A-Z Index and Glossary
-
CBR
- Central Biorepository Spotlight: Bipolar Disorder
- Central Biorepository Spotlight: Cardiovascular Disease
- Central Biorepository Spotlight: Cardiovascular Disease
- Central Biorepository Spotlight: COVID-19 Research
- Central Biorepository Spotlight: Food Allergy
- Central Biorepository Spotlight: Medical Genomics
- Central Biorepository Spotlight: Michigan Genomics Initiative (MGI)
- Central Biorepository Spotlight: Organ Transplants
- Central Biorepository Spotlight: Prechter Bipolar Genetic Registry
- Central Biorepository Spotlight: U-M Pregnancy Biobank
- Pre-Onboarding Considerations
-
common-rule
Content related to the Common Rule published by OHRP. Institutional Review Boards (IRBs) are responsible for applying the Common Rule protections for federally sponsored human subjects research, and the Common Rule is the general basis for IRB review for most studies regardless of funding.
- IRBMED Transition to Revised Common Rule Grid This grid is designed to assist researchers in ensuring that their research complies with all applicable requirements of the revised Common Rule.
-
COVID-19
-
CRAO
- Billing Calendar & Study Applications - template letters
- CMS IDE Change
- CRAO Analyst
- CRAO Chatter - April 2012
- CRAO Chatter - August 2012
- CRAO Chatter - December 2012
- CRAO Chatter - July 2012
- CRAO Chatter - June 2012
- CRAO Chatter - May 2012
- CRAO Chatter - November 2012
- CRAO Chatter - October 2012
- CRAO Chatter - September 2012
- CRAO Organizational Chart
- Dental School Guidelines
- Department Billing Directors
- Device Study Procedure Flow Chart
- FAQs - Clinical Research Discounts
- MBECT - Adding Items Form
- MBECT - Best Practices for Billing Calendar Comments
- MBECT - Bundle Listing
- MBECT - Clinical Research Billing Town Hall From June 2013
- MBECT - Enrollment Policy FAQs
- MBECT - Exempt Study Enrollment Guide
- MBECT - FAQs
- MBECT - Helpful Hints for Code Selection
- MBECT - Items Word Search Tips
- MBECT - Making an Exempt Study
- MBECT - MCRU Time & Events Table
- MBECT - Presentation to Cardiology at the April 2013 C3RG Meeting
- MBECT - Quick Reference Guide
- MBECT - Sponsor Request Form
- MBECT MLearning - Billing Calendar Activity
- MBECT MLearning - Billing Calendar Cycles & Visits
- MBECT MLearning - Billing Calendar Header
- MBECT MLearning - Billing Calendar Items & Search Filter
- MBECT MLearning - Billing Calendar Overview
- MBECT MLearning - Billing Calendar Visits
- MBECT MLearning - Item Favorites
- MBECT MLearning - Personnel Input
- MBECT Tips & Tricks - Special Edition 02282013
- MBECT Tips & Tricks - Special Edition 03012013
- MBECT Tips & Tricks - Special Edition 03042013
- MBECT Tips & Tricks - Special Edition 03052013
- MBECT Tips & Tricks - Special Edition 05062013
- MBECT Tips & Tricks - Special Edition Go Live Checklist
- MBECT Tips & Tricks - Special Edition Go Live Checklist 1 Day Left
- MBECT Tips & Tricks - Special Edition Go Live Checklist 2 Days Left
- MBECT Tips & Tricks - Special Go Live Edition
- MBECT Tips & Tricks - Volume 1 Complete
- MBECT Tips & Tricks - Volume 1, Issue 1
- MBECT Tips & Tricks - Volume 1, Issue 2
- MBECT Tips & Tricks - Volume 1, Issue 3
- MBECT Tips & Tricks - Volume 1, Issue 4
- MBECT Tips & Tricks - Volume 1, Issue 5
- MBECT Tips & Tricks - Volume 1, Issue 6
- MBECT Tips & Tricks - Volume 1, Issue 7
- MBECT Tips & Tricks - Volume 2, Issue 1
- MBECT Tips & Tricks - Volume 2, Issue 11
- MBECT Tips & Tricks - Volume 2, Issue 12
- MBECT Tips & Tricks - Volume 2, Issue 13
- MBECT Tips & Tricks - Volume 2, Issue 14
- MBECT Tips & Tricks - Volume 2, Issue 15
- MBECT Tips & Tricks - Volume 2, Issue 16
- MBECT Tips & Tricks - Volume 2, Issue 17
- MBECT Tips & Tricks - Volume 2, Issue 18
- MBECT Tips & Tricks - Volume 2, Issue 19
- MBECT Tips & Tricks - Volume 2, Issue 2
- MBECT Tips & Tricks - Volume 2, Issue 20
- MBECT Tips & Tricks - Volume 2, Issue 21
- MBECT Tips & Tricks - Volume 2, Issue 22
- MBECT Tips & Tricks - Volume 2, Issue 23
- MBECT Tips & Tricks - Volume 2, Issue 24
- MBECT Tips & Tricks - Volume 2, Issue 25
- MBECT Tips & Tricks - Volume 2, Issue 26
- MBECT Tips & Tricks - Volume 2, Issue 27
- MBECT Tips & Tricks - Volume 2, Issue 28
- MBECT Tips & Tricks - Volume 2, Issue 29
- MBECT Tips & Tricks - Volume 2, Issue 3
- MBECT Tips & Tricks - Volume 2, Issue 30
- MBECT Tips & Tricks - Volume 2, Issue 31
- MBECT Tips & Tricks - Volume 2, Issue 32
- MBECT Tips & Tricks - Volume 2, Issue 33
- MBECT Tips & Tricks - Volume 2, Issue 34
- MBECT Tips & Tricks - Volume 2, Issue 35
- MBECT Tips & Tricks - Volume 2, Issue 36
- MBECT Tips & Tricks - Volume 2, Issue 37
- MBECT Tips & Tricks - Volume 2, Issue 38
- MBECT Tips & Tricks - Volume 2, Issue 39
- MBECT Tips & Tricks - Volume 2, Issue 4
- MBECT Tips & Tricks - Volume 2, Issue 5
- MBECT Tips & Tricks - Volume 2, Issue 6
- MBECT Tips & Tricks - Volume 2, Issue 7
- MBECT Tips & Tricks - Volume 2, Issue 8
- MBECT Tips & Tricks - Volume 2, Issue 9
- MBECT Tips & Tricks - Volume 3, Issue 1
- MBECT Tips & Tricks - Volume 3, Issue 2
- MBECT Tips & Tricks - Volume 3, Issue 3
- MBECT User Security Form
- MiChart Research Enrollment Policy Slides
- Obtaining a Charge Description Master Number
- Volume 2, Issue 10
-
CTSO
Tag for CTSO documents/downloads
-
Data Office
This tag is used to identify events and news items sponsored by the Data Office.
-
eRRM
Content related to eResearch Regulatory Management, the web-based 'smartform' system that provides review and approval processes for the U-M Institutional Review Boards (IRBs) and Ancillary Committees (as well as for Institutional Biosafety Committe (IBC)).
-
Grant Services & Analysis
- 2014 VA MoU
- 2016 Cycle III
- 2017 CYCLE 2
- 2017 Cycle 3
- 2017 Cycle I
- 2017 Cycle II
- 2017 Cycle III
- 2017 VA MoU
- 2018 1
- 2018 2
- 2018 3
- 2018 Cycle 1
- 2018 Cycle 1
- 2018 Cycle III
- 2018 Cycle III
- 2018 Cycle III (with correction)
- 2018 Nov GPAC
- 2019 1
- 2019 2
- 2019 Cycle I
- 2019 Cylce III
- 2020 Cycle III
- 2020 Over the Cap
- 2020 VA MoU
- 2020 VA MoU.xlsx
- 2020 VA MoU.xlsx (updated 1-31-20)
- 2021 Cycle I
- 2021 Cycle II
- 2021-22R01BootCamp Sample Timeline
- 2021_va_mou.xlsx
- Additional Certification DHHS Career Development
- Additional Certification DHHS Fellowship
- Administrative Shell of a NIH Research Grant
- April 2020 GPAC Email
- Biosketch Fellowship Format
- Biosketch Instructions
- Brand Newer F Series
- BRCF State of Research - FY 2021 Q2
- Budget Justification Instructions
- Budget Template - 2015 VA MoU
- Budget Template - 2016 VA MoU
- Budget Template - 2018 VA MoU
- Budget Template - Oldest VA MoU
- Budget Template - Over the Cap
- Budget Template - Over the Cap Prior 2018
- Budget Template - PHS 398 Budgets Change Year to Year
- Budget Template - PHS 398 Program Projects Straight
- Budget Template - PHS 398 Single Budget Straight
- Budget Template - Quick Calculations
- Budget Template - SF424 Categorical
- Budget Template - SF424 Modular
- Budgeting a Clinical Trial 2012
- Central Purchasing Unit Guidelines
- Common Goods List 2016
- Considering All the Costs - Presentation
- Consortium/Contractual Arrangements
- Corrected 2019 Cycle I
- Cycle 1 2020 Erin
- Cycle III 2019
- Demonstrating Institutional Support
- Demonstrating Institutional Support
- Demonstrating Institutional Support: Using the Facilities & Other Resources element to highlight the U-M resource-rich environment
- Disclosure of Other Support – Resources
- Email GPAC 2020 April
- ePRO Purchasing Request in M-Pathways
- Erin 2019 Cycle 2
- Erin Cycle 3 2019
- Erin Cycle II 2020
- F Series 4-21
- Facilities & Other Resources Instructions
- Final 12-22-22 NIH Story FFY2022 vs FFY2021
- FINAL CLOSEOUT
- Final FFY 2020 NIH Story - 1-8-21 Data
- Forms E
- Forms F (2020)
- FORMS F Key Updates GPAC
- FORMS F Key Updates GPAC- Revised
- General Grant Review Checklist
- General Space Rules
- GPAC CTSO Migration Finance - November 2017
- GPAC FORMS F Key Updates
- GPAC FORMS F Power Point
- GPAC FORMS F Power Point April 2020
- GPAC Notes - April 2013
- GPAC Notes - April 2014
- GPAC Notes - December 2013
- GPAC Notes - December 2017
- GPAC Notes - February 2014
- GPAC Notes - July 2013
- GPAC Notes - July 2014
- GPAC Notes - June 2013
- GPAC Notes - May 2014
- GPAC Notes - November 2013
- GPAC Notes - November 2015
- GPAC Notes - November 2017
- GPAC Notes - October 2013
- GPAC Notes - October 2017
- GPAC Notes - September 2013
- GPAC Notes - September 2017
- GPAC Notes NIH 424 Human Subjects & Clinical Trials Information - December 2017
- Grant Proposal Editing Services
- Grants Office Top 10: The Perfectly Routed Proposal
- Indirect Cost Waiver Form
- January 23, 2019 Admin.Personnel in eRPM & GL
- January 23, 2019 PAAC Meeting Notes & Agenda
- Letter Template
- Multiple PI Plan Instructions
- NEW 2020 Cycle One
- New F Series
- New K Series 11/21/19
- NEW New 2020 Cycle 1
- NEW Over the cap
- New T Series
- NEW VA MOU
- NEW!! 2019 Cycle III
- Newer Newest F
- Newest F doc April 2021
- Newest F Series 11-22-19
- Newest K Series 11-22-19
- Newest Newest F Series 11-22-2019
- Newest T Series 11-22-19
- NIH Checklist 4--21
- NIH CYCLE II
- NIH CYCLE II 2021
- NIH FORMS-D Research Proposal Review Checklist
- NIH FORMS-E Research Proposal Review Checklist 9-10-19
- NIH FORMS-E Research Proposal Review Checklist
- NIH Large-Scale Proposal Services
- NIH Research Proposal Checklist - FORMS F
- NIH Research Proposal Review Checklist
- OCTOBER PAAC w/ LINKS
- Office Depot List
- Oligo Pricing 2016
- ORSP Checklist for NSF
- ORSP Checklist for US Army Medical
- ORSP Standard Operating Procedure
- Other Support Examples
- Other Support Template
- over the cap 2020
- Over The Cap 2020
- Over the Cap 2020 (Updated 1-31-2020)
- Over the Cap 2020 xlsx.
- Over the Cap After 2017
- Over the Cap Before 2017
- OVER THE CAP!
- Over the Cap-1/7/2018 and After
- Over_the -Ca 2021.xlsx
- PAAC Action Items - May 2013
- PAAC Agenda & Meeting Notes - April 2016
- PAAC Agenda & Meeting Notes - February 2018
- PAAC Agenda & Meeting Notes - January 2018
- PAAC Agenda & Meeting Notes - June 2016
- PAAC Agenda & Meeting Notes - March 2018
- PAAC Agenda & Meeting Notes - May 2018
- PAAC Agenda & Meeting Notes - October 2017
- PAAC Agenda & Meeting Notes - September 2017
- PAAC Agenda - April 2013
- PAAC Agenda - August 2013
- PAAC Agenda - December 2015
- PAAC Agenda - February 2015
- PAAC Agenda - January 2015
- PAAC Agenda - June 2013
- PAAC Agenda - June 2015
- PAAC Agenda - March 2015
- PAAC Agenda - March 2016
- PAAC Agenda - May 2013
- PAAC Agenda - October 2013
- PAAC Agenda - October 2015
- PAAC Agenda - September 2013
- PAAC Checklist - August 2013
- PAAC Employer Shared Responsibility Presentation
- PAAC eRecon and WebNow - August 2013
- PAAC Forecasting Tool
- PAAC IC Basis
- PAAC JE Denials
- PAAC M-Marketsite Profile Setup Information
- PAAC Meeting Notes - April 2014
- PAAC Meeting Notes - August 2013
- PAAC Meeting Notes - December 2013
- PAAC Meeting Notes - December 2015
- PAAC Meeting Notes - February 2014
- PAAC Meeting Notes - February 2015
- PAAC Meeting Notes - January 2014
- PAAC Meeting Notes - January 2015
- PAAC Meeting Notes - June 2014
- PAAC Meeting Notes - June 2015
- PAAC Meeting Notes - March 2015
- PAAC Meeting Notes - March 2016
- PAAC Meeting Notes - May 2014
- PAAC Meeting Notes - November 2013
- PAAC Meeting Notes - October 2015
- PAAC Meeting Notes - September 2013
- PAAC Mentorship handout - August 2013
- PAAC Mentorship Handout - June 2013
- PAAC Mission and Goals - April 2013
- PAAC MReports - June 2013
- PAAC MReports Management Reports
- PAAC OCT NOTES
- PAAC Other Support Comparison
- PAAC Post Award Overview - April 2013
- PAAC Procurement - May 2013
- PAAC Procurement Future State Map - May 2013
- PAAC Procurement Models - September 2013
- PAAC Procurement Update
- PAAC Research Administrators Poster
- PAAC Research Performance Progress Reports (RPPR)
- PAAC Salary Cap Reporting
- PAAC Salary Cap Review & VA IPAs - October 2013
- Potential Activities for Research Staff during the Assignment to Remote Work
- Printable Routing Chart
- Procurement update - PAAC 2014
- Proposal Finalization Checklist
- Proposal Review General Checklist
- Recharge Service Units in Grant Proposals
- Research Administration: Onboarding and Introduction to Resources You Should Know
- Research Patient Care Agreement
- Research Procurement - Customizing Headers
- Review Checklist
- Sample Biosketch
- Sample SF424 Application
- SoR - Biomedical Research Core Facilities (BRCF)
- SoR - Calendar Review & Analysis Office
- SoR - Complete State of Research
- SoR - Data Office for Clinical and Translational Research
- SoR - Fast Forward Medical Innovation
- SoR - Grant Review & Analysis
- SoR - Institutional Review Board (IRBMED)
- SoR - Overall State of Research
- SoR - Unit for Laboratory Animal Medicine (ULAM)
- Space Representation & Approvals for PAFs
- Space Representation & Approvals for PAFs - Long Version
- State of Research Grants Office FY2020 Q3
- State of Research - Complete - FY 2021 Q2
- State of Research - Cover Page - FY 2021 Q2
- State of Research - CRAO - FY 2021 Q2
- State of Research - CRAO - FY 2023 Q2
- State of Research - DOCT - FY 2021 Q2
- State of Research - DOCTR - FY 2023 Q2
- State of Research - Grants Office - FY 2021 Q2
- State of Research - Grants Office FY 2023 Q2
- State of Research - Grants Office FY 2023 Q2
- State of Research - IRBMed - FY 2021 Q2
- State of Research - IRBMed - FY 2023 Q2
- State of Research - ULAM - FY 2023 Q2
- State of Research BRCF Q4 2020
- State of Research Complete FY2020 Q3
- State of Research COMPLETE Q4 2020
- State of Research COVER PAGE Q4 2020
- State of Research Cover Page-FY 2020 Q3
- State of Research CRAO FY2020 Q3
- State of Research CRAO Q4 2020
- State of Research DOCTOR Q4 2020
- State of Research FFMI FY2020 Q3
- State of Research FFMI Q4 2020
- State of Research GRANTS Q4 2020
- State of Research IRBMed FY2020 Q3
- State of Research IRBMED Q4 2020
- State of Research ULAM Q4 2020
- State of Research- FFMI Q3 2021
- State of Research- Grants Office- Q3 2021
- State of Research-Complete Q3 2021
- State of Research-Complete-FY2023 Q2
- State of Research-Cover Page Q3 2021
- State of Research-Cover Page-FY 2023 Q2
- State of Research-CRAO Q3 2021
- State of Research-DOCTR Q3 2021
- State of Research-IRBMed-Q3 2021
- Submission Service Policy
- Surgery Tier 1 Procedures
- Surgery Tier 2 Procedures
- Taubman Resume
- Testing website document
- UFA Quick Reference Card
- UFA Review Step-by-Step
- UMMS Salary Cap (FFY12) Implementation
- Under Construction
-
hipaa
Content related to the Health Insurance Portability and Accountability Act Privacy Rule, which regulates the use of medical records for research purposes (and for other purposes).
-
IRBMED
- Additional Requirements for Department of Defense Research
- Anonymous, Coded, and De-identified Data in Human Subjects Research - script
- Assent Requirements and Waivers - presentation
- Assent Requirements and Waivers - script
- Association for the Accreditation of Human Research Protection Programs (AAHRPP) - presentation
- Becoming a Research Volunteer
- Biorepository Registration Decision Tree
- Checklist of Federally Required Elements of Informed Consent
- Child Assent Guidelines
- Collaborator Agreements: IAAs, IIAs, and CIAs - presentation
- Collaborator Agreements: IAAs, IIAs, and CIAs - script
- Course Descriptions
- Course Levels and Subject Groups
- De-Identified Data and Limited Data Sets
- Department of Defense Research (Part One) - presentation
- Department of Defense Research (Part One) - script
- Department of Defense Research (Part Two) - presentation
- Department of Defense Research (Part Two) - script
- Enrolled for Human Subjects Studies in eResearch
- eResearch Application Section 25-1 2011-06-03
- eResearch Application Section 25-2 2011-06-03
- eResearch Application Section 25-4 2011-06-03
- eResearch Application Section 25-6 2011-06-03
- eResearch Application Section25-3 2011-06-03
- eResearch Changing the Principal Investigator
- eResearch Creating a Scheduled Continuing Review (SCR)
- eResearch Creating an Amendment
- eResearch Editing/Stacking a Document
- eResearch Friend Accounts Step-by-Step Procedures
- eResearch PI & Study Team Quick Reference Card
- eResearch Study Approval & Contingencies
- eResearch Tracking a Submitted Application
- Exempt Human Subjects Research eResearch Submit
- FDA guidance on IRB inspections
- FDA Guidance: Mobile Medical Applications (February 9, 2015)
- FDA Inspections of Institutional Review Boards - presentation
- FDA Inspections of Institutional Review Boards - script
- Flexibility Initiatives: Exemption 7 and Two-Year Approval - presentation
- Flexibility Initiatives: Exemption 7 and Two-Year Approval - script
- Foreign Language Short Forms - Arabic
- Foreign Language Short Forms - Chinese
- Foreign Language Short Forms - English
- Foreign Language Short Forms - English of Arabic
- Foreign Language Short Forms - French
- Foreign Language Short Forms - Russian
- Foreign Language Short Forms - Spanish
- Guidelines for Stacking Documents in eResearch
- Guidelines For Using Magnitude Of Harm In Categorizing Risk Level
- IC MiChart Instructions
- ICH GCP checklist
- Independent/Commerical IRB
- IRB-HSBS Guidance on Lotteries & Sweepstakes
- IRBMED and Central IRBs: FAQs
- IRBMED and Chesapeake IRB Presentation Slideshow from the "IRBMED and Chesapeake IRB" Presentation on July 30, 2013
- IRBMED Seminar Series - April 2015 Agenda
- IRBMED Seminar Series - April 2015 Anatomy
- IRBMED Seminar Series - April 2015 Data
- IRBMED Seminar Series - April 2015 Protecting
- IRBMED Seminar Series - April 2015 Tips
- IRBMED Seminar Series - April 2017 Continuing
- IRBMED Seminar Series - April 2017 Revisions
- IRBMED Seminar Series - April 2017 Scope Scope of the Revisions
- IRBMED Seminar Series - April 2017 Single
- IRBMED Seminar Series - January 2016 AAHRPP
- IRBMED Seminar Series - January 2016 Agenda
- IRBMED Seminar Series - January 2016 Biorepositories
- IRBMED Seminar Series - January 2016 Changes
- IRBMED Seminar Series - January 2018
- IRBMED Seminar Series - May 2014 Case Study
- IRBMED Seminar Series - May 2014 Central
- IRBMED Seminar Series - May 2014 HIPAA
- IRBMED Seminar Series - May 2014 Introduction
- IRBMED Seminar Series - May 2014 Social & Behavioral
- IRBMED Seminar Series - May 2014 Tips
- IRBMED Seminar Series - November 2017
- IRBMED Seminar Series - October 2017
- IRBMED Seminar Series - October 2017 Consideration
- IRBMED Seminar Series - October 2017 Institutional
- IRBMED Seminar Series - October 2017 Outcomes
- IRBMED Seminar Series - September 2014 Agenda
- IRBMED Seminar Series - September 2014 Apps
- IRBMED Seminar Series - September 2014 Challenges
- IRBMED Seminar Series - September 2014 MIAP
- IRBMED Seminar Series - September 2014 Mock
- IRBMED Seminar Series - September 2014 Site
- IRBMED Seminar Series - September 2014 Version
- IRBMED Seminar Series - September 2017
- IRBMED Seminar Series Agenda - October 2016
- IRBMED Standard Operating Procedures (Full Version)
- IRBMED Standard Operating Procedures - Definitions Appendix
- IRBMED Standard Operating Procedures - Part 1
- IRBMED Standard Operating Procedures - Part 10
- IRBMED Standard Operating Procedures - Part 11
- IRBMED Standard Operating Procedures - Part 12
- IRBMED Standard Operating Procedures - Part 13
- IRBMED Standard Operating Procedures - Part 2
- IRBMED Standard Operating Procedures - Part 3
- IRBMED Standard Operating Procedures - Part 4
- IRBMED Standard Operating Procedures - Part 5
- IRBMED Standard Operating Procedures - Part 6
- IRBMED Standard Operating Procedures - Part 7
- IRBMED Standard Operating Procedures - Part 8
- IRBMED Standard Operating Procedures - Part 9
- IRBMED Transition to Revised Common Rule Grid This grid is designed to assist researchers in ensuring that their research complies with all applicable requirements of the revised Common Rule.
- MCIT Source Documentation Information
- Mobile Medical Apps (FDA Guidance) - presentation
- Mobile Medical Apps (FDA Guidance) - script
- Non–UM Institutional IRB (Typically an Academic Institution)
- Parental Permission in Research Involving Minors - presentation
- Privacy Board Flowchart
- Privacy board Panel Discussion – 2011.10.18
- Quorum Site Information Questionnaire
- Reporting Mechanism & Timeframe for Info & Occurrences (Non-AE)
- Repository: Application Supplement Form
- res_irbmed_umic-signnow01
- res_irbmed_umic_script-signnow02
- res_irbmed_umic_signnow02
- Risk Assessment for Devices FDA Guidance
- Schulman Associates cover page
- Secondary Use Applications - script
- Stacking documents in eResearch
- Standard Adverse Event Reporting Guidelines for INTERNAL AEs Occurring at UM
- Statement of Practice PEERRS Certification Requirements
- Submitting an AE in eResearch
- U-MIC - Central Institutional Review Boards PDF
- U-MIC - Central Institutional Review Boards Presentation
- U-MIC - Certificates of Confidentiality PDF
- U-MIC - Certificates of Confidentiality Presentation
- U-MIC Anonymous, Coded, and De-identified Data
- U-MIC Belmont Report P1 PDF
- U-MIC Belmont Report P2 PDF
- U-MIC ClinicalTrials.gov PDF
- U-MIC ClinicalTrials.gov Presentation
- U-MIC Cognitively Impaired Subjects & Legally Authorized Representatives Presentation
- U-MIC Community-Based Participatory Research PDF
- U-MIC Community-Based Participatory Research Presentation
- U-MIC Conflicts of Interest PDF
- U-MIC Conflicts of Interest Presentation
- U-MIC Continuing Review Changes Presentation
- U-MIC Data and/or Biospecimen PDF
- U-MIC Data and/or Biospecimen Presentation
- U-MIC Data Management & Security PDF
- U-MIC Data Management & Security Presentation
- U-MIC Deception & Concealment PDF
- U-MIC Deception & Concealment Presentation
- U-MIC EFIC PDF
- U-MIC EFIC Presentation
- U-MIC Electronic Data Security PDF
- U-MIC Electronic Data Security Presentation
- U-MIC Enrollment of Human Subjects PDF
- U-MIC Enrollment of Human Subjects Presentation
- U-MIC eResearch Regulatory Management Upgrade Presentation
- U-MIC eResearch: Viewing Submission Summaries PDF
- U-MIC eResearch: Viewing Submission Summaries Presentation
- U-MIC Exemption Changes Common Rule (2018)
- U-MIC Exemptions 1, 2, and 2A PDF
- U-MIC Exemptions 1, 2, and 2A Presentation
- U-MIC Expedited Review: Category 5 PDF
- U-MIC Expedited Review: Category 5 Presentation
- U-MIC FDA Guidance
- U-MIC FERPA PDF
- U-MIC FERPA Presentation
- U-MIC GINA PDF
- U-MIC GINA Presentation
- U-MIC HIPAA PDF
- U-MIC HIPAA Presentation
- U-MIC HRPP Presentation
- U-MIC HUDs PDF
- U-MIC HUDs Presentation
- U-MIC IC Emergency Care Setting PDF
- U-MIC IC Emergency Care Setting Presentation
- U-MIC IC FDA Guidance Presentation
- U-MIC IC FDA Guidance Presentation
- U-MIC IC Genetic Sub-Studies PDF
- U-MIC IC Genetic Sub-Studies Presentation
- U-MIC IC Sample & Eligibility Screening PDF
- U-MIC IC Sample & Eligibility Screening Presentation
- U-MIC ICH-GCP PDF
- U-MIC ICH-GCP Presentation
- U-MIC Informed Consent Changes Common Rule Presentation
- U-MIC Informed Consent Documentation PDF
- U-MIC Informed Consent Documentation Presentation
- U-MIC Investigator Responsibilities HRPP & Common Rule PDF
- U-MIC Investigator Responsibilities HRPP & Common Rule Presentation
- U-MIC IRB Membership Requirements & Quorum PDF
- U-MIC IRB Membership Requirements & Quorum Presentation
- U-MIC IRB Regulatory Determinations PDF
- U-MIC IRB Regulatory Determinations Presentation
- U-MIC Lotteries as Incentives PDF
- U-MIC Lotteries as Incentives Presentation
- U-MIC Meeting Minutes PDF
- U-MIC Meeting Minutes Presentation
- U-MIC Multisite Research PDF
- U-MIC Multisite Research Presentation
- U-MIC OHRCR electronic data security guidance
- U-MIC PHI PDF
- U-MIC PHI Presentation
- U-MIC Post-Approval Study Monitoring P1 Presentation
- U-MIC Post-Approval Study Monitoring P2 Presentation
- U-MIC Prisoners in Epidemiological Research PDF
- U-MIC Prisoners in Epidemiological Research Presentation
- U-MIC Prisoners P1 PDF
- U-MIC Prisoners P1 Presentation
- U-MIC Prisoners P2 PDF
- U-MIC Prisoners P2 Presentation
- U-MIC Privacy & Confidentiality PDF
- U-MIC Scheduled Continuing Review PDF
- U-MIC Scheduled Continuing Review Presentation
- U-MIC Significant & Nonsignficant Risk Devices PDF
- U-MIC Significant & Nonsignficant Risk Devices Presentation
- U-MIC Third Parties PDF
- U-MIC Third Parties Presentation
- U-MIC UPIRSOs or UaPs PDF
- U-MIC UPIRSOs or UaPs Presentation
- U-MIC Vulnerable Subject Populations Presentation
- U-MIC Waivers of Informed Consent Presentation
- U-MIC Writing Informed Consent Documents P1 PDF
- U-MIC Writing Informed Consent Documents P1 Presentation
- U-MIC Writing Informed Consent Documents P2 PDF
- U-MIC Writing Informed Consent Documents P2 Presentation
- UM Federal Wide Assurance (FWA) #00004969
- Umbrella Projects - presentation
- Umbrella Projects - script
- Using Notes as Place Markers in eResearch - presentation
- Using Notes as Place Markers in eResearch - script
- Version Control of Informed Consent Documents - presentation
- Version Control of Informed Consent Documents - script
- Waiver Under ORHP FDA HIPAA
- Who May Consent for Participation in Research Studies
- Working with Chesapeake IRB
- Working with NCI CIRB (CIRB)
- Working with Non-UM IRBs
- Working with Quorum Review IRB
- Working with Schulman Associates IRB
- Working with Western IRB
-
RD
tag for Research Development documents
- Freelance Editors - Aldrich
- Freelance Editors - Anderson
- Freelance Editors - Balch
- Freelance Editors - Bielawski
- Freelance Editors - Brinkman
- Freelance Editors - Connett
- Freelance Editors - DeLyria
- Freelance Editors - Dozier
- Freelance Editors - Duncan
- Freelance Editors - Emerson
- Freelance Editors - Fischer
- Freelance Editors - Fleming
- Freelance Editors - Granger
- Freelance Editors - Holler
- Freelance Editors - Jacques
- Freelance Editors - Katie Lang
- Freelance Editors - Lang
- Freelance Editors - Lusk
- Freelance Editors - Maurer
- Freelance Editors - Newman
- Freelance Editors - Pessin
- Freelance Editors - Talpos
- Freelance Editors - Theuring
- Freelance Editors - Traphagen
- Freelance Editors - Zeller
- Freelance Graphics Specialists - Gallagher
- Sharpening Your Focus: Are you Fuzzy about Clear Writing
- Sharpening Your Focus: Basic Budget Blunders
- Sharpening Your Focus: Federal Contracts vs. Grants
- Sharpening Your Focus: Find your Research Niche
- Sharpening Your Focus: Know your Audience
- Sharpening Your Focus: Letters of Support
- Sharpening Your Focus: NIH Innovation Section
- Sharpening Your Focus: NIH Paylines & Percentiles
- Sharpening Your Focus: NIH Renewals: Know When to Hold’ em
- Sharpening Your Focus: Preliminary Data? How much?
- Sharpening Your Focus: Proposal Title
- Sharpening Your Focus: Recipe for Great Team Science
- Sharpening Your Focus: Should I apply for an R21?
- Sharpening Your Focus: Specific Aims Tailored
- Sharpening Your Focus: Writing the Research Approach
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Research Development
This is a tag for events and news items sponsored by Research Development.
- 2017 R01 Boot Camp Timeline
- Biostatistics for Grants: Clinical
- Biostatistics for Grants: Pre-Clinical
- Centralized Pilot Programs Policy
- Connecting the Dots of Innovation
- Inserting Graphics into Grant Applications & Other Word Documents
- Lessons for New PI's
- NIH Authentication of Key Biological and/or Chemical Resources
- Potential Activities for Research Staff during the Assignment to Remote Work
- R01 Boot Camp: Chalk Talks
- Research Roadmap
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U-MIC
IRBMED U-MIC presentations or voiceover script (PDF)
- Additional Requirements for Department of Defense Research
- Anonymous, Coded, and De-identified Data in Human Subjects Research - script
- Assent Requirements and Waivers - presentation
- Assent Requirements and Waivers - script
- Association for the Accreditation of Human Research Protection Programs (AAHRPP) - presentation
- Collaborator Agreements: IAAs, IIAs, and CIAs - presentation
- Collaborator Agreements: IAAs, IIAs, and CIAs - script
- Department of Defense Research (Part One) - presentation
- Department of Defense Research (Part One) - script
- Department of Defense Research (Part Two) - presentation
- Department of Defense Research (Part Two) - script
- Enrolled for Human Subjects Studies in eResearch
- FDA guidance on IRB inspections
- FDA Guidance: Mobile Medical Applications (February 9, 2015)
- FDA Inspections of Institutional Review Boards - presentation
- FDA Inspections of Institutional Review Boards - script
- Flexibility Initiatives: Exemption 7 and Two-Year Approval - presentation
- Flexibility Initiatives: Exemption 7 and Two-Year Approval - script
- IRB-HSBS Guidance on Lotteries & Sweepstakes
- Mobile Medical Apps (FDA Guidance) - presentation
- Mobile Medical Apps (FDA Guidance) - script
- Parental Permission in Research Involving Minors - presentation
- res_irbmed_umic-signnow01
- res_irbmed_umic_script-signnow02
- res_irbmed_umic_signnow02
- Secondary Use Applications - script
- U-MIC - Central Institutional Review Boards PDF
- U-MIC - Central Institutional Review Boards Presentation
- U-MIC - Certificates of Confidentiality PDF
- U-MIC - Certificates of Confidentiality Presentation
- U-MIC Belmont Report P1 PDF
- U-MIC Belmont Report P2 PDF
- U-MIC ClinicalTrials.gov PDF
- U-MIC ClinicalTrials.gov Presentation
- U-MIC Cognitively Impaired Subjects & Legally Authorized Representatives Presentation
- U-MIC Community-Based Participatory Research PDF
- U-MIC Community-Based Participatory Research Presentation
- U-MIC Conflicts of Interest PDF
- U-MIC Conflicts of Interest Presentation
- U-MIC Continuing Review Changes Presentation
- U-MIC Data and/or Biospecimen PDF
- U-MIC Data and/or Biospecimen Presentation
- U-MIC Data Management & Security PDF
- U-MIC Data Management & Security Presentation
- U-MIC Deception & Concealment PDF
- U-MIC Deception & Concealment Presentation
- U-MIC EFIC PDF
- U-MIC EFIC Presentation
- U-MIC Electronic Data Security PDF
- U-MIC Electronic Data Security Presentation
- U-MIC Enrollment of Human Subjects PDF
- U-MIC Enrollment of Human Subjects Presentation
- U-MIC eResearch Regulatory Management Upgrade Presentation
- U-MIC eResearch: Viewing Submission Summaries PDF
- U-MIC eResearch: Viewing Submission Summaries Presentation
- U-MIC Exemption Changes Common Rule (2018)
- U-MIC Exemptions 1, 2, and 2A PDF
- U-MIC Exemptions 1, 2, and 2A Presentation
- U-MIC Expedited Review: Category 5 PDF
- U-MIC Expedited Review: Category 5 Presentation
- U-MIC FDA Guidance
- U-MIC FERPA PDF
- U-MIC FERPA Presentation
- U-MIC GINA PDF
- U-MIC GINA Presentation
- U-MIC HIPAA PDF
- U-MIC HIPAA Presentation
- U-MIC HRPP Presentation
- U-MIC HUDs PDF
- U-MIC HUDs Presentation
- U-MIC IC Emergency Care Setting PDF
- U-MIC IC Emergency Care Setting Presentation
- U-MIC IC FDA Guidance Presentation
- U-MIC IC FDA Guidance Presentation
- U-MIC IC Genetic Sub-Studies PDF
- U-MIC IC Genetic Sub-Studies Presentation
- U-MIC IC Sample & Eligibility Screening PDF
- U-MIC IC Sample & Eligibility Screening Presentation
- U-MIC ICH-GCP PDF
- U-MIC ICH-GCP Presentation
- U-MIC Informed Consent Changes Common Rule Presentation
- U-MIC Informed Consent Documentation PDF
- U-MIC Informed Consent Documentation Presentation
- U-MIC Investigator Responsibilities HRPP & Common Rule PDF
- U-MIC Investigator Responsibilities HRPP & Common Rule Presentation
- U-MIC IRB Membership Requirements & Quorum PDF
- U-MIC IRB Membership Requirements & Quorum Presentation
- U-MIC IRB Regulatory Determinations PDF
- U-MIC IRB Regulatory Determinations Presentation
- U-MIC Lotteries as Incentives PDF
- U-MIC Lotteries as Incentives Presentation
- U-MIC Meeting Minutes PDF
- U-MIC Meeting Minutes Presentation
- U-MIC Multisite Research PDF
- U-MIC Multisite Research Presentation
- U-MIC OHRCR electronic data security guidance
- U-MIC PHI PDF
- U-MIC PHI Presentation
- U-MIC Post-Approval Study Monitoring P1 Presentation
- U-MIC Post-Approval Study Monitoring P2 Presentation
- U-MIC Prisoners in Epidemiological Research PDF
- U-MIC Prisoners in Epidemiological Research Presentation
- U-MIC Prisoners P1 PDF
- U-MIC Prisoners P1 Presentation
- U-MIC Prisoners P2 PDF
- U-MIC Prisoners P2 Presentation
- U-MIC Privacy & Confidentiality PDF
- U-MIC Scheduled Continuing Review PDF
- U-MIC Scheduled Continuing Review Presentation
- U-MIC Significant & Nonsignficant Risk Devices PDF
- U-MIC Significant & Nonsignficant Risk Devices Presentation
- U-MIC Third Parties PDF
- U-MIC Third Parties Presentation
- U-MIC UPIRSOs or UaPs PDF
- U-MIC UPIRSOs or UaPs Presentation
- U-MIC Vulnerable Subject Populations Presentation
- U-MIC Waivers of Informed Consent Presentation
- U-MIC Writing Informed Consent Documents P1 PDF
- U-MIC Writing Informed Consent Documents P1 Presentation
- U-MIC Writing Informed Consent Documents P2 PDF
- U-MIC Writing Informed Consent Documents P2 Presentation
- Umbrella Projects - presentation
- Umbrella Projects - script
- Using Notes as Place Markers in eResearch - presentation
- Using Notes as Place Markers in eResearch - script
- Version Control of Informed Consent Documents - presentation
- Version Control of Informed Consent Documents - script