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LSUSHC-NO Principal Investigator: Study Title:

LSUHSC-New Orleans Institutional Review Board Prevention and Early Treatment of Acute Lung Injury (PETAL) - CIRB Application for Continuing Review or Closure

PLEASE NOTE: IBC reapproval is still required as applicable. Please attach updated COI Attestations for local team. Please ensure study team members have current CITI training within the past three years.

1. Study Information:

A. Has the study received any amendments or risk:benefit changes within the past year? Yes* No

*Please provide a brief summary of changes:

B. Have there been any site changes in which the study will be conducted under the local PI? If residential home visits are requested, please refer to Chancellor’s Memo 16. Yes* No

*Please provide new sites:

C. What is the total number of local subjects enrolled within the past year: What is the total number of local subjects enrolled overall:

What is the total number of local subjects voluntarily withdrawn in the past year: What is the total number of local subjects withdrawn by the PI/SI in the past year:

D. Does the study still involve the enrollment of:

Minors? No Yes Vulnerable Populations? No Yes Pregnant Women? No Yes LSUHSC-NO Employees/Staff? No Yes* Refer to IRB Guidebook section 5.6 LSUHSC-NO Students? No Yes* Refer to IRB Guidebook section 5.6 Prisoners? No Yes* Refer to Chancellor’s Memo 45

E. Is subject/data enrollment still open? Yes* No E.1 Subjects are in treatment or survival follow-up that involve no more than minimal risk OR procedures that would have been performed as routine clinical practice for monitoring of disease regardless if described in the protocol

PETAL Application for Reapproval or Closure, LSUHSC-NO November 8, 2016 1 of 4 LSUSHC-NO Principal Investigator: Study Title:

E.2 Subjects are in treatment or survival follow-up that require research interventions that would not have been performed as routine care or monitoring for clinical indications, even if interventions involve no more than minimal risk

E.3 Subject accrual is completed at this site but is in data analysis stage

E.4. Study is completed at this site and may be fully closed. Please include brief summary of study findings if not already included with LeadIRB documentation.

2. Informed Consent Language. Please attach two (2) redacted local ICF/Assent Forms with this application

N/A- LeadIRB granted Documentation of ICF Waiver of Consent/Documentation of Consent

A. Has any local consent processes changed within the past year? Yes* No

*Please describe new consent process changes:

3. HIPAA/Waiver of Authorization. Please attach two (2) redacted LSUSHC-NO HIPAA Authorizations with this application

N/A- LeadIRB granted HIPAA/waiver of Authorization.

4. Funding. If any changes have been made to the funding source in the past year, please attach. N/A

Please indicate the new source of funding:

PI Attestation: I, as a local Investigator, am aware that I will remain responsible for the following during the conduct of the study at our local site:  Adhering to the protocol and conduct of the study  Adhering to LSUHSC-NO Institutional Policy(s) regarding research  Providing to the LSUHSC-NO IRB access to all study documents, either in electronic version or via the PETAL CC website.  Ensuring local regulatory documentation is maintained, including the conduct and training of the local study team members and delegation of duties as such

2 LSUSHC-NO Principal Investigator: Study Title:

 Reporting of any local SAEs and/or protocol deviations/noncompliance to the LSUHSC-NO IRB within the timeframes as stated in the LSUHSC-NO IRB Guidebook, Sections 4.7-4.8  Providing notification for all future regulatory documents to LSUHS-NO IRB including re- approvals, amendments, and amended informed consent forms.

PI Printed Name:

PI Signature:

Date:

PETAL Application for Reapproval or Closure, LSUHSC-NO November 8, 2016 3 of 4 LSUSHC-NO Principal Investigator: Study Title:

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