Resources

Table of Contents 

1. UAHS Research Administration Resources
2. UA IRB Resources
3. UA and UAHS Resources
4. UA HIPAA-Compliant Digital Resources
5. External Resources
6. Informed Consent
7. Data Management Plans
8. Data and Safety Monitoring Boards (DSMB)
9. Certificates of Confidentiality
10. Single IRB Policy
11. Clinical Trials
12. Audits & Quality Assurance
13. Good Documentation Practice 
14. Source Documentation Tips

UAHS Research Administration Resources:

• Clinical Trial Acronyms
• Clinical Trial Resources page
• UAHS Research Administration Contract Status Report and Facilities Directory

UA IRB Resources:

• UA IRB Guidance for Researchers
• UA IRB Study Documentation Resources and Links to Regulations
• UA IRB eIRB Information

UA and UAHS Resources:

• 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)
  • RLSS Training
  • Good Laboratory Practices
  • BioSafety
  • Radiation Safety
  • Respiratory Protectio 
• Native Peoples Technical Assistance Office (NPTAO)
  • Arizona Tribes & Research Policies
• UACC Scientific Review Committee
• UACC IIT Template

UA HIPAA-Compliant Digital Resources:

• REDCap 
• Approved PHI Solutions
• Communicating Health Information Online
• Zoom for Health
  • HIPAA Zoom portal

External Resources:​

• NIH Human Subjects Research
• FDA Clinical Trials and Human Subject Protection
• Office for Human Research Protections (OHRP)

Informed Consent:

• OHRP Informed Consent FAQs
• Informed Consent for Secondary Research with Data and Biospecimens (pdf)
• Informed Consent and Genomics​

Data Management Plans:

• 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 Certificate of Confidentiality information
• FDA Certificate of Confidentiality information 

Single IRB Policy:

• NIH Single IRB for Multi-Site or Cooperative Research
• OHRP Single IRB Exception Determinations
• UA IRB Single IRB Research and Forms

Clinical Trials:

• 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

Audits & Quality Assurance:​