3.1 Source Data Verification

When you review the conformity of data in CRFs, you can use the OpenClinica Source Data Verification (SDV) feature to track your evaluations, helping to ensure the Study is complete, accurate, and verifiable.

With the SDV feature, OpenClinica presents CRFs in a table format for you to verify. You can view the table either by Event CRF or by Subject, and filter the table to show only CRFs that match criteria you specify. After you verify the data, you can mark CRFs as verified, either individually or as a group.

You can also use the Source Data Verification table to determine the CRFs that have been verified and those that have not.

When you add CRFs as part of creating the Study Event Definition, you specify if Source Data Verification is not applicable, not required, partially required, or 100% required for the CRF.

What does 'partially required' mean? Often there are CRFs which require 100% review, meaning every field on every CRF should be reviewed (such as for Adverse Events). Other CRFs, however, may only need to be partially reviewed. OpenClinica does not define what "partial" means, but it would be defined in your monitoring plan and you would instruct your team as to how to use this. Typically there are two ways that "partial" is used in organizations:

  1. An organization may identify several fields in a CRF which are critical to the study. Monitors would be instructed to review only these fields in a CRF (rather than the whole CRF) for all of the subjects. 
  2. A monitor may review every field in the CRF but may only do this for a percentage of the subjects (instead of all subjects). 

Approved for publication by Benjamin Baumann (bbaumann), Principal. Signed on 2014-03-24 9:21AM

Not valid unless obtained from the OpenClinica document management system on the day of use.