Change of Investigator Form
1. Submission information: Use this form to submit changes in an approved study’s principal/qualified investigator (PI), subinvestigator (Sub-I) and/or key personnel information.
2. Submission instructions: Submit via Secure eSubmission or email to Submissions@sairb.com.
SECTION 1.0: Study & Contact Information
1. IRB No.:
2. Current PI Name:
3. Sponsor:
4. Protocol No.:
5. Contact information for this submission:
Name:
Company:
Phone:
Email:
SECTION 2.0: Change of Investigator & Site Information
Change of PI Information >>> Complete questions 1. and 2.:
1. Has the current PI had a change in name only?
No
Yes >>> Provide the PI’s new name:
2. Is approval of a PI change being requested?
No
Yes >>> Complete a. through f.:
a. Provide the name of the new PI:
First:
Middle:
Last:
Suffix:
Credentials:
b. What is the planned implementation date for the PI change?
c.
Submit a copy of the new PI’s CV signed an dated within the past 2 years, if not already on file with Schulman.
d.
Submit a statement from the sponsor/CRO approving the change of PI.
e. What human research protection education and training has the new PI received? Check all that apply:
Reviewed FDA Information Sheets, TCPS Tutorial (CAN), GCP Guidelines and the Belmont Report
Attended educational seminar(s) or received training on human subject protection provided by the sponsor/CRO/research site or
other entity
Completed formal education/training in human subject protection via web-based or published modules (e.g. NIH, OHRP video
training series, or CITI)
Human subject protection training has not yet been completed, but is scheduled to be completed prior to the new PI/QI taking
over the study
Other:
f. Will any other responses or information provided in the initial submission documents to Schulman change as a
result of this PI change?
No
Yes >>> Submit a revised response to each applicable question:
Change of Sub-I Information >>> Complete questions 3. through 5.:
3. Has a current Sub-I had a change in name only?
No
Yes >>> Provide the Sub-I’s old:
and new:
names.
4. Are Sub-Is for the study being removed?
No
Yes >>> Provide the names of the Sub-Is being removed:
5. Are new Sub-Is for the study being added?
No
Yes >>> Complete a. through c.:
a. What is the planned date for the new Sub-I(s) to begin working on the study?
b. Has the PI ensured that new Sub-Is selected for the study are appropriately qualified (by education, training, and
experience) to perform all of the study related duties that have been delegated to them?
Yes
No >>> Provide an explanation:
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Change of Investigator Form
c. List all new 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 new 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, TCPS Tutorial (CAN), GCP Guidelines
and the Belmont Report
Attended educational seminar(s) or received training on human subject
protection provided by the sponsor/CRO/research site or other entity
Completed formal education/training in human subject protection via webbased or published modules (e.g. NIH, OHRP video training series, or CITI)
Human subject protection training has not yet been completed, but is
scheduled to be completed prior to study initiation at the site
Other:
CV is (check one):
Sub-I
Attached
-OR-
On File with
Schulman
Key
Personnel
NA; minimal
risk study
Reviewed FDA Information Sheets, TCPS Tutorial (CAN), GCP Guidelines
and the Belmont Report
Attended educational seminar(s) or received training on human subject
protection provided by the sponsor/CRO/research site or other entity
Completed formal education/training in human subject protection via webbased or published modules (e.g. NIH, OHRP video training series, or CITI)
Human subject protection training has not yet been completed, but is
scheduled to be completed prior to study initiation at the site
Other:
CV is (check one):
Sub-I
Attached
-OR-
On File with
Schulman
Key
Personnel
NA; minimal
risk study
* Curriculum Vitae (CV) must reflect experience, be signed and dated within the past 2 years.
Change of Site Contact Information >>> Complete question 6.:
6. Is there a change of site contact associated with the change of site information?
No
Yes >>> Complete the Contact Change Form
Note: Site contacts receive access to Schulman SiteAccess in order to download IRB documents and review status information.
Change of Site Location Information >>> Complete question 7.:
7. Is there a change of primary or additional site information associated with the investigator change?
No
Yes >>> Submit the Change of Site Information Form
SECTION 3.0: Financial Interest & Regulatory History
This section is only required for change of PI and addition of new Sub-I(s) or key personnel.
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 new 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 for each investigator with a financial interest related to the research.
*Investigator: Includes the PI/QI, all Sub-Is and research staff involved in this research study, as well as spouses and dependent children of the PI/QI,
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.
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Change of Investigator Form
2. Within the last 5 years, has any new investigator associated with this study been audited by a regulatory authority
(e.g. FDA, OHRP, HPFB, or EPA)?
No
Yes >>> Complete a.:
a. Provide the information for all audits within the last 5 years (submit additional sheets if necessary):
Was a 483 or Inspection Exit
Regulatory
Audit
Audit Correspondence:
Investigator
Notice, or other agency’s
(e.g. 483, EIR, Inspection Exit Notice, Site Response)
Authority
Dates
equivalent received?
Attached
No
Previously submitted
Yes
Not yet available; will submit when available
3. Has any new investigator associated with this study:
 Had a sponsor, CRO, or an IRB/REB terminate, suspend, or impose restrictions or sanctions on a protocol?
 Had an IRB/REB 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/provincial medical board take a disciplinary action against his/her license?
 Had a state/provincial 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 4.0: Study Status & IC Information
1. What is the status of study enrollment?
Enrollment open
Enrollment closed
Site not yet initiated
2. 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:
Note: A revised IC will not be generated for sites that have closed to enrollment and have no active subjects unless specifically
requested by the Sponsor/CRO. If enrollment reopens at your site contact Schulman.
3. Does the change of investigator information result in the need for change(s) to the current Schulman approved IC(s)?
No
Yes >>> Complete a. through c.:
a. Indicate one of the following:
Request Schulman apply the appropriate changes to the current Schulman approved IC(s).
Requested changes attached via tracked changes to the MS Word version of the current Schulman approved IC(s).
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 Schulman upon review of the change(s).
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 the associated cost for:
All previously translated languages
Only specified languages:
Note: Confirm authorization for translations with the sponsor/CRO prior to submission, if necessary.
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Change of Investigator Form
SECTION 5.0: Investigator Certification & Signature
As the individual responsible for completing this form, my signature certifies that:
1.
I am the Principal/Qualified Investigator (PI) or the PI's designee authorized to submit on behalf of the PI/QI;
2.
The PI/QI and all study personnel are aware of their responsibilities for conducting research as defined by the applicable federal,
state, provincial and local law, ICH GCP guidelines and as set forth on the Schulman IRB website at www.sairb.com;
3.
Subject related study activities will not be conducted by new investigators prior to receving Schulman approval;
4.
The research site has and will maintain adequate facilities, including equipment and appropriate levels of qualified 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 PI/QI and all study personnel have reviewed the information regarding safeguards for vulnerable group(s) and agree to the
appropriate safeguards; and
7.
All information provided in this form is true and accurate, has been reviewed by the PI/QI and communicated to all study personnel.
Principal Investigator [US]/Qualified Investigator [CAN] or Designee – Signature
Signature Date (mm/dd/yyyy)
Principal Investigator [US]/Qualified Investigator [CAN] or Designee – Print Name & Title
Version: August 28, 2015*
© 2015 Copyright SCHULMAN
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