Change/Addition of Clinician for Humanitarian Use Device (HUD)

1. Submission information: Use this form to submit changes to the Clinician(s) or Facility(s) associated with the use of an approved HUD.
2. Submission requirements: Visit the Submitting a Device Study page of the Schulman IRB website for detailed HUD submission requirements.
3. Submission instructions: Submit via Secure eSubmission or email to .
SECTION 1.0: Contact & Billing Information
1. IRB No.: / 2. Current Primary Clinician Name:
3. Project (Protocol) No.: / 4. HUD Holder (sponsor):
5. Contact information for this submission:
Name: / Company:
Phone: / Email:
SECTION 2.0: Change of Clinician/User & Facility Information
This request is to:
☐ change the primary clinician. > Complete question 1.: a. through e. below:
☐ add clinician(s)/user(s). Complete question 1.: a. through e. below:
☐ remove clinician(s)/user(s). Complete question 2.: a. and b. below:
☐ change the name of a previously approved clinician/user. Complete question 3.: a. through c. below:
1.  Submit the following items for review:
a.  A copy of signed and dated CV within the past 2 years if not already on file with Schulman.
b.  Clinician letter documenting proposed use of the device, the HUD procedure, any screening procedures associated with its use and any follow-up tests or procedures to be employed (template available).
c.  A copy of any documentation of HUD specific training required by the HDE holder (per Instructions for Use or the FDA’s HDE approval letter).
d.  Provide name and address of facility(s) of proposed use.
e.  Provide name of clinician:
2.  Supply the following information:
a.  Name of Clinician(s)/User(s) to be removed:
b.  Name of facility(s) where clinician was approved to use the device:
3.  Supply the following information:
a.  Previous name of clinician(s)/user(s):
b.  Current (updated) name of clinician/user:
c.  A copy of CV with updated name and related information.
Primary Clinician or Designee – Signature / Signature Date (mm/dd/yyyy)
Primary Clinician or Designee – Print Name & Title
Version: May 5, 2017 / © 2017 Copyright SCHULMAN / Page 1 of 1