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 Project Management Team for further clarification.
2. Eligible data extracted from registry
The Project Management Group (PMG) perform an extraction of data from the registry based on the study criteria.
3. Centres with eligible patients invited to participate
Centres with eligible cases are identified and each centre lead is sent an invitation to participate in the study with a deadline of around 2-3 weeks to respond (yes or no). In their response, centre leads can identify another member of the team who will become the main contact for the further collection of data for the study.
4. Data collection period
Once all responses are logged, a 2nd e-mail is then sent to each participating centre along with the list of eligible IDs and the timeline for data collection in the registry (usually 2-3 months).
5. Initial data analysis
After the deadline for data collection, the Study dataset is provided to the Study PI through a secure OneDrive server. After a period of analysis, if there is a need to contact participating centres to request clarification of or missing data then this can be done via each centres secure OneDrive study folders - which are shared with the PI.
6. Identification of missing data/clarification of data
Where required, the PI can share centre-level datasets with missing data highlighted in the centre's study folder. The centre is requested to then enter the missing data in the Registry, or indicate on the centre-study dataset the reason the data is missing (e.g. data not available).
7. PI collates data and performs analysis
After the deadline for data clarification, the PMG will perform a repeat data extraction and provide it to the Study PI. The PI also collects all of the completed centre datasets and performs the analysis. The Study PI may need to re-contact the participating centres for clarification of specific data or omissions. This will be done via the PMG.
8. PI disseminates findings
At the end of the study, PI disseminates results via presentation at congress and then publication.
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