Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies

Focus Groups as Used by the Food and Drug Administration

OMB: 0910-0497

IC ID: 236674

Documents and Forms
Document Name
Document Type
Other-List of Stakeholders
Other-Invitation Letter
Other-User Guide
Other-Task Force Paper
Other-Visualization Paper
Other-Informed Consent
Other-Notification of Eligibility
Other-Follow up Email
Other-Moderator Guide
Other-Background Rationale
Other-Protocol
Other-null
IC Document
Information Collection (IC) Details

View Information Collection (IC)

Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies CDER
 
New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-List of Stakeholders Appendix A - List of Potential Stakeholders.docx Yes No Printable Only
Other-Invitation Letter Appendix B - Invitation Letter.docx Yes No Printable Only
Other-User Guide Appendix B2 - User Guide.docx Yes No Printable Only
Other-Task Force Paper Appendix B3 - ISPE-ISPOR Joint Task Force Paper.pdf Yes No Printable Only
Other-Visualization Paper Appendix B4 - Design Visualization Paper.pdf Yes No Printable Only
Other-Informed Consent Appendix C - Consent Form.docx Yes No Paper Only
Other-Notification of Eligibility Appendix D - Notification of Eligibility.docx Yes No Printable Only
Other-Follow up Email Appendix E - Follow-up email for Acknowledgement Permission.docx Yes No Printable Only
Other-Moderator Guide Appendix F - Moderator Guide.pptx Yes No Printable Only
Other-Background Rationale Appendix F1 - Background Rationale.pptx Yes No Printable Only
Other-Protocol Structured Reporting Evaluation Protocol 2019.docx Yes No Printable Only
Other-null Appendix B1 - Structured Reporting Template.docx Yes No Printable Only

Health Health Care Services

 

34 0
   
Individuals or Households
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 34 0 34 0 0 0
Annual IC Time Burden (Hours) 68 0 68 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
OMB Approval Memo 0497 OMB Approval Memo for Evaluating a Structured Reporting Template 2019.docx 06/26/2019
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