The Process For Using and Re-Using Data from the Registry

Once a study has been approved by the DAC and the initial fee paid, there is a step-by-step process for obtaining and using the data from the Registry and which is outlined below. All applicants who require data as well as centres who are participating in studies are advised to familiarise themselves with the process and can contact the I-DSD Project Team for further clarification.

1. The study details are added to the website ( along with a one-page summary outlining the study and the inclusion/exclusion criteria.

2. The Project Management Group (PMG) perform an extraction of data from the registry based on the study criteria. 

3. Centres with eligible cases are identified and each centre lead is sent an individual email with the registry IDs of eligible patients and a deadline of around 1 month for centres to agree or decline to participate in the study.  In their response, centre leads should indicate which IDs they can contribute to the study.  This is also an opportunity to identify another member of the team who will become the main contact for the further collection of data for the study.

4. Once the centre lead has approved the approach from the PMG within the deadline, the Study dataset is provided to the Study PI through a secure server. 

5. The PMG creates secure a Study Folder and this is placed within each centre’s secure Centre Folder.  The Centre Folder is shared only with the centre lead and nominated team members.  The Study Folder within the Centre Folder can also be shared with the Study PI.  This means that the Study Folder is accessible to both the Centre and the Study PI with edit rights.  The Study PI cannot access any data other than their specific Study Folder. Through the Centre, the Study PI may be provided with other datasets that contain the fields required for eligible cases from previous Registry studies. An e-mail with more detailed instructions about the study is issued by the Study PI (either directly or via the PMG).  This e-mail will specify the data to be collected and the timelines for data collection. 

6. At this point, the Study PI will create a data collection template or a CRF (Case Report Form) a that lists all the data fields being collected in the study.  Using the latest data supplied to the Study PI by the PMG, the Study PI will pre-fill the data fields in the CRF with the already collected registry data and create a CRF for each centre with all the eligible patients at that centre. The Study PI can then add the additional fields that are collected as part of routine clinical practice but are not currently included in the registry to these study CRFs.

7. The partially filled CRFs are added to the Study Folder in each Centre Folder and the centre lead or centre contact is notified by the Study PI of the timeline to complete the CRF. Although the missing data for existing Registry fields can be completed in the CRF or in the Registry, we advise that Centres do the latter as this will help with future studies that use the same datasets. The PMG will perform a repeat data extraction after the deadline and review the Study Folders with the PI.

8. After the deadline for data collection, the Study PI collects all of the completed CRFs and performs the analysis. The Study PI may need to re-contact the participating centres for clarification of specific data or omissions.

9. At the end of the study, once the results have been disseminated, the Study PI supplies the complete raw dataset to the PMG for re-use in other projects.

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