CRDW Data Access Request

CRDW Data Access Request

CONTACT INFORMATION

PI Name*

Enter your full name

Institution Name*

Enter the name of your Institution, School or Unit

Primary Contact Email*

Provide your email address so that we can follow-up with your request

Primary Contact Phone Number

Phone

Affiliation*

Rutgers

RWJBH

Other

Department Head / Hospital CEO*

Please provide the name of your Department Head or Hospital CEO

Email of the Department Head / CEO*

Please provide email address of your Department Head / CEO. We will need it for research approval on Data Usage Agreement (DUA)

PROJECT INFORMATION

Project Title*

Enter a short name of your project

Description of the Project*

Provide a short description of the project, 50 words or less please.

Project Significance*

Briefly explain the significance of the project.

Project Duration*

Anticipated time to complete the project once the data is received.

Type of Data Requested*

De-Identified Data (Safe Harbor)

Limited Data Set (LDS)

Unknown/Not Applicable

IRB INFORMATION

Note: Please consult the NJ ACTS Regulatory Core for assistance in determining the answers to the following questions if needed. Furthermore, the QA vs. Human Subject Research Flow diagram available on the Rutgers HRPP website may be helpful for determining whether your project requires IRB review and approval.)

Human Subject*

Does this project meet the definition of Human Subjects Research in accordance with § 45 CFR 46.102?

YES

IRB*

Do you have IRB approval?

Yes

IRB determination for Non-Human Subjects*

Do you require an official Rutgers IRB determination that this project does not meet the definition of human subjects research (for example, for publication purposes)?

YES

HRPP tool

You must complete the Rutgers HRPP Non-Human Research Self-Certification Tool and upload a pdf of this submission.

Rutgers eIRB number (if applicable)

Upload Documentation*

Your request can't be processed without a proper IRB documentation. Please attach to the form.

For Human Subject Research: (1) eIRB approval notice AND (2) a stamped copy of the IRB approved protocol

For Non-Human Subject Research: upload either (1) the IRB Determination letter for non-Human Subjects OR (2) PDF file of Non-Human Research Self-Certificate (3) Your Study Research Protocol

Data Requirements description (Optional)

Drag and drop files here or

DATA REQUIREMENTS

Note: If the elements (D1-D3) below are included in a stand alone document or IRB protocol, you may upload the document in the Upload Documentation Section above.

Otherwise, please provide the following information:

D1: Additional Information*

Include diagnoses names, icd9/icd10 codes

D2: Patient Data Collection*

Specify key inclusion criteria, e.g. demographics, age, disease stage, status, medication, treatment modalities, etc

D3: Time period*

Time range of the data needed for this study

Notes

Any additional information

Send me a copy of my responses

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