The Importance of Managing Study Start-up Content and Data Together

Study start-up content consists of documents generated during the study start-up process, such as investigator site contracts, informed consent forms, and financial disclosures. These documents form the basis for decision making during the study start-up process, and are also used to illustrate good clinical practice and compliance. 

Whereas, data is typically information that can be reused or reported on. It is often merged into a document itself. In study start-up, data takes the form of milestones like planned country ethics committee approval, projected site initiation visits, and site activation greenlight.

Nearly 70% of study start-up milestones (i.e., data) on the critical path to site activation are tied to documents, yet today milestones and documents are managed separately. For example, milestones might be managed in a clinical system or tracking spreadsheet, and documents in a content management system such as Microsoft SharePoint. The documents are also typically exchanged with a non-trackable system like email. The result is a difficult puzzle to put together. The correct version of documents needs to be uploaded into the content management system, all steps have to be manually tracked, and data from the documents needs to be entered into the tracker to manage the status of the milestones.

Managing study start-up content and data together in a single application, however, allows organizations to remove duplicate study start-up processes, spend less time tracking, and more time executing on business processes. Checklists can go away. Document exchange is done within the system. Milestones can be used to track documents and activities. And sites get activated faster.

To learn more strategies to accelerate site activation read about inVentiv Health’s vision and Jen Goldsmith’s June 2016 Applied Clinical Trials article, “A New Approach to an Old Problem – Speeding Study Startup.”