Product Safety Form

1. Submission information: Use this form to submit new or updated product safety information, including investigator brochures (IBs), patient package inserts (PPIs), device information, safety committee reports and/or any other information related to product risk.
2. Submission instructions: Submit via Secure eSubmission or email to .
SECTION 1.0: Study & Contact Information
1. Date: / 2. IRB No.:
3. Sponsor: / 4. Protocol No.:
5. The item(s) submitted for review on this form are for use at (choose one):
A single site > Complete a. and b.:
a. Principal/Qualified Investigator’s name:
b. If required, Sponsor/CRO approval is attached.
A subset of sites > List all site(s) by PI/QI name or IRB#:
All sites (sponsor/CRO only) Complete c.:
c. Specify the site locations: USA Canada
6. Contact information for this submission:
Name: / Company:
Phone: / Email:
SECTION 2.0: Product Safety Item Information
1. What type of item are you submitting? Check all that apply and provide the additional information as applicable:
Updated Product Information (e.g. IB, PPI, Device Info) Provide the item date: and number (if applicable):
Required summary of changes are attached.
Device Report (e.g. Annual Report, MDR Report) Provide the report date:
Safety Committee Report (e.g. DSMB, DMC) Provide the report date:
Other: / Provide the item date:
2. What is the status of study enrollment?
Enrollment open / Enrollment closed / Site(s) not yet initiated
3. What is the status of study subjects? Check all that apply:
Subjects active / No subjects active / Subjects in follow-up only (not receiving active intervention [e.g. IP, device])
Other:
4. Does this submission result in the need for change(s) to the current Schulman approved protocol?
No
Yes Item previously submitted to Schulman / -OR- / Submitting item via Protocol/Informed Consent Change Form
5. Does this submission result in the need for change(s) to the current Schulman approved IC template for the study?
No / Yes Complete a. through c.:
a. Requested changes attached via tracked changes to the MS Word version of the current Schulman approved IC.
b. The revised IC is intended to be presented to: Check all that apply.
New enrollees / Only subjects receiving active intervention (e.g. IP, device)
All current subjects / Other:
Provide rationale if requesting not to reconsent all actively enrolled subjects:
Note: The final determination will be made by the Board upon review of the item.
c. Specify one of the following regarding IC translation:
No IC translation is needed.
I will obtain my own translation through a certified translator and provide for Schulman review prior to use.
I authorize Schulman to translate the IC and associated cost for: All previously translated sites and languages
Only specified sites and languages:
Note: Confirm authorization for translations with the sponsor/CRO prior to submission, if necessary.
6. Does this submission affect any other active studies under Schulman review using the same product?
No / Unknown / Yes Complete a.:
a. Will there be protocol and/or IC changes for the other studies?
No Provide an explanation:
Yes Provide the protocol number(s) and anticipated submission date(s):
Version: April 17, 2015* / © 2015 Copyright SCHULMAN / Page 1 of 2