Supporting GLP Compliance With Prelude EDC

Good Laboratory Practice (GLP) is a set of principles and guidelines followed by researchers involved in non-clinical health and environmental safety studies. GLP compliance ensures that the studies are conducted with high quality, reliability, and integrity.

So how does an electronic data capture (EDC) system support GLP-compliant studies? With the right design, an EDC can provide structure and workflows so that researchers can more easily adhere to GLP guidelines; so that the study is ultimately GLP-compliant.

What Does It Mean to Be GLP-Compliant and Why Is It Important?

Being GLP-compliant means adhering to the requirements outlined in GLP regulations and guidelines. These requirements – laid out in 21 CFR Part 58 in the Food and Drug Administration’s (FDA) Code of Federal Regulations – cover various aspects of study conduct, documentation, quality assurance, and facility management. When reviewing “GLP-compliant” submissions, regulatory authorities are looking for proof these requirements were met.

GLP compliance is crucial for reliable data, regulatory compliance, safety assessment, scientific credibility, and international cooperation.

How Does Prelude’s EDC Support GLP-Compliant Studies?

GLP requirements, detailed in 21 CFR Part 58, include 21 CRF Part 11 compliance and proper documentation practices. This is where Prelude can help.

21 CRF Part 11

Part 11 regulations establish the necessary criteria for both electronic records and signatures. These include:

• Electronic Signature: Allows researchers to review and sign off on electronic case report forms (eCRFs), without needing a paper and pen.
• Edit Checks: Automated checks that ensure data entered into the EDC meet predefined criteria.
• Username and Password: Enables only authorized users access to the EDC.
• Audit Trail: Provides a record of all system activity; any changes made to the data are tracked and recorded.
• Role-based System Access: Confirms who can view, edit, sign, and review down to the field level.

These capabilities are part of Prelude’s EDC core feature set. Learn more about Prelude’s EDC.

Document Management

Part 58 details the proper documentation practices – including SOPs, traceability, version control, storage, retrieval, archival, and data integrity – to meet GLP requirements and maintain the integrity and reliability of study data.

Prelude’s EDC allows researchers to organize and access all study documents, including site-level forms, for example, to track maintenance and calibration records. Learn more about Prelude’s Document Management features.

But, Prelude also offers modules for additional functionality that supports preclinical and lab studies.

Additional Functionality

Prelude offers additional functionality that supports preclinical and lab studies. These include the following:

• Pharmacokinetics (PK) Sampling: To accurately capture PK data – dosing and sampling time – with one click.
• Randomization: With blocks, strata, and blinding – to conform with any protocol.
• Group Based Entry: To expedite data capture by entering animal subject data at the group level (e.g., barn or cage) to push to the individual animals’ electronic case report forms (eCRFs).

Learn more about Prelude modules.

What Are the Benefits of Using an EDC to Support GLP Studies?

Using an Electronic Data Capture (EDC) system to support GLP (Good Laboratory Practice) studies offers several benefits:

1. Enhanced Data Integrity: EDCs provide built-in data validation checks, highlighting deviations and ensuring that data entered meet predefined criteria. This helps to minimize errors, inconsistencies, and missing data, enhancing the integrity of study data.
2. Improved Data Accuracy: EDCs reduce the reliance on transcription by enabling direct data capture at the source. This reduces transcription errors and improves accuracy, as data are entered electronically and automatically populated into the system.
3. Streamlined Data Management: EDCs facilitate efficient data management by centralizing and organizing study data in a secure electronic environment. Data collected in the EDC can be extracted and exported for submission to regulatory authorities. This eliminates the need for paper-based records, simplifies data retrieval, and enhances overall study documentation and traceability.
4. Real-time Data Monitoring: EDCs allow for real-time monitoring of study data, enabling prompt identification of issues or discrepancies. This includes change reasons required to explain updated data points and signature workflows to ensure data have been reviewed and finalized. This allows researchers to address data quality concerns promptly and take corrective actions, ensuring study integrity and compliance.
5. Enhanced Data Security: EDCs provide robust security measures to protect sensitive study data. They offer controlled access, audit trails, data encryption, and backup capabilities, ensuring data confidentiality, integrity, and availability as required by GLP regulations.
6. Efficient Collaboration and Communication: EDCs enable seamless collaboration among study team members, facilitating data sharing, query resolution, and review processes. This improves communication and streamlines GLP studies’ review and approval workflows.
7. Compliance with Regulatory Requirements: EDCs can be configured to comply with GLP regulations and guidelines, including electronic signature capabilities and data audit trails. This ensures adherence to regulatory requirements for data management and documentation.
8. Time and Cost Savings: EDCs allow for automation (such as dosing calculations based on inputs) and reduce manual data entry and paperwork, leading to time and cost savings. Data can be entered, monitored, and analyzed more efficiently, reducing the administrative burden and improving overall study productivity.

By leveraging an EDC, researchers and organizations can benefit from improved data integrity, accuracy, management, security, collaboration, and compliance. These advantages ultimately contribute to the overall quality and efficiency of GLP studies.

What Do the Benefits Look Like by Role?

Study Director

• Protocol available to all users at all times
• All study data available for review and verification from your computer
• Data exporting for easy archiving

Quality Assurance Unit (QAU)

• Monitoring and investigating findings
• Read-only role
• Review documentation uploaded by study personnel

Users

• User-friendly user interface
• Edit checks prevent human error
• Email notifications of study milestones

Test Facility Management

• Easily see that the appropriate personnel are enrolled in the study
• Ensure personnel are appropriately trained
• Assure that deviations are recorded within the system

Sponsor

• Read-only account that can track study progress
• Can create their own reports
• Data exports compliant with CVM eSubmitter

Any Concerns?

While using an EDC (electronic data capture) to support GLP studies is beneficial, there may be concerns about the risks associated with such a system. These might include ease of use, potential loss of access, archiving data, or simply not knowing how to validate such a system. The biggest challenge may be convincing researchers who typically track data on paper to switch to an EDC system.
However, the risks can be mitigated by carefully selecting an EDC that supports GLP-compliant studies and validating the provider’s system. Learn more about validating an EDC.

In conclusion, GLP compliance is essential for research, particularly when conducting studies prior to testing a drug on human subjects. While there may be concerns, particularly when switching from paper to a computer system, the benefits outweigh the risks, which can be mitigated by selecting an EDC that supports GLP-compliant studies.

Learn more about Prelude’s EDC and how we can help support your GLP-compliant studies.