Resource Library

• ALCOA-C: A Framework for Data Quality (UNC-Chapel Hill NC TraCS RCMU (vimeo.com))
• Cures Act Implications for Clinical Research (UNC-Chapel Hill SOM CRSO (med.unc.edu))
• ORARC Tipsheet: Inclusive Demographic Data Collection (ORARC – Office of Regulatory Affairs and Research Compliance (cdn1.sph.harvard.edu)

• Common Invoiceable Items for Study Budgets (UNC-Chapel Hill SOM CRSO (med.unc.edu))
• RAM Tracker Dashboard Guide (UNC-Chapel Hill Research OSP (research.unc.edu))
• RAM Tracker Transparency Guide (UNC-Chapel Hill Research OSP (research.unc.edu))
• Prepaid Card Guidance (UNC-Chapel Hill Research OSP (research.unc.edu)) 
• Prepaid Card Program Accounting Process (UNC-Chapel Hill Finance Operations, Office of Finance and Budget (finance.unc.edu))
• OSP Forms and Tools (UNC-Chapel Hill Research OSP (research.unc.edu))
• Carolina Talent Online Class: Introduction to the Prepaid Administration Tool (PAT) (UNC-Chapel Hill Finance Operations (unc.csod.com))  
• Prepaid Card Manual (UNC-Chapel Hill Finance Operations, Office of Finance and Budget (finance.unc.edu))  
• Budget Development Tools (UNC-Chapel Hill Research OCT (research.unc.edu))

UNC-Chapel Hill:

• Investigator Training (Lineberger Cancer Network Learning Portal (learn.unclcn.org))
• Principal Investigator Training (Research Compliance Program (research.unc.edu))

Other Sources:

• Educational Resources for Investigators (OHRP – Office of Human Research Protections (hhs.gov))

• File Organization (UNC-Chapel Hill SOM CRSO)
• How to Add an External User to Microsoft Teams (UNC Health & UNC-Chapel Hill SOM)
• Manager Toolkit (UNC-Chapel Hill HR)
• Study Team Meeting Agenda Template (UNC-Chapel Hill SOM CRSO)
• SOM Work Instructions Template (UNC-Chapel Hill SOM CRSO)

• Community Engagement Studio Toolkit 2.0 (MVA – Meharry-Vanderbilt Alliance (trialinnovationnetwork.org))
• Community Outreach Guide, Tips for research staff and Principal Investigators to “normalize” clinical trials in your community (RIC – Recruitment Innovation Center, Trial Innovation Network (trialinnovationnetwork.org))
• Patient Advisor Toolkit 1: Orientation for Patient Advisory Committees (PAT-1) (HIPxChange, University of Wisconsin-Madison (hipxchange.org))
• About the Community Engagement Alliance (CEAL) Against COVID-19 Disparities (CEAL (covid19community.nih.gov))
• Referring Providers Outreach Guide (RIC – Recruitment Innovation Center, Trial Innovation Network (trialinnovationnetwork.org))
• Resource for Integrating Community Voices into a Research Study: Community Advisory Board Toolkit (SC CTSI – Southern California Clinical and Translational Science Institute (sc-ctsi.org)) 
• Toolkit for Developing Community Partnerships (SC CTSI – Southern California Clinical and Translational Science Institute (sc-ctsi.org))
• Tools for Stakeholder Engagement in Research (HIPxChange, University of Wisconsin-Madison (hipxchange.org))

Recruitment and Retention

UNC-Chapel Hill:

• Clinical Trial Accrual Tool Template (SOM CRSO (med.unc.edu))

Other:

• Cohort Retention Tools (OACIS – Outcomes After Critical Illness and Surgery, Johns Hopkins University School of Medicine (improvelto.com))
• Covid-19 Recruitment + Retention Toolkit (RIC – Recruitment Innovation Center, Trial Innovation Network (trialinnovationnetwork.org))
• Diversity, Inclusion, and Equity in Clinical Research Website (MRCT Center of Brigham and Women’s Hospital and Harvard (mrctcenter.org))
• Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials (CTTI – Clinical Trials Transformation Initiative (ctti-clinicaltrials.org))
• Faster Together, Enhancing the Recruitment of Minorities in Clinical Trials (RIC – Recruitment Innovation Center, Trial Innovation Network; Meharry-Vanderbilt Alliance (coursera.org))
• Including Pediatric Populations in Research: Challenges and Strategies for Recruitment (OCTRI – Oregon Clinical & Translational Research Institute (ohsu.edu))
• Maximizing Impact: Leveraging Digital & Traditional Tools for Recruitment and Retention Success (SC CTSI – Southern California Clinical and Translational Science Institute (new.sc-ctsi.org))
• NIH Inclusion Outreach Toolkit: How to Engage, Recruit, and Retain Women in Clinical Research (NIH ORWH – Office of Research on Women’s Health (orwh.od.nih.gov))
• Recruitment and Retention Plan Document for Coordinating Centers (RIC – Recruitment Innovation Center, Trial Innovation Network (med.unc.edu/crso))
• Recruitment and Retention Plan Document for Sites (RIC – Recruitment Innovation Center, Trial Innovation Network (med.unc.edu/crso))
• Research Recruitment During Modified Operations (OCTRI – Oregon Clinical & Translational Research Institute (ohsu.edu))
• Recruiting Healthy Subjects for Research Studies Using Epic’s Electronic Health Record (OCTRI – Oregon Clinical & Translational Research Institute (trialinnovationnetwork.org))
• Recruitment and Retention Plan (RRP) (RIC – Recruitment Innovation Center, Trial Innovation Network (trialinnovationnetwork.org))
• Study Recruitment: Using Digital Tools to Increase Participation (Ohio State University Center for Clinical and Translational Science (trialinnovationnetwork.org))
• Study Website Toolkit (RIC – Recruitment Innovation Center, Trial Innovation Network (trialinnovationnetwork.org))
• Tips and Tricks for Successful Research Recruitment: A Toolkit for a Community-Based Approach (SC CTSI – Southern California Clinical and Translational Science Institute (slideshare.net))
• The Art of Recruitment (Trial Innovation Network (trialinnovationnetwork.org)) 

Informed Consent

UNC-Chapel Hill:

• Checklist for Documenting the Informed Consent Discussion Template (SOM CRSO (med.unc.edu)
• Contextual Note for Documenting the Informed Consent Discussion in the Study Record Template (SOM CRSO (med.unc.edu))
• Contextual Note for Documenting the Informed Consent Discussion in the EMR Template (SOM CRSO (med.unc.edu))
• Elements of the Informed Consent Form and HIPAA Authorization (SOM CRSO (med.unc.edu))
• Tips on the Remote Consent Process (SOM CRSO (med.unc.edu))

Other Sources:

• Health Literacy Checklist for Research Communication (OCTRI – Oregon Clinical & Translational Research Institute (trialinnovationnetwork.org)
• Health Literacy in Clinical Research: IRB Checklist (MRCT Center of Brigham and Women’s Hospital and Harvard (mrctcenter.org)) 

Education and Training

UNC-Chapel Hill:

• HIPAA Training (UNC-Chapel Hill SOM (med.unc.edu)
• Trainings for UNC Research Personnel (UNC-Chapel Hill NC TraCS RCMU (rcmu.tracs.unc.edu))

Other Sources:

• A Comprehensive Guide for Clinicians and Researchers with a Focus on Needlesticks and Blood Draws: Helping Your Patients with Intellectual and Developmental Disabilities (VKC – Vanderbilt Kennedy Center (trialinnovationnetwork.org)
• DIAMOND Portal (University of Michigan, University of Rochester, Ohio State University & Tufts University (diamondportal.org)
• Educational Videos (OHRP – Office of Human Research Protections (hhs.gov))
• Educational Videos on INDs, IDEs & ClinicalTrials.gov (ReGARDD – Regulatory Guidance for Academic Research of Drugs and Devices (regardd.org))
• Exploratory Workshops (OHRP – Office of Human Research Protections (hhs.gov))
• Luminaries Lecture Series (OHRP – Office of Human Research Protections (hhs.gov))
• Training Checklist for Someone Working with IRBs (OHRP – Office of Human Research Protections (hhs.gov))

Study Procedures

• Dissemination of Research Results (VICTR – Vanderbilt Institute for Clinical and Translational Research (victr.vumc.org))

IRB 

• IRB Standard Operating Procedures (UNC-Chapel Hill OHRE (policies.unc.edu))
• IRB Dates and Deadlines for Review (UNC-Chapel Hill OHRE (research.unc.edu))
• IRBIS Online Submission Guide (UNC-Chapel Hill OHRE (research.unc.edu))
• The Research Clinic: An Interactive Research Integrity Exercise (ORI – Office of Research Integrity (ori.hhs.gov))
• Single IRB Training: Lead Study Team (Trial Innovation Network (trialinnovationnetwork.org)) 
• Single IRB Training: Relying Site Human Research Protections Module (Trial Innovation Network (trialinnovationnetwork.org)) 

Data and Safety Monitoring

• Data and Safety Monitoring Guidance For PI-initiated Research (UNC-Chapel Hill SOM CRSO (med.unc.edu))
• DMC vs IRB: What’s the Difference? (Advarra (med.unc.edu))

Quality Assurance (QA)/ Quality Improvement (QI)

• Quality Assurance and Quality Improvement (QA/QI) FAQs (UNC- Chapel Hill NC TraCS Regulatory, OHRE (med.unc.edu))
• Quality Assurance (QA) and Quality Improvement (QI) Screening Checklist (UNC Chapel Hill NC SOM CRSO, TraCS Regulatory, OHRE (med.unc.edu))

Roles and Responsibilities

• Office of Sponsored Programs Roles and Responsibilities Matrix (UNC-Chapel Hill OSP (research.unc.edu))

Regulatory Forms and Templates

• Regulatory forms and templates (UNC-Chapel Hill Research OCT (research.unc.edu))

• CTTI Quality by Design Project: Critical to Quality Factors Principles Document (CTTI – Clinical Trials Transformation Initiative (ctti-clinicaltrials.org))
• Gamification Toolbox (Trial Innovation Network (trialinnovationnetwork.org)) 
• Person-Centeredness of Research Scale (MVA – Meharry-Vanderbilt Alliance (meharry-vanderbilt.org))
• Research Registry Toolkit (UNC-Chapel Hill SOM NC TraCS (registrytoolkit.unc.edu))

• Bloom Process Mapping Tool (UNC Chapel Hill SOM CRSO (med.unc.edu))