University of Pennsylvania  Institutional Review Board

Modification Form

PRINCIPAL INVESTIGATOR: DATE:

PROTOCOL TITLE:

PROTOCOL #:

CAMPUS ADDRESS/MAIL CODE:

REVIEW BOARD:

SPONSORING AGENCY:

INSTITUTIONAL (Office of Research Services) #:

Federal regulations require IRB approval before implementing proposed changes, including any alteration in content or form to the protocol, consent form or supportive materials (Investigator’s Brochure, questionnaires, surveys, recruitment materials, study personnel list etc).

Please complete and return this form with the required documents (see required materials checklist below, #6)

Refer to the SOP RR 404 for Definitions and IRB Submission Requirements.

The information requested is needed for a comprehensive review, monitoring and oversight of research involving human subjects. Contact with the sponsor to obtain information for multi-center projects may be necessary.

A.AMENDMENTS See SOP RR 404 for definition.

1. CURRENT STATUS OF STUDY: (check only one)
Currently in progress (# of subjects entered at Penn: Other performance sites: )
Study has not yet begun (no subjects entered)
Closed to subject enrollment (remains active); # subjects on therapy /intervention ; # subjects in long-term follow-up only
2. THIS SUBMISSION CHANGES THE FOLLOWING STUDY DOCUMENTS:
(check all that apply)
Protocol Amendment Updated Version Date:
Protocol Summary Amendment Updated Version Date:
Consent Form Amendment Updated Version Date:
Investigator’s Brochure Updated Version Date:
Recruitment MaterialsSpecify:
Study PersonnelSpecify:
Voluntary suspension of: Enrollment / Study
OtherSpecify:
3. THIS AMENDMENT REQUIRES THE FOLLOWING LEVEL OF REVIEW: EXPEDITED* CONVENED IRB
Rationale for this determination:
(*Please refer to the end of this form for list of modifications that may be reviewed through expedited mechanism)
4. DOES THIS AMENDMENT ALTER THE RISK/BENEFIT PROFILE OF THE STUDY? Y N
Rationale:
5. DOES THIS AMENDMENT AFFECT THE CONSENT DOCUMENT? Y N
Our site plans to re-consent all active subjects
Our site plans to re-consent all subjects in follow-up
Our site plans to re-consent all subjects in follow-up and all active subjects
Our site does not plan to obtain re-consent
*If your site does not plan to obtain re-consent, please rationale for this determination:
6. FOR ALL AMENDMENTS PLEASE PROVIDE THE FOLLOWING:
IRB modification form (1 expedited; 15 convened IRB)
Summary/ table listing all changes, location in respective documents, and rationale for changes (1 expedited; 15 convened IRB)
Tracked changes versions of amended protocol summary, consent forms, HIPAA form, recruitment materials, etc (1 expedited; 15 convened IRB)
Tracked changes version of full protocol, Investigator’s Brochure, package inserts, or device manuals if being revised (1 expedited; 3 convened IRB)
Clean document (1 expedited; 3 convened IRB)
*Please see last page for instruction on track changes
*For modifications requiring full board review, please submit 15 collated sets (each set containing 1 copy of each of the revised documents)

EXCEPTIONS

See SOP RR 404 for definition.If the action disrupts the study progress, such that the study design and results would be compromised, or the action compromises the safety and welfare of study subjects, prospective IRB approval is required.

Date or Time Frame of Proposed Exception:
Description of Protocol Exception:
Reason and Rationale of Proposed Exception:
Explanation why action will be one-time, rather than permanent:
PI assessment on impact on study progress or the safety and welfare of subjects:

DEVIATIONS:

See SOP RR 404 for definition. If the impact on the protocol disrupts the study design or compromises the safety or welfare of the subjects, the deviation must be reported to the IRB within 10 business days.

Date Deviation Occurred:
Date Deviation Identified:
Description of Deviation:
Explanation of why Deviation Occurred:
PI assessment on impact on study progress or the safety and welfare of subjects:
PI assessment on whether to provide to participants information relating to protocol changes when such information might relate to their willingness to continue to take part in the research
Correction Actions Taken/Preventative Measures Implemented:

Form completed by (Name/Title):

Signature of Person Completing the Form:

Contact information

Name:

Mailing Address including mail code:

Phone:

Fax:

Email:

By signing this form the principal investigator and the person completing theform (if other than the investigator) certify that he/she has disclosed to the IRB all relevant information that might affect the risk-to-benefit analysis of this study.

Principal Investigator Name:

Principal Investigator Signature:

Date:

[IRB USE ONLY]

ACKNOWLEDGED

APPROVED EXPEDITED

SIGNATURE:

DATE:

If the change represents more than minimal risk to subjects, it must be reviewed and approved by the IRB at a convened meeting. For a modification to be considered more than minimal risk, the proposed change would increase the risk of discomfort or decrease benefit. The IRB must review and approve the proposed change at a convened meeting before the change can be implemented unless the change is necessary to eliminate an immediate hazard to the research participants. In the case of a change implemented to eliminate an immediate hazard to participants, the IRB will review the change to determine that it is consistent with ensuring the participant’s continued welfare.

Examples:

** For track changes: turn on the reviewing toolbar (viewtoolbarsreviewing). You can accept all changes from current point forward by clickingthe arrow next to Accept Change icon in toolbar, and then clicking Accept All Changes in Document.

Use either balloons with tracked changes—OR-- to format for underlines (for additions) and strikethrough (for deletions) Either (1) click Show (in the reviewing toolbar)  options  unclick “use balloons in print and web layout” – OR-- (2) use ctrl-U (for underline), and format font strikethrough (for strikethrough).

Page 1 of 3Version: 14 Dec 2010