What are the basic requirements for electronic data collection in clinical trials of medical devices?

There are precise rules for the use of electronic systems in clinical trials involving medical devices. These are defined in the current version of ISO14155. The aim of all data collection is, and therefore even with completely digital clinical studies, it is the Data Authenticity, Accuracy, and Reliability to ensure the system from development to taking out of service.

Compliance with ISO27001 also makes sense for the information security management system, particularly in order to be able to take advantage of the benefits of decentralised digital clinical trials (DDCT).

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Various aspects must be implemented:

‍1. Validation: The system must prove that it works

Any electronic data collection system (e.g. digital test sheets or databases) must be thoroughly tested in advance. Validation includes:

- Functional test: Is the system stable and error-free?

- Long-term performance: Does it continue to work reliably even after updates or faults?

- Compatibility: Can it securely process data from paper forms or other sources?

2. Written procedures: Clear rules for all processes

For each system, written instructions must be drawn up which regulate the following points for the following areas:

- Safety: Protection against unauthorised access (such as passwords or encryption).

- Data backup: Regular backups and emergency plans for data loss.

- Amendments: Every adjustment to the system must be documented and approved.

- Decommissioning: Data must be archived and transferred when the system is changed or being shut down.

‍3. Data integrity: completeness and traceability

During and after a clinical trial, the information must be complete and all changes must be traceable.

- Traces of change (audit trail): Every data correction is logged — who changed what, when and why? Original data is retained.‍

- Completeness: No gaps in data sets (e.g. missing patient records).

- Logical consistency: The data must be plausible (e.g. a date of birth must not be in the future).

Note: Data protection laws may require the deletion of data in individual cases, but this must be documented.

4. Access control: Who can do what?

With the highly sensitive data and the effects of a clinical trial on the health of participants or future patients, only qualified specialists may have access to the information in the electronic system in accordance with the documented roles and processes.

‍- User lists: Only authorised persons have access — with precisely defined rights (e.g. “read only” or “edit”).

- Logging: It is recorded who accesses the system and when.

- Signature requirement: The study director or an authorised person must confirm the data release by electronic signature.

5. Training and compliance with masking

After an electronic system has been validated and put into operation, all persons who will use the system must be trained and, if necessary, instructed in its use. Masking the group assignment is a prerequisite for scientific integrity.

‍- Training: All users must be trained to use the system.

- Comply with masking: In studies (e.g. placebo vs. active ingredient) involving masking (blinding), it must be ensured that the system does not reveal any information about the group allocation.

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Why is that important?

Only Compliance with These Standards Ensures That Clinical Trials transparent, reproducible and legally secure Are carried out and the results are valid and reliable (credible). Electronic systems reduce sources of error (e.g. illegible handwriting in sheets of paper) and speed up data evaluation — crucial for the approval of medical devices under EU Medical Devices Regulation (MDR).

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Clinical trials for approval or reimbursement purposes for medical devices belong digitized and don't you leave anything to chance? Especially not us!
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Feel free to arrange a first non-binding consultation with us. We're here for you!

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