Sharing your data
Please check with email@example.com if you are allowed to share data with researchers from other universities or institutes and under which conditions. Most of the larger cohort studies use standardized data analyses plans to request data. For some studies we use data access agreements or other research contracts.
If you want to share data with co-researchers outside VUmc or GGZ inGeest please do not use cloud services such as Dropbox, Google Drive or OneDrive. While the cost of using an online Cloud service may be low, the expenses/costs associated with the repercussions of a breach could be very high. When you need secure file storage and/or share these with colleagues (also from other universities) you can use SURFfilesender or ask our datamanagers how to proceed.
Archiving your data
For audits and inspections we are obliged to archive all our research information in a standardized manner. The science committee GGZ inGeest (CWO) can help you set up this Trial Master File / Investigator Site File (TMF/ISF). All essential research documents need to be filed on paper as well. Essential documents are documents that enable the reconstruction of the data collection, for example approval letters by the METc and other communication with the METc, insurance documents, informed consents etc. These documents need to be kept in their orginal form, on paper with original signatures.
For digital archiving use the local project maps on the network of GGZ inGeest or VUmc. We use the standardardized map structure of the Clinical Research Bureau (CRB) of Amsterdam UMC/VU. These maps reflect which documents should be in the TMF/ISF. Information in Dutch about the TMF is on intranet GGZ inGeest.
At location Oldenaller there is room for non digital materials that need to be archived (the original (raw) data recorded in a physical form). Examples: Questionnaires, analogue tapes, lab results and paper logbooks. If there are electronic versions of the original data, i.e. scanned questionnaires (images), then the paper versions should not be stored in the physical archive. Contact person for the physical archive is Anna Paauw.
More information about what should be archived can be found in the Quality Handbook APH.