Electronic Source Data in Clinical Studies

12 October, 2015, by ClinCaptureTeam

The move to conduct clinical trials from paper to Electronic Data Capture (EDC) has accelerated over the past 10 years in an overall effort to increase data quality, regulatory compliance and to reduce cost. However, paper is still prevalent at clinical sites, as the FDA requires record retention for CRF supporting data that is typically stored in source documents. Two years ago, in an effort to move away from paper inefficiencies, the U.S. Food and Drug Administration (FDA) issued its final guidance on Electronic Source Data in Clinical Investigations. 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.

Recently, a new product category of eSource solutions has entered the market to meet needs that EDC systems cannot fulfill. According to the Food and Drug Administration (FDA) eSource Guidance of 2013: “Electronic source data are data initially recorded in electronic format. 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.

Investigators like the flexibility and versatility of pen and paper, and they perceive computerized systems as a drain on their productivity. The Internet is not always easily accessible from the clinical sites, especially overseas. This is why new eSource solutions are built on tablets that can address these two hurdles. Tablet applications are designed to “look and feel” just like paper, but they offer the efficiency of an electronic document. Unlike case report forms (CRFs), which only capture the data necessary for analysis, eSource documents encompass the much broader goal of providing affirmative documentary evidence related to a subject case history and site audit, and allow for random, ad-hoc comments.

Other benefits of eSource documents include increase in clinical data quality through validation checks and the removal of unnecessary duplication of data, as well as the reduction of monitor site visits by eliminating source document verification (SDV) and enabling remote document review. However, despite the many benefits, esourced documents can still be challenged from a GCP compliance perspective.

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. Collected data can be entered into eCRFs directly on the condition that it meets all regulations. If the clinical data is transferred to an eCRF from an EMR, then that EMR is considered the source. The FDA has made it clear that clinical trial monitors and auditors should have access to verify the data in the EMR.

Electronically collected data can be kept on or off-site. On-site storage can present many logistics challenges such as data corruption or loss, SOPs, software validation plan, restricted access and many others. Data not store locally should be under the control of the investigator in order for it to be compliant. Thin-client architecture, which delivers e-sourced data straight into the CRO’s remote server, can sometimes also be GCP non-compliant.

The FDA has made substantial efforts in supporting the use of electronic data solutions in the past couple of years. Among the many benefits, eSourcing helps control fraud as it is far more difficult to fabricate electronic records over paper ones.