IRB End Oversight Request

SP Code:	Date:

Title:

Protocol #:

Principal Investigator:

P.I. Routing Location:	Phone:

Research Coordinator:	R.C. Routing Location:

Report Due:

Date of Original Approval:

Is all intervention or interaction with human research participants and/or their identifiable (including coded) data complete?

Intervention includes both physical procedures by which data are gathered and manipulation of the participant or their environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator, research staff and the participant.

No (STOP – IRB Oversight must continue)

Yes

Will any study data that are being stored internally contain either direct or indirect identifiers or codes to identifiable information?

No

Yes - answer the following:

List the identifiers/codes to be retained internally:

Note the length of time data will be retained internally with identifiers/codes:

Provide justification (scientific, legal, health, etc.) for retaining data with identifiers internally for

this period of time:

Explain where the data will be stored and how it will be secured internally:

Explain who will have access to data with direct identifiers and for what purposes:

Will any study data that are being stored externally contain either direct or indirect identifiers or codes to identifiable information?

No

Yes - answer the following:

List the identifiers/codes to be retained externally:

Note the length of time data will be retained externally with identifiers/codes:

Provide justification (scientific, contractual, health, etc.) for retaining data with identifiers

externally for this period of time:

Explain where the data will be stored and how it will be secured externally:

Explain who will have access to data with direct identifiers, and for what purposes:

Please keep in mind that you are responsible for maintaining research records, including copies of signed consent documents, for a period of six years past the date the project is officially terminated with the IRB.

SIGNATURE

I certify that statements herein and attached are true and complete to the best of my knowledge.

Signature of Principal Investigator	Date

Printed Name of Principal Investigator	Routing Location

Printed Name of Person Completing Report	Routing Location

Submit completed paperwork to: Office of Research Integrity & Protections - 1R4

Version – April 26, 2016

Institutional Review Board

Scheller, Lori A

2016-07-18

Knecht, Justin E

Marshfield Clinic