Request for Participant User File (PUF)

Request for Participant User File (PUF)

EXHIBIT A TO APPENDIX I DATA USE AGREEMENT
Thank you for your interest in NACOR data use. Please complete all required fields (*) and contact AskAQI@asahq.org with any questions.

Only active NACOR participants are permitted to request data at this time.

If you, or your organization, is not an active NACOR participant, please contact us at AskAQI@asahq.org for additional information regarding participation or partnership opportunities.

CONTACT INFORMATION
Principal Investigator (PI) Name*

First NameLast Name
PI Credentials*
(e.g. MD, DO, CRNA, Resident, etc.)
PI Role*
(e.g. Anesthesiologist, Professor, etc.)
Institution/Affiliation*
PI Email*
example@example.com
PI Phone Number*
Please enter a valid phone number.
Contributor Details (co-investigators, mentors, and/or institutional contacts)
Describe statistical expertise available within your group or institution: *
NOTE: AQI recommends a statistician be formally involved whenever possible

DATA USE REQUEST FORM
I, PI Full Name* , agree as a recipient of Anesthesia Quality Institute (AQI) data to the following principles and constraints.

AQI is an accredited Patient Safety Organization under the provisions of the federal Patient Safety and Quality Improvement Act of 2005.

The de-identified data (“Data”) I am receiving is for the purpose of:
Data Use Methodology
1. Is this a new or updated request?

New requestUpdate to a prior requestNew request due to project extension or intended dataset re-use
2. Brief research objective:*
Briefly describe the study objective
3. Research question and hypothesis:*
State your specific research question and hypothesis
4. Study design*
Describe your study design
5. Brief study background:*
Briefly describe the scientific background and rationale for the proposed study
6. Population & inclusion/exclusion criteria:*
Define your study population (e.g. Px, Dx, time, etc.) and state the inclusion/exclusion criteria
7. Target comparison group(s):*
Enter NA if no comparison is being made
8. Intended subgroup analysis
Describe any planned subgroup analyses or enter "NA" if not applicable
9. Target Outcome(s) Definition and Measurement:*
Describe the primary, and any secondary, outcomes including how they will be defined and measured.
10. Statistical Methods and Control for Confounding:*
Please describe the statistical methods to be used, including strategies to control for confounding factors
11. Please describe any previous experience you have using NACOR data:
Indicate "NONE" if no prior experience
12. If applicable, describe available funding for this project:
Indicate "NONE" if no available funding
13. Intended use(s) of study results (select all that apply):*

Peer-reviewed publicationExternal presentationInternal investigationMarketingOther
14. Any supporting documentation (optional):

Cancelof

REVIEW & APPROVAL
By submitting this application, you acknowledge and agree that you have completely disclosed all of your intended uses for the requested data above. If approved, you agree to be bound by all applicable AQI policies and procedures including, but not limited to, manuscript review processes and protocols to ensure scientific reliability and data use consistent with approved methods, and obtaining your own IRB approval if needed.

Accordingly, you acknowledge and agree that AQI has the right to review all proposed scientific publications, request reasonable amendments thereto, and veto any proposed scientific publications arising from data use inconsistent with approved methods. You agree that AQI is not responsible for, and does not necessarily endorse, study conclusions.

If your NACOR data use request is approved, AQI will confirm and follow-up with a Qualified Expert Agreement (QEA) and Data Use Agreement (DUA) for review and signature before any NACOR data is provided. You agree to adhere to the terms of such agreements with AQI and AQI’s Data Use Policy. You understand that should AQI provide you with data, it is intended solely for your use, and disclosure to anyone besides those that sign agreements with AQI is strictly prohibited unless expressly agreed to in writing by AQI.
Principal Investigator:
Full Name* Signature* Date*
Should be Empty:

Request for Participant User File (PUF)

Data Use Methodology