Partial SV terminology

SV

Source verification.

SV Pool

A collection of subjects. You can add subjects to this collection either manually or through an auto-selection process.

General Pool

All the subjects in the study at a site.

Auto-select Pool

The automatically selected portion of the SV Pool. The selections are based on the SV Target Rate.

SV Target Rate

The percentage at which you want subjects to be selected for source verification after the initial subjects are verified.

Excluded Subject

A subject that is not in the SV Pool and is not eligible for consideration for automated selection.

Subjects that are excluded from the SV Pool are still available to be selected for critical items.

Manual Pool

The manually selected portion of the SV Pool.

SV Eligible Pool

The subjects that can be added to the SV Pool through the auto-selection process, based on the SV Target rate.

For example:

SV Eligible Pool = [General Pool] – [SV Pool] – [Excluded subjects]

Critical Form

A form that must be source verified even if the corresponding subject is not a member of the SV Pool.

• Critical forms are those forms, which contain data of critical importance to the sponsor, that must be source verified for all subjects in a site.
• Examples of such data might be Adverse Event forms and Concomitant Medication forms. Sponsors can assign a set of forms to the critical forms list for a site.

Critical item or itemset

An SV Required item or itemset that is designated as critical in any of three ways:

• In the Central Designer application during study design.
• Using MedML in the InForm application.
• Using the Set SV Settings dialog box in the InForm user interface.

  Only items or itemsets that are SV Required can be designated as critical. Not all items on a form need to be critical.