When you submit a data change request (DCR), the system will ask you to provide the information currently in the system, as well as how you would like the information updated. Please keep in mind that all data change requests must be approved by a Study Manager. We will not be able to process any requests without this approval.
- Submitted - A DCR has been entered into the system and assigned a number. The number should be quoted in any follow-up calls or emails. Requests from a role not delegated with approval authority (i.e. study manager) will be routed for approval. A DCR cannot be processed without study team approval.
- Approved - A request has been approved and goes to the data management team for further review and processing.
- Clarification Required - The request requires further information before it can be processed. Please review the comment from the data management team and reply.
- Completed - A DCR was submitted, reviewed, and the data change was made. The DCR is now resolved.
- Declined - A study manager has rejected a data change request, and it will not be processed. The DCR is now resolved.
Certain data changes may be automated, so the system changes the data without involvement from our data management team. These types of changes will be made once approval is obtained. If you are requesting an update to more than one data point or a complex data change, then please select "other" from the "Request Type" drop-down menu.
If this is an urgent request, please follow up with your Study Manager, or contact our Technical Support line at the appropriate number listed here http://www.endpointclinical.com/help-desk/
*** Unblinding data may not be changed by eDRS. These requests should be submitted to email@example.com on a paper data change form (DCF) with the approval signature present.