Studies Using Leftover Specimens that are Not Individually Identifiable
Single Site Study Submission Form
1. Submission information: Use this form to request an alteration of the requirements of Informed Consent for In Vitro Diagnostics
Device Study Using Leftover Human Specimens that are Not Individually Identifiable. Review the available FDA Guidance Document for
additional information, including studies that do not qualify for this type of review.
2. Standard leftover specimen study submission requirements:
Study Device Labeling / Brochure
Protocol
3. Submission instructions: Submit via Secure eSubmission or email to Submissions@sairb.com.
SECTION 1.0: General Information
1. Protocol No.:
2. Protocol Acronym:
3. Sponsor:
4. CRO (if applicable):
5. Principal Investigator (PI) Name:
First:
Middle:
Last:
Suffix:
Credentials:
6. Primary Site:
Site Name:
Address:
City:
State:
Phone:
Postal Code:
Country:
Email:
7. Will the research or study-related procedures be conducted at additional site locations under the same PI?
No
Yes >>> Complete a. and b.:
a. How many additional locations will be used to conduct this study?
b. Provide the names and addresses of all additional locations where the study will be conducted:
SECTION 2.0: Contact & Billing Information
1. *Primary Site Contact:
Name:
Company:
Address:
City:
State:
Phone:
Email:
Title:
Country:
Postal Code:
2. *Primary Study Contact:
Name:
Title:
Company:
Address:
City:
State:
Phone:
Postal Code:
Country:
Email:
Note: Study contacts receive access to Schulman WebPortal™ 3D or SiteAccess in order to review status information and IRB documents. Attach a list if
you would like access for additional users at this time. Visit the Contact Us page of the Schulman website to add or remove access later.
3. *Party responsible for Schulman fees:
Name:
Company:
Address:
City:
State:
Phone:
Postal Code:
Country:
Email:
4. Send invoices via:
Email
Hard Copy
Title:
5. Purchase Order Number (if applicable):
*If there are additional contacts, attach the additional contact information.
SECTION 3.0: Study Information
1. Provide the source of funding for the study:
Pharmaceutical or Medical Device Company
Not-for-Profit Sponsor
US Government >>> Complete a. and b.:
Other:
a. Specify the funding agency:
b. Has an IRB reviewed the grant application for the version of the protocol being submitted?
Yes
No >>> Submit the grant for review by Schulman IRB.
Version: April 17, 2015*
© 2015 Copyright SCHULMAN
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Studies Using Leftover Specimens that are Not Individually Identifiable
Single Site Study Submission Form
2. If using an In Vitro diagnostic device, does this study meet the IDE exemption criteria at 21CFR812.2(c)(3)?
No
Yes
3. What types of specimens does this study use? Check all that apply:
Leftover specimens that are remnants of specimens collected for routine clinical care or analysis that would have been discarded
Leftover specimens previously collected for other research purposes (not collected specifically for the proposed investigation)
Specimens obtained from a specimen repository
4. Does this study include specimens that are not individually identifiable (the identity of the subject is not known and
may not be readily ascertained by the investigator or any other individuals associated with the investigation, including
the sponsor)?
No
Yes
Note: If the specimen is coded, it will be considered to be not individually identifiable if neither the investigator(s) nor any other individuals associated
with the investigation or the sponsor can link the specimen to the subject from whom the specimen was collected, either directly or indirectly through
coding systems.
5. Are the specimens provided to the investigator(s) without identifiers with the supplier of the specimens having
established policies and procedures to prevent the release of personal information?
No
Yes
6. Does any clinical information accompany the specimens?
No
Yes >>> Complete a.:
a. Does the information make the specimen source identifiable to the investigator, sponsor, or any other individual
associated with the investigation?
No
Yes
7. Are the individuals caring for the patients different from and do not share information about the patient with those
conducting the investigation?
No
Yes
N/A
SECTION 4.0: Research Site Information
1. Describe the primary site facility:
Dedicated Research Facility
Surgery Center >>> Submit a Research Oversight Jurisdiction Form
Private Practice
Nursing Care Facility >>> Submit a Research Oversight Jurisdiction Form
Free-standing Psychiatric Facility
Hospice >>> Submit a Research Oversight Jurisdiction Form
Public Health Clinic
Other:
Hospital or Hospital System Owned or Affiliated >>> Submit a Research Oversight Jurisdiction Form
If checked, provide the name of the hospital system or parent organization:
University/Academic Medical Center Owned or Affiliated >>> Submit a Research Oversight Jurisdiction Form
If checked, provide the name of the university/academic medical center or parent organization:
2. Is the primary site under the jurisdiction of or affiliated with another IRB or human research protection program
(HRPP)?
No
Yes >>> Submit a Research Oversight Jurisdiction Form if not previously completed.
3. Has the site or PI previously submitted to another IRB for review of this study?
No
Yes >>> Complete a. and b.:
a. Was it disapproved or withdrawn?
No
Yes >>> Submit written documentation of the disapproval or withdrawal.
b. Are you requesting transfer of IRB oversight?
No
Yes >>> Submit a Transfer of IRB Form.
4. Are there any state or local laws governing research at the site which extend requirements for this study beyond
those established by federal regulations and/or Schulman IRB?
No
Yes >>> Provide an explanation:
Note: If unsure, please contact a healthcare attorney or local or state government.
Version: April 17, 2015*
© 2015 Copyright SCHULMAN
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Studies Using Leftover Specimens that are Not Individually Identifiable
Single Site Study Submission Form
5. Is this study being conducted under an FWA (Federalwide Assurance) at the primary or any additional site location?
No
Yes >>> Complete a. and b.:
a.
Submit an IRB Authorization Agreement
An IRB Authorization Agreement or equivalent is already
-ORor equivalent
on file with Schulman
b. In Section 6.0 include all key study personnel working on the project in addition to the PI and Sub-Is.
Note: Consider all sites that may be involved in the conduct of the research where an FWA may apply. Refer to the Submit FWA Study page of the
Schulman website for additional submission requirements.
SECTION 5.0: Research Experience, Education & Training
1. List the PI and all Sub-Is for this study and indicate the clinical research experience and human research protection
education and training for each. For federally funded studies and/or research under a FWA, also list key personnel
working on the project. Submit supplement sheets if necessary to list all individuals.
Role
Name (First Last) *Experience
Education & Training
Reviewed FDA Information Sheets, GCP Guidelines and the Belmont Report
PI
CV is:
Attended educational seminar(s) or received training on human subject
protection provided by the sponsor/CRO/research site or other entity
Attached
Completed formal education/training in human subject protection via web-based
-ORor published modules (e.g. NIH, OHRP video training series, or CITI)
Human
subject protection training has not yet been completed, but is scheduled
On File with
to
be
completed
prior to study initiation at the site
Schulman
Other:
Reviewed FDA Information Sheets, GCP Guidelines and the Belmont Report
Sub-I
CV is:
Attended educational seminar(s) or received training on human subject
protection provided by the sponsor/CRO/research site or other entity
Attached
-ORCompleted formal education/training in human subject protection via web-based
-ORor published modules (e.g. NIH, OHRP video training series, or CITI)
Key
Human
subject protection training has not yet been completed, but is scheduled
Personnel
On File with
to
be
completed
prior to study initiation at the site
Schulman
Other:
Reviewed FDA Information Sheets, GCP Guidelines and the Belmont Report
Sub-I
CV is:
Attended educational seminar(s) or received training on human subject
protection provided by the sponsor/CRO/research site or other entity
Attached
-ORCompleted formal education/training in human subject protection via web-based
-ORor published modules (e.g. NIH, OHRP video training series, or CITI)
Key
Human
subject protection training has not yet been completed, but is scheduled
Personnel
On File with
to
be
completed
prior to study initiation at the site
Schulman
Other:
* Curriculum Vitae (CV) must reflect experience, be signed and dated within the past 2 years.
SECTION 6.0: Financial Interest
1. Each investigator* is required to disclose any of the following financial interests when those financial interests are
related to the research**. During the last 12 months, has any investigator involved in this study:
 Been an officer, director or employee of the sponsor or CRO of this research study;
 Held ownership interest (equity or stock options) related to the research whose value when aggregated for the immediate family is
greater than $5,000 or 5% interest in any single publicly traded company;
 Held ownership interest related to the research of any value held in a non-publicly traded company;
 Had any proprietary interest related to the research;
 Received, or made any arrangement to receive, any significant payments of other sorts related to the research to support activities
of the investigator (exclusive of the costs of conducting the research study); OR
 Entered into any financial arrangement related to the research whereby the value of compensation paid or of equity owned could
be affected by the outcome of this study?
No
Yes >>> Submit a Conflict of Interest Disclosure Form for each investigator with a financial interest related to the research.
*Investigator: Includes the PI, all Sub-Is and research staff involved in this research study, as well as spouses and dependent children of the PI, Sub-Is
and research staff.
**Related to the Research: A financial interest is related to the research when financial interest is in the sponsor, product or service being tested, or
competitor of the sponsor, product or service being tested in this research study.
Note: Visit the Conflict of Interest page of the Schulman website for additional information and definitions.
Version: April 17, 2015*
© 2015 Copyright SCHULMAN
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Studies Using Leftover Specimens that are Not Individually Identifiable
Single Site Study Submission Form
SECTION 7.0: Regulatory History
1. Within the last 5 years, has the site or any investigator associated with this study been audited by a regulatory
authority (e.g. FDA, OHRP, or EPA)?
No
Yes >>> Complete a.:
a. Provide the information for all audits within the last 5 years (submit additional sheets if necessary):
Regulatory
Audit
Was a 483 or other agency’s
Audit Correspondence:
Investigator
(e.g. 483, EIR, Site Response)
Authority
Dates
equivalent received?
Attached
No
1
Previously submitted
Yes
Not yet available; will submit when available
2. Has any investigator associated with this study:
 Had a sponsor, CRO, or an IRB terminate, suspend, or impose restrictions or sanctions on a protocol?
 Had an IRB refuse to review a protocol?
 Had a regulatory authority terminate a study?
 Had a hospital/healthcare facility take an adverse action against his/her clinical privileges/medical staff membership, e.g.,
suspension, revocation, or restriction?
 Resigned his/her medical staff membership or surrendered clinical privileges while under investigation by the medical staff or its
designee?
 Been convicted of or charged with a felony?
 Had a state medical board take a disciplinary action against his/her license?
 Had a state medical board notify him/her that complaints and/or charges are currently pending investigation?
No
Yes >>> Submit copies of all relevant documents and/or provide an explanation:
SECTION 8.0: Investigator Certification & Signature
As the individual responsible for completing this form, my signature certifies that:
1. I am the Principal Investigator (PI) or the PI's designee authorized to submit on behalf of the PI;
2. The PI and all study personnel are aware of their responsibilities for conducting research as defined by the applicable federal, state,
and local law, ICH GCP guidelines and as set forth on the Schulman IRB website at www.sairb.com;
3. No study activities will occur prior to receiving the approval letter from Schulman;
4. The research site has and will maintain adequate facilities, including equipment and appropriate levels of trained staff, to conduct
the proposed research safely;
5. Responses to the financial interest questions are accurate and complete and constitute a full disclosure of any conflicting interests
and activities of any investigator or staff involved in this research at this site. The requirements to disclose any potential conflict of
interest have been discussed with these individuals and any conflicts of interest that arise during the course of the study will be
disclosed to Schulman;
6. The protocol, clinical trial agreement or other contract with the sponsor/CRO of this study states: the responsible party who will
provide medical care in case of study-related injury and who will pay for the care (e.g., sponsor, site, subject, insurance provider);
the sponsor/CRO is required to promptly report any findings of study monitors that could affect the safety of participants or
influence the conduct of the study at this site, and will be promptly forwarded to Schulman; the sponsor/CRO is required to send
routine and urgent data and safety monitoring reports to the site, and will be promptly forwarded to Schulman; and the
sponsor/CRO is required to report to the site any study results uncovered within two (2) years of study closure that could directly
affect subject safety, and will be promptly forwarded to Schulman; and
7. All information provided in this form is true and accurate, has been reviewed by the PI and communicated to all study personnel.
Principal Investigator or Designee – Signature
Signature Date (mm/dd/yyyy)
Principal Investigator or Designee – Print Name & Title
Version: April 17, 2015*
© 2015 Copyright SCHULMAN
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