Once a study has been approved by the DAC, there is a step-by-step process for obtaining and using the data from the Registry 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 Group for further clarification.
2. Eligible data extracted from registry
The Project Management Group (PMG) Data Team perform an extraction of data from the registry based on the study criteria (core data).
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 weeks to respond (yes or no). In their response, centre leads can identify another member of their 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 (those that said yes) along with the IDs of eligible patients and the timeline for data entry into the registry (usually 2-3 months).
5. Initial data analysis
After the deadline for data collection, the study data is extracted and cleaned and then provided to the Study PI using the secure University File Transfer system for a limited period of 2 weeks. 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 by the PMG.
6. Identification of missing data/clarification of data
Where required, the PI can share centre-level datasets with missing data highlighted with the PMG, who can in turn share in the centre's secure OneDrive study folder. The centre is requested to then enter the clarified or missing data in the Registry, or should provide 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 clarified data is provided to the Study PI in the next scheduled data tranche. The PI performs the analysis.
8. PI disseminates findings
At the end of the study, the PI disseminates results via presentation at congress and then publication. Centres providing data for the study are acknowledged accoring to the study publication plan.
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