Institutional Review Board
Amendment/Addenda Application
This form is to be submitted whenever there is a change to an existing protocol (amendment) or an additional procedure is added to a protocol, or supplemental information is provided (addendum) such as recruitment materials, translated documents, addition of study personnel.
A cover letter or additional information may also be attached. Changesmust be summarized on this form or a sponsor's summary letter can be attached. If there are revisions to any documents (protocol, consent) the revised portions of the pertinent documents must be highlightedor the changes tracked, or the application package will be returned to the Investigator. Changes or additions to protocols may not be initiated until IRB approval has been obtained.
1.IRB Number:
2.Protocol Title:
3.Sponsor:
4.Principal Investigator:
Phone: / () -
5.Co-Investigator:
Phone: / () -
6.Study Coordinator:
Phone: / () -
7.Primary Contact:
Phone: / () -
AMENDMENT [change to an existing protocol or other study documents]
Please indicate the type of change:
Amendment to Protocol:
Amendment # Version date:
Modification of Consent Form(s)
Change in Investigational Drug or Device / Investigator’s Brochure update:
IB # Version date:
Package Insert change/update:
Version date:
Update of 1572 or Financial Disclosure
Change in Study Title
Change in Principal Investigator
Change in Co-Investigator(s) or other study staff / Change in number of subjects to be enrolled at BCHO
Change in Funding/Sponsorship
Change of existing study site(s)
Other:
AMENDMENT (Cont'd.)
Please indicate the impact of the change on subject safety or participation. Check all that apply:
No impact.Minor impact.Major impact.
Minimal additional procedures or time on study.
Significant increase in risk or time on study and requires re-consent.
Requires re-consent.
Requires suspension or termination of study activities.
ADDENDUM OR OTHER NEW INFORMATION [additional procedure added to a protocol or
supplemental information is provided, e.g., recruitment materials]
Please indicate the type of change or new information:
Addendum to Protocol
Submission of translated documents (consent, advertisements, flyers, etc.)
Advertisement or other recruitment materials
Poster submission
Addition of study site(s)
Notification of other external IRB review or action
Notice/Summary of regulatory agency inspection
Other:
Please indicate the impact of the change or new information on subject safety or participation. Check all that apply:
No impact.Minor impact.Major impact.
Minimal additional procedures or time on study.
Significant increase in risk or time on study and requires re-consent.
Requires re-consent.
Requires suspension or termination of study activities.
EXPLANATION OF CHANGE OR ADDITION
Please describe the changes in detail and attach supporting documentation as needed. If changes have been made to the informed consent document please attach a highlighted and clean copy incorporating those changes, in addition to a tracked electronic copy sent by e-mail.
RISK – BENEFIT ASSESSMENT
1.How many subjects have been enrolled at BCHO to date?
2.Are the risks to subjects affected (increased or decreased) by the amendment or addendum? / Yes
No
If yes, describe how the change will affect the risk-benefit ratio for the subjects.
3.Is it necessary to inform subjects who have already consented to participate in the research of the amendment or addendum? / Yes
No
If yes, should they be asked to sign the full revised informed consent form OR should an addendum to the informed consent document be prepared for discussion with the subjects? .
Select one: Full Revised Informed Consent Document Consent Addendum
Certification of the Principal Investigator: I understand the requirements of applicable laws and regulationsgoverning research involving human subjects. I certify that all personnel associated with this project will continue to conduct the project in full compliance with the aforementioned requirements. I will not implement changes in the previously approved research without prior approval of the IRB, except where changes are necessary to eliminate apparent immediate hazards to subjects or others.
Principal Investigator’s SignatureDate
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