Collaboration Corner – Research Compliance Newsletters

• Collaboration Corner 2009 Vol 4 No 10(2) (PDF)
  [iRIS^™ Electronic IRB System Implementation, "To Discover" Days, Revised Policy on "Remuneration of Subjects"]
• Collaboration Corner 2009 Vol 4 No 10(1) (PDF)
  [Tips for Financial Management of Grant Awards (PTAEOs); UPDATE: Currently Established Master Agreements]
• Collaboration Corner 2009 Vol 4 No 9(2) (PDF)
  [FDA Requirements Regarding IRB Registration; Human Subject Protection Program – Recertification Reminder; Helpful Tips]
• Collaboration Corner 2009 Vol 4 No 9(1) (PDF)
  [Clinical Technology Symposium]
• Collaboration Corner 2009 Vol 4 No 8(2) (PDF)
  [“To Discover” Days; Continuing Review]
• Collaboration Corner 2009 Vol 4 No 8(1) (PDF)
  [Clinical Technology Symposium; RB&C Pediatric Innovation Day]
• Collaboration Corner 2009 Vol 4 No 7(2) (PDF)
  [Form FDA 1572; Translation & Interpretation Services for Non-English Speaking Participants; Education Update]
• Collaboration Corner 2009 Vol 4 No 7(1) (PDF)
  [The Patent Examination Process; Claim Example & Formal Requirements; Substantive Examination]
• Collaboration Corner 2009 Vol 4 No 6(2) (PDF)
  [IRB Registration; Revisions to (N) Checklist; New Policy: Quality Improvement Activities; Education Update]
• Collaboration Corner 2009 Vol 4 No 6(1) (PDF)
  [Master Agreements; Currently Established Master Agreements; Who to Contact]
• Collaboration Corner 2009 Vol 4 No 5(2) (PDF)
  [Identity Theft Program (new UH policy); NIH Challenge Grant Research protocol review; Update protocols approved prior to June 2006; Blood Draw Study Regulatory requirements]
• Collaboration Corner 2009 Vol 4 No 5(1) (PDF)
  [Patent Filing Requirements: Part 3: Best Mode]
• Collaboration Corner 2009 Vol 4 No 4(2) (PDF)
  [Exempt Human Research Amendment Clarification; HSP Certification; Converting Sponsor provided ICFs]
• Collaboration Corner 2009 Vol 4 No 4(1) (PDF)
  [Financial Management of Grant Awards; 2008-2009 Close for CWRU; 2009 Space Survey]
• Collaboration Corner 2009 Vol 4 No 3(2) (PDF)
  [Research and HIPAA]
• Collaboration Corner 2009 Vol 4 No 3(1) (PDF)
  [Patent Filing Requirements: Part 2: Enablement]
• Collaboration Corner 2009 Vol 4 No 2(2) (PDF)
  [UHCMC IRB Policy Updates (IRB FAQ, Statement of Compliance Protocol submission requirements, Other Vulnerable Populations); Investigator Certification Reminder]
• Collaboration Corner 2009 Vol 4 No 2(1) (PDF)
  [Guidance from the FDA: Investigational New Drug Application / Investigational Device Exemption process]
• Collaboration Corner 2009 Vol 4 No 1(2) (PDF)
  [A message from the VP; 2008 Achievements]
• Collaboration Corner 2009 Vol 4 No 1(1) (PDF)
  [Policy Updates: IND/IDE; IRS Mileage Rate; FDA Record Retention Guidance]

Archived Collaboration Corner Newsletters

• Collaboration Corner 2008 Vol 3 No 12(2) (PDF)
  [Study Closure for Lack of Response; iRIS^™ Electronic IRB System Implementation]
• Collaboration Corner 2008 Vol 3 No 12(1) (PDF)
  [Patient Reimbursement System; University Hospitals Required Safety Training]
• Collaboration Corner 2008 Vol 3 No 11(2) (PDF)
  [Patent Filing Requirements: Part 1: Written Description]
• Collaboration Corner 2008 Vol 3 No 11(1) (PDF)
  [NIH Guidance on Genome-Wide Association Studies]
• Collaboration Corner 2008 Vol 3 No 10(2) (PDF)
  [Education Programs; Check your CREC; New Staff]
• Collaboration Corner 2008 Vol 3 No 10(1) (PDF)
  [Human Subject Research Billing]
• Collaboration Corner 2008 Vol 3 No 9(2) (PDF)
  [Report on Informed Consent Documentation Initiative]
• Collaboration Corner 2008 Vol 3 No 9(1) (PDF)
  [Confidential Disclosure and Nondisclosure Agreements]
• Collaboration Corner 2008 Vol 3 No 8(2) (PDF)
  [New Case Report Policy; CREC Reminder; CR Helpful Tip; Clinical Trial Listing]
• Collaboration Corner 2008 Vol 3 No 8(1) (PDF)
  [Building an Accurate Budget; Contact Information]
• Collaboration Corner 2008 Vol 3 No 7(2) (PDF)
  [Informed Consent Requirements for Medical Records; Case Study]
• Collaboration Corner 2008 Vol 3 No 7(1) (PDF)
  [Effects of Grant Applications on Patents; Education Update: Patient Billing]
• Collaboration Corner 2008 Vol 3 No 6(2) (PDF)
  [Corporate Compliance; Exemption Requests; Transferring CITI Credits; HIPAA Update]
• Collaboration Corner 2008 Vol 3 No 6(1) (PDF)
  [Grants Accounting; Adjustment Request Policies]
• Collaboration Corner 2008 Vol 3 No 5(2) (PDF)
  [Office of Research Compliance and Education (Monitoring & Education)]
• Collaboration Corner 2008 Vol 3 No 5(1) (PDF)
  [Bi-monthly newsletter; Grants and Contracts Submissions]
• Collaboration Corner 2008 Vol 3 No 4 (PDF)
  [Informed Consent Documentation Initiative; Signature Blocks on Consent and Assent Documents; Helpful Note: Version Dates; IRB Website Updates]
• Collaboration Corner 2008 Vol 3 No 3 (PDF)
  [Confidentiality/Non-Disclosure and Material Transfer Agreements; INDs and IDEs; Research Education Series]
• Collaboration Corner 2008 Vol 3 No 2 (PDF)
  [HIPAA Authorization Template; Emergency Use versus Compassionate Use; Research Education Series]
• Collaboration Corner 2008 Vol 3 No 1 (PDF)
  [Helpful Tips; Common Non-Compliance Finding; Education Program: New Topic]
• Collaboration Corner 2007 Vol 2 No 12 (PDF)
  [Non-Human Subject Research; Protocol Version Dates; Clinical Trial Registration]
• Collaboration Corner 2007 Vol 2 No 11 (PDF)
  [Assent; Inclusion of children in research]
• Collaboration Corner 2007 Vol 2 No 10 (PDF)
  [Obtaining Gift Cards: CASE & UHCMC; Partial Waivers of Consent and HIPAA Authorization]
• Collaboration Corner 2007 Vol 2 No 9 (PDF)
  [Informed Consent Template; Responsible Conduct of Research Education Seminars and Workshops]
• Collaboration Corner 2007 Vol 2 No 8 (PDF)
  [New Guidelines: Enrollment of Subjects with Decisional Impairment in Research]
• Collaboration Corner 2007 Vol 2 No 7 (PDF)
  [Exempt Research; HIPAA Authorization Reminder; The Office of Technology Management]
• Collaboration Corner 2007 Vol 2 No 6 (PDF)
  [IRB Rosters available on-line; Updates to IRB Policies, Procedures, Forms and Templates; Policy Revision: Closure versus Termination]
• Collaboration Corner 2007 Vol 2 No 5 (PDF)
  [Revisions to the Adverse Event Reporting Policy]
• Collaboration Corner 2007 Vol 2 No 4 (PDF)
  [Pregnant Women in Research]
• Collaboration Corner 2007 Vol 2 No 3 (PDF)
  [Common Non-Compliance Findings, Part I: Failure to Report Adverse Events and Other Reportable Events; and NEW: Genetic Research Ethics Consultation Service / Rapid Ethics Action Consult Team]
• Collaboration Corner 2007 Vol 2 No 2 (PDF)
  [Inclusion of Illiterate, non-English speaking subjects, and pregnant women and fetuses in research studies; NEW: HIPAA Authorization Template Language]
• Collaboration Corner 2007 Vol 2 No 1 (PDF)
  [Prompt Reporting of Protocol Amendments; Requirements for Continuing Review Submissions]
• Collaboration Corner 2006 Vol 1 No 9 (PDF)
  [2007 Monitoring Schedule; Laboratory Reference Ranges: Update for Regulatory Binder; Top 10 Monitoring Findings: 2006]
• Collaboration Corner 2006 Vol 1 No 8 (PDF)
  [Recruitment Material; Privacy versus Confidentiality; Helpful Tip: Who can be a Principal Investigator]
• Collaboration Corner 2006 Vol 1 No 7 (PDF)
  [Informed Consent Observations; Monitoring: Grants and Contracts; Helpful Tip : How to "Track Changes" in Research Documents]
• Collaboration Corner 2006 Vol 1 No 6 (PDF)
  [Obtaining Laboratory Reference Ranges for Regulatory Binders; Update: Clinical Trials Brochure Available Online; Revisions to the UHC IRB Policies and Procedures; Protocol Summary at Continuing Review; Certification Pursuit Program (CPP)]
• Collaboration Corner 2006 Vol 1 No 5 (PDF)
  [Documentation of the Informed Consent Process; New UHC IRB Procedure: Advertisements to Receive an Approval Stamp; Helpful Tip : When to File an Informed Consent Document in a Patient's Medical Records]
• Collaboration Corner 2006 Vol 1 No 4 (PDF)
  [Regulatory Binder: Definition and Content; Helpful Tip: Human Tissues and Histology Services]
• Collaboration Corner 2006 Vol 1 No 3 (PDF)
  [Revisions to the UHC IRB Policies and Procedures Manual Helpful Tips; The General Clinical Research Center; Update your contact information]
• Collaboration Corner 2006 Vol 1 No 2 (PDF)
  [Research Compliance Monitoring Program…What to expect; Helpful Tips: Reporting Adverse Events for Related Studies]
• Collaboration Corner 2006 Vol 1 No 1 (PDF)
  [An Introduction: Research Collaboration Corner; What is the UHC Office of Research Compliance; Why am I being contacted by the UHC ORC? Research Compliance Monitoring Program; Helpful Tips: Investigator Drug Services]