This blog is from Matt Kibby, our BBK Principal who oversees the TCN team. In this blog, Matt talks about document management.
Producing patient recruitment materials, whether they are patient- or physician-facing requires an extensive quality control process. Proper tracking of edits, versions, and approvals are key to ensuring all bases have been covered before reaching the production phase.
I am sure that everyone has had an experience where they printed ten copies of the wrong version of their presentation; it happens. You panic. You deal with it.
Rather than “panicking and dealing with it,” BBK is able to track originating copy documents through client approvals, IRB- / EC-approvals, cultural adaptation, and production in the Document Manager module housed within TCN.
Document Manager streamlines the process of version control and approvals all in one location. The step-by-step process ensures that the final materials are accurate and have gone through all of the appropriate channels before distribution. There are five key factors that make this module efficient and effective:
- Ease of use
- Continuous improvement
Document Manager has built-in security features throughout the system including permissions per user class, safeguarding that only authorized users have the rights to view or make edits to documents. The system also logs who makes edits and when those edits were made while always maintaining the history of documents. Approvals are tracked when statuses are updated by those authorized users. Documents will not move to the next step until all requirements are met – you cannot cheat the system.
In the same way that the security features safeguard who can see the documents and make the requisite approvals, the optimal process workflow of all documents from conception through to production has been built in to the system. System controls ensure that documents cannot be sent to ethics committees before sponsor clinical team and legal approval. From there, documents cannot be sent for cultural adaptation until ethics committee approval. Once documents have been translated and adapted, a user cannot pass them on to countries for which they have not been adapted – and so on. It ensures that even when there are thousands of versions floating through the system, they all end up in the right hands.
Ease of use:
There are many features within Document Manager that help in creating a user-friendly environment. The drag and drop feature make life easy for users when documents are ready to move on to the next step. There is also an icon key located within the module that helps explain all of the different document statuses. For example, a lock image indicates that a document has been locked and can no longer be edited. You may be wondering how you would know when you have an action within document manager. Well, customized color coding makes the documents very interactive and self-explanatory. Whenever you need to provide an action, those documents will appear red when you log in.
Maintenance of documents is sustained by retaining all the different versions of a document by their self-describing naming convention within the database. By housing all of these versions, it is easy to follow the document as it grows throughout the feedback and approval process. If there is some confusion as to why an edit was made, it is simple to look back at the previous iterations and edits for a consult.
Continuous improvement is a staple within TCN, and Document Manager is no exception. Advances to the system are constantly being evaluated and updated. Document Manager’s advances even include the opportunity for regulatory bodies to log in to the system, download the documents needing approval, and update statuses of rejection or approval. Document manager will always morph to the market while always maintaining its core policies and structure.
Document Manager provides structure and security while ensuring the proper approval process is followed. Stay tuned for future advancements!
Editor’s note: This blog is the third in a seven-part series on TrialCentralNetSM (TCN), a single infrastructure for managing everything from enrollment metrics to clinical trial reference documents through all phases of development and approval, as well as customized reports, training, and communications. The goal of this series is to give you the “backstory” – a BBK insider’s view of the system from the perspectives of those who build, manage, and rely on it. They’re passionate about the system they so tirelessly build and manage – and you’ll hear that come through in their writing.