About Partial Source Data Verification for Protocol Amendments

When you change a subject visit template, you create a new version of that template. This new version results in a protocol amendment. When you apply the protocol amendment to the subjects, the following processing occurs:

1. The subject visits that are no longer valid are deleted.

2. CRF (case report form) records associated with the subject visits are deleted.

3. New subject visits are created.

4. New CRFs are created with values for PSDV (partial source data verification) fields from the latest version of the subject visit template.

   For CRFs that already have values for PSDV fields, new CRFs are also created. The values for fields that are not available in the subject visit template are copied from the prior CRFs to the new CRFs, and the values for PSDV fields are copied from latest version of the subject visit template to the new CRFs.

5. Activities are created according to the protocol amendment.