Critical forms

Critical Forms are those forms whose data is determined to be of critical importance to the sponsor and must be source verified for all subjects in a study at a site. Examples of such data might be Adverse Event forms and Concomitant Medication forms.

Critical Forms are specified by site in the InForm application as those forms that always require source verification, for all subjects at that site.

For each site, you can select a subset of forms to include in the Critical Forms list. This list identifies all the forms to be source verified for all subjects in the study (that is, the General Pool). These are forms that must be source verified even if the corresponding subject is not a member of the SV Pool.

You can:

• Choose which forms to verify across all subjects.

  For example, the demographic, adverse events, and concomitant medications for all subjects.

• Force the source verification of specific forms all of the time.
• Change the form selection criteria at any time during the study.

After you define the Critical Forms list, the InForm application processes the list of subjects in the SV Pool to determine which form instances require source verification for the site. You can run this process multiple times during the study to determine the set of form instances that require source verification for the site.

You can specify Critical Forms through the InForm user interface or using MedML. For more information, see Configuring Partial SV or the Utilities Guide.