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Collaboration Corner

Collaboration Corner – Research Compliance Newsletters

Collaboration Corner 2012 Vol 7 No 2 (PDF)
[Research Credentialing Process for Non-UH Personnel who access UH PHI for Research Purposes]
Collaboration Corner 2012 Vol 7 No 1 (PDF)
[A Message from the Vice President of Research & Technology]
Collaboration Corner 2011 Vol 6 No 11 (PDF)
[Research Misconduct Policy Update]
Collaboration Corner 2011 Vol 6 No 10 (PDF)
[Research Billing: The Basics]
Collaboration Corner 2011 Vol 6 No 9 (PDF)
[Understanding Common IRB Stipulations]
Collaboration Corner 2011 Vol 6 No 8 (PDF)
[Monitor/Auditor Access to UHCare]
Collaboration Corner 2011 Vol 6 No 7 (PDF)
[Standard Operating Procedures (SOPs)]
Collaboration Corner 2011 Vol 6 No 6 (PDF)
[Handling Multiple Amendments to the IRB for a Single Study]
Collaboration Corner 2011 Vol 6 No 5 (PDF)
[Department Review: Revised Research Policies]
Collaboration Corner 2011 Vol 6 No 4 (PDF)
[Department Review: The Initial Step]
Collaboration Corner 2011 Vol 6 No 3 (PDF)
[Informed Consent Update: New FDA Language Required Regarding ClinicalTrials.gov: March 7, 2011]
Collaboration Corner 2011 Vol 6 No 2 (PDF)
[Continuing Review]
Collaboration Corner 2011 Vol 6 No 1 (PDF)
[Using iRIS – The UHCMC Electronic IRB Submission System]

Archived Collaboration Corner Newsletters

Collaboration Corner 2010 Vol 5 No 10 (PDF)
[Research Participants – Withdrawal from Research]
Collaboration Corner 2010 Vol 5 No 9 (PDF)
[Converting to the New Form Version in iRIS; iRIS User Tip – Revising Study Documents in iRIS]
Collaboration Corner 2010 Vol 5 No 8 (PDF)
[Administrative Withdrawal of IRB Submissions; Human Subject Protection Program – Recertification Reminder; Handling and Shipment of Biological Specimens – Required Training]
Collaboration Corner 2010 Vol 5 No 7 (PDF)
[What is the Office of Management and Budget (OMB) Circular A-133 Audit?; OHRP Research Community Forum]
Collaboration Corner 2010 Vol 5 No 6 (PDF)
[Plan for Obtaining Informed Consent; Addressing Confidentiality in a Protocol]
Collaboration Corner 2010 Vol 5 No 5 (PDF)
[iRIS User Tip – Revising Study Documents in iRIS; Need Assistance with iRIS?]
Collaboration Corner 2010 Vol 5 No 4 (PDF)
[EMR Training For Researchers] [EMR Research Workflow Brochure (PDF)]
Collaboration Corner 2010 Vol 5 No 3 (PDF)
[Genetic Information Non-Discrimination Act (GINA): IRB Requirements; Continuing Review Reminder and Notices of Expiration]
Collaboration Corner 2010 Vol 5 No 2 (PDF)
[Review and Signoff of Grant Expenditures; Revenue Review]
Collaboration Corner 2010 Vol 5 No 1 (PDF)
[Closure of IRB Approved Protocols, UH Case Medical Center IRB Roster and Meeting Dates Available Online, NIH Announces Changes to Grant Application]
Collaboration Corner 2009 Vol 4 No 12(1) (PDF)
[iRIS IRB System is Now Open!, Continuing Research Education Credits Reminder]
Collaboration -Corner 2009 Vol 4 No 11(1) (PDF)
[Reporting Adverse Events]
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]
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]