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

At medXteam, clinical data is our core focus. As a CRO, we not only conduct clinical trials (studies) with medical devices in accordance with the MDR and ISO 14155, but also offer all other options and forms of data collection. We place particular emphasis on structured and quality-assured data storage to create a reliable evidence base. Our expertise ranges from the planning and implementation of electronic data collection systems to the analysis of complex study data. In this article, we explain why a database is key to efficient and regulatory-compliant data use.

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 Devices Implementation Act (MPDG)
ISO 14155

1 Introduction

Conducting clinical trials for medical devices requires precise and compliant data collection and management. The collected data must not only be complete and accurate, but also meet the regulatory requirements of the Medical Device Regulation (EU) 2017/745 (MDR), Good Clinical Practice (GCP), and the General Data Protection Regulation (GDPR). Despite this, many study centers still rely on Excel spreadsheets to manage study data – a practice associated with significant risks and drawbacks.

This blog post first explains the essential requirements for data storage in clinical trials. It then analyzes in detail to what extent Excel spreadsheets can – or cannot – meet these requirements and what advantages a database-driven solution offers.

2. Requirements for data storage in clinical trials

Clinical trials with medical devices are subject to strict regulatory requirements, in particular the Medical Device Regulation (EU) 2017/745 (MDR) and the Good Clinical Practice (GCP) guidelines. Furthermore, data protection requirements under the General Data Protection Regulation (GDPR) apply. Therefore, compliant data storage must meet the following criteria:

• Audit trails for change traceability: An audit trail is an automatic log of all changes to a database. It records who made which changes and when. This ensures that all changes are transparent and traceable, which is essential for regulatory audits. Excel spreadsheets do not offer a built-in audit function, meaning changes can be manipulated unnoticed or intentionally.
• Role-based access control to protect sensitive data: Not every user of a clinical trial should have access to all data. Role-based access control ensures that only authorized individuals can view or edit specific data. For example, investigators may view patient data, while statisticians may only edit anonymized datasets. Excel does not offer fine-grained access control, so sensitive data is often inadequately protected.
• Secure Encryption and Data Backup: Secure data storage requires encryption both during transmission and at rest ("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 is lacking in Excel, leaving data vulnerable to security breaches and accidental deletion.
• Standardized and validated data entry: Faulty or inconsistent data can distort the results of a clinical study. Databases enable consistent and error-free data entry through defined input formats, mandatory fields, and validation mechanisms. Such validations are only possible to a limited extent in Excel and are often prone to errors.

3. Excel spreadsheets vs. database systems

Excel spreadsheets are widely used in many study centers, but they do not adequately meet the requirements mentioned above. While suitable for simple spreadsheet calculations, they reach their limits when processing large amounts of data and complying with regulatory requirements. Database systems, on the other hand, offer a structured and secure environment for managing clinical trial data.

Audit trails: In Excel, changes can be made at any time and saved without being tracked. In a database system, every change is logged, thus preventing manipulation.

Access control: While Excel files can be password-protected, this doesn't offer granular access control. Databases allow you to define different user roles with specific permissions.

Security: Databases offer encryption and regular backups, while Excel files are vulnerable to data loss and security breaches.

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 with large amounts of data, while databases are designed for large studies and enable efficient processing.

The most important differences are summarized in the table below.

Table 1: Differences in the feasibility of the requirements

4. Additional challenges and risks with Excel lists

In addition to the limitations mentioned above, the use of Excel lists entails further risks:

• Lack of automation: Repeated manual data entry increases the potential for errors.
• Difficulties with multi-user access: Working on an Excel file simultaneously can lead to inconsistencies and data loss.
• High hidden costs: Errors in Excel spreadsheets often lead to additional work, as manual corrections, double-checking, and investigations become necessary. This can result in significant delays and increased costs.
• Lack of robust validation mechanisms: While modern database systems ensure that only valid and complete data can be entered, Excel offers very limited validation options. For example, erroneous or duplicate entries cannot be reliably prevented.
• High susceptibility to human error: Excel spreadsheets are prone to accidental changes, overwrites, or the unintentional deletion of important data.
• Insufficient data integrity assurance: Data can easily be altered or manipulated without being traceable, which can lead to problems during regulatory audits.

5. Advantages and disadvantages of Excel spreadsheets and database systems

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

Advantages of Excel lists

• Easy to use: Most users are familiar with Excel, which allows for quick implementation.
• Low costs: No additional software or licensing costs, as Excel is often already available.
• Flexibility: Tables can be created and customized quickly.
• No high technical effort required: No complex IT infrastructure is needed.

Disadvantages of Excel lists

• Missing audit trails: Changes are not traceable and can be altered unnoticed or intentionally.
• Inadequate data security: No integrated mechanisms for encryption or differentiated access control.
• Lack of scalability: As the data volume grows, the file becomes unwieldy and slow.
• Increased susceptibility to errors: No automatic validations or plausibility checks are possible.
• Difficult collaboration: Simultaneous editing by multiple 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.
• Increased data security: Integrated encryption and differentiated authorization levels.
• Automatic validations: Plausibility checks minimize errors and ensure data consistency.
• Improved scalability: Even large amounts of data can be processed and managed efficiently.
• Efficient collaboration: Multiple users can access the system simultaneously with clearly defined roles.

Disadvantages of database systems

• Higher initial investment: Implementation and licensing can be costly at first.
• Training effort: Users need to familiarize themselves with the new software.
• Technical infrastructure required: Usually requires IT support and regular maintenance.

Excel spreadsheets offer a fast and cost-effective way to store data, but have significant shortcomings in terms of security, scalability, and traceability. Particularly problematic is their failure to meet the regulatory requirements of the MDR, GCP, and GDPR. The lack of audit trails, insufficient access control, and high susceptibility to errors make them unsuitable for use in clinical trials.

Database systems, on the other hand, are specifically designed to meet regulatory requirements. They offer automated auditing mechanisms, ensure secure and scalable data storage, and enable efficient collaboration with clearly defined access rights. Although initial implementation involves higher costs and training efforts, the long-term advantages in terms of security, compliance, and efficiency outweigh these.

6. Best practices for implementing a database system

Migrating from Excel spreadsheets to a database-driven solution requires careful planning and implementation. The following best practices can help:

• Needs assessment and system selection: Before implementing a database system, the specific requirements of the clinical trial should be analyzed. This includes regulatory requirements, security requirements, and desired functions such as automated reports or interfaces to other systems.
• User training: Successful implementation requires that all users become familiar with the new software. This reduces errors and increases system acceptance.
• Data migration: Existing data from Excel must be carefully transferred to the new database. It should be checked whether any inconsistencies or erroneous entries need to be corrected.
• Security and access concept: A comprehensive authorization system ensures that only authorized users can access specific data. Furthermore, 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 includes updates and backups to ensure data integrity.
• Documentation and inspection readiness: All processes related to the use of the database should be documented in order to demonstrate compliance during regulatory inspections.

7. Conclusion

At first glance, Excel spreadsheets may seem like a simple and cost-effective way to manage clinical trial data. However, the associated risks – from a lack of data security and limited traceability to high hidden costs due to error correction – make them an unsuitable solution for compliant clinical trials.

Database systems offer a structured, secure, and scalable alternative. They ensure compliant data storage, reduce potential errors, and significantly improve the efficiency of clinical trials. While implementing such a solution requires an initial investment in technology and training, it offers significant long-term benefits in terms of security, compliance, and cost reduction.

Therefore, it is advisable for study centers and sponsors to adopt database-supported systems early on and to move away from Excel lists as the primary tool for study data management.

8. How we can help you

We would be happy to support you in the development, implementation, and use of a database-driven system. As your CRO, we will also handle the complete data management and monitoring via the EDC system.

We support you throughout your entire project with your medical device, starting with a free initial consultation, help with the introduction of a QM system, study planning and execution, right up to technical documentation - always with primary reference to the clinical data on the product: from the beginning to the end.

Do you already have some initial questions?

You can get a free initial consultation here : free initial consultation