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AAHRPP Accreditation Standards
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AAHRPP Advance, Summer 2010, Vol. 7, No. 3
With articles on:
- New Data Support Benchmarking
- Sponsors, CROs Looking for Accreditation
- HRPP Performance: Figures and Charts
- Accreditation: 214 Organizations
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AAHRPP Advance, Spring 2010, Vol. 7, No. 2
With articles on:
- Compliance: Accredited organizations again fare better with FDA
- Competition: Pharma urged to use accredited sites
- Collaboration: Harvard streamlines research review
- Accreditation: 206 organizations
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AAHRPP Advance, Winter 2010, Vol. 7, No. 1
With articles on fewer burdens, more protections:
- In the Final Revised Accreditation Standards
- With a Longer Accreditation Period
- By Working with Accreditation Directors before You Apply
- In Deciding Whether to Check or Uncheck th
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AAHRPP Advance, Fall 2009, Vol. 6, No. 4
With articles on
HRPP Innovations: Quality Research IS Ethical Research at
- The University of Colorado Denver
- The University of Texas Health Science Center at Houston
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AAHRPP Advance, Summer 2009, Vol. 6, No. 3
With articles on:
- Comment on Proposed Revised Accreditation Standards
- Increasing Focus on COI
- AAHRPP Seeks New Data
- Doing The Right Thing Leads to The Smart Thing
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AAHRPP Advance, Spring 2009, Vol. 6, No. 2
With the upper chart on page 7 corrected
With articles on:
- Pfizer Is First Drug Company Accredited
- Improving the Accreditation Process
- As Funding Increases, Put Some Aside to Earn Trust
- Fewer Problems for the Accredited
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AAHRPP Advance, Winter 2009, Vol. 6, No. 1
With articles on:
- Maintaining Research Protections During an Economic Downturn
- Online COI Disclosure at Cleveland Clinic
- New OHRP Director Outlines Priorities
- 2009 AAHRPP Conference Registration
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AAHRPP Advance, Fall 2008, Vol. 5, No.4
With articles on:
- AAHRPP Accredits First Private Research Site
- Looking Ahead: Your Input on Standards
- Accreditation Reshapes Research Enterprise
- Reviewing Prisoner Research at UC Irvine
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AAHRPP Advance, Summer 2008, Vol. 5, No. 3
With articles on:
- Managing COI in Human Research: Organizations Call for More Progress
- AAHRPP Standards for Financial COI
- UAB and Children’s Hospital: Two Different, Effective Approaches to Managing COI
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AAHRPP Advance, Spring 2008, Vol. 5, No. 2
With articles on:
- Quality Improvement: Research or Non-Research? AAHRPP’s Perspective
- More than 100 Organizations Now Accredited
- Conference Showcases Challenges, Solutions
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AAHRPP Advance, Winter 2008, Vol. 5, No. 1
With articles on:
- IRBs and Behavioral and Social Science Research: Finding the Middle Ground
- Revised Application Process for Accreditation: Site Visits Focus More on Practice
- Accreditation Fosters Networking, Collaboration
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AAHRPP Advance, Fall 2007, Vol. 4, No. 3
With articles on:
- The Role of the Organizational Official: Unparalleled Influence and Responsibility
- AAHRPP Accreditation Results in Tangible Benefits
- Officials Cite Improved Protections, Compliance, Respect and Other Benefits
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AAHRPP Advance, Summer 2007, Vol. 4, No. 2
Special Accreditation Edition,
With articles on:
- Improving the Accreditation Process: Streamlined Approach Maintains Standards
- Reaccreditation Starts Now
- A Guide to the Self-Assessment
- Preparing for Your Site Visit
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AAHRPP Advance, Spring 2007, Vol. 4, No. 1
With articles on:
- Research Enterprise Feeling Positive Impact of AAHRPP, Accredited Organizations
- BRANY: A Unique Model for Oversight, Protection
- Trends Point to Increased Demand for Accreditation
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AAHRPP Advance, Winter 2006, Vol. 3, No. 4
With typographical errors corrected on page 7
With articles on:
- Five Years of Advancing Human Protections and Ethical Research
- UI and WIRB Set Example for Accreditation
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AAHRPP Advance, Fall 2006, Vol. 3, No. 3
With articles on:
- AAHRPP Accredits First International Center
- The Global Research Enterprise: A Growing Market Brings Growing Concerns
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AAHRPP Advance, Summer 2006, Vol. 3, No. 2
With articles on:
- 2006 Conference: A Roadmap to Quality HRPPs
- ― Ask Legal Counsel: Understanding and Making the Most of the IRB-Counsel Relationship
- ― Regulations and Guidance: A Discussion with FDA And OHRP
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AAHRPP Advance, Spring 2006, Vol. 3, No. 1
With articles on:
- AAHRPP Awarded $4.9 Million Contract to Accredit VA Facilities
- Accreditation an Asset to Community Hospitals
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AAHRPP Advance, Winter 2005, Vol. 2, No. 4
With articles on:
- AAHRPP Accreditation: Gold Standard and Standard Practice
- AAHRPP Welcomes First Supporting Members
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AAHRPP Advance, Fall 2005, Vol. 2, No. 3
With articles on:
- The Need for Accreditation in An Increasingly Complex Research Enterprise
- Who Should Consider Accreditation?
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AAHRPP Advance, Summer 2005, Vol. 2, No. 2
With articles on:
- Understanding―and Acknowledging―the Public’s Perspective
- NHC: Serving Our Constituencies As a Founding Member
- OHRP Thoughts on Accreditation
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AAHRPP Advance, Spring 2005, Vol. 2, No. 1
With articles on:
- Strengthening the Clinical Research Enterprise:
- Accredited Teaching Hospitals Respond
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AAHRPP Advance, Winter 2004, Vol. 1, No. 2
With articles on:
- Accreditation’s Role in the Behavioral Sciences
- Clinical Research Safety and Accreditation of Human Research Protection Programs—
A View from PhRMA
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AAHRPP Advance, Fall 2004, Vol. 1, No. 1
With articles on:
- Accreditation Spotlight: Cedars-Sinai Medical Center
- American Council on Education Supports AAHRPP Accreditation
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Making the Business Case for Accreditation
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2009 Metrics on HRPP Performance
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AAHRPP Accreditation Procedures
Gives an overview of the procedures AAHRPP uses to provide accreditation services.
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AAHRPP Accreditation Standards
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AAHRPP Proposes Changes to Standards, Conflict-of-Interest Provisions
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Annual Report Form
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Checking or Unchecking the Boxes on the FWA, 4/22/10
Learn what checking or unchecking means to your organization.
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Checking or Unchecking the Boxes on the FWA, 4/29/10
Learn what checking or unchecking means to your organization.
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Evaluation Instrument for Accreditation
Use to evaluate a Human Research Protection Program. Organizations should use this document to conduct a self-assessment for their Step 1 application.
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Finding Flexibility in the Regulations
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Getting Started Registration
Learn how to conduct your self-assessment by registering for your own Getting Started Webinar.
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Guidance on Completing the Tables in the Application and Annual Report Forms
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If You Needed an Outside IRB, Could You Find One?
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Industry Summit
Report: Multi-Regional Clinical Trials Project
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Instructions to Apply for Initial Accreditation and Reaccreditation
Detailed instructions about the application process, including how to conduct a self-assessment and prepare your application package.
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Organizational Conflict of Interest, 6/23/10
Learn how organizations implement policies and procedures for organizational conflict of interest.
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Pfizer First Pharma Company to Receive Accreditation for Study Subject Protections
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Pfizer Presentation at 2009 Annual Conference
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Pfizer Presentation at 2009 Annual Conference
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Principles of Accreditation
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Providing Equivalent Protections to Participants When Conducting Research outside the U.S.
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Reviewing Clinical Trials: A Guide for the Ethics Committee
By Johan P.E. Karlberg, M.D., Ph.D., and Marjorie A. Speers, Ph.D.
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Sites Need Strict Rules on Conflict of Interest
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Standards Comparison
Compare the previous AAHRPP Accreditation Standards (in effect until February 28, 2010) and the AHRPP Accreditation Standards (in effect beginning March 1, 2010).
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Step 1 Application Form for Accreditation
Document to be completed, signed, and included with Step 1 application package when applying for initial accreditation
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Step 1 Application Form for Reaccreditation
Document to be completed, signed, and included with Step 1 application package when applying for reaccreditation
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Step 2 Application Form for Accreditation
Document to be completed, signed, and included with Step 2 application package when applying for initial accreditation.
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Step 2 Application Form for Reaccreditation
Document to be completed, signed, and included with Step 2 application package when apply for reaccreditation.
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Template for Application Section C
Use this form as a template to create the index of supporting documents (Section C) for your application.
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Template for Application Section F (Protocol List)
Use this spreadsheet as a template to create your protocol list (Section F) for your application.
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Template for IRB Rosters
Use this spreadsheet as a template to create your IRB roster (Section D) for your application.
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Tip Sheet: Criteria for Approval of Research
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Tip Sheet: Determining Whether an Activity is Research Involving Human Participants
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Tip Sheet: Documenting Discussions and Decisions on Research Studies
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Tip Sheet: Evaluating Maintenance of Confidentiality of Data in Proposed Research
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Tip Sheet: Evaluating Protections of Privacy Interests of Participants in Proposed Research
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Tip Sheet: Evaluating Provisions for Monitoring Data and Safety in Proposed Research
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Tip Sheet: Evaluation of IRB Chairs, Vice-Chairs, IRB Members and IRB Staff
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Tip Sheet: Exemptions: Criteria for Making Determinations
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Tip Sheet: Exemptions: Determinations and Review
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Tip Sheet: Financial Conflict of Interest for Researchers and Research Staff
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Tip Sheet: Following the Guidelines of the ICH-GCP
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Tip Sheet: Human Research Protection Program Plan
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Tip Sheet: IRB or EC Authority and Independence
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Tip Sheet: IRB or EC Member and Consultant Conflict of Interest
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Tip Sheet: Non-compliance
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Tip Sheet: Regulatory Requirements for Investigators Who Hold INDs or IDEs
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Tip Sheet: Reporting of Unanticipated Problems, Terminations, Suspensions, and Non-compliance
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Tip Sheet: Review of Research by the Convened IRB or EC
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Tip Sheet: Review of Research by the Expedited Procedure
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Tip Sheet: State and Local Law
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Tip Sheet: Sufficient Information to Determine Whether the Regulatory Criteria for Approval are Met
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Tip Sheet: Suspensions and Terminations of IRB or EC Approval
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Tip Sheet: The IRB or EC Member Roster
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Tip Sheet: Unanticipated Problems Involving Risks to Participants or Others
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