Validating electronic source data in clinical trials

Pharmaceutical and provider networks can also leverage wearables to integrate with their current initiatives encouraging behavior change towards a healthier lifestyle.

In this guidance, the agency promotes capturing source data in electronic form to assist in ensuring the reliability, quality, integrity and traceability of data from electronic source to electronic regulatory submission.One way for e-source solutions to comply with regulations and guidelines is to make the first data recording on paper or keep the source data in the clinical investigator’s control by entering it in a medical record or a medical record system.The FDA doesn’t regulate EMR, therefore it is not subject to 21 CFR Part 11 requirements.Industry professionals say that the real benefit of adopting wearables would come from educating healthcare consumers and empowering them to better manage their symptoms.But they are not convinced that the patients’ data should be a part of their formal health record.

They can include information in original records and certified copies of original records of clinical findings, observations, or other activities captured prior to or during a clinical investigation used for reconstructing and evaluating the investigation.” In other words, this is data that is entered directly into a digital format without having to first record it on paper and then transfer it to an electronic data capture solution.