IRBMED
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- 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