Study Staff:
Education Policy for Investigators and Relevant Research Personnel (CC-RC-0004)
Travel and Employee Reimbursement Policy (Formerly OP-0443)
Volunteer Onboarding (Formerly 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 (Formerly OP-0477)
Procurement for Non-Capital Goods and Services (Formerly OP-0452)
Contracts:
Contract Review and Approval (Formerly OP-0346) MTA/DUA SOP
Clinical Trials:
Mandatory Subject Enrollment in Clinical Trial Management System (Formerly OP-661) Rush ClinicalTrials.gov SOP
Data & Records:
Data Access Governance and Classification (Formerly OP-0471)
Data Transfer Security (Formerly OP-0423)
Document and Media Destruction (Formerly 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 (Formerly OP-0252)
Visitor Management at RUMC
Technology:
HIPAA Security (HS-0001)
IT 0.100 Information Security Policy
IT 0.300 Systems Service and Acquisition Policy
IT 10.00 Media Protection Policy
IT 19.00 Asset Management and Lifecycle Policy
