Distinguishing Quality Projects from Research Activities
Conducting Clinical Research at Renown
Clinical Trials.gov Registration
Access Control and Authorization for the CTMS
Management of CTMS UserID, Password and PIN
Certificate of Confidentiality
Research Quality Review (not-for-cause audits) and Post Approval Monitoring (PAM)
For Cause Audits
Noncompliance, Suspension, Termination or Misconduct in Research
Recruitment Incentives to Research Personnel
Research Productivity
Investigator Qualifications
Non-Renown Employed Research Staff Qualifications
Education and Training of Investigators and Key Personnel
Roles and Responsibilities of Research Personnel in Non-Clinical Trials Research
Research Confidentiality Disclosure Agreements
Legal Review of Research Contracts
Research Grants: Application, Submission, and Award Management
Registration and Application Process for Electronic Submission of NIH Grants
Renown Health Data Use Agreement
Research Intellectual Property
COI – Investigators
Response to External Requests for Information – non-data related
Legally Authorized Representative
Informed Consent Process and Documentation
Documentation of Research in Medical Records
Essential Documents in the Conduct of a Clinical Trial
Monitoring Visits
External Audits
Study Close Out
Biological Sample Collection and Use
Use and Maintenance of Research Laboratories
Use of the Research Specimen Storage Area
Packaging and Shipping of Laboratory Specimens
Use of Liquid Nitrogen
Ordering, Delivery and Handling of Dry Ice
Use of Test Article at Renown Facilities
Use of Test Article When Followed at Non-Renown Facility
Use of Outside Approved Test Article when admitted to Renown Facility
Test Article Destruction
Research Billing Compliance
Research Business Services Study Start-Up Management
Research Business Services In-Study Management
Research Business Services Study Close-Out
Research Escalation Process
Medicare Coverage Determination Analysis Template
Research Subject Matter Injury Language
Research Feasibility Checklist
Research Dictionary
Research Process Maps
Research Close-Out Checklist