Recruitment / Study-Related Material Submission Form
1. Submission requirements: Visit the Recruitment & Study-Related Materials page of the Schulman website for detailed submission
requirements.
2. Submission instructions: Submit via Secure eSubmission or email to Recruitment@sairb.com. Including all information requested
below (e.g., MA#) will help facilitate efficient processing.
SECTION 1.0: Study & Submission Information
1. Date:
2. IRB No.:
3. Sponsor:
4. Protocol No.:
5. The material(s) submitted for review on this form are for use at:
A single site >>> Complete a. and b.:
a. Principal/Qualified Investigator’s name:
b.
If required, Sponsor approval is attached.
All sites (sponsor/CRO only) >>> Complete c. and d.:
c. Specify the site locations:
USA
Canada
d. Would you like to allow sites to access these materials via Schulman SiteAccess™? Choose one:
No
Yes
Schulman should only allow sites access to the following approved/acknowledged material(s):
Note: Schulman will process submitted material for all open sites unless otherwise directed. Any institutional requirements for local IRBs
must be communicated to Schulman at the time of submission. Recruitment/study-related materials are only distributed electronically via
the WebPortal™ / SiteAccess™ or email.
6. Contact information for this Recruitment/Study-Related Material submission:
Name:
Company:
Phone:
Email:
SECTION 2.0: Recruitment / Study-Related Material Information
Item Name:
1. Is this item being resubmitted due to a “Revise and Resubmit” request by Schulman?
No
Yes >>> Provide the Material Item# (MA):
2. Has any version of this item been approved within the protocol document?
No
Yes
3. Has Schulman previously reviewed this item or a similar item for another study?
No
Yes >>> Provide the Protocol#:
, MA#:
, and attach a summary of changes:
4. Will this item require translation?
No
Yes >>> Complete a. and b.:
a. Who will be responsible for obtaining the translation? Choose one:
Sponsor or CRO >>> Submit a Certificate of Translation (COT); reference the Translations Guidance
Schulman >>> List language(s) and dialect(s):
b. Has the the English version received Schulman approval?
No
Yes >>> Provide the MA#:
Item Name:
1. Is this item being resubmitted due to a “Revise and Resubmit” request by Schulman?
No
Yes >>> Provide the Material Item# (MA):
2. Has any version of this item been approved within the protocol document?
No
Yes
3. Has Schulman previously reviewed this item or a similar item for another study?
No
Yes >>> Provide the Protocol#:
, MA#:
, and attach a summary of changes:
4. Will this item require translation?
No
Yes >>> Complete a. and b.:
a. Who will be responsible for obtaining the translation? Choose one:
Sponsor or CRO >>> Submit a Certificate of Translation (COT); reference the Translations Guidance
Schulman
>>> List language(s) and dialect(s):
b. Has the the English version received Schulman approval?
No
Yes >>> Provide the MA#:
Version: March 6, 2015*
© 2015 Copyright SCHULMAN
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Recruitment / Study-Related Material Submission Form
Item Name:
1. Is this item being resubmitted due to a “Revise and Resubmit” request by Schulman?
No
Yes >>> Provide the Material Item# (MA):
2. Has any version of this item been approved within the protocol document?
No
Yes
3. Has Schulman previously reviewed this item or a similar item for another study?
No
Yes >>> Provide the Protocol#:
, MA#:
, and attach a summary of changes:
4. Will this item require translation?
No
Yes >>> Complete a. and b.:
a. Who will be responsible for obtaining the translation? Choose one:
Sponsor or CRO >>> Submit a Certificate of Translation (COT); reference the Translations Guidance
Schulman >>> List language(s) and dialect(s):
b. Has the the English version received Schulman approval?
No
Yes >>> Provide the MA#:
Item Name:
1. Is this item being resubmitted due to a “Revise and Resubmit” request by Schulman?
No
Yes >>> Provide the Material Item# (MA):
2. Has any version of this item been approved within the protocol document?
No
Yes
3. Has Schulman previously reviewed this item or a similar item for another study?
No
Yes >>> Provide the Protocol#:
, MA#:
, and attach a summary of changes:
4. Will this item require translation?
No
Yes >>> Complete a. and b.:
a. Who will be responsible for obtaining the translation? Choose one:
Sponsor or CRO >>> Submit a Certificate of Translation (COT); reference the Translations Guidance
Schulman >>> List language(s) and dialect(s):
b. Has the the English version received Schulman approval?
No
Yes >>> Provide the MA#:
Item Name:
1. Is this item being resubmitted due to a “Revise and Resubmit” request by Schulman?
No
Yes >>> Provide the Material Item# (MA):
2. Has any version of this item been approved within the protocol document?
No
Yes
3. Has Schulman previously reviewed this item or a similar item for another study?
No
Yes >>> Provide the Protocol#:
, MA#:
, and attach a summary of changes:
4. Will this item require translation?
No
Yes >>> Complete a. and b.:
a. Who will be responsible for obtaining the translation? Choose one:
Sponsor or CRO >>> Submit a Certificate of Translation (COT); reference the Translations Guidance
Schulman >>> List language(s) and dialect(s):
b. Has the the English version received Schulman approval?
No
Yes >>> Provide the MA#:
Note: For additional items, use the Recruitment/Study-Related Material Supplement Form. Schulman reserves the right to request
additional revisions to previously approved materials.
SECTION 3.0: Rush Review
1. Would you like Schulman “Rush Review” service on the English version to guarantee delivery within one (1) business
day of any material(s) submitted on this form?
No
Yes >>> Complete a. and b.:
a. Specify which material item(s):
b.
By checking here, I confirm that I agree to the fees for Rush Review service of recruitment/study-related materials.
Rush Review does not apply to translated items. For additional information, contact translation@sairb.com.
Note: Sites requesting Rush Review service are required to include written sponsor/CRO approval for Schulman and associated fees.
Failure to include sponsor/CRO approval will result in standard processing.
Version: March 6, 2015*
© 2015 Copyright SCHULMAN
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