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Submission Application for Change of Principal Investigator
Protocol #:
Sponsor:
IRB ID#:
EXITING PRINCIPAL INVESTIGATOR (PI) INFORMATION
Please provide information about the person who is relinquishing responsibility
for the future conduct of the research.
1.
Exiting Principal Investigator’s Name:
NEW PRINCIPAL INVESTIGATOR (PI) INFORMATION
Please provide information about the person who will take over responsibility for the conduct of the
research. Attach a copy of the PI’s current medical license, CV, and DEA registration (if the study
involves controlled substances).
If you are approved to act as Principal Investigator for this study, will you continue to conduct the
study using only the procedures already approved at only the site(s) already approved?
2.
*If No, do not complete this form. Instead, you must submit a SUBMISSION APPLICATION FOR
THE INVESTIGATOR/SITE and a SUPPLEMENTAL SITE FORM(S) (if applicable) to obtain approval for any
additional site(s) at which you will conduct study procedures.
Yes
No
Yes
No
Yes
No
Yes
No
Note: This form may be used if there is a change in compensation.
3.
Principal Investigator’s Name:
4.
Principal Investigator’s Company Name:
5.
Principal Investigator’s Mailing Address:
6.
PI’s Phone:
PI’s Fax:
Will the phone number on the informed consent document change?
7a.
If Yes, please provide the new phone number: (
)
Phone number to be removed: (
x
)
-
-
x
Will the primary site contact person change?
7b.
If Yes, please provide the following:
New Contact person for this site:
Phone:
Add this contact person to SilverLink for this study: Yes
E-mail:
No
Will any sub-investigators be added to the study?
7c.
If Yes, please attach a CV and complete the Additional Sub-Investigator(s) Information section
of the CHANGE IN SITE INFORMATION FORM for any new sub-investigators.
APP208 Submission Application for Change of Principal Investigator
Version: 5.6 Effective Date: 8.19.15
Page 1 of 5
8.
PI’s Email:
9.
PI Degree(s):
10.
Medical License # :
11.
DEA Registration # (if applicable):
PI Specialty(ies):
State:
Expiration Date:
N/A
Expiration Date:
N/A
Will the PI conduct research involving an investigational drug in the State of Massachusetts?
12.
If Yes, please complete and attach the Massachusetts Compliance Agreement located on our
website, www.sterlingirb.com (under Forms). In addition, please provide the Research
Registration number under which the study will be conducted:
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Is the PI Board certified?
13.
If Yes, please select the certifying Board, and fill in the area(s) of specialty.
ABMS:
AOA:
ABPM:
ABPS:
Other:
Note: A list of ABMS Boards is available at http://www.abms.org/About_ABMS/member_boards.aspx.
Has the PI received an FDA 483 within the last 5 years, or ever received a Warning Letter or
Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (“NIDPOE”)?
14.
15.
16.
17.
If Yes, please attach all audit-related correspondence including, but not limited to, the FDA 483,
Warning letter, Establishment Inspection Report (EIR), NIDPOE, response from the PI and any
follow-up correspondence from the regulatory agencies.
In how many ongoing studies is the Investigator listed as the PI?
As a Sub-Investigator?
Is the PI ‘Clinical Research Investigator’ certified? (i.e. ACRP)
If Yes, please list the certifying organization:
How long has the PI been conducting research?
List the totals in the following categories that the PI currently supervises:
18.
19.
Locations:
Sub-Investigators:
Research Staff:
Approximate number of active subjects:
Within the last five (5) years, has the PI been involved with and/or implicated in any legal,
professional, or regulatory actions or restrictions (entered into either voluntarily or involuntarily)
related to the practice of medicine or research?
If Yes, please attach an explanation and all pertinent correspondence.
20.
Has the PI ever been disapproved by an IRB, had a sponsor or IRB suspend or terminate a
study for any reason, or impose any sanctions or restrictions on them?
If Yes, please attach an explanation and if an IRB action, the IRB’s contact information.
APP208 Submission Application for Change of Principal Investigator
Version: 5.6 Effective Date: 8.19.15
Page 2 of 5
Please indicate the training and education the Principal Investigator has received in Good Clinical Practices, the
Belmont Report, HIPAA and FDA regulations:
21.
NIH Clinical Research Training Course
OHRP Human Subject Assurance Training Modules
CITI Training Modules:
Basic Modules
Continuing Education Modules
NCI Human Participant Protections Education for Research Teams
Human subject protection training has not been completed, but is scheduled to be
completed prior to assuming responsibility for the study
Other (identify training):
Name of medical facility to be used in the event of an emergency:
Distance from research site?
22.
Does the PI have privileges at this facility? Yes
No
NOTE: While the PI is not required to have privileges at this medical facility, it must be
located within a reasonable distance from the research site.
Does the PI have an obligation to use another IRB for this site’s participation in this study?
23.
If Yes, attach a written statement from the other IRB acknowledging Sterling IRB’s review of this
research. A SAMPLE HOSPITAL/UNIVERSITY IRB RELEASE letter is available at www.sterlingirb.com
in the “forms” section.
Yes
No
Describe how the PI plans to provide adequate oversight and supervision of the conduct of this study.
24.
(To the extent it applies or will apply at any point during the study, please specifically address how the PI plans to manage
complex studies, a large number of subjects, studies conducted at multiple locations, and numerous studies being conducted
concurrently)
For example, routine meetings with the research team to review study progress, routine meetings with the study sponsor or
representative, a description of the procedures for the timely correction and documentation of problems identified during the
study, periodic review of the performance of delegated tasks, etc.
Will the compensation to study subjects change from what was indicated on the previous PI’s
Submission Application?
25.
If Yes, do not submit this application to the IRB if you are not ready to
*complete the following:
Yes
No
a. What is the new amount per visit?
b. When will payment occur?
*You may also attach a schedule of payment if it answers both a & b.
APP208 Submission Application for Change of Principal Investigator
Version: 5.6 Effective Date: 8.19.15
Page 3 of 5
FINANCIAL DISCLOSURE
Indicate by marking “Yes” or “No" if any financial interests or arrangements (as described below) apply to the new PI
their spouse, or their dependent children.
If any information provided in the Financial Disclosure section changes during the course of the study, or within one
year after the last participant completed the study as specified in the protocol, Sterling IRB must be immediately
notified.
26.
27.
28.
29.
30.
31.
32.
33.
34.
Financial arrangement entered into between the sponsor of this study and the investigator
whereby the value of the compensation for conducting the study could be influenced by its
outcome. For example, compensation that is explicitly greater for a favorable outcome, or
compensation to the investigator in the form of an equity interest in the sponsor or in the form of
compensation tied to the sales of the product, such as royalty interest.
For publicly traded entities: the value of any remuneration received from the entity in the past
12 months plus the current value of any equity interest in the entity exceeds $5,000*, and this
financial interest reasonably appears to be related to the investigator’s responsibilities for this
study. For purposes of this definition, “remuneration” includes salary and any other payment for
services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship)
and “equity interest” includes any stock, stock option, or other ownership interest as determined
through reference to public prices or other measures of fair market value.
For non-publicly traded entities: the aggregate value of any remuneration received from the
entity in the past 12 months exceeds $5,000* or any equity interest is held (e.g., stock, stock
option, or other ownership interest) and this financial interest reasonably appears to be related
to the investigator’s responsibilities for this study.
Any significant equity interest in this study’s sponsor (i.e., any ownership interest, stock options,
or other financial interest) whose value cannot be readily determined through reference to
public prices. This generally applies to interests in a sponsor that is not a publicly-traded entity.
Intellectual property or other proprietary rights and interest (e.g. patents, copyrights,
trademarks, licensing agreements) that reasonably appear to be related to the investigator’s
responsibilities for this study (e.g. rights/interest in the tested product); includes receipt of
income related to such rights and interests.
Reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not
reimbursed to the investigator so that the exact monetary value may not be readily available)
related to the investigator’s responsibilities for this study; provided, however, that this disclosure
does not apply to travel that is reimbursed or sponsored by a Federal, state, or local
government agency, an institution of higher education as defined at 20 U.S.C.1001(a), an
academic teaching hospital, or a research institute that is affiliated with an institution of higher
education.
An ownership interest, stock options or other financial interest in this study that is valued at
$10,000 or more* or 5 % or greater* ownership.
Receipt of significant payments of other sorts with a cumulative monetary value of $25,000 or
more made by this study’s sponsor to the investigator or their institution to support activities of
the investigator exclusive of the costs of conducting this or other clinical studies, (e.g., a grant
to fund ongoing research, compensation in the form of equipment or retainers for ongoing
consultation or honoraria).
An executive, director, or employee of the sponsor of this study.
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
If “Yes” was marked to any question(s) in this “Financial Disclosure” section, Sterling IRB
requires that a completed Financial Disclosure Form, located on our website at www.sterlingirb.com
(under forms), be attached for the new PI.
Please verify that you have answered all questions and included all required
attachments.
APP208 Submission Application for Change of Principal Investigator
Version: 5.6 Effective Date: 8.19.15
Page 4 of 5
INVESTIGATOR COMPLIANCE AGREEMENT
I have received and read the protocol and its appendices and other materials provided by the Sponsor. I agree to the
terms of the study and to follow the provisions of the protocol and all appendices. I will also abide by any changes
called for in subsequent amendments or revisions, unless I notify Sterling IRB (Institutional Review Board) otherwise
in writing.
 I have read and understand the protocol, and will abide by it. I will not make any changes to the protocol
without prior written approval from Sterling IRB.

I agree that either I or someone under my supervision will verbally explain the current Informed Consent form
as approved by Sterling IRB in a language understood by the prospective research subject. A signed copy
will be given to each research subject for their records.

I agree that all tests, procedures and the dispensing of test articles required by the protocol will be performed
by individuals who are qualified by education, licensure and/or the governance of the local medical board to
perform these tasks.

I certify that this site is adequately equipped to manage adverse events that may occur during the course of
this study and that unexpected events should be reported within 10 business days to the Sponsor and
Sterling IRB, and that all fatal or life threatening events should be reported immediately.

I agree to conduct this study in accordance with applicable federal regulations, state and local laws, the ICH
Guidelines for GCP, the principles of the Belmont Report, and HIPAA privacy regulations, regarding research
in human subjects.

I acknowledge that I am responsible for reporting to Sterling IRB any and all unanticipated problems involving
risks to study subjects or others.

I acknowledge that I am responsible for reporting to Sterling IRB any significant protocol deviations within 10
business days of the site becoming aware of the event, and for obtaining IRB approval of all Sponsor-granted
exceptions prior to initiation except where necessary to eliminate apparent immediate hazard to human
subject(s) (see Investigator Handbook).

I understand that Sterling IRB has the right to visit the research site at any time, with appropriate notice.

I will renew this application annually (or at more frequent intervals if requested by Sterling IRB).

I agree that I and the research staff will monitor participants for potential harm and take steps to minimize or
mitigate those harms and risks when possible.

I understand that falsification of information provided to Sterling IRB may result in sanctions by the IRB,
notification to the Sponsor and notification to my state medical licensing board.

I agree that this research project will not be put into effect until the Sterling IRB approval is received.
PRINCIPAL INVESTIGATOR:
I hereby certify that the information on this Submission Application is accurate to the best of my knowledge.
I attest that, as a Principal Investigator, I have read the Investigator Compliance Agreement and understand
that I am responsible for the conduct of this research study. I acknowledge that Sterling Institutional Review
Board has the authority to oversee this study and suspend the study if necessary to protect the rights and
welfare of the study subjects.
Printed Name of Principal Investigator:
____________________________________________________
Signature of Principal Investigator
APP208 Submission Application for Change of Principal Investigator
Version: 5.6 Effective Date: 8.19.15
Date
Page 5 of 5