Partial SV FAQs

What is partial SV?

In large studies, you may want to source verify a subset of data points marked as SV Required. Partial source verification (Partial SV) is a feature that allows you to provide parameters for selecting a subset of these data points for verification.

You configure Partial SV at the site level, and you can set parameters for subjects, forms, and items.

If I use Partial SV settings, can I source verify more than is required?

Yes. Partial SV allows you to specify the minimum amount of source verification that is required, but you can always verify more.

How does Partial SV subject selection work?

In terms of Partial SV, there are several groups, or pools of subjects at a site. When you configure your Partial SV settings, you are sorting subjects at each site into the pools. Take a look at the graphic below.

Graphic.SV Pool. Surrounding text describes 210682.bmp.

General Pool—All of the subjects at a site.
SV Pool—Subjects whose data requires source verification because they're in the Auto-Select Pool or the Manual Pool.
- Auto-Select Pool—Subjects who were selected by the SV Target Rate or Number of initial subjects settings.
- Manual Pool—Subjects who you manually added using the Enter subject number drop-down list, or by importing a subject list.
SV Eligible Pool—Subjects who are available to be added to the SV Pool. Subjects in the SV Eligible Pool can be added to the SV Pool if you manually add them, or if you increase the SV Target Rate or Number of initial subjects settings.
Excluded Subjects—Subjects who can't be added to the Auto-Select Pool in the SV Pool. The only way you can require source verification for these subjects' data is by manually adding them using the Enter subject number drop-down list, or by including them in an imported subject list.
Note: Items associated with excluded subjects can still be marked as critical.

If I decrease my SV Target Rate, how does InForm choose which subjects to remove from the SV Pool?

InForm ranks the subjects by the current number of forms that are source verified, and removes subjects with the fewest source verified forms first. Those subjects return to the SV Eligible Pool. This ensures that the least amount of additional source verification work is required when the target rate is reduced.

For example:

If subject 01-004 has one form source verified, subject 01-007 has two forms source verified, and subject 01-012 has three forms source verified:

The process returns 01-004 to the SV Eligible Pool if the rate reduction called for removing a single subject.
If the rate reduction called for removal of two subjects from the Auto-select Pool, then subjects 01-004 and 01-007 would be returned.
This occurs so that reduction of the Auto-select Pool maintains a preference for retaining subjects with the highest number of SV Complete forms for the study. This ensures that the least amount of additional source verification work is required when the target rate is reduced.

I imported a subject list, and then configured my Partial SV settings so that the first 5 subjects are source verified. Why isn't the data for my imported subjects marked as SV Required?

Imported subjects are not part of the Auto-select Pool, and they do not affect the SV Target Rate for the site.

What's the difference between excluding a subject from source verification and deselecting a subject for source verification?

Deselected subjects are subjects that you initially selected for source verification, but subsequently deselected. After you deselect a subject for source verification, it is still possible for the subject to be selected for source verification in the future by the automatic subject selection settings (Number of initial subjects and Subject selection rate after initial subjects).

Excluded subjects are removed from the SV Eligible Pool, which means they aren't considered in the automatic subject selection settings, and are not SV required unless you manually select them for source verification. You can, however, mark an item associated with an excluded subject as critical.

Excluded subjects:

Are not restricted in any other way from participating in the study events, visits, and so on.
Still require their critical forms to be source verified.
Are still available to be selected as subjects for critical items.

Do my Partial SV settings automatically recalculate?

Yes. Certain changes to the Partial SV pools can cause the auto-select settings (SV Target Rate or Number of initial subjects) or criticality settings to recalculate. For example, if your target rate is 5%, InForm determines how many subjects are equal to 5% of the SV eligible subjects at the site. If you import 100 subjects to the SV Eligible Pool, InForm needs to recalculate to determine how many subjects are equal to 5% of the new number of SV eligible subjects. This recalculation happens automatically, when you move the subjects.

The following changes to Partial SV configuration settings trigger a recalculation of Partial SV settings:

You move a subject from the SV Eligible Pool to the Manual Pool.
You move a subject from the SV Eligible Pool to the Excluded Subjects Pool.
You move a subject from the Manual Pool to the SV Eligible Pool.
You move a subject from the Auto-Select Pool to the Manual Pool.
You move a subject from the Auto-Select Pool to the Excluded Subjects Pool.
You move a subject from the Excluded Subjects list to the Manual Pool.

The following study changes trigger a recalculation of Partial SV settings:

Subjects are transferred to or from your site.
Subjects are withdrawn from the study.
A new form is added to the study, or an existing form is removed from the study.
An item is added to or removed from a form.

When I transfer a subject, is the subject assigned to the same Partial SV Pool at the new site?

It depends. Subjects in the Excluded Subjects Pool remain in the Excluded Subjects Pool at their new site. All other subjects are added to the Manual Pool. After the transfer is complete, InForm recalculates the Partial SV settings at the original site if subjects from the SV Eligible, Manual, or Auto-Select Pools were transferred.

What is a critical form, and why would I mark a form as critical?

A critical form is a form that you want to be source verified for all subjects at a site, including subjects who aren't members of the SV Pool. When you mark a form as critical, all of the items on the form must be source verified.

You might mark forms such as AE and ConMed forms as critical because you want to make sure that all adverse events and concomitant medications are properly documented for regulatory agencies.

Note: Forms can be automatically marked Verified if they have no items to be verified. Those forms aren't included in the set of forms you can select using Partial SV.

What is a critical item and why would I mark an item as critical?

A critical item is an item that you want to require source verification for, and that is designated as SV Required and critical during study design in Central Designer or by using the Partial SV settings in InForm to override the Central Designer setting. Using the Partial SV configuration settings, you can override the study design settings to mark an item as critical for all forms or a subset or forms, and all subjects or a subset of subjects.

Because an item is already considered critical if it's on a critical form, or is associated with a subject whose data is required to be source verified, you only need to explicitly mark an item as critical if it wouldn't otherwise be source verified.

You might mark an item as critical if it's only used on a form that is not critical, and is used by an excluded subject, which means that it would not be source verified unless you made it critical.

Can I mark an item in an itemset as critical?

No. If you want to require source verification of an item in an itemset, you need to mark the entire itemset as critical, and source verify all of the items in the itemset.

What if the item I want to mark critical isn't listed in the Set SV Settings dialog box?

The Set SV Settings dialog box only lists items that are marked SV Required. To mark an item as critical, you first have to set it to SV Required using Central Designer.

How can I tell if an item is critical?

An asterisk (*) appears at the beginning of the item question for a critical item. In addition, the Effective SV state on the Set SV settings dialog box is Critical for items marked as critical for one or more forms.

I marked an item as critical for all forms, but I want to change it so that it's only critical for a subset of forms. Can I do that?

Yes. When you make the change, the item becomes critical for the subset of forms that you selected, and the study default setting is applied to all other forms.

Why do I see more items in the Set SV Settings dialog box than on the actual forms?

Partial SV is configured per site, and the Set SV Settings dialog box lists items from every study version the site has ever been on.