Submitting an HCIA Research DUA Request Faith Asper, M.H.S., CIPP/G Director Work performed under CMS Contract #HHSM-500-2013-00166C
Overview Describe the request process Provide a detailed review of the required materials for a research DUA request Discuss each request document and tips for completion Provide resources 2 Work performed under CMS Contract #HHSM-500-2013-00166C
Overview of Request Process Resea earcher cher ResDAC CMS GDIT CMMI PO Draft identifies as Packet Research Packet DMP Review Reviews Revisions Final Packet CMS Analyst Privacy Board Decision Processing/ Notification Onboarding Process may take 8-12 weeks 3 Work performed under CMS Contract #HHSM-500-2013-00166C
ResDAC CMMI Request Center 4 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials & Tips for Completion 5 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials List Requ quest est Docume ument nt Not otes es 1. Request Letter ResDAC has created a template 2. Executive Summary The Executive Summary is the main document reviewed by a. Physical receipt the CMS Privacy Board. b. VRDC It includes a Data management plan, which is reviewed by GDIT. 3. Study Protocol Please supply the proposal that CMS approved. 4. Data Use Agreement Please complete the 6-page DUA. DUA Attachment B Acknowledgement that requestor is allowed to identify physicians. 5. Signature Addendum to This is needed for individuals that will access the data and DUA are NOT supervised by either the User (#16 of DUA) or Custodian (#17 of DUA). This will also be needed if the VRDC seat holder if he/she did not sign #16 or #17 of the DUA. 6 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials List, continued Requ quest est Docume ument nt Not otes es 6. Evidence of Funding Include the CMS grant award face sheet as evidence that this request is an CMMI awardee and therefore, data are free of charge. 7. Information Only No Fee ResDAC will produce an information only, no fee cost invoice Cost Invoice so that all individuals involved with the request know that there is no charge for the data and why. 8. CMMI Specifications This document outlines the data that are requested and Worksheet where data are to be shipped. 9. IRB Waiver Approval Institutional review board waiver approval is necessary for all research requests. 10. HIPAA Attestation Document that requests the researcher identify whether the request is being submitted as a Research ch or Health th Care Operati ations ns request. Other file specific materials Examples include: Variable justifications for Part D and Assessment data and Part D DUA Attachment A 7 Work performed under CMS Contract #HHSM-500-2013-00166C
1. Request Letter 8 Work performed under CMS Contract #HHSM-500-2013-00166C
2a. Executive Summary – Physical Data This is the Exec Summary used when physical data are requested. 9 Work performed under CMS Contract #HHSM-500-2013-00166C
2b. Executive Summary – VRDC Access This is the Exec Summary used when VRDC access is requested. 10 Work performed under CMS Contract #HHSM-500-2013-00166C
Executive Summary Resources Executive summary physical receipt of data ˗ DPSP Information Security and Privacy Best Practices Executive summary for VRDC access ˗ http://www.resdac.org/cms- data/request/materials/cms-vrdc-executive-summary- template ResDAC “Tips” documents describe how to complete the Executive summary. 11 Work performed under CMS Contract #HHSM-500-2013-00166C
3. Study Protocol Please supply a copy of the proposal that CMS awarded. This should include a detailed description of the project being performed. 12 Work performed under CMS Contract #HHSM-500-2013-00166C
4. Data Use Agreement CMS will assign after submission This should be the Awardee Organization Name 13 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Use Agreement Include the name of the project. Insert a CMS contract No if you have received one. Most requests will not have one. 14 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Use Agreement List specific files and years requested. Leave SOR blank. Year for the crosswalk files should be the year that it was provided. (i.e. 2015) CMS has an automatic 1 yr retention period. 15 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Use Agreement If signature addenda are needed, include that under #12 as well as Attachment A and/or B. 16 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Use Agreement #16 is the individual that is authorized to sign on behalf of the Requesting Organization. Must include physical address (No PO Boxes). #17 is the individual that is responsible for the data security. 17 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Use Agreement CMMI PO will sign #20 after final package is submitted to CMS. 18 Work performed under CMS Contract #HHSM-500-2013-00166C
4a – DUA Attachment B Person that signed #16 of DUA should sign here. 19 Work performed under CMS Contract #HHSM-500-2013-00166C
5. Signature Addendum to the DUA Insert study name as it appears on the DUA. Please select custodian. Must include Must be physical physical address. signature. 20 Work performed under CMS Contract #HHSM-500-2013-00166C
6. Evidence of Funding 21 Work performed under CMS Contract #HHSM-500-2013-00166C
7. Information Only No Fee Cost Invoice ResDAC will supply to the requestor 22 Work performed under CMS Contract #HHSM-500-2013-00166C
8. Specifications Worksheet Data Request Details 23 Work performed under CMS Contract #HHSM-500-2013-00166C
8. Specifications Worksheet Contact Information This should be the individual that is knowledgeable about the request. This should be the individual that signed #16 of the DUA. 24 Work performed under CMS Contract #HHSM-500-2013-00166C
9. Institutional Review Board (IRB) Waiver Approval Please provide your IRB Waiver approval from your IRB or from an independent IRB IRB documentation needs to include ˗ Name of the IRB ˗ Review data & expiration date ˗ Study title (that matches the study title on DUA) ˗ Principal Investigator name More information on ResDAC website: http://www.resdac.org/cms- data/request/materials/common-rule-and-hipaa- waiver-approval 25 Work performed under CMS Contract #HHSM-500-2013-00166C
10. HIPAA Attestation 26 Work performed under CMS Contract #HHSM-500-2013-00166C
Request Materials List, continued Requ quest est Docume ument nt Not otes es File Specific fic Material rials 11. Part D Variable Please provide the Part D variable justification worksheet that Justification is found within the specifications worksheet. 12. DUA Part D Attachment A If requesting Part D data, requestor should sign the Part D Attachment A 13. Assessment Variable The Assessment variable justification worksheets are Justification separate Excel spreadsheets found on our website. 27 Work performed under CMS Contract #HHSM-500-2013-00166C
File Specific Materials 11. Part D variable justification worksheet Select the variable, provide reason for selection, & risk level. 28 Work performed under CMS Contract #HHSM-500-2013-00166C
File Specific Materials 12. Part D Attachment A 29 Work performed under CMS Contract #HHSM-500-2013-00166C
File Specific Materials 13. Assessment variable justification worksheet Select the variable, provide reason for selection. 30 Work performed under CMS Contract #HHSM-500-2013-00166C
Resources Templates are available on the website “Tips” documents are available for several of the request documents. It provides an explanation of what is needed for each document and question. 31 Work performed under CMS Contract #HHSM-500-2013-00166C
What Next? Prepare a draft (no signatures) Email to resdac@umn.edu and request a review ResDAC staff will guide you through the review process. 32 Work performed under CMS Contract #HHSM-500-2013-00166C
Research Request Process • CMS Project officer identifies request as research Step 1 • Requestor obtains materials from ResDAC CMMI website • Requestor emails drafts to resdac@umn.edu Step 2 • ResDAC reviews and provides comments/corrections • ResDAC returns materials to requestor Step 3 • Requestor revises all, obtains necessary signatures, and returns finals to ResDAC Step 4 • ResDAC forwards finals to CMS Step 5 • CMS Privacy Board reviews • Privacy analyst sends decision notification to Eric Hanson and Gino Sisti; Eric or Gino sends to CMMI PO, requestor, and GDIT Step 6 • GDIT processes data request and prepares physical shipment or onboarding to VRDC Step 7 33 Work performed under CMS Contract #HHSM-500-2013-00166C
Summary Request materials will be on ResDAC website Templates, tips documents, and webinars available on ResDAC website ResDAC staff are available by phone, email, web to answer any questions you have when completing the materials ˗ Email: resdac@umn.edu ˗ Phone: 1-888-973-7322 ˗ Web: http://www.resdac.org 34 Work performed under CMS Contract #HHSM-500-2013-00166C
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