Document - r01 DART Submission

[anthonycpichardo]

r01_dart_submission

1. Link to the document and add relevant team members to the card.

• [ ] Add the link the current draft of the documentation for the issue:

2. Link to issues that must be edited in the document in the issue_tracker and feature_tracker. (use the # for the link to the issue)

• [ ] Issue lzim/mtl_code#7
• [ ] Issue #
• [ ] Issue #

Dart Request - 5 Page Submission Guide

All of the information below can be found with a combination of 4 documents/platforms:

- complete grant application PDF in TeamPSD > Grants - Clinical Trials registration at clinialtrials.gov - IRB protocol application & approval letters in TeamPSD > IRB - RDIS (Research & Development Information System) at rdispaloalto.net

Page 1 Information

• [x] Short Name for Study : - Grant application (use own discretion to shorten)
• [x] Does our project have an IRB or other project number? Each of our projects has 3 numbers: - federal Identifier # from the funding agency: under Grants in TeamPSD - clinicaltrials.gov identifier #: search for project on the clinical trials website - IRB protocol #: under protocol application in IRB in TeamPSD
• [x] Approval Expiration Date? - IRB Approval letter
• [x] Study Start Date : - Clinicaltrials.gov registration; note: don't use the dates in the Grants application as they may have updated
• [x] Anticipated Study Close Date : - Clinicaltrials.gov registration; don't use the dates in the Grants application as they may have updated
• [x] Has our study been determined to be an exempt human subjects study? - IRB protocol application
• [x] If no, informed consent required orally or in writing? HIPPA authorization in writing? IRB Approval for waiver of informed consent? - IRB protocol application
• [x] Does the study have IRB or Privacy Board approval for a waiver of HIPPA authorization? If not, is the waiver only for recruiting/eligibility or for the entire study? - IRB protocol application

Page 2 Participant List

• [x] List of team members and their requirement needs (Notifications, Data Access or CAPRI/JLV Access)

Page 3 Data Sources

• [x] Determine Data Storage Location (VINCI or On Premise Server [Need Location Details]) Keep consistent to what was specified on RDIS. Tap an HQ member for RDIS info if needed.
• [x] Data Access Systems: Would we like to use the SAS Grid in VINCI?
• [x] Are we sending any data external to VHA? Need location details if so. Company/Agency Name and address and we will need to fill out a DUA Keep consistent to what was specified on RDIS. Tap an HQ member for RDIS info if needed.
• [x] What identification level do we need? Real SSN, Scrambled SSN, or Identifiable data but no real/scrambled SSN Keep consistent to what was specified on RDIS. Tap an HQ member for RDIS info if needed.
• [x] Required Data Sources : Do we need anything other than CDW Production?
• [x] NDS Approval for CDW access

Page 4 Documents

• [x] Required Documents to be uploaded - vary based on our selections made above.

Page 5 Submission

• [x] Submit request - missing documents or items will be displayed here.

Documents

Research Request Memo

• Blank form found here

Research Study Institutional Review Board (IRB) Approval Letter

• Located in TeamPSD > IRB, but originally downloaded from Stanford IRB website eprotocol.stanford.edu under Actions > Download Approval Letter
• From CIRB, local VAMC, or University Affiliate
• IRB letters are needed from each site
• Key Items needed:
  • PI Name
  • Study Name
  • Approval Date
  • Expiration Date
  • Signed by the Chair of the IRB

Research and Development RD Committee Approval Letter

• Located in TeamPSD > rdis, but originally downloaded from RDIS website at rdispaloalto.net under Initial Approval Letter

IRB Approval of Waiver of HIPAA-Compliant Authorization

• Should include
  • VA Facility Name
  • Title of Study
  • PI Name
  • Brief description of PHI used for IRB
  • Must have Chair of IRB Signature

Research Protocol

• Should include:
  • Introductory paragraph
  • Statement of the Problem
  • Purpose
  • Significance of the Study
  • Research Questions and/or Hypotheses and/or Null Hypotheses
  • Background
  • Methodology
  • Procedure and time frame
  • Analysis plan
  • Scope and limitations
  • Use the most up to date Protocol

CDW-Domain Checklist

• Blank form found here

[lzim]

@anthonycpichardo
Can we confirm whether this is done?

[anthonycpichardo]

Yes the DART submission is complete for the R01