If you have questions about completing this form, contact the HRPP office, 203-785-4688, or hrpp@yale.edu
.
HIC Protocol Number:
Title of Research Project:
Principal Investigator:
Department:
Yale Academic Appointment:
Campus Address:
Campus Phone: Fax: Pager: E-mail:
Protocol Correspondent Name & Address:
Campus Phone: Fax: E-mail:
Yale Cancer Center CTO Protocol Correspondent Name & Address (If applicable):
Campus Phone: Fax: E-mail:
Business Manager:
Campus Phone Fax : E-mail:
Faculty Advisor: (required if PI is a student, resident, fellow or other trainee)
Yale Academic Appointment:
Email:
Campus Phone:
Current Research Team Members and Their Affiliation:
Name
Role:
Affiliation:
Yale/Other Institution
(Identify)
Role:
Role:
NetID
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Role:
Role:
Role:
Role:
Role:
Are all Yale-affiliated individuals listed on this protocol employees of Yale University? ☐ YES ☐ NO
If NO, indicate which study personnel are not: Click here to enter text.
For any Yale-affiliated study personnel who are not Yale employees, are they covered by a personal services agreement? Click here to enter text.
As the Principal Investigator of this research project, I certify the following:

That the information provided in this application is complete and accurate.
 That I assume full responsibility for the protection of human subjects and the proper conduct of the research.
 That subject safety is of paramount concern, and every effort is made to protect subjects’ rights and welfare.
 That the research is performed according to ethical principles and in compliance with all federal, state and local laws, as well as Yale University policies regarding the protection of human subjects.

That all members of the research team are kept apprised of the research goals and progress of the study.

That I will obtain continuing approval from the HIC for this research study and obtain approval for any subsequent revisions prior to initiating any revision of the project.

That I will report to the HIC any unanticipated problems involving risk to participants (including serious unanticipated adverse events at least possibly related to the protocol) in accordance with HIC policies.

I will identify a qualified successor should I cease my role as principal investigator and will facilitate a smooth transfer of investigator responsibilities.
____________________________________
Signature of PI Date
_________________________
Signature of Faculty Advisor*(if necessary)
__________________
Print name of Advisor Date
*Faculty Advisor is in compliance with the requirements set forth by the University according to the
Faculty Handbook requirements for serving as a PI, and qualifies to serve as the faculty advisor of this project. Faculty Advisor assumes all of the roles and responsibilities of a Principal Investigator even though the student may be called a PI.
Investigator Interests :
Does the principal investigator, or do any research personnel who are responsible for the design, conduct or reporting of this project or any of their family members (spouse or dependent child) have an incentive or interest, financial or otherwise, that may affect the protection of the human subjects involved in this project, the scientific objectivity of the research or its integrity? Note: The Principal Investigator
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(Project Director), upon consideration of the individual’s role and degree of independence in carrying out the work, will determine who is responsible for the design, conduct, or reporting of the research.
See Disclosures and Management of Personal Interests in Human Research http://www.yale.edu/hrpp/policies/index.html#COI
☐
Yes
☐
No
Do you or does anyone on the research team who is determined by you to be responsible for the design, conduct or reporting of this research have any patent (sole right to make, use or sell an invention) or copyright (exclusive rights to an original work) interests related to this research protocol?
☐ Yes ☐ No
If yes to either question above, list names of the investigator or responsible person:
The Yale University Principal Investigator, all Yale University co-investigators, and all Yale University individuals who are responsible for the design, conduct or reporting of research must have a current financial disclosure form on file with the University’s Conflict of Interest Office. Yale New Haven
Hospital personnel who are listed as co-investigators on a protocol with a Yale University Principal
Investigator must also have a current financial disclosure form on file with the University’s Conflict of
Interest Office. If this has not been done, the individual(s) should follow this link to the COI Office
Website to complete the form: http://www.yale.edu/coi/
NOTE: The requirement for maintaining a current disclosure form on file with the University’s Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital personnel.
Whether or not they are required to maintain a disclosure form with the University’s
Conflict of Interest Office, all investigators and individuals deemed otherwise responsible by the
PI who are listed on the protocol are required to disclose to the PI any interests that are specific to this protocol.
1. Is this study designed to specifically recruit any of the following (Choose all that apply):
☐ Children
☐
Decisionally impaired
☐ Economically Disadvantaged
☐ Females of childbearing potential
☐ Fetal material, placenta, or dead fetus
☐
☐
☐
☐
☐
☐
Healthy Controls
Non-English Speaking
Employees
Pregnant women
Prisoners
Students
2. Funding Source: Indicate ALL of the CURRENT and ACTIVE funding source(s) for this study.
Check all boxes that apply.
Has the funding source changed since this HIC application was last renewed?
☐ Yes ☐ No
PI Title of Grant Name of Funding Funding Funding Mechanism
Source
☐ Federal
☐
State
☐
Non Profit
☐
IRES PT Proposal
Number: Click here to enter text.
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☐
Industry
☐
Other For Profit
☐
Other
☐
Federal
☐
State
☐
Non Profit
☐
Industry
☐
Other For Profit
☐
Other
Award Expiration: Click here to enter text.
☐
Contract# Click here to enter text.
☐
Contract Pending
☐
Investigator/Department
Initiated
☐
Sponsor Initiated
☐
Other, Specify: Click here to enter text.
☐
IRES PT Proposal
Number: Click here to enter text.
Award Expiration: Click here to enter text.
☐
Contract# Click here to enter text.
☐
Contract Pending
☐
Investigator/Department
Initiated
☐
Sponsor Initiated
☐
Other, Specify: Click here to enter text.
☐
IRES PT Proposal
Number: Click here to enter text.
☐
Federal
☐
State
☐
Non Profit
☐
Industry
☐
Other For Profit
☐
Other
Award Expiration: Click here to enter text.
☐
Contract# Click here to enter text.
☐
Contract Pending
☐
Investigator/Department
Initiated
☐
Sponsor Initiated
☐
Other, Specify: Click here to enter text.
3 . Location[s] of the study: Please identify the hospital, in-patient or outpatient facility, school or other agency that will serve as the location of the research. Choose all that apply:
☐ APT Foundation, Inc.
☐
Cancer Data Repository/Tumor Registry
☐ Church Street Research Unit (CSRU)
☐ Keck Laboratories
☐
Magnetic Resonance Research Center
(MR-TAC)
☐ Clinical Neuroscience Research Unit (CNRU) ☐ Yale Cancer Center/Smilow
☐
Connecticut Mental Health Center
☐
Yale Cancer Center/Clinical Trials Office
☐ Department of Veterans Affairs, West Haven* (CTO)
☐ Haskins Laboratories ☐ Yale-New Haven Hospital
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☐ Hospital Research Unit (HRU)
☐ John B. Pierce Laboratory, Inc.
☐
Yale-New Haven Hospital-Saint Raphael Campus
☐ Yale University PET Center
☐ International Research Site (Specify location(s)): Click here to enter text.
☐ Other locations, Specify: Click here to enter text.
*Note: Studies that include the West Haven VA must have the approval of the WHVA IRB (VA-
HSS)
4. Protocol History a. When was this HIC application first approved? Click here to enter text.
b. When was approval for this HIC application last renewed? Click here to enter text.
c. Is the study in data analysis ONLY ? Yes ☐ No ☐
Note: If the study is in data analysis only and all of the data being analyzed is de-identified, submit a
Request to Close form , and not a renewal application.
5. Lapse in IRB approval
Has IRB approval of the study lapsed (expired) since the last annual renewal ? Yes ☐ No ☐
If yes, explain why IRB approval was not achieved in time to ensure continuous approval of the protocol. Click here to enter text.
If yes, during this lapse period have any subjects been

Recruited Yes
☐
No
☐
Number of subjects: Write here

Enrolled Yes
☐
No
☐
Number of subjects: Click here to enter

Seen for study interventions (e.g, administering drugs, performing surgery, counseling)
Yes
☐
No
☐
Number of subjects: Click here to enter

Seen for research interaction, (e.g., collecting urine or blood, conducting an MRI, conducting interviews, asking for informed consent to use medical records)
Yes
☐
No
☐
Number of subjects: Click here to enter text.

Seen for follow-up or treatment Yes
☐
No
☐
Number of subjects: Click here to enter text.
During this lapse period has there been any:
Collection of data Yes
☐
No
☐
Data analysis
Sharing of Data
Yes
☐
No
☐
Yes
☐
No
☐
Other (Describe): Click here to enter text.
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What corrective actions are planned to prevent this type of deviation from occurring in the future?
Click here to enter text.
It is a violation of federal regulation and University policy to continue to conduct research activities once IRB approval for a study has lapsed unless permission is granted by the Yale IRB to continue research interventions. Such permission will be granted by the IRB when discontinuing the research interventions may jeopardize the health or welfare of a participant.
Contact the Yale HRPP office immediately if permission is required to continue research interventions on a study participant.
Under no circumstances can federal funds be expended on research and research-related activities during a lapse period. If this study is federally funded, you must immediately contact your Grant and Contract Administration (GCA) and Grants and Contract Financial Administration (GCFA) representatives.
6.
What is the purpose of this research project? Click here to enter text.
7.
Medical Record Reviews : for studies that are exclusively retrospective medical record reviews:
1. How many records have been reviewed since the last approval/reapproval? Write here
2. How many records have been reviewed since the beginning of the study? Write here
3. Are records still being reviewed? Yes ☐ No ☐
4. Has the use and/or distribution of protected health information been consistent with the use and distribution noted in the current HIPAA Research Authorization form that was reviewed and acknowledged by the HIC and/or the HIPAA Waiver that was approved by the HIC? Yes ☐ No ☐
If no, attach an appropriately revised Research Authorization Form and the Medical Record Review form and explain why the use and/or distribution differs from the original plan.
8. Repositories : For studies that involve or include a repository for biological specimens and/or data: a. How many specimens and/or individual data sets have been collected since the beginning of the study? Click here to enter text.
b. How many specimens and/or individual data sets have been collected since the last reapproval? Click here to enter text.
c. Are specimens and/or individual data sets still being collected? Yes ☐ No ☐
9 . Progress of the study to date : Please explain the study progress since the last full approval (initial or annual).
Click here to enter text.
10 . Publications/ Dissemination : Please list any publications (published or in press) derived from this study in the past year as well as any informal dissemination of results that have been conducted in the past year or are planned in the coming year, beyond the published peer-reviewed scientific literature
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process. (e.g., newsletters, presentations at professional meetings, universities, or in community settings)
Click here to enter text.
11. Enrollment: What is the targeted enrollment (HIC approved number needed to complete the research) for this protocol? Click here to enter text.
a.
From the beginning of the study to date : i. How many subjects have consented to participate? Click here to enter text.
ii. How many subjects completed the study, including all research interventions and follow up? Click here to enter text.
iii. How many subjects dropped out or were lost to follow-up? Click here to enter text.
b. Since the last HIC annual renewal i.
How many subjects consented to participate Click here to enter text.
ii. Number found to be ineligible Click here to enter text.
iii. Number who became active study participants Click here to enter text.
iv. Number who were excluded because of non-compliance Click here to enter text.
v. Number who withdrew Click here to enter text.
State reasons for withdrawal, if known: Click here to enter text.
vi. Number who were lost to follow up Click here to enter text.
vii. Number who completed all interventions and follow-up Click here to enter text.
c. Subject Enrollment : Has subject enrollment progressed as planned? Yes ☐ No ☐
If no, please explain why and whether this will impact the ability to complete this study.
Click here to enter text.
i. Is the accrual to date sufficient to meet targeted enrollment? Yes ☐ No ☐ ii. Will the targeted enrollment be possible to achieve within the stated study duration? Yes ☐ No ☐ iii. Is a change to the number of subjects to be enrolled requested? Yes ☐ No ☐
If yes, attach amendment request form with rationale. d. Enrollment of non-English speaking individuals: i.
Since the beginning of the study, how many non-English speaking individuals have been enrolled using a short form for consent purposes? Provide number and the language of translation in the table below.
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Language Occurrences of use of short form in this language
12. Study Status : Please characterize the status of the study by checking each item that is applicable and answering the questions below: a. Are subjects still being enrolled? Yes ☐ No ☐ If No what is the date enrollment stopped? MM/DD/YY b. For currently enrolled subjects: i. How many remain on study intervention? Click here to enter text.
ii. Are all subjects in long term follow-up ONLY ? Yes ☐ No ☐
If yes, what does it consist of? Click here to enter text.
13. Study Extension : Is an extension to the expected duration of the study requested?
Yes ☐ No ☐ If yes, attach amendment request form with rationale.
14. Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs), including Adverse
Events (AEs):
14a.
Please account only for those events that were:
Unexpected – in terms of nature, specificity, severity or frequency given 1) the research procedures describe and 2) the characteristics of the subject population being studied, AND
Possibly or definitely related to the participation in the research AND
Suggest that the research places subjects or others at a greater risk of harm (or were serious).
Since the last continuing review (i.e., last renewal),
(1) How many UPIRSOs (including AEs) have occurred at Yale? Click here to enter text.
(2) How many UPIRSOs (including AEs) have resulted in a temporary or permanent interruption of study activities by the Principal Investigator or sponsor (e.g., suspension of enrollment) to avoid potential harm to subjects? Click here to enter text.
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(3) How many INTERNAL events were reported to the Yale IRB? [event occurred at a site under the jurisdiction of the Yale IRB (IRB of record)]: Click here to enter text.
(4) How many EXTERNAL events were reported to the Yale IRB? [ event occurred at a site NOT under the jurisdiction of the Yale IRB (at another institution in a multicenter clinical trial)]: Click here to enter text.
NOTE: External events that do not meet the reporting requirements (e.g., not related or not involving risk) and that are not relevant to the protection of Yale research subjects or others should NOT be reported to the IRB.
(5) If the Yale Principal Investigator is the study chair for a multi-center study, how many UPIRSOs
(including AEs) have occurred at all participating sites? Click here to enter text.
(6) Were each of these events reported to a Yale IRB and other organizations as appropriate?
Yes ☐ No ☐
(7) Are there any updates to previously reported UPIRSOs (including AEs) that should be reported to a Yale IRB? Yes ☐ No ☐
If yes, please include such updates.
14b. Attach, in summary form, a list of all related internal and external events involving risk to subjects or others that occurred since the last renewal but did not meet prompt reporting requirements. [See
IRB Policy 710 for more information]. If appropriate, such summary may be a simple brief statement that events have occurred at the expected frequency and level of severity as previously documented.
In lieu of a summary of external events, a current DSMB report can be submitted if the study is subject to oversight by a DSMB (or other monitoring entity that is monitoring the study on behalf of an industry sponsor).
15. Frequency/Magnitude : Is the frequency and/or magnitude of expected side effects different from what was anticipated? Yes ☐ No ☐ If yes, please explain: Click here to enter text.
16.
Complaints: Have there been any complaints received in the past year relating to this study (e.g., complaints from subjects, study staff, employees or others who have knowledge of the study, or relating to the conduct of the study)?
Yes ☐ No ☐ If yes, how many? Click here to enter text.
Please describe the complaint(s) and resolution.
Click here to enter text.
17. Protocol Deviations/Noncompliance: a. In the past year, how many protocol deviations/instances of noncompliance have occurred at Yale
(or another site if Yale serves as the lead site or coordinating center) that required prompt reporting to the HIC? Click here to enter text.
b. In the past year, how many protocol deviations/instances of noncompliance have occurred at Yale
(or another site if Yale serves as the lead site or coordinating center) that did NOT require prompt reporting to the HIC? Click here to enter text.
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List all deviations that occurred in the past year (regardless of whether or not they were previously reported) below (adding additional lines to the table if needed) or include the below table as an attachment.
Date of
Deviation/ noncompliance
Subject
Study ID number
Brief Description of deviation/ noncompliance
Did the deviation/ noncompliance require prompt reporting to the HIC
(yes/no)
Date
Reported to
HIC*
(if applicable)
Corrective and
Preventative Action
(CAPA) measure implemented
( if appropriate ) c. Were all deviations/instances of noncompliance that required prompt reporting submitted to the
HIC per University policy and other organizations as appropriate? Yes ☐ No ☐ N/A ☐
If no, please explain.
Click here to enter text.
d. Are there any updates to previously reported protocol deviations/instances of noncompliance? Yes
☐
No
☐
N/A
☐
If yes, please summarize. Click here to enter text.
18.
Study Audits/Reviews: Was this study audited during this last year by FDA, OHRP, external sponsor or cooperative group? Yes ☐ No ☐
If yes, please attach the report provided and your response ( if applicable ).
19. Data and Safety Monitoring : Is this study monitored by a Data and Safety Monitoring Board
(DSMB) or a Data and Safety Monitoring Committee (DSMC)? (Do Not Include Monitoring Visits by
Sponsors or their CROs.) Yes ☐ No ☐
19a. Were there any summary reports or recommendations issued by the DSMB or DSMC in the past year? Yes ☐ No ☐
If yes attach the summary report or recommendations.
19b.
Did the DSMB or DSMC meet during the past year? Yes
☐
No ☐
If yes, did this/these meeting(s) take place in accordance with the IRB-approved protocol, including documentation of the proceedings? Yes ☐ No
☐
If no, please explain. Click here to enter text.
20. Amendment History : Have any protocol amendments been approved in the past year?
Yes ☐ No ☐ If yes, state dates and purpose of amendment ( e.g., August 201X, dose modification; September 201X, new investigator added) . Click here to enter text.
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21. Risk/Benefit Ratio : Since the last HIC review has anything occurred or is there any new information which may affect the risk/benefit ratio, either from the literature or from the Principal
Investigator’s findings? Yes ☐ No ☐ If yes, please explain: Click here to enter text.
22. Other Relevant Information : Please specify
* any reports from related studies done at Yale or elsewhere,
* any multi-center trial reports which might have implications, either positive or negative, for your research.
* If applicable, any significant marketing developments, such as approval of marketing in any country or withdrawal or suspension from marketing in any country.
Click here to enter text.
Attach copies of relevant publications or trial reports.
23. Confidentiality/Privacy: Have the methods and procedures used to safeguard the confidentiality and privacy of subjects and their data as outlined in the approved protocol been adhered to?
Yes ☐ No ☐ If no, please explain the mechanisms that will be implemented to ensure the proper use and continued protection of these data: Click here to enter text.
24. Certificate of Confidentiality : Does this study have Certificate of Confidentiality?
Yes ☐ No ☐ If yes, what is the expiration date of the Certificate? MM/DD/YY
25. Progress Reports/External Reporting: a. If this study is Investigator-Initiated, was a progress report submitted to the external funding agency/sponsor ( if any )? Yes ☐ No ☐ N/A ☐
If yes, please submit a copy of the progress report.
If no, please explain. Click here to enter text.
b.
If this study is Investigator-Initiated and the PI holds the Investigational New Drug (IND)
[the PI is also the Sponsor Investigator (SI)], was an IND annual report submitted to the
FDA? Yes ☐ No ☐ N/A ☐
If yes, please submit a copy of the most recent IND annual report.
If no, please explain. Click here to enter text.
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