Study Staff:
Education Policy for Investigators and Relevant Research Personnel (CC-RC-0004)
Travel and Employee Reimbursement Policy (OP-0443)
Volunteer Onboarding (OP-0401)
Budgeting, Billing, & Research Finance:
Billing for Clinical Research (Non-Device) (CC-RC-0001)
Billing for Routine Costs of Clinical Device Trials (CC-RA-07)
Coverage Analysis
Procurement for Direct Capital Goods and Services (OP-0477)
Procurement for Non-Capital Goods and Services (OP-0452)
Contracts:
Contract Review and Approval (OP-0346) MTA/DUA SOP
Clinical Research:
Coming Soon CTO SOPs
Clinical Trials:
Mandatory Subject Enrollment in Clinical Trial Management System (OP-661) Rush ClinicalTrials.gov SOP
Data & Records:
Data Access Governance and Classification (OP-0471)
Data Transfer Security (OP-0423)
Document and Media Destruction (OP-0382)
Record Retention (CC-G04)
Research Data – Access, Ownership and Retention (CC-RC-0001)
IRB Administration:(Note: All IRB policies can be collectively found in the IRB Folder )
Appointment of IRB Members, Alternatives, and Chairs (RA-IRB-101)
Disclosure and Management of Conflicts of Interest by IRB Members (RA-IRB-103)
Documentation and Storage of Minutes (RA-IRB-300)
Establishment and Maintenance of IRB Regulatory Files (RA-IRB-301)
Finders Fee and Bonus Payments (RA-IRB-117)
Initial and Ongoing Training of Rush (RA-IRB-102)
Maintenance of IRB Regulatory Files (RA-IRB-301)
Scope and Purpose of the Rush Institutional Review Board (RA-IRB-100)
Structure and Communication Plan for the RUMC HRPP (RA-IRB-121)
Pharmacy:
Investigational Drug Data Sheet (IDS 3)
Investigational Drug Use Control (IDS 1)
Pharmaceutical Waste Disposal
Pharmacy Dispensing of Controlled Substances used in Animal Research
Temperature (Refrigerator, Freezer, and Room) and Humidity (Room) monitoring for Inpatient Pharmacy
Non-Formulary Use of Drugs and Biological Products Granted Emergency Use Authorization
Research Participant Informed Consent and Interaction:
Alteration or Waiver of Informed Consent for Research Subjects
Elements and Documentation of Informed Consent for Research Subjects (RA-IRB-200)
Enrollment of Subjects Who Do Not Read, Speak, or Understand Written or Spoken English (RA-IRB-202)
HIPAA Privacy (HP-0002)
Interpreter and Translation Services (OP-0252)
Visitor Management at RUMC
Technology:
Computer Devices & Media Controls (OP-0385)
Email Communications and Third Party Storage (OP-0512)
HIPAA Security (HS-0001)
RUMC External Cloud and Managed Devices (OP-0433)
