Under what circumstances can an EDC system be used as a source of health data in a clinical investigation of medical devices?

In 2024, the digital transformation in the field of clinical studies is characterised by competing requirements for data security and efficiency achieved through digitisation. The interpretations of the conditions under which data collected in modern and high-quality EDC systems are suitable to serve as source data need to be harmonised quickly.

In clinical investigations, source data is essential in order to be able to verify the validity of the results.

What is source data?

Source data is the data that is recorded in a clinical study, e.g. to document the condition, laboratory values or the image of a special feature of patients by doctors, nurses or other professional groups in the healthcare system. Printed (usually in paper form), electronic (digital) or optical (film material) documents can be used here, taking into account the applicable international and national laws and guidelines.

Why is source data important in clinical studies?

In clinical studies, all data used for analysis and interpretation for use in a report or publication must be documented in so-called source data. From there, they can then be transferred to other databases. It is important that the so-called source data is always available for comparison (checking the source data) of the data in a database and can be verified. The procedures for verifying the source data are subject to national or regional regulations relating to the protection of personal data.

What are the conditions and requirements for the use of EDC systems as source data?

According to this, data in an Electronic Data Capture (EDC) system can be used as source data in clinical investigations of medical devices under certain conditions. The argumentation is based on the EMA guidelines and the recommendations on decentralised clinical studies (EMA/226170/2021 and Recommendation paper on decentralised elements in clinical trials).

Prerequisites for the suitability of data documented in the EDC system as source data are

• validation of the EDC system to ensure that it meets the requirements for data integrity, accuracy, reliability, authenticity and consistency. This includes documentation of system validation and regular reviews.
• Clear policies for user administration, including assigning user rights and ensuring that all users are properly trained to use the system correctly.
• Existence of security measures to prevent unauthorised access to the data. These include encryption, firewalls and access controls.
• Existence of protocols for the secure transmission and storage of data to ensure the security, integrity and availability of data. This includes the use of certified copies and ensuring traceability of data.
• EDC system must comply with the regulatory requirements of the EMA, FDA and other relevant authorities. This includes compliance with Good Clinical Practice (GCP) and other relevant guidelines.
• Integration of the EDC system into processes that are constantly improved by standard-compliant quality management and risk-based.

This means that, under the right conditions, data in an EDC system can be used as source data in clinical investigations of medical devices. The benefits in terms of data integrity, efficiency and security far outweigh the risks in modern clinical research. Compliance with regulatory requirements and the protection of patient data is mandatory.

For those who want to know exactly how source data is defined legally and normatively:

Source data is defined in ICH-GCP E6(R2), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice), the law that regulates drug trials as information contained in the original records or in officially certified copies of records of clinical findings, observations or other activities of a clinical study. This information is necessary in order to be able to retrace and evaluate the study at a later date.

This is also defined in ISO14155, which regulates clinical studies (investigations) of medical devices. According to this, source data is all information contained in the original documents or in officially confirmed copies of original documents. This information comes from clinical findings, observations or other activities carried out during a clinical study. It is necessary in order to be able to understand and analyse the clinical study later. A source document is therefore either the original or a confirmed copy of a printed, optical or electronic document containing this important data.

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