A S S O C I A T E S I R B
Protocol/Informed Consent Change Form
1.Submission information: Use this form to submit changes to the protocol (e.g. amendment, administrative change) or informed consent document (IC) for Board review.2.Submission instructions: Submit via Secure eSubmission oremail 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 participating site(s) by PI/QI name or IRB#:
All sites (sponsor/CRO only) Complete c.:
c.Specify the site locations: USA Canada Complete d.:
d. Has the item(s) been submitted to Health Canada?
No Provide an explanation:
Yes No Objection Letter (NOL)/Acknowledgement attached / -OR- / Submitted to Health Canada on:
Note: Schulman will process submitted item(s) for all open sites unless otherwise directed. Any institutional requirements for local IRBs must be communicated to Schulman at the time of submission.
6.Contact information for this submission:
Name: / Company:
Phone: / Email:
SECTION 2.0: Protocol/IC Change Information
1. What type of item are you submitting? Check all that apply and provide the additional information as applicable:
Protocol Amendment/Revised Protocol Provide the amendment/revision date: and number (if applicable):
Required summary of changes are attached.
Dear Subject/Dear Investigator Letter Provide the letter date: / -OR- / Not dated
Administrative Letter/Change/ProtocolClarification Letter Provide the letter/change date:
Revised IC List all ICs for the study that will be revised by this request:
Required rationale and sponsor/CRO approval, if required, is attached.
NewIC/Addendum Provide the rationale for all requested revisions and documentation of sponsor/CRO approval.
Required rationale and sponsor/CRO approval, if required, is attached.
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 include any product safety updates (e.g., revised IB, package inserts, etc.)?
No
Yes Item previously submitted to Schulman / -OR- / Submitting item via Product Safety Submission 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 approvedIC.
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 owntranslation 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 create a sub-study to the protocol?
No / Yes Submitthe Sub-Study/Additional Research Submission Form and completea. and b.:
a.Will all Schulman approved sites be participating in the sub-study?
Yes / No List the participating site(s) by PI name or IRB#:
b.Submit the Revised Compensation Formfor all site(s) participating in the sub-study.
7. Does this submission create an extension to the protocol?
No / Yes Completea. and b.:
a.Will all Schulman approved sites be participating in the extension?
Yes / No List the participating site(s) by PI name or IRB#:
b.Submit the Revised Compensation Formfor all site(s) participating in the extension.
8. Does this submission modify the study subject compensation/reimbursement?
No / Yes Complete a.:
a.Who will be responsible for submitting Revised Compensation Forms for sites?
Sponsor/CRO / Sites
Note: Site approval documents cannot be released until a Revised Compensation Form is received for each site.
9. Does this submission result in the need to submit recruitment or study-related materials for Board review?
No / Yes Submit all materials for review using the Recruitment/Study-Related Material Submission Form.
Note: Board review of recruitment and study-related materials will be sent under separate cover.
Version: April 17, 2015 / © 2015 Copyright SCHULMAN / Page 1 of 2