Every year, thousands of documents are created to document clinical trials according to applicable regulations (EMA, FDA, ICH, etc.). Most of these documents are generated in paper, in study sites, based on generic templates, with no direct connection to the sponsor document management systems (paper or electronic).
Documents are then faxed or emailed to the corresponding local contact when possible or documents are sent by courier when paper file is needed. The documents received by the sponsor can undergo quality control, translation before being finally archived at sponsor’s premises. Such a manual filing is time consuming and generates non-regulated e-copies
A document collection system allows the preparation of pre-filled templates for the study documentation and the importation of study documents from various locations
The objectives of an electronic document collection includes:
- decreasing the possibility of mistakes at documents completion thanks to pre-filled templates
- allowing in-stream electronic indexing of the study file documentation and easing this indexing through the use of bar-codes
- electronic tracking of the study documentation
- decreasing both the cost and possibility of document loss linked to the transfer of paper documentation between local offices and headquarters.
- decreasing the ecological impact linked to multiple paper copies and their distribution