When the Clinical Research Data Center at Tohoku University Hospital needed a more efficient and effective way to manage clinical and quality documents, they chose Agatha.

Located in Sendai, Japan, Tohoku University Hospital is a general hospital that belongs to a national university corporation. It has a 190-year history, the longest among university hospitals in Japan. Designated as a Clinical Research Core Hospital, it plays a major role in conducting global standard clinical research in accordance with the Medical Care Law.

The Clinical Research Data Center assists in managing data and documents for clinical research projects at the hospital. They offer consulting services related to quality control and statistics to ensure the reliability of the clinical results, as well as support for investigators in creating protocols, CRFs, entering and assigning subjects, progress management, data management, monitoring, statistical analysis, creating reports and other tasks.

For the Center, managing documents manually for many research projects imposed a great workload. Individual projects had their own document management schemes and folder structures and tamper prevention and version control were not ensured systematically. The result was high costs, slow processes, and compliance risks.

Addressing Requirements with Agatha Applications

When the Center set out to look for a solution, the goals were to streamline operations, enhance compliance, reduce wasted time, and enable collaboration with external study stakeholders.

After a review of options, they chose Agatha and implemented Agatha’s applications for managing SOPsquality processes, and clinical research documents.

Implementing Agatha applications addressed all their requirements and allowed the Clinical Research Data Center to achieve ISO9001 certification. The applications embed best practices and required procedures, a big improvement over trying to ensure consistency by imposing rules on staffers to do so manually.

Also, because they support many investigators and research projects, a unified approach using Agatha means the Center can be more efficient, provide more services to more projects, and help accelerate each study.

A Q&A with the Prof. Takuhiro Yamaguchi, Director of the Clinical Research Data Center, and Junya Kimura, Medical Information Expert

How did you manage these processes and documents before?

Previously, we managed documents and files on Windows file servers in the data center. This posed a great burden on us, as we had to enforce rigorous rules for filenames and storage, and what’s more, we had to keep the original paper documents for some of them. So, we decided to deploy a system that has version control and anti-tampering features to enhance our document management scheme.

And how do you use Agatha applications?

We use Agatha in two areas. One is our QMS documents and SOPs, and the other is research project documents.

We used to keep paper documents as the originals for QMS documents and SOPs, and we would save electronic files chronologically, our naming rule being ‘file server + document name + date.’ With Agatha, the staffers create documents, upload them to Agatha, and the director approves them on the system. Agatha doesn’t allow us to edit wrong versions or intentionally tamper with documents, because all transactions are logged in the system. So now, we can secure the reliability of documents automatically, rather than manually as before. We use an electronic signature for documents.

How are things different now?

Now, staffers can view the latest versions of QMS documents and SOPs on Agatha. We’re currently shifting from paper to digital for clinical study documents. We conduct projects that are already underway as before and start new projects on Agatha. We are now able to manage documents of all projects systematically by a standardized scheme, as it applies to all projects, using the same folder structure across them. Before each project, or each staffer had their own storage locations and folder structures, but now we have a standard management framework. So, it’s now easier when a new staffer is assigned to a project, as everyone knows where documents should be.

Currently, our staffers upload documents sent by researchers onto Agatha to manage them there. But we’re also planning to implement new processes so that investigators can upload, review and approve documents themselves.

What benefits did you get when you started using Agatha?

The great thing was we were able to share documents from anywhere, without a hitch, when the Tokyo Office of Tohoku University was launched in July. We believe it would have been impossible to share documents with the Tokyo Office without Agatha, and this could have created the bottleneck.

Also, now we have ISO 9001 certification, and our staffers are far more self-aware about document management now. Having a DMS made some things effortless and automatic, while it made us do some things consciously. This made us think about document version control, storage, and ID and password management, and other security matters.

For example, the official document approval procedure requires drafting, review, and electronic signature for approval. We’re now fully aware of the meaning of approval and signature.

By having Agatha, we also became able to systematically manage documents by making use of the system’s features such as version control, anti-tampering, and approval logs. But it goes beyond that. It was a great gain for us that the entire staff came to understand the benefits and risks of document management and systems from using Agatha… so the impact was not just through processes, but also in the awareness of the importance of those processes by the team members.

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