The EU Commission Directive 2005/28/EC 63 Chapter 4 Article 16 requires easy access to all relevant documents to enable monitoring and verifying the quality, conduct, and compliance of any clinical trial. The sponsor is expected to know which documents will be required and create a trial master file (TMF) of all the documents relevant for the study, demonstrating compliance on articipant safety and process integrity.
FDA defines the goal of a TMF as ensuring that sponsors and investigators are adhering to the principles and guidelines of good clinical practice (GCP). In the U.S., it also means that the clinical trials are aligned with the International Council for Harmonization Good – Clinical Practice (ICH-GCP) guidelines.
In different regions, different regulations by the national and local governments require the CROs and sponsors to have different documentation. This should be indexed appropriately in the TMF and you also need a stand-alone file that reflects the continuous and final state of the TMF, capturing the full story of the clinical trial without the participating sponsor or site requiring to provide clarifications.
Manual management of documentation can be a nightmare due to the complexities involved. The digital equivalent, electronic TMF or eTMF, comes to the rescue of the pharmaceutical and biotechnology industries. The eTMF provides real-time access from anywhere, anytime with appropriate controls to manage files and document workflows, facilitate collaboration, and also manage metadata and audit trails. Regulatory bodies also have guidelines for the eTMF such as FDA’s CFR 21 Part 11.
To understand how CQ Clinical eTMF solution can help you manage essential trial documents, stay inspection ready and collaborate in real-time with study partners, request a personalized demo.
Where You Store Your eTMF Matters: OneDrive, Dropbox Aren’t Adequate
Though most companies in the life sciences industry have moved to electronic documentation, they often do not use an electronic Trial Master File (eTMF) solution to store them. The documents not only need to be created and capture the clinical trial process, but they also need to be preserved, archived and removed after a specified period as per regulatory guidelines. This becomes difficult in the usual file hosting systems such as Dropbox or OneDrive. These systems may enable creating, reviewing, approving, collaborating and managing documents. But archiving and preserving requires a more specialized system like the eTMF from CQ Clinical.
Archiving: File hosting systems also provide an archiving option but it is not the same as what a system like CQ eTMF provides. The CQ solution enables storing documents for as long as needed while ensuring secure access. The documents are distributed in different geographic locations for business continuity and disaster management. It also automatically checks the documents entering the archive for bad data and sends alerts if it is corrupt or does not have metadata. The documents are checked periodically to ensure there is no loss or corruption in the period it is retained. This enables replacing the corrupted ones with clean versions stored in other locations.
Preserving: This is another critical feature where the CQ Clinical eTMF ensures the guaranteed readability and usability of the eTMF. Some regulations require the eTMF to be retained for 25 years. With the fast-paced evolution of hardware and software technologies, formats change and old documents may become obsolete. With digital preservation, along with the original copy, the document is also automatically preserved in a format that ensures its integrity for regulatory compliance as well as ensuring it remains readable in the future.
Metadata: This is really the data about your data! By providing tags, files can be categorized easily and searching through hundreds of documents becomes simplified. The metadata can be of two types:
- Descriptive metadata, which includes information such as the title, author, date of publication, description etc.
- Technical metadata that describes the technical properties of the digital file or the particular hardware and software such as where it is located, the structure of the data etc.
File hosting systems provide this in a very limited way.
Audit Trail: FDA 21 CFR 11.10 and ICH E6 (R2) mandates audit trails that capture the history of access and amendments done on each document. Noncompliance can lead to severe fines and reputational damage apart from delaying manufacturing as it is important to ensure data integrity. It requires information such as:
- Who logged into the system and when?
- When was a record accessed, downloaded and modified, including details of the changes to the metadata and retention rules?
- A log specifying the reason for the changes to the files and associated metadata
CQ Clinical eTMF — For Real-Time Visibility
Based on the DIA TMF Reference Model, the CQ eTMF solution increases real-time visibility into all TMF artifact activities and integrates with other quality and compliance-critical functions. Administration as well as the entire eTMF lifecycle, right from assigning, creating, collaborating, reviewing, and approving all TMF artifacts, is simplified and can be handled with greater efficiency.
Secure collaboration between contributors such as sponsors, CROs, vendors, and study sites is enabled in an organized manner without compromising on quality, completeness, compliance and a constant state of inspection-readiness. Pre-built templates, ZIP file downloads to facilitate file submissions, folder structure access on clinical study record level, and restricted/user permission configured file access are some of the other features that make this solution ideal for the pharmaceutical and life sciences companies for eTMF.
The eTMF with its artifacts, reports, approvals, record views, reviews, alerts etc. on CQ Clinical can be accessed from anywhere, anytime, and from any device securely. This ensures business continuity and improves clinical efficiency, visibility and flexibility.
In case of any changes or corruption to the artifact, the solution sends notifications that enable timely action. Further, study teams can use the Chatter function to discuss changes to artifacts in real time, thereby speeding up the process. They can also have easy access to the discussions that led up to the decision in the same system.
Full text search of documents is made easy with metadata, improving productivity of the study teams. Reporting on data collected in the system, viewing and assessing critical metrics, collaborating, dashboards about timeliness, quality, missing approvals, expiring documents and completeness of your eTMF — everything is made possible within the system.
Most importantly, CQ eTMF solution helps be inspection-ready and fully compliant with 21 CFR Part 11, Annex 11, GDPR, and HIPAA regulations including compliant eSignatures and fully automated audit trails.
To know more about the CQ Clinical eTMF solution and how it makes you compliant and inspection-ready, visit: https://www.compliancequest.com/clinical-etmf/
Request for a personalized demo: https://www.compliancequest.com/personalized-demo/