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[DOCX File]Regulatory Binder Checklist
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It is the responsibility of the investigator to ensure compliance with Good Clinical Practice (GCP), institutional review board (IRB), and applicable regulatory requirements. This document serves as a template and may be modified for study-specific needs/requirements.
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[DOCX File]12- Feasibility studies Feasibility Studies are ...
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The full board meets once per month. (Typically the last working Friday of each month) If an application requires full board review, the principal investigator will be asked to make a brief presentation of the application at the meeting, and to respond to IRB inquiries.
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[DOC File]Application for IRB Approval of Interventional Studies
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Completed application with all supporting documents (Hard copy and Soft copy (CD) should be submitted to. Institutional Review Board (IRB) Christian Medical College. Office of Research, I st Floor, Carman Block, Bagayam, Vellore 632 002 India. E-mail: research@cmcvellore.ac.in. Tel: 0416 -2284294, Fax: 0416 – 2262788, 2284481.
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[DOC File]Application for IRB Approval of Observational (case ...
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Completed application with all supporting documents (Hard copy and Soft copy) should be submitted to: Institutional Review Board (IRB) Christian Medical College. Office of Research, I st Floor, Carman Block, Bagayam, Vellore 632 002 India. E-mail: research@cmcvellore.ac.in. Tel: 0416 -2284294, Fax: 0416 – 2262788, 2284481.
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[DOCX File]BRANY Services
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You’re the Lead PI/Site/Sponsor for a multi-site study, BRANY IRB is the single IRB for the study, and you need to introduce a new study to BRANY IRB. A member of the BRANY team. has instructed you to complete . xForm #401 . Do not use the 401 . xForm. if you are seeking IRB approval as a Participating Site. 501-Single IRB: Site Application
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[DOC File]Guidelines For Documenting IRB Meetings
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IRB Chair, or designee, must review and approve the minutes within 7 days of the meeting. Checklist: IRB Meeting Minutes. V November 10, 2009 Page 3 of 6. V November 10, 2009 Page 1 of 6. Institutional . Review Board
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[DOC File]Cal Poly Pomona - Human Research Protections Program
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Institutional Review Board (IRB) Protocol Application. IRB principles: respect for persons, beneficence, justice. Cal Poly Pomona (CPP) is committed both to research in the advancement of teaching and science and to the protection of the individuals involved in those efforts.
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[DOC File]New Study Submission Application - Sterling IRB
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Sites will submit initial PI/site submission application directly to Sterling IRB . OR *The Sponsor/CRO will submit initial PI/site submission applications on behalf . of the site *Note: any initial submission application received directly from the site will be held pending Sponsor/CRO approval Protocol Title:
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[DOC File]Investigational Device Exemption (IDE) Submission Checklist
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Please check (() 1. Cover Letter. Statement that submission is an original IDE application Sponsor Information (Name, Address) Sponsor Contact (Name, Telephone Number, Fax) Device Name and Intended Use Manufacturer Information (Name, Address) Manufacturer Contact (Name, Telephone Number, Fax) If an investigation involves an exception from informed consent for emergency …
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[DOC File]University of San Diego
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IRB APPLICATION CHECKLIST. BEFORE you submit this application, please check off each of the following. Any applications missing any of the following will be returned to the applicant. _WF_ 1) You and everyone named. on the application . have taken the online IRB training course and attached a …
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Sample irb application submissions