29 | | - The RDCIT instance of OpenClinica currently sits on a server in Cambridge ... |
| 29 | - The RDCIT instance of OpenClinica currently sits on a server in Cambridge this instance is '''not secure for storing Patient Identifiable Data''' and so is called OC Anonymous. |
| 30 | - RDCIT have commissioned a server in a data centre in Liverpool that will comply with various security requirements and so will be suitable for patient identifiable data. This will be called OC Secure and should be ready in June. |
| 31 | - Both servers are visible on N3 and the equivalent university network. |
| 32 | |
| 33 | === Remaining Issues |
| 34 | |
| 35 | After the presentation several questions and issues were raised, some of which require further clarification: |
| 36 | |
| 37 | - Ethics and Consent: It may be necessary to re-consent patients to put their data on the RDCIT OpenClinica instance. GEL has ethics policy that should be reusable for this project. |
| 38 | - Data Sharing: There seemed to be no consensus on whether Data Sharing Agreements would have to be created for all involved organisations. It was put forward that as long as a responsible clinician entered or approved each individual data entry, it should be OK. Whether the Trsusts would be OK with this is another matter. RDCIT was going to seek clarification from the Department of Health. |
| 39 | - Responsibility for the coding and mapping of the data lies with the study team, although technical assistance may be available from RDCIT through the Theme coordinator. |
| 40 | - Funding for IT should be covered by the BRU budget as this is an amendment to the BRU contract. |
| 41 | - Requests for new users, groups and permissions should be made to RDCIT. There is no devolved user / permissions admin. |