Clinical Trial Document Management System: A Case Study at Tohoku University Hospital Clinical Trial Data Center

A case of enhancing document management in clinical research through tamper prevention and version control!

We would like to introduce a case study on the implementation of "Agatha Basic" by the Tohoku University Hospital Clinical Trial Data Center, which supports data management for clinical research conducted by Tohoku University. At this center, managing documents on a file server involved significant operational burdens, such as strictly adhering to file naming and storage rules, and converting important documents into paper versions. After the implementation, we received feedback that document sharing could be done smoothly without being constrained by location. 【Case Overview】 ■ How Agatha is Used - Management of QMS documents and SOPs at the data center - Management of research project documents ■ Benefits of Implementation - Utilized system functions such as version control, tamper prevention, and approval records in operations - Became able to recognize and manage the benefits and risks of document management and systems *For more details, please download the PDF or feel free to contact us.

Document and Data Management