Database instead of Excel lists: Why a structured data storage in clinical studies with medical devices is decisive

At MedxTeam, the focus is on clinical data. In this context, as CRO, we not only carry out clinical tests (studies) with medical devices in accordance with MDR and ISO 14155, but also offer all other options and forms of data collection. We attach particular importance to structured and quality -assured data storage in order to create a reliable evidence base. Our expertise ranges from the planning and implementation of electronic data acquisition systems to the analysis of complex studies data. In this article, we explain in this article why a database is the key to efficient and regulatory data.

Abbreviations

GCP Good Clinical Practice

MDR Medical Device Regulation; EU Regulation 2017/745

Underlying regulations

EU Regulation 2017/745 (MDR)
General Data Protection Regulation (GDPR)
Medical Device Environmental Constitution (MPDG)
ISO 14155

1 Introduction

The implementation of clinical studies in the field of medical devices requires precise and ruling data acquisition and management. The data collected must not only be complete and correct, but also the regulatory requirements of the Medical Devices Ordinance (EU) 2017/745 (MDR-Medical Device Regulation), the Good Clinical Practice (GCP) and the General Data Protection Regulation (GDPR) . Nevertheless, many study centers continue to use Excel lists to manage study data-a practice associated with considerable risks and disadvantages.

In this blog post, the essential requirements for data storage in clinical studies are first explained. Then it is analyzed in detail to what extent Excel lists can meet these requirements-or not-and what advantages a database-based solution offers.

2. Requirements for data storage in clinical studies

Clinical studies with medical devices are subject to strict regulatory requirements, in particular the Medical Devices Ordinance (EU) 2017/745 (MDR-Medical Device Regulation) and the Good Clinical Practice (GCP) guidelines. Data protection requirements according to the General Data Protection Regulation (GDPR) also apply. The following criteria must therefore meet the rule -compliant data storage:

• Audit trails for traceability of changes An audit trail is automatic logging of all changes to a database. He records who made which changes when. This ensures that all changes are transparent and understandable, which is essential for regulatory exams. Excel lists do not offer an integrated audit function, so that changes can be manipulated unnoticed or deliberately manipulated.
• Roll -based access control to protect sensitive data not every user of a clinical study should have access to all data. Roll -based access control ensures that only authorized persons can view or edit certain data. For example, test doctors can view patient data, while statisticians can only process anonymized data records. Excel does not offer fine granular access control, so that sensitive data are often insufficiently protected.
• Safe encryption and data backup A safe data storage requires encryption both during the transmission and in the storage ("data-at rest" and "data-in-transit"). Regular backups are also necessary to prevent data loss. While database systems support encryption and automatic backups by default, this functionality lacks Excel, which means that data is susceptible to security gaps and accidental deletion.
• Standardized and validated data input Incorrect or inconsistent data can falsify the results of a clinical study. Databases enable a consistent and error -free data entry through defined input formats, mandatory fields and validation mechanisms. In Excel, such validations can only be limited and often feasible.

3. Excel lists vs. database systems

Excel lists are widespread in many study centers, but only insufficiently meet the above requirements. While they are suitable for simple spreadsheets, they reach their limits when processing large amounts of data and compliance with regulatory requirements. Database systems, on the other hand, offer a structured and safe environment for the administration of clinical studies.

Audit trails: Changes can be made at any time in Excel and saved without tracking. Any change is logged in a database system so that manipulations can be excluded.

Access control: Excel files can be protected with passwords, but they do not offer differentiated access control. Databases make it possible to define different user roles with specific permissions.

Security: Databases offer encryption and regular backups, while Excel files are susceptible to data losses and security violations.

Data quality: Excel does not allow comprehensive validation of inputs, while databases offer mechanisms to check and ensure data consistency.

Scalability: Excel reaches its performance limits for large amounts of data, while databases are designed for large studies and enable efficient processing.

The most important differences are summarized below.

Table 1: Differences in the sales of the requirements

4. Additional challenges and risks in Excel lists

In addition to the above restrictions, the use of Excel lists harbors further risks:

• Missing automation: Repeated manual data entries increase the error potential.
• Difficulties in multi-user access: At the same time working on an Excel file can lead to inconsistencies and data loss.
• High hidden costs: Errors in Excel lists often lead to additional workload, since manual corrections, double tests and research are necessary. This can lead to considerable time delays and additional costs.
• No robust validation mechanisms: While modern database systems ensure that only valid and complete data can be entered, Excel only offers very limited options for validation. For example, incorrect or double entries cannot be reliably prevented.
• High susceptibility to human errors: Excel tables are susceptible to accidental changes, overwriting or the unintentional deletion of important data.
• A lack of securing data integrity: Data can be easily changed or manipulated without this being understandable, which can lead to problems with regulatory exams.

5. Advantages and disadvantages of Excel lists and database systems

When deciding between Excel lists and a professional database system, both the advantages and the disadvantages of both options should be carefully weighed.

Advantages of Excel lists

• Simple use: Most users are familiar with Excel, which enables quick implementation.
• Low costs: no additional software or license costs, since Excel is often already available.
• Flexibility: tables can be created and adapted quickly.
• No high technical effort: no elaborate IT infrastructure required.

Disadvantages of Excel lists

• Missing audit trails: Changes are not understandable and can be changed unnoticed or deliberately changed.
• Inadequate data security: no integrated mechanisms for encryption or differentiated access control.
• Missing scalability: With growing data volume, the file becomes confusing and slow.
• Increased susceptibility to errors: no automatic validation or plausibility tests possible.
• Difficult cooperation: Simultaneous processing by several users can lead to inconsistencies or data loss.

Advantages of database systems

• Regulatory compliance: meets the requirements of the MDR, GCP and GDPR through audit trails and access controls.
• Higher data security: integrated encryption and differentiated authorization levels.
• Automatic validations: Plausibility tests minimize errors and ensure data consistency.
• Better scalability: Even large amounts of data can be processed and managed efficiently.
• Efficient cooperation: Several users can access the system with clearly defined roles at the same time.

Disadvantages of database systems

• Higher initial investment: Introduction and licensing can initially be expensive.
• Training effort: Users have to familiarize themselves with the new software.
• Technical infrastructure necessary: ​​usually requires IT support and regular maintenance.

Excel lists offer a quick and inexpensive possibility of data storage, but have considerable deficits in terms of security, scalability and traceability. It is particularly problematic that you do not meet the regulatory requirements of the MDR, GCP and GDPR. Missing audit trails, lack of access control and a high susceptibility to errors make you unsuitable for use in clinical studies.

Database systems, on the other hand, are specially designed to meet regulatory requirements. They offer automated test mechanisms, ensure safe and scalable data storage and enable efficient cooperation with clearly defined access rights. Although the introduction is initially associated with higher costs and training effort, the long -term advantages in relation to security, compliance and efficiency outweigh.

6. Best practice for the introduction of a database system

The conversion of Excel lists to a database-based solution requires careful planning and implementation. The following best practices can help:

• The specific requirements of the clinical study should be analyzed before the introduction of a database system . This includes regulatory requirements, safety requirements and desired functions such as automated reports or interfaces to other systems.
• Training of users: Successful implementation requires that all users are familiarized with the new software. This reduces errors and increases the acceptance of the system.
• Data migration: Exist data from Excel must be carefully transferred to the new database. It should be checked whether inconsistencies or incorrect entries must be adjusted.
• Safety and access concept: A comprehensive authorization system ensures that only authorized users can access certain data. In addition, security measures such as two-factor authentication should be implemented.
• Regular validation and maintenance: The system should be regularly checked for functionality and compliance with regulatory requirements. This also includes updates and backups to ensure data integrity.
• Documentation and inspection reading: All processes in connection with the use of the database should be documented in order to be able to demonstrate compliance in regulatory inspections.

7. Conclusion

At first glance, Excel lists may be a simple and inexpensive way to manage clinical studies. However, the associated risks - from a lack of data security to limited traceability to high hidden costs through error corrections - make an unsuitable solution for controlling clinical studies.

Database systems offer a structured, safe and scalable alternative. You ensure that the data storage is compliant, reduce sources of error and significantly improve the efficiency of clinical studies. The introduction of such a solution requires an initial investment in technology and training, but offers significant advantages with regard to security, compliance and cost reduction in the long term.

For study centers and sponsors, it is therefore advisable to rely on database-based systems at an early stage and to say goodbye to Excel lists as a primary tool for study data management.

8. How we can help you

We are happy to support you with regard to the structure and implementation and use of a database -based system. As Cro, we also take over the complete data management via the EDC system and monitoring.

So we support you during your complete project with your medical device, starting with a free initial consultation, help with the introduction of a QM system, study planning and implementation to technical documentation - always with primary reference to the clinical data on the product: from the beginning until to the end.

Do you already have some initial questions?

You can find free initial consultation here : Free initial consultation