Resources
Table of Contents
- UAHS Research Administration Resources
- UA IRB Resources
- UA and UAHS Resources
- UA HIPAA-Compliant Digital Resources
- External Resources
- Informed Consent
- Data Management Plans
- Data and Safety Monitoring Boards (DSMB)
- Certificates of Confidentiality
- Single IRB Policy
- Clinical Trials
- Audits & Quality Assurance
UAHS Research Administration Resources:
- Clinical Trial Acronyms
- Clinical Trial Resources page
- UAHS Research Administration Contract Status Report
- UA IRB Guidance for Researchers
- UA IRB Study Documentation Resources and Links to Regulations
- UA IRB eIRB Information
- CATS (Clinical and Translational Sciences Research Center)
- HIPAA Privacy Program
- Office for Responsible Outside Interests (OROI) (formerly known as Conflict of Interest Office)
- Data Library
- Research Laboratory & Safety Services (RLSS)
- Native Peoples Technical Assistance Office (NPTAO)
- UACC Scientific Review Committee
UA HIPAA-Compliant Digital Resources:
External Resources:
- NIH Human Subjects Research
- FDA Clinical Trials and Human Subject Protection
- Office for Human Research Protections (OHRP)
- OHRP Informed Consent FAQs
- Informed Consent for Secondary Research with Data and Biospecimens (pdf)
- Informed Consent and Genomics
- NIH Data Management and Sharing Plan (2023)
- DMPTool for creating Data Management Plans
- Writing a Data Management & Sharing Plan
Data and Safety Monitoring Boards (DSMB):
- NIH Data and Safety Monitoring
- NIH Data and Safety Monitoring Plan attachment information
- FDA Guidance on Establishing and Operating DSMBs for sponsors
- UACC Data Safety and Monitoring Board
- UA HSPP Quality Assurance Program
Certificates of Confidentiality:
- NIH Single IRB for Multi-Site or Cooperative Research
- OHRP Single IRB Exception Determinations
- UA IRB Single IRB Research and Forms
- NIH Clinical Trial Requirements
- Does Your Human Subjects Research Study Meet the NIH Definition of a Clinical Trial?
- NIH Definition of Clinical Trial Case Studies
- Audit Management
- HSPP Quality Assurance Program
- Self-Assessment Review Checklist
- Protocol Adherence Assessment Checklist
- Inclusion/Exclusion Adherence Assessment Checklist
- Consent Documentation and Process Adherence Assessment Checklist
- Coordinator Corner
Blanca Pernic
Quality Program Officer
(520) 621-5196