet with study participants, collect data, and organize it is key to meeting your study timelines.

With paper source, it’s easy to misplace essential documents for a study, or to lose them altogether. Paper clips may come loose, or papers may get thrown out on accident. I have spent hours with staff to search through bins and bins of document when this has happened. Through eSource, everything is in one place, eliminating the risk of misplacing documents or not having everything you need as you collect data.

eSource offers significant advantages over paper source. Electronic documentation offers greater accuracy, compliance, security, quality, and decreases the deviation burden of clinical research sites. eSource offers such benefits as edit checks/alerts, missing data flags, and capabilities for remote investigator sign-off and remote quality checks. Additionally, electronic source records decrease time and effort for source and electronic data capture (EDC) data entry verification.

Switching to eSource has the potential to reduce the workload for sites by streamlining their entire documentation process. The improved efficiencies in data entry vs. handwritten notes, along with a clear step-by-step process for each specific visit, reduces patient visit times.

Leveraging eSource can also provide a significant reduction in errors and missed procedures at sites thanks to real-time data validation. When I did find errors, the audit logs and queries directly on the eSource page were considerably easier to review than the traditional pile of sticky notes that we are all accustomed to utilizing in piecing the story together.

Frequently Asked Questions

How can leveraging eSource benefit clinical research sites?

Leveraging eSource can significantly reduce errors and missed procedures at sites due to real-time data validation.

What potential workload reduction can switching to eSource offer for sites?

Switching to eSource has the potential to reduce the workload for sites by streamlining their entire documentation process.

What advantages do electronic source records offer over paper source?

Electronic source records decrease time and effort for source and electronic data capture (EDC) data entry verification, and offer greater accuracy, compliance, security, quality, and decreased deviation burden.

Why is maximizing time efficiency crucial in clinical research?

Maximizing time efficiency in clinical research is crucial for meeting study timelines.

What benefits does electronic documentation offer over paper source?

Electronic documentation offers benefits such as edit checks/alerts, missing data flags, and capabilities for remote investigator sign-off and quality checks.

How does eSource help in time management in the clinical research industry?

In the fast-paced clinical research industry, time management is of utmost importance, and eSource provides clear step-by-step processes for each specific visit, reducing patient visit times.