North Shore-Long Island Jewish Health System Institutional Review Board

Application for Requested Modifications

NOTE: THIS FORM MUST BE TYPED. HANDWRITTEN FORMS WILL NOT BE ACCEPTED.

When to Use This Form

  • This form should be used when you want to modify your IRB approved study. Changes(amendments/modifications) to a protocol may not be initiated without prior IRB approval, except when necessary to eliminate immediate hazards to subjects.
  • This form should not be used for reportable events or study termination.
  • All modifications toTAPprotocols must be reviewed and approved by theCOPPprior to submission to the IRB.

IRB Version: 4/30/2015Page 1 of 3

North Shore-Long Island Jewish Health System Institutional Review Board

Submission Instructions

For detailed instructions on how to submit a modification, please review submission instructions online here: All submissions should be sent through email to the IRB at: . Protocols and consent forms should be submitted in an editable format such as Word, Excel, etc. Please contact the IRB office at 516-321-2100with any questions.

General Study Information
Date: / IRB #
Principal Investigator: / Department/Division:
Protocol Title:
Study Coordinator: / Phone: / Email:
Study Status: Actively enrollingClosed to enrollment, subjects in follow-up
Is this study NIH Funded? Yes No
  • If yes, has NIH approval been granted for this modification? Yes No (If yes, please provide the NIH Approval Letter)

NOTE TO INVESTIGATORS

  • CHANGES TO PREVIOUSLY APPROVED STUDY DOCUMENTS SHOULD BE SUBMITTED WITH THE CHANGES TRACKED (USING THE TRACKED CHANGES FUNCTION IN MICROSOFT WORD)
  • If your study is being conducted under a clinical trial agreement or has a budget, please make sure to contact the GMO office () if this modification will impact that agreement and/or budget.

Protocol Updates/Amendments
It is REQUIRED that you provide the following:
1 / A detailed summary from the investigator describing the changes and how they impact on patient care/treatment (If the space below does not suffice, please attach additional pages.):
2 / A complete copy of the revised protocol, with the changes tracked.
  1. Please provide the updated version date:
  2. Has the revised protocol been submitted within 90 days of the revision being released?
  • If it has been more than 90 days, please provide a corrective action plan, to assure that future modifications will be submitted within a timely manner, to the IRB for review:

3 / Any other relevant documentation
Consent Form Changes
It is REQUIRED that you attach:
1 / A copy of the revised consent, with the changes tracked.
  1. Please provide the updated version date:

2 / A summary of changes if not associated with a protocol amendment.
Other Changes
Submission or modification of recruitment materials, survey instruments, investigator’s brochure, etc.
1 / Please describe modification:
A copy of the revised document(s), with the changes tracked should be submitted.
Personnel Changes
1 / If you are removing personnel, please list their names here:
2 / If you are adding new personnel, complete the table below. New personnel must have the followingcomplete:
  • Required Education: Information on the required trainings can be found online here: Completion Dates can be found online at
  • External Interest (COI) Disclosures for Research: As of July 1, 2013, all NSLIJHS researchers with access to the eRA portal must complete their annual External Interest (COI) Disclosure electronically at era.northshorelij.com/login.asp. Those without access should complete the paper Conflict of Interest Questionnaire available online at

Name
/
Required Education
/ Obtaining Informed Consent? /
External Interest (COI) Disclosures
for Research
Human Subjects Training(CITI)
Date
/
Researcher Registration
Date
/
COI CITI Training
Date / Date of Disclosure / Management Plan Required?† / Disclosures for all personnel being addedhave been reviewed & are accurate as of the date of this submission?
Y N / Y N / Y N*
Y N / Y N
Y N / Y N
Y N / Y N
Y N / Y N
Y N / Y N
Y N / Y N
Y N / Y N
Y N / Y N
Y N / Y N
Y N / Y N
If additional space is needed, you can find a study personnel addendum at
*If an individual’s disclosure is not up to date, he/she should revise the disclosure using the appropriate method.
*Note: Only those who have been approved by the IRB to obtain informed consent may do so.
3 / If this study has been deemed greater than minimal risk by the IRB, submit a current medical license for anyone who will be obtaining consent.
4 / Are all investigators being added employed by NS-LIJ Health System? Yes No.
  1. If no, please indicate which investigators are employed elsewhere and where they are employed:

5 / Confirm that all investigators on this study have the adequate resources to protect human subjects:
Yes No
6 / Explain how staff is qualified; include any training and expertise specific to the conduct of this study. Include information about relevant licenses/medical privileges, as applicable:
7 / Detail processes to inform staff of the protocol and their duties and functions for this study:
8 / Sponsor Investigators OR N/A
Complete if: The PI is a NSLIJ Investigator holding an IND or IDE. All NSLIJ study personnel involved in a study in which the PI holds an IND/IDE need to complete a HRPP approved GCP training, such as the CITI Program GCP Curse, 2-day Navigating Clinical Research class, or a Transcelerate accredited course. If personnel have taken a course other than CITI or Navigating Clinical Research, please submit the certificate with the training completion date.
Study Personnel Name / GCP Training Date / Name of GCP Training Course
Change of Principal Investigator
Indicate person replacing the current PI on the study:
Name:
/ Phone:
Dept/Div:
Mailing Address:
/
Email:
1 / Is this person currently listed on the protocol? Yes No If no, complete the conflict of interest disclosure.
2 / Will he/she be obtaining informed consent from subjects? Yes No N/A
3 / Attach revised study documents (e.g., protocol/consent) reflecting change of PI and contact information.
Note: All active subjects must be promptly notified that the PI has changed. Notification must be documented in research record.

I am no longer able to serve as PI on the above study. (Insert name of new PI) has the appropriate knowledge and credentials to serve as PI on this study and I have provided him/her with all of the necessary information and critical documents for the study.

______

Signature of Current Principal Investigator

I have reviewed the study, the critical documents, etc. and accept responsibility to serve as the PI on this study.

______

Signature of New Principal Investigator

Protocol Exception

1.Please describe the exception:

2. Explain the reason for the exception:

PRINCIPAL INVESTIGATOR SIGNATURE

By signing below I attest that the modifications, if approved and implemented, will notresult in a change of the risk/benefit ratio nor will they affect a change in the study’s overall objective(s).

______

Signature of (New) Principal Investigator

IRB Version: 4/30/2015Page 1 of 3