Cottage Health Data Use Committee
For DUC Use: / Project Development / Data Request / Please Initial below: / Date:
Date reviewed / Pre-Assessment Tool / Dept VP:
IRB# / COO/EVP:
The information presented in this pre-assessment tool will be reviewed and evaluated by the Data Use Committee (DUC) to determine the scope of the project (e.g. research, QI, EBP) and to ensure that all HIPAA and Privacy regulations are in place prior any collection of data.
Please type directly into this form.
Person submitting request: / Phone: / E-Mail:
Please list all individuals involved: / Phone: / E-Mail:
Project Title:
Sponsor, if any:
Sites/departments where the project will take place:
Will this project involve participation of employees (nurses / residents) as subjects? YES NO
If yes, attach an email from Diana Lovan indicating that HR has reviewed this PAT and approves of the project.
Is this project fulfilling a school requirement? No Yes School Name:
If yes, the school requires approval(s) from CHIRB CH Administration
You may not mention Cottage Health by name in any presentations or written reports.
Project Design
The intended scope of this project/data collection request is (please check only one):
Research Quality Improvement Other (explain):
Evidence Based Practice(attach sufficient published research to support “evidence”)
For clarification of the above definitions, seeComparing and Contrasting Research EBP QIat the end of this document.
The request involves (check all that apply):
A drug or device: ______
A procedure/patient interaction
Data collection/record review/survey/quality assurance results
The population studied includes (check all that apply):
Adults Children (< 18 years) Pregnant women/fetuses
Individuals who are severely ill or incapacitated/mentally or cognitively disabled/substance abusers
Will subjects be consented to participate in the project?
Yes No
If no, please explain why: ______
Contact Jeanne Li (x59245, ) with any questions you have with this section.
  1. What is the illness / type of population you are targeting?
  1. Why is this drug / intervention needed?
  1. What are the objectives ofthe project?
  1. How many patients are expected to be included?
  1. What specifically is going to be / was done with the participants and when?
  1. How many arms / treatment groups will be included?
  1. What are the inclusion and exclusion criteria?
  1. What are the outcomes based on safety and efficacy?
  1. What is the statistical plan / how will the data be analyzed?

Data

Attach a list of discrete and specific data points required for the project.
(Some good examples include “date of birth” and “asthma” instead of “medical history” and “chronic diseases”.)
Will you be performing a chart review or requesting a generated report? Chart Review Generated Report
Where will this data be retrieved? (e.g., CottageOne, institutional registry, physician’s office medical record)
Will you need help analyzing data? Yes No
Information security will determine how the data will be stored.
Will any of the individuals involved (refer to the individuals listed on page 1) be non-CH employees? Yes No
If yes, specify: ______
Will all individuals involved need access to the data? Yes No
Will the data and/or the findings leave Cottage Health for any reason? (e.g., external collaborators, publications, presentations) YES NO
If yes, specify if the shared data will contain any identifiers listed above OR will it be anonymous? Contain identifiers Anonymous

Protected Health Information (PHI)

Which of the following identifierswill be associated with the data you propose to collect? Check all that apply. None of the data listed below will be collected.

Names / Telephone Numbers
Address / E-mail Addresses
Fax Numbers / Medical Record Numbers
Social Security Numbers / Account Numbers
Health Plan Beneficiary Number / Vehicle Identifiers and Serial Numbers
Certificate/License Numbers / Web Universal Resource Locators (URL)
Device Identifiers and Serial Numbers / Biometric Identifiers (finger and voice prints)
Internet Protocol (IP) Address Numbers / Any Elements of Dates (specify which of the following identifiers you will use: birth date, admission date, discharge date, date of death, age over 89)
Any Geographic Subdivisions Smaller Than a State (specify which of the following identifiers you will use: county, city, parish, or zip code)
Full face photographic images and comparable images / Any other unique identifying number, characteristic, or code (please specify):
Is there any other information that you would like to share with us?

My signature below attests that the information given in this request is correct to the best of my knowledge and that I shall willingly comply with any/all required data use policies and parameters surrounding this request. I acknowledge that the DUC review is only one of the approvals I may need in order to conduct the project, and will not begin the project until all of the necessary approvals have been secured.

______

Printed Name Signature Date

I have met with the individual interested in conducting the project and have determined that the project is feasible. I have reviewed the overhead needed to conduct the study and I am able and willing to support it.

My signature below attests that the individual will have the support of the department to conduct the project, and will be provided with sufficient resources to properly conduct and complete the project.

______

Director/Manager’s Printed Name Signature Date

Manager’s Comments:

This Pre-Assessment Tool will not be accepted until reviewed and signed by your director/manager.
Comparing and Contrasting

Research, Evidence Based Practice and Quality Improvement

Research / EBP / QI
Purpose / Generate new knowledge / Change Practice / Improve Patient Care
Method / - Qualitative
- Quantitative
- Long Complex / - Qualitative articles
- Quantitative articles
- Expert opinion
- Guidelines
- Lengthy / - PDCA
- Short
- Simplistic
Sample / - Related to purpose & research question
- Representative / Related to identified population / Unit or organization
Data Collection / -Ensure external and internal validity & trustworthiness
-Long term / - Critical appraisal of articles (other people’s research)
- Searching for best evidence / - Short term
- Action plan & evaluation
Human Subjects / IRB review and approval / Data Use Committee / Data Use Committee
Results / Seeks to add to professional literature / Seeks to impact practice / Seeks to improve processes in unit and organization
Implications / - Comprehensive
Understanding of issues in a phenomenon
- QI implications / - Use of (other people’s) research to impact practice
- QI implications / - Change processes
- Decrease cost
- Increase efficiency
- Increase patient & staff safety
- Improve satisfaction
Dissemination / - Scientific community (National and international) / New standards of practice / Unit and organization

Revised 2-23-17 jl/liPage 1