Minimizing Regulatory Risks with ALCOA during Oncology Studies

Jackie Brusch

Many clinical trials today are still using paper to collect data. Over this 5-part blog series, we’ll examine some of the common challenges with data collection during oncology trials today and explore how you can overcome these challenges. Check back on the following dates to read the blogs in this 5-part series!


The importance of minimizing regulatory risks during oncology studies

Regulators strongly favor including the patient perspective in oncology studies. This leads to more post-progression and follow up data which requires high compliance. eCOA solutions support this by minimizing the potential risks.

eCOA solutions make it easy to capture Patient Reported Outcomes from anywhere in the world and in real-time. By meeting the ALCOA standard in a way that paper cannot, eCOA solutions contribute to higher compliance.

ALCOA stands for:

Attributable. With eCOA solutions, subjects have a unique PIN code and activity

is date and time stamped. Audit trails also track data entry.

Legible. Typed entries and standardized response options provide clean,

comprehensible data.

Contemporaneous. Reminders and alarms prompt subjects to enter data at the right time. They also alert study teams if data is missing to ensure compliance. Finally, alarms and reminders allow you to control or eliminate retrospective data.

Original. PRO data is captured directly from the subject in electronic form which eliminates the need for Source Data Verification.

Accurate. Built-in logic and real-time edit checks prevent incomplete and inconsistent data entries. Standardized response options provide objective data.

Are your studies enabling risk or deterring it?

This completes our 5-part oncology-focused eCOA blog series. We hope you enjoyed it! Have questions for us?  Contact us.  Want to re-read the blogs? Do so here.

About the Author

Jackie Brusch

Jackie Brusch is the Content Marketing Manager at CRF Health.

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