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. Please note, that no subject related activities, unless related to subject safety, will occur prior
to receiving the approval letter and informed consent from Schulman.
2. Submission instructions: Submit via Secure eSubmission or email to Submissions@sairb.com.
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/ Protocol Clarification 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.
New IC/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
Version: September 30, 2015*
-OR-
Submitting item via Product Safety Submission Form
© 2015 Copyright SCHULMAN
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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
a.
Yes >>> Complete a. through c.:
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 create a sub-study to the protocol?
No
Yes >>> Submit the Sub-Study/Additional Research Submission Form and complete a. 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 Form for all site(s) participating in the sub-study.
7. Does this submission create an extension to the protocol?
No
Yes >>> Complete a. 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 Form for 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: September 30, 2015*
© 2015 Copyright SCHULMAN
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