Data Entry/Review module

 

About SDV marks

Source Data Verification (SDV) is a process usually 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 can be raised for a question that has been frozen but not for a question that has been locked.

A typical SDV process

  1. The Data Monitor creates an SDV.

  2. The Data Monitor visits the site and checks the marked data against the original information source.

  3. If satisfied that the data is in order, the Data Monitor changes the status of the SDV to Done.

  4. 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 to Queried.

  5. SDVs which are no longer required may be set to Cancelled.

SDV Statuses

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

SDV status priority

When a subject/visit/eForm/repeating question group contains questions with SDVs of differing statuses, the following hierarchy applies:

 

  1. Queried

  2. Planned

  3. 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.

Reporting

If they have been configured to appear as links on the home page, the following standard reports give details about SDVs.

 

 

 

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