Multisite Submission Form for Studies Using Leftover Specimens That Are Not Individually

Studies Using Leftover Specimens that are Not Individually Identifiable

Multisite 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 NotIndividually Identifiable. Review the availableFDA Guidance Document for additional information, including studies that do not qualify for this type of review.
2.Standard multisite leftover specimen study submission requirements:
Study Device Labeling/Brochure
Protocol
3.Submission instructions: Submit via Secure eSubmissionor email .
SECTION 1.0: General Information
1. Protocol No.: / 2. Protocol Acronym:
3. Sponsor: / 4. CRO (if applicable):
5.Estimated number of sites submitting to Schulman:
6.Are sites allowed to submit for initial review directly to Schulman?No / YesNoYes
SECTION 2.0: Contact & Billing Information
1. *Primary Study Contact: / Name: / Title:
Company: / Address:
City: / State: / Phone:
Postal Code: / Country: / Email:
Note:Study contacts receive WebPortal™ 3Daccess to review status information and IRB documents.Attach a list if you would like WebPortal™ 3D access for additional users at this time. Visit the WebPortal™ 3D Access Request page of the Schulman website to add or remove access later.
2. *Party responsible for Schulman service fees:
Name: / Title:
Company: / Address:
City: / State: / Phone:
Postal Code: / Country: / Email:
3. Send invoices via:Email Hard Copy / 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. throughc.: / Other:
a. Specify the funding agency:
b.Has an IRB reviewed the grant application for the version of the protocol being submitted? No / YesNoYes
If No, submit the grant for review by Schulman IRB.
c. Confirm that all sites will conduct this study under an FWA:
By checking here, the sponsor/CRO agrees to advise all submitting sites that this study must be conducted under their FWA.
Note: Refer to the Federalwide Assurances page of the Schulman website for additional submission requirements.
2. Was this study previously submitted to another IRB for review?
No / Yes Complete a. and b.:
a. Was it disapproved or withdrawn?
No / Yes Attach a detailed explanation.
b. Are you requesting transfer of IRB oversight?
No / Yes Submit theTransfer of IRB Addendum.
3. If using an In Vitro diagnostic device, does this study meet the IDE exemption criteria at 21CFR812.2(c)(3)?
No / Yes
4. 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
5. 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.
6. 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
7. 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
8. 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
9.By what date are approval documents needed in order to meet the goal of initiating the study?
SECTION 4.0: Sponsor/CRO Certification Signature
As the individual responsible for completing this form, my signature certifies that:

I am the Sponsor/CRO designee authorized to submit the study to Schulman for review on behalf of the Sponsor/CRO;
The Sponsor/CRO or its designee will monitor all research sites throughout the study;
If applicable, the Sponsor/CRO or its designee will report all Unanticipated Problems Involving Risks to Human Subjects or Others (“Unanticipated Problems”) and Unanticipated Adverse Device Effects (UADEs) within ten (10) business days of discovery, and within twenty-four (24) hours of discovery if the Unanticipated Problem/UADE involves a death;
The Sponsor/CRO or its designee will notify Schulman of any new findings that could directly affect subject safety discovered within two (2) years of study closure (the last site’s closure with Schulman);
I authorize WebPortal™ 3D access for all individuals listed on this form and will notify Schulman within three (3) business days if any contacts are no longer authorized or require WebPortal™ 3D access; and
All information provided in this form is true and accurate and has been communicated to all Sponsor/CRO study personnel.