14th DIA Conference on European Electronic Document Management

As the pharmaceutical industry moves to a primarily digital environment, most clinical sites are left with file cabinets, boxes and perhaps rooms of paper generated for past trials. It is understood that the documents are controlled by the site, but who owns the retention decision and financially supports it has long been a question with different interpretations. The decision to retain the paper can have both a regulatory and legal ingredients with a perhaps dash of reluctance added for interest. We will present a case study from one sponsor company who has adopted a global process to provide answers to the sites burdened with paper as part of the overall look at site based documentation.