Planned
SDV is yet to be done
Queried
There is some problem with the data verification
Done
Source data has been verified satisfactorily
Cancelled
The SDV mark is no longer required
Source Data Verification (SDV) is a process carried out by a Data Monitor and consists of cross-checking the data collected for subjects with the original information source. This is a way of checking that the data being input into MACRO is genuine and accurate. The process is sometimes known as Source Document Verification.
SDV marks can be created at the question, eForm, visit or subject level, although only one SDV can be created for each question, eForm, visit and subject.
An SDV mark can be raised for a question that has been frozen but not for a question that has been locked. More information...
The Data Monitor creates an SDV mark.
The Data Monitor visits the site and checks the marked data against the original information source.
If satisfied that the data is in order, the Data Monitor changes the status of the SDV mark to Done.
If the data does not match, or if there is any other query to be resolved, the Data Monitor changes the status of the SDV mark to Queried.
SDVs which are no longer required may be set to Cancelled.
An SDV can have one of four statuses:
|
Planned |
SDV is yet to be done |
|
Queried |
There is some problem with the data verification |
|
Done |
Source data has been verified satisfactorily |
|
Cancelled |
The SDV mark is no longer required |
When a subject/visit/eForm contains questions with SDVs of differing statuses, the following hierarchy applies:
Queried
Planned
Done
For example, if an eForm contains questions with the SDV statuses 'Planned' and 'Queried', it will always be represented by the 'Queried' icon as this has the highest priority.