Document R21 DART

[jessfroe]

DART documentation checklist

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: Work for this being tracked on lzim/mtl_code#7

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 #451
• [ ] Issue #392
• [ ] 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

• [ ] Short Name for Study : - Grant application (use own discretion to shorten)
• [ ] 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
• [ ] Approval Expiration Date? - IRB Approval letter
• [ ] Study Start Date : - Clinicaltrials.gov registration; note: don't use the dates in the Grants application as they may have updated
• [ ] Anticipated Study Close Date : - Clinicaltrials.gov registration; don't use the dates in the Grants application as they may have updated
• [ ] Has our study been determined to be an exempt human subjects study? - IRB protocol application
• [ ] If no, informed consent required orally or in writing? HIPPA authorization in writing? IRB Approval for waiver of informed consent? - IRB protocol application
• [ ] 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

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

Page 3 Data Sources

• [ ] 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.
• [ ] Data Access Systems: Would we like to use the SAS Grid in VINCI?
• [ ] 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.
• [ ] 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.
• [ ] Required Data Sources : Do we need anything other than CDW Production?
• [ ] NDS Approval for CDW access

Page 4 Documents

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

Page 5 Submission

• [ ] 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

[anthonycpichardo]

Work for this being tracked on https://github.com/lzim/mtl_code/issues/7

[lzim]

Thanks @anthonycpichardo

I had to head out from #hqhuddle to talk COVID-19 grant with Tom, but I wanted to make sure we keep this review moving.

Note, this key link from your comment goes in the top of the master document card. This is consistent with the feedback you had when you joined, that we folks deviate from keep the key information at the top, things get kinda hectic. 🌪️ I've added it above.

Work for this being tracked on lzim/mtl_code#7

FYI: @staceypark

[lzim]

I believe this is done, right? Now we're just waiting on VINCI to finalize the ORD_R21 build?

@anthonycpichardo @staceypark

[staceypark]

@lzim @anthonycpichardo is the build finished? Or is that the thing we're having the date issues with...

[anthonycpichardo]

@lzim @staceypark This is done now.

Closing