Crosswalk: Qualifying Clinical Trial Attestation Form

Revision

Burden Change

Reason for Change

Type of Change

2022 (new version)

2021 (old version)

The form did not clearly specify that the The attestation form has been revised
Principal Investigator can also sign as
to include a signatory option for the
the Health Care Provider.
principal investigator as well as the
Health Care Provider.

The form was updated to ensure that the
participant’s enrollment in the study was not
delayed by the need to see a second physician for
signature.

No

The form did not distinguish the
Principal Investigator from the Health
Care Provider so that the form can be
signed in counterparts.

The attestation form contains two
Revision
signature lines, one for the Health Care
Provider and another for the principal
investigator.

The update will allow for both the Health Care
Provider and/or Principal Investigator to sign.

No

The form included the Name and
Subject of the qualified clinical trial.

The attestation form no longer includes
the Name/Subject of the qualified
clinical trial and instead includes the
National Clinical Trial Number.

This change streamlines the information included
on the form to one single identifier for the clinical
trial.

No

Revision

The form included a link to the qualified The attestation form replaced the link to Revision
trial and the NCT number from
the qualified trial with “NCT (form
clinicaltrials.gov.
clinicaltrials.gov)”.

This update eliminates confusion for the health care No
provider and/or principal investigator by removing
the reference to the Secretary's website.

The form requested that the NPI
number is present.

The NPI number has been eliminated
from the attestation form.

The NPI was not required by law.

No

The form required the name and
Medicaid ID of the beneficiary be
gathered twice.

The attestation form now request the
Revision
name and Medicaid ID of the beneficiary
once opposed to twice.

This update eliminates dupliation of information.

No

Revision

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

The form consist of two pages.

The attestation form has been
condensed to one single page.

Revision

This update consolidates the most relevant content No
into a single page.

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.

Type of Change: Rev = Revision, Del = Deletion, Add = Addition, and Red = Redesgnation.