Research Documents

Scientific Review Committees Initiate A Study E-Forms & Systems Supporting Your Trial COVID-19 Guidance
 

These documents are from the Piedmont Healthcare Institutional Review Board.
 

General Documents

• 2021 Meeting Schedule
• Glossary
• Charter
• IRB Composition, Compliance and Registration Statement
• IRB Fee Schedules
• IRB Frequently Asked Questions
• Member COI and Voting Process
• Piedmont use of WCG IRB, Inc.

Guidance Documents

• ABCs of IRBs
• Compassionate Use Guidance
• Elements of Informed Consent
• Emergency Use of a Medical Device
• Genetic and Other Sample Research Guidance
• HUD/HDE IRB Requirements
• If Not Research, What?
• IRB Policies
• Is This Research?
• Lay Summary Guidance
• Physician Referrals

Submission Forms and Templates

• Affiliated Site Renewal and Closure Notification
• Alterations or Waiver of Informed Consent
• Assent/Information Sheet for Clinical Study (ages 7-12)
• Assent (ages 13-17) and Parental Permission for Clinical Study
• Continuing Renewal and Permanent Closure Request Form
• HIPAA Authorization Form
• Informed Consent Template
• Institutional Authorization Agreement (IAA)
• Internal Death Report (To view this, you may need to upgrade Adobe Reader or open in Internet Explorer.)
• Investigator Assurances
• New Protocol Application Form
• Protocol Deviation / Violation Report Form
• Protocol Template
• Request for Modification (To view this, you may need to upgrade Adobe Reader or open in Internet Explorer.)
• Request for Verification of Exempt Status
• Short Form – English
• Short Form – Spanish
• Specimen Protocol Template
• Subject Authorization Revocation Letter
• Unanticipated Problems and Serious Adverse Events
• Verbal Consent Script

Video Demonstrations

• Informed Consent Process
• IRBNet Registration
• IRBNet Registration for monitors
• IRBNet Submissions Guide for Study Coordinators
• Staff e-reg binder process demonstration
• UP Reporting December 2019 remix

Electronic Systems

• Clinical Conductor CTMS
• Epic
• IRBNet
• RedCap

Electronic Forms

• Lab Deviation Variance
• ORS In-take Form
   

Student Research

• Confidentiality Agreement
• Sponsor Agreement
• Student Researcher Application
• Welcome Letter