Amendment, Sponsor Waiver Or Exception

MODIFICATION REQUEST FORM

(Amendment, Sponsor Waiver or Exception)

ALL MODIFICATION REQUESTS MUST BE REVIEWED/APPROVED AND SIGNED/DATED BY THE PRINCIPAL INVESTIGATOR

Use the attached form to request IRB approval of the following:

• Proposed changes to your current IRB approval
• A proposed change which impacts an individual subject but does not change the overall protocol (for example: sponsor waiver or exception)

Do NOT use this form:

• To report a change to the currently approved protocol which has already been implemented without prior IRB approval (Use the Protocol Deviation-Violation form)
• In emergency situations involving unanticipated problems involving risk to human subjects or others (Contact the IRB staff at 509-343-2121)
• To close a study (Final report)

Modifications for Full Board Review

Any change that involves risk to subjects, or others, or significantly affects the nature of the study. Examples include but are not limited to: revision to the study design; revision to the recruitment plan, adding/revising inclusion/exclusion criteria, newly identified side effect or adverse event related to the study drug/device.

Submit the following:

1. Two (2) paper copies of the revised protocol
2. Two (2) copies of any other pertinent materials
3. Twenty-five (25) copies of the summary of changes provided by the sponsor
4. Twenty-five (25) copies of the Modification Request Form
5. Twenty-five (25) copies of the revised informed consent/assent (if applicable) with revisions highlighted
6. One (1) electronic clean informed consent/assent
7. An electronic version of all submitted documents

Modifications for Expedited Review –

Minor revisions that are no more than minimal risk, risks to subjects are not increased, or revision is not a significant alternation of the study design. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Submit the following:

1. One (1) copy of the revised protocol
2. One (1) copy of any other pertinent material
3. One (1) copy of the summary of changes provided by the sponsor
4. One (1) copy of the Modification Request Form
5. One (1) copy of the revised informed consent/assent (if applicable) with revisions highlighted or tracked
6. One (1) electronic clean informed consent/assent

Change in Principal Investigator -

Change in the Principal Investigator REQUIRES the signature of the new PI, which will signify his/her willingness to assume the PI responsibilities for the study.

For research being conducted at Providence Holy Family, Providence Sacred Heart Medical Center and Children’s Hospital, or a Providence Medical Group practice you must contact Providence Medical Research Center to ensure Providence credentialing and conflict of interest in research requirements have been met prior to submission of your request. Contact information is located on the Home Page of our website

Change in Research Personnel –

For research being conducted at Providence Holy Family, Providence Sacred Heart Medical Center and Children’s Hospital, or a Providence Medical Group practice you must contact Providence Medical Research Center for approval to add personnel. Providence credentialing and conflict of interest in research requirements must be met prior to submission of your request to add research personnel. Contact information is located on the Home Page of our website.

Location where research is conducted –

For research being conducted at Providence Holy Family, Providence Sacred Heart Medical Center and Children’s Hospital, or a Providence Medical Group practice you must contact Providence Medical Research Center for approval to add a new Providence site. Contact information is located on the Home Page of our website.

Sponsor waiver or exception –

A sponsor waiver or exception is considered a modification to the protocol. Most sponsors will not grant a waiver or exception. However, if one is requested and approved, it must also be approved by the IRB prior to implementation. See Amendment, Sponsor Waiver or Exception SOP.

The sponsor must provide approval of waiver or exception in writing and this information must accompany the modification request submitted to the IRB. Examples of waivers that may be granted by a sponsor include but are not limited to: Subject does not meet age criteria for enrollment by 6 months, but otherwise meets inclusion/exclusion criteria; one lab value does not meet inclusion/exclusion criteria by a small amount; a follow up visit date may be missed because subject is out of town.

Remember –

• Allow ample time for processing of this modification request. Changes may not be implemented prior to receiving IRB approval.
• Do not send instruction pageswith your request.

ALL MODIFICATION REQUESTS MUST BE REVIEWED/APPROVED AND SIGNED/DATED BY THE PRINCIPAL INVESTIGATOR
MODIFICATION REQUEST FORM

(Amendment, Sponsor Waiver or Exception)

Full Board Review Expedited Review Sponsor Waiver/Exception

Date of Submission:

IRB No:

PI:

Protocol Number:

Protocol Title (is this a title change Yes No):

Date of SponsorModification:

Sponsor’s revision (or amendment) number:

Sponsor:

Person completing: Phone: E-mail:

Are any subjects still participating?

Yes Still receiving study interventions

Long term follow up only (all protocol interventions have been completed)

No

Revisions

Provide detail in Summary Section

Submit documents as noted above or below

1572

Assent form (for studies with a pediatric population), version date:

Change in conflict of interest for key research personnel – submit Conflict of Interest Disclosure Form. Also requires reporting to Providence Medical Research Center, if research being conducted at a Providence entity.

Change in Principal Investigator – see instructions above

Estimated number of subjects – provide rational for increase or decrease

Study wide: Local:

Extension toproject end date – provide new end date and rational for extension

Informed Consent, version date:

Inclusion/Exclusion Criteria

Investigator’s Brochure (drug studies), version date:

Submit Summary of Changes from study sponsor

Instructions For Use (device studies), version date:

Submit Summary of Changes from study sponsor

Location where research is conducted (addition or removal) – if adding a Providence research site - see instructions above

Protocol, version date:

Submit Summary of Changes from study sponsor

Research procedure (addition or removal)

Study design (including objectives)

Study personnel – see instructions above

For each addition, specific if delegated to obtain informed consent ornot

Study status

Submit copy of notification from study sponsor

Subject population

Subject recruitment

Submit new or revised recruitment material

Waiver or exception from sponsor

Submit written approval from sponsor

Other (submit supporting documentation if applicable):

Summary of Revisions

**Briefly summarize revisions**

**Principal Investigatorsignature required for all modification requests **

My signature below indicates that I have reviewed and approve the information contained in this modification request. As the Principal Investigator I am responsible to ensure all sub-investigators and key research personnel are aware of these revisions.

______

Printed Name

______

Signature of Principal Investigator Date

**FOR CHANGE IN PRINCIPAL INVESTIGATOR **

Principal Investigator assuming responsibility for the study must sign below

My signature below indicates that I agree to assume all responsibility of this study as the new Principal Investigator.

______

Printed Name

______

SignatureDate

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