10 October 2011 NIHR TMN Annual Meeting Tomasz Kurdziel
|
|
|
- Nigel Rice
- 6 years ago
- Views:
Transcription
1 Introduction to the CSP Module 10 October 2011 NIHR TMN Annual Meeting RIBA London Tomasz Kurdziel Lead RM&G WYCLRN
2 Agenda Introduction to the CSP Module CSP Process overview & staged implementation New features in IRAS National Institute for Health Research 2
3 What is the CSP Module The NIHR CSP Module is a new web based application which supports the CSP process. Itis built on the Oracle WebCenter platform and replaces CSP ReDA Access to the new system will initially be provided to existing users of CSP ReDA which will eventually be phased out once the new CSP Module is established tblihd The CSP Module is one part of the Research and Development Management Information System (RDMIS) which is currently being developed by the NIHR IS Function in order to support information management across all parts of the NIHR National Institute for Health Research 3
4 CSP Module Release 1.0 CSP Module will replace CSP ReDA and the CSP Tracker held at the CSP Unit It will include systems for the following processes Portfolio Eligibility Validate R&D submissions Perform Study Wide Governance QC Study Wide Governance Validate SSI Submissions Perform Local Governance (site and/or PIC) QC Local Governance (optional) Grant NHS Permission Process Amendments Reporting National Institute for Health Research 4
5 CSP Module Task View National Institute for Health Research 5
6 CSP Module Document View National Institute for Health Research 6
7 CSP Module Document View Documents will be divided into Levels Study Wide Local Each hlevel will be divided id d into Categories Ct Each Category will be divided into Document types Mirrors the IRAS checklist Documents coming in from IRAS will be automatically uploaded National Institute for Health Research 7
8 CSP Module Study View (CLRN) National Institute for Health Research 8
9 CSP Module Study View (NHS) National Institute for Health Research 9
10 CSP Module Notifications When certain tasks are complete, an notification is sent to inform the researcher When a certain stage of the process is completed a new task will automatically appear National Institute for Health Research 10
11 CSP Module PICs Participant Identification Centre (PIC) review will now be allocatedand and undertaken in the samewayaslocalresearch as site (SSIF) governance The governance review criteria reflect that it is a PIC but some reviews may be Not Applicable (see CSP Operating Manual for guidance) PICs are listed in Part C of the R&D Form National Institute for Health Research 11
12 CSP Process overview oe e & implementation
13 Submit PAF in IRAS Create Project in IRAS 1. Validate PAF 2. Perform Potential Portfolio Eligibility 3. Assign RAF Submit R&D Application 5. Confirm Portfolio Eligibility 4. Validate R&D Submission 6.Allocate study-wide Governance Reviewers & QCs 7. Perform study wide governance 8. Perform study wide QC Submit SSI Application 9. Validate SSI Submission 10. Allocate local Governance Reviewers and QCs 11. Perform local governance 12. Perform local QC (optional) 13. Grant NHS Permission National Institute for Health Research
14 Staged Implementation All new projects created in IRAS (v3.3) from the evening of 18th July2011will be submitted electronically from IRAS into CSP Module (e.g. R&D Form and study documents uploaded onto the R&D Form IRAS checklist) All projects already created in IRAS (v3.2 and earlier) prior to 18 th July 2011 will be able to submit the Portfolio Application Form (PAF), R&D Form and Site Specific Information Form (SSIF) electronicallyfrom IRAS into CSP Module. Supporting study documents, as per the IRAS check list will need to be sent by e mail to the Lead CLRN at the time of submission of the forms Migration of studies from CSP ReDA to CSP Module being undertaken National Institute for Health Research 14
15 Amendments The investigator submits amendments by attaching the amendmentdocuments documents to the R&D Form Document Checklist and resubmitting from the R&D submission tab (exact process tbc) The CSP Module detects that an Amendment has been submitted and the Amendment tvalidation task kis sent to the Amendment Validator at the Lead CLRN who validates the amendment and completesthe the Amendment Summary Form and uploads to document store Once the Amendment has been validated an Amendment Review task is allocated to Amendment Reviewers at each site National Institute for Health Research 15
16 Amendments Substantial / Non substantial amendments are handled the same way within CSP Amendment related documentation (notice of amendment form, covering letter, revised study documents [clean and tracked changes]) sent to Lead CLRN at same time as to REC / MHRA The sponsor can implement the amendment on an R&D level, within 35 days of the Lead CLRN confirmation the amendment is valid subject to the following: (1) regulatory approval is in place (2) letter of no objection has been received from the site CI / Sponsor provides amendment information / documents to PIs National Institute for Health Research 16
17 Amendments As part of the amendment review, R&D assess: (1) resource (local research team) required to support the amended study (2) impact on support departments (3) financial implication of the amended study (4) requirement for new site agreement / financial contract R&D can provide written Continuing NHS Permission either before or after the 35 day period Sft Safety related ltdamendments can be implemented with immediate effect. Formal letter from the CI / Sponsor should support this as part of the document set Regulatory approval sent to Lead CLRN once received National Institute for Health Research 17
18 New Features es in IRAS
19 New Features in IRAS At the same time as CSP Module went live, new features were introduced to IRAS CSP Application Form now called Portfolio Application Form Filter Q5 has changed o5a asks about BRU, BRC funding (Yes = processed through CSP but no PAF needed) o5b asks do you want to apply for Portfolio (Yes = PAF needed to apply to Portfolio) English sites and PICs on Part C are selected from standard lists, and SSI Forms created from Part C Uploading documents to IRAS checklist for electronic submission Draft R&D and SSI Applications can optionally be submitted National Institute for Health Research 19
20 IRAS Filter Question 5a + 5b National Institute for Health Research 20
21 Selecting sites in Part C National Institute for Health Research 21
22 Selecting sites in Part C National Institute for Health Research 22
23 Uploading Documents National Institute for Health Research 23
24 Uploading Documents National Institute for Health Research 24
25 Uploading Documents National Institute for Health Research 25
26 Uploading Documents National Institute for Health Research 26
27 Draft Applications National Institute for Health Research 27
28 Thank you any yquestions? s?
External IRB Instructions for the Registration Pathway in OSIRIS
External IRB Instructions for the Registration Pathway in OSIRIS Studies approved by external IRBs are still required to be submitted to the University of Pittsburgh IRB using our electronic application
SYRACUSE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM STANDARD OPERATING PROCEDURES 02 06/30/10 08/01/07 1 OF 6
TITLE: IRB CONTINUING REVIEW REVISION NUMBER SYRACUSE UNIVERSITY HUMAN RESEARCH PROTECTION PROGRAM STANDARD OPERATING PROCEDURES REVISION DATE (SUPERSEDES PRIOR VERSION) EFFECTIVE DATE DOCUMENT NUMBER:
AMENDMENTS TO PREVIOUSLY APPROVED RESEARCH 3/01/2016
DUKE UNIVERSITY HEALTH SYSTEM Human Research Protection Program AMENDMENTS TO PREVIOUSLY APPROVED RESEARCH 3/01/2016 The Duke University Health System Institutional Review Board (DUHS IRB) requires that
IRB Staff Administration Guide
March 2013 Table of Contents IRB Process Overview 3 IRB Submission Types 3 Study Process Overview 4 Ancillary Review Overview 5 Initiating Ancillary Reviews 5 Notifications and Ancillary Review Feedback
Purpose: The following serves to aid Principal Investigators (PI) in the submission of Amendments to AURA-IRB. Document includes: Acronyms and Legend
AURA-IRB Amendment Guidelines Principal Investigators (PI) End Users: Principal Investigators (PI) who enter studies. Purpose: The following serves to aid Principal Investigators (PI) in the submission
T-TESS Updates and STRIVE. Principals Meeting September 14, 2017 Sylvia Lozano Hoyer
T-TESS Updates and STRIVE Principals Meeting September 14, 2017 Sylvia Lozano Hoyer 1 Upcoming Tasks and Deadlines Assign Appraisal Types in Eduphoria Send T-TESS Appraisal Agreement Form for less-than-annual
University of Pennsylvania Institutional Review Board. Reliance Agreement Guidance: Penn as Central IRB FAQ
Reliance Agreement Guidance: Penn as Central IRB FAQ This document is designed to answer questions frequently asked by individuals who want to know more about Penn s policies and procedures related to
What does FORCE do? FP 6: 2 ways to submit Forms C Excel sheets (as before) Highly recommended to use as from now FORCE
What does FORCE do? 2 possibilities to access to FORCE: Old way: via SESAM, being phased out by end 2009 New way: via the European Commission Authentication Service (ECAS) Recommended to use as from now
University of Pennsylvania Institutional Review Board. Reliance Agreement Guidance: How to Apply for External IRB Review
Reliance Agreement Guidance: How to Apply for External IRB Review This document provides step by step instructions on how to submit a request for the Penn IRB to rely on an External IRB using the HS-ERA
IRBManager Quick Start Guide Dashboard Overview and Status of xform
Page 1 of 10 IRBManager Quick Start Guide Dashboard Overview and Status of xform SECTIONS OF DASHBOARD Upon logging in, your Dashboard will appear similar to the screen below: 1 2 3 4 Your Dashboard is
Hazard Reporting Training Guide
Hazard Reporting Training Guide Using the Public Portal v1.4 WHS Version Control Document Title: Hazard Training Guide using the Public Portal Document Issue: Version 1.4 Date Issued: 22 July 2014 Issue
Using Referential and Organisation master data in eaf
29 June 2018 EMA/819524/2017 version 2 Information Management Division Using Referential and Organisation master data in eaf Table of Contents 1. Purpose of the document... 2 2. Introduction... 2 3. Referential
Reporting an Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) to the IRB
INSTITUTIONAL REVIEW BOARD (IRB) OFFICE FOR HUMAN RESEARCH PROTECTION Reporting an Unanticipated Problem Involving Risks to Subjects or Others (UPIRTSO) to the IRB UPIRTSO Flowchart Content Applies To
I. Summary. II. Responsibilities
IRB Procedures 9a: Full review procedures Revision date: October 6, 2008, revision November 11, 2009, revision July 17, 2010, revised January 27, 2011, revised February 9, 2015, revised October 15, 2015
University of Pennsylvania Institutional Review Board. Reliance Agreement Guidance: Post-Approval Submissions
Reliance Agreement Guidance: Post-Approval Submissions This document is designed to provide guidance on the requirements and submission processes for Amendments, Continuing Review, Reportable Events, and
Baptist Health Institutional Review Board. Study Closure Report (Expedited Review) IRB #: Study Title:
Baptist Health Institutional Review Board Study Closure Report (Expedited Review) (Please complete ALL sections of this form. Incomplete forms will be returned) Principal Investigator: E-mail: Phone #:
Click IRB Resources Frequently Asked Questions
Q: How do I log in to the Click IRB system? A: To log in to Click IRB, go to Citrix to open the list of viewable applications. Select the Click application icon. You will be presented with a Click session
GUIDE TO DAILY OPERATIONS
Institutional Review Board 3624 Market St., Suite 301 S Philadelphia, PA 19104-6006 Phone: 215-573-2540 GUIDE TO DAILY OPERATIONS Version 8.1 2, May 2016 Introduction, Table of Contents, and Format INTRODUCTION
Work Planning and Control: SSRL Implementation for User Experiments
Work Planning and Control: Revision Record Revision Number Revision Date Description of Change R1 March 14, 2018 General updates. Previous document number: ESRD-WPC-001. R0 November 20, 2009 Initial Release.
Your Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System
Your Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System Now that your institution has joined SMART IRB, what s next? Start using the Agreement right away for IRB reliance
Organisation Management Services (OMS) operating model
3 July 2017 EMA/459105/2016 version 3 Information Management Division Organisation Management Services (OMS) operating model Table of contents 1. Executive summary... 2 2. OMS operating model... 2 2.1.
NHS Terms and Conditions of Service 2018 Pay, transition and ESR
NHS Terms and Conditions of Service 2018 Pay, transition and ESR 3 July 2018 Aim of today To understand: the new pay structure the transitional arrangements how ESR will interact with the new pay arrangements
Investigator Manual. If you have questions about whether an activity requires IRB review, contact the IRB Office.
CM-999 001 1 May 2015 Page 1 of 5 What is the purpose of this manual? This document is designed to guide you through policies and procedures related to the conduct of human research that are specific to
Signature Date Date First Effective: Signature Date Revision Date:
Revision #10 TITLE: Continuation Review Page 1 of 10 Approved By: ORI Director Signature Date Date First Effective: 05-17-05 Approved By: Nonmedical IRB Chair Signature Date Approved By: Medical IRB Chair
Your Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System
Your Roadmap to Single IRB Review Getting Started with SMART IRB & the Online Reliance System Now that your institution has joined SMART IRB, what s next? Start using the Agreement right away for IRB reliance
IRB MEETING ADMINISTRATION
1. POLICY Steering Committee approved / Effective date: 9/11/15 Except when an expedited review procedure is appropriate or an exemption determination may be made, the IRB will review proposed research
STANDING COMMITTEE ON RESEARCH AND STATISTICS (SCRS) (Hotel Velázquez, Madrid, 28 September to 2 October 2015) TENTATIVE AGENDA
STANDING COMMITTEE ON RESEARCH AND STATISTICS (SCRS) (Hotel Velázquez, Madrid, 28 September to 2 October 2015) TENTATIVE AGENDA 1. Opening of the meeting 2. Adoption of Agenda and arrangements for the
Doc. No. SCI-001 / 2014
STANDING COMMITTEE ON RESEARCH AND STATISTICS (SCRS) (Hotel Velázquez, Madrid, 29 September to 3 October, 2014) TENTATIVE AGENDA Original: English 1. Opening of the meeting 2. Adoption of Agenda and arrangements
Commercial/ Central IRB An independent organization that provides IRB review services
Page 1 of 12 Reliant Review Research Conducted at Multiple Sites Introduction: Reliant Review engages reliance agreements to reduce duplicative IRB reviews, aiming to promote greater efficiency and consistency
Version 7 October Utilisation Strategy for Speed Camera Enforcement
Version 7 October 2009 Utilisation Strategy for Speed Camera Enforcement Introduction The main aim of the Staffordshire Safer Roads Partnership is to reduce road casualties. The range of measures available
Health and Safety Inspection Procedure
Template v4 WILTSHIRE POLICE FORCE PROCEDURE Health and Safety Inspection Procedure Effective from: 25.03.2012 Last Review Date: 10.05.2015 Version: 2.0 Next Review Date: 10.05.2018 TABLE OF CONTENTS PROCEDURE
Hazard Training Guide
Hazard Training Guide Using the Main Application v1.5 WHS Version Control Document Title: Hazard Training Guide using the Main Application Document Issue: Version 1.5 Date Issued: 12 Aug 2014 Issue Date
Access will be via the same Player Registration tab via the Player Registrations Officer role section.
The process for registering a player via the Whole Game System Portal requires input from the club, player, league, and in some instances the County FA. Once the league has confirmed the set-up process
Disaster Recovery Grant Reporting System (DRGR) NSP2 Quarterly Performance Report (QPR) Checklist
Name of Grantee: QPR Date Range(s): Reviewer(s): Program Manager: Date Performed: Overall Review Activity Review Guide for Review of a QPR in DRGR NSP2 Specific Requirements All Reviewed See Attached Comments
IRB-REQUIRED INVESTIGATOR ACTIONS
Version No: 2 Effective Date: 11/01/02 Revised: 06/10/2005 09/08, 05/2009 1. POLICY IRB-REQUIRED INVESTIGATOR ACTIONS SOP: RI 801 Page 1 of 4 Between IRB initial approval of a protocol and the time of
7.0 DEVIATION and EXCEPTION of a PREVIOUSLY APPROVED PROTOCOL
7.0 DEVIATION and EXCEPTION of a PREVIOUSLY APPROVED PROTOCOL 7.1 OBJECTIVE To describe the policies and procedures for reviewing a modification or a deviation/exception to a previously approved protocol.
Central IRBs: Where Does the UR Fit into the Picture?? Kelley O Donoghue Tiffany Gommel Emily Flagg April 15 th 2015
Central IRBs: Where Does the UR Fit into the Picture?? Kelley O Donoghue Tiffany Gommel Emily Flagg April 15 th 2015 University of Rochester Office for Human Subject Protection (OHSP) www.rochester.edu/ohsp
IRB COMPOSITION AND IRB MEMBER ROLES AND RESPONSIBILITIES
IRB COMPOSITION AND IRB MEMBER ROLES AND RESPONSIBILITIES 1. Overview Each IRB must be appropriately constituted for the volume and types of human research to be reviewed, in accordance with federal regulations.
Archery Australia Inc High Performance Committee
Policy Name: National High Performance Program (NHPP) - Compound 2014 Responsibility Archery Australia Inc High Performance Committee Effective 1 July 2014 Policy Number 1070 Version Version 1 CONTENTS
Submitting Continuing Reviews and/or Amendments to the IRB
Submitting Continuing Reviews and/or Amendments to the IRB Tufts-New England Medical Center Tufts University Health Sciences IRB Education Series 2006 Presentation may only be reused or reprinted with
USOC ATHLETE ADVERTISING WAIVER SYSTEM. User Guide October 2015
USOC ATHLETE ADVERTISING WAIVER SYSTEM User Guide October 2015 2 TABLE OF CONTENTS Advertising Guidance 3-4 What You Need to Start Submitting...5 Signing Up..6-9 User Dashboard Overview..10-13 Logging
Suburban Friendship League
1 1 1 1 1 1 1 1 0 1 0 1 0 1 Suburban Friendship League Frequently Asked Questions Regular Season Scheduling (February 1, 00) The following are a list of Frequently Asked Questions relating to regular season
Date Effective 4/21/2008 Identification
OHSU Research Integrity Office Human Research Protection Program Policies & Procedures Title: Research with Medical Devices Date Effective 4/21/2008 Identification Supersedes P&P dated: Page 1 of BACKGROUND
I. Summary. II. Responsibilities
IRB Procedure 11a: Continuing Review Revision Date: May 15, 2007, revised November 11, 2009, revision July 17, 2010, revised March 1, 2011, revised February 9, 2015 I. Summary The IRB policy is to make
UNIVERSITY OF GEORGIA Institutional Review Board
UNIVERSITY OF GEORGIA Institutional Review Board Continuing Review Number: Date: Author: Approved By: Page(s): UGAHRP-057-2 01/20/2017 HSO IRB Page 1 of 7 1. PURPOSE 1.1. The UGA IRB has developed this
Effective Date Revisions Date Review by the Convened Institutional Review Board
Review by the Convened Institutional Review Board Effective Date Revisions Date 8.1.2018 1.0 Purpose: The purpose of this standard operating practice (SOP) is to define and describe the process of review
Signature Date Date First Effective: Signature Date Revision Date: 07/18/2011
University of Kentucky Office of Research Integrity and Institutional Review Board Revision #4 TITLE: HIPAA in Research Page 1 of 8 Approved By: ORI Director Signature Date Date First Effective: 06-10-05
RUGBY ONTARIO OPERATIONS MANUAL (ROOM) BRIDGING DOCUMENT (February 2018)
RUGBY ONTARIO OPERATIONS MANUAL (ROOM) BRIDGING DOCUMENT (February 2018) This document is designed to assist members by highlighting the main changes from the 2017 version to the 2018 version of the Rugby
INTERIM ADVICE NOTE 171/12. Risk Based Principal Inspection Intervals
INTERIM ADVICE NOTE 171/12 Risk Based Principal Inspection Intervals Summary This Interim Advice Note sets out the requirements and guidance for service providers using risk based inspection intervals.
Info Sheet - Operations Office for Human Research Studies
Guidance on Single IRB Review Process This document outlines how the DFCI IRB may rely on an external IRB to serve as the IRB of record for a DF/HCC site or Investigator. The Dana-Farber Cancer Institute
CUNY HRPP Procedures: Multisite Non-Exempt Human Subjects Research
CUNY HRPP Procedures: Multisite Non-Exempt Human Subjects Research 1. Applicability These procedures apply to non-exempt multi-site research involving human subjects in which CUNY is engaged. Please refer
Standard Operating Policy and Procedures (SOPP) 3:
Standard Operating Policy and Procedures (SOPP) 3: INITIAL AND CONTINUING REVIEW BY THE IRB: REQUIREMENTS FOR SUBMISSION OF APPLICATIONS, APPROVAL CRITERIA, EXPEDITED AND CONVENED COMMITTEE REVIEW AND
Children s Hospital of Philadelphia Committees for the Protection of Human Subjects Policies and Procedures. IRB Review Processes
Page: 1 of 8 I. PURPOSE II. III. IV. The purpose of this standard operating procedure is to describe IRB review processes, including pre-review, review, and post-review procedures. POLICY STATEMENT The
ZIMS for Studbooks Training Index
ZIMS for Studbooks Training Index This document contains an index of topics that covers ZIMS for Studbooks functionality and features. Each section provides a description of the topic followed by the features
SMART IRB Agreement Implementation Checklist and Documentation Tool
SMART IRB Agreement Implementation Checklist and Documentation Tool Purpose: (1) to highlight the flexible provisions of the SMART IRB Agreement, and (2) to document which options institutions will implement
University of Cincinnati. Radiation Safety Committee Operations Guidelines Statement of Policy (RSC Guidelines) RSC Guidelines (revision 5)
University of Cincinnati Radiation Safety Committee Operations Guidelines Statement of Policy (RSC Guidelines) Table of Contents 1 Purpose of the Guidelines 1 2 Committee 1 3 Meetings 4 4 Committee Purpose,
Glove Management. PDA Ireland Chapter Dublin 04 th Oct Dr. Aidan Harrington DPS Group
Glove Management PDA Ireland Chapter Dublin 04 th Oct 2018 Dr. Aidan Harrington DPS Group Agenda Regulatory Requirements Glove Integrity & Contamination Control Current Practices for Glove Management Benchmarking
KHSAA BASS FISHING Frequently Asked Questions (as of May, 2012) GENERAL INFORMATION
KHSAA BASS FISHING Frequently Asked Questions (as of May, 2012) This list will be updated as topics are resolved. Keep in mind that there are various approval requirements for much of the information,
To assure knowledge and compliance by documenting the annual administrative review and continuing IRB review of non-exempt projects for the IRB.
Institutional Review Board.... University of Missouri-Columbia.. Standard Operating Procedure Annual Review of Research Annual Review of Research Effective Date: January 21, 2019 Original Approval Date:
US Youth Soccer National League Charter as of October 25, 2017
US Youth Soccer National League Charter as of October 25, 2017 PART I. GENERAL ORGANIZATION Section 101. National Competitions, National League, and Definitions (a) US Youth Soccer shall conduct annually
Yale University Institutional Review Boards
Yale University Institutional Review Boards 100 PR.1 Review by a Convened Institutional Review Board (IRB) Overview... 1 Meeting Dates and Distribution of Materials... 1 Materials Provided to Members for
UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW OF RESEARCH
UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW OF RESEARCH I. PURPOSE This document outlines the University of Tennessee Health Science Center Institutional
SOP #2-2 Version #1 Date First Effective: December 14, Page 1 of 6
Page 1 of 6 OBJECTIVE To describe policies and procedures for all types of protocol submissions that require review by the IRB after investigators receive initial approval. This includes protocol submissions
SITE NAME: ISF DOCUMENT VERSION CHECKLIST Complete yes or no to confirm the presence or absence of each document specified.
1. TRIAL MANAGEMENT CTC Contact List 8 29/07/2016 Y N CTC Contact List (superseded) 7 29/09/2015 Y N CTC Contact List (superseded) 6 24/02/2015 Y N CTC Contact List (superseded) 5 03/09/2014 Y N CTC Contact
NRA MANUAL OF CONTRACT DOCUMENTS FOR ROAD WORKS. Introduction to the NRA Manual of Contract Documents for Road Works. Volume 0 Section 0 Part 1
Volume 0 Section 0 Part 1 NRA SD 01/12 NRA MANUAL OF CONTRACT DOCUMENTS FOR ROAD WORKS Introduction to the NRA Manual of Contract Documents for Road Works February 2012 St. Martin s House, Waterloo Road,
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW AND REAPPROVAL OF RESEARCH
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW AND REAPPROVAL OF RESEARCH I. PURPOSE This document outlines the required elements of University of Tennessee
National Paralympic Committee Presidents / Secretaries General. Bonn, 31 October 2013 XG/IPC IPC Athlete Registration and Licensing Programme
National Paralympic Committee Presidents / Secretaries General Bonn, 31 October 2013 XG/IPC 2014 IPC Athlete Registration and Licensing Programme Dear NPC Presidents/Secretaries General, The purpose of
NRA MANUAL OF CONTRACT DOCUMENTS FOR ROAD WORKS
Volume 0 Section 0 Part 1 NRA SD 01/13 NRA MANUAL OF CONTRACT DOCUMENTS FOR ROAD WORKS Introduction to the NRA Manual of Contract Documents for Road Works March 2013 St. Martin s House, Waterloo Road,
SPOR webinar: Using OMS & RMS data in eaf
SPOR webinar: Using OMS & RMS data in eaf 28 November 2017 An agency of the European Union Draft Agenda 1. Case for SPOR (why, how, what) 2. RMS in summary 3. OMS in summary 4. Using RMS in eaf 5. Using
Archery Australia Inc High Performance Committee
Policy Name: National High Performance Program (NHPP) - Recurve 2014 Responsibility Archery Australia Inc High Performance Committee Effective 1 st April 2014 Policy Number 1060 Version Version 3 CONTENTS
USA Jump Rope Tournament Software User Guide 2014 Edition
USA Jump Rope Tournament Software User Guide www.usajumprope.org Table of Contents Contents System Requirements... 3 System Conventions... 4 Phase 1 Tournament Pre registration Preparation... 5 Name Your
New Offshore Scheme Frequently Asked Questions
Below is a list of the questions we are most often asked by DPOs currently working through the training scheme to become certified DP Operators. Please read through them carefully before contacting The
RESEARCH SUBMISSION REQUIREMENTS
1. POLICY IRB members rely primarily solely on the documentation submitted by investigators for initial and continuing review. Therefore this material must provide IRB members with enough information about
Range Technical Team Advisors
National Rifle Association of America Range Technical Team Advisors Standard Operating Procedures (SOP) (Must Read) Effective August 01, 2014 2013 Range Services 2 NATIONAL RIFLE ASSOCIATION OF AMERICA
University of Iowa External/Central IRB Reliance Process Standard Operating Procedure (SOP)
University of Iowa External/Central IRB Reliance Process Standard Operating Procedure (SOP) I. OVERVIEW The purpose of this Standard Operating Procedure is to define a process for all University of Iowa
STANDING COMMITTEE ON RESEARCH AND STATISTICS (SCRS) (Hotel Weare Chamartin - Madrid, 1-5 October 2018) TENTATIVE AGENDA
1. Opening of the meeting STANDING COMMITTEE ON RESEARCH AND STATISTICS (SCRS) (Hotel Weare Chamartin - Madrid, 1-5 October 2018) TENTATIVE AGENDA 2. Adoption of Agenda and arrangements for the meeting
EBA s REVIEW OF THE IRB APPROACH
EBA s REVIEW OF THE IRB APPROACH EIFR seminar on internal models Paris, 15 December 2016 Dorota Siwek Why does the IRB Approach have to be reviewed? Lack of trust regarding the use of internal models:
Annual Health Check Guide
Annual Health Check Guide 2017-18 FA Charter Standard PAGE 1 CONTENTS 2017-18 ANNUAL HEALTH CHECK Process 4 Whole Game System 5 CRITERIA Adult 7 Youth 8 Development 9 Community 10 CRC & QUALIFICATIONS
Code for the Provision of Chargeable Mobile Content Services
Code for the Provision of Chargeable Mobile Content Services 1. Preamble 1.1 The Office of the Telecommunications Authority (OFTA) and the Consumer Council received a number of complaints in 2009 regarding
Initial Review. Approved By: Michele Kennett, JD, MSN, LLM Associate Vice Chancellor for Research. Table of Contents
Institutional Review Board University of Missouri-Columbia Standard Operating Procedure Initial Review Initial Review Effective Date: September 1, 2004 Original Approval Date: September 1, 2004 Revision
1 Licence Fees. National Paralympic Committee Presidents / Secretary General Via . Bonn, 30 October 2017 RM/IPC
National Paralympic Committee Presidents / Secretary General Via Email Bonn, 30 October 2017 RM/IPC 2018 IPC Athlete Registration and Licensing Programme Dear NPC Presidents/Secretaries General, We will
IRB APPLICATION CHECKLIST
The application for IRB approval may appear daunting at first, but most questions are straightforward. For those that may require some interpretation or specialized knowledge, this guide (which is essentially
Cayuse IRB Policy and Procedure Manual
Table of Contents Cayuse IRB Policy and Procedure Manual Cayuse IRB Policy and Procedure Manual... 1 Submitting a New IRB Protocol...2 Purpose of the Policy...2 Procedures...2 Modification of an Existing
FedRAMP Plan of Actions and Milestones (POA&M) Template Completion Guide. Version 2.0
FedRAMP Plan of Actions and Milestones (POA&M) Template Completion Guide Version 2.0 January 31, 2018 DOCUMENT REVISION HISTORY DATE VERSION PAGE(S) DESCRIPTION AUTHOR 02/18/2015 1.0 All Publish Date FedRAMP
A study on the relation between safety analysis process and system engineering process of train control system
A study on the relation between safety analysis process and system engineering process of train control system Abstract - In this paper, the relationship between system engineering lifecycle and safety
Review of Research by the Convened IRB
Office for the Protection of Research Subjects (OPRS) Institutional Review Board FWA# 00000083 Review of Research by the Convened IRB 201 AOB (MC 672) 1737 West Polk Street Chicago, IL 60612-7227 Phone:
CENTRAL DATABASE OF HANDICAPS (CDH) CLUB USER GUIDE. June Version 1
CENTRAL DATABASE OF HANDICAPS (CDH) CLUB USER GUIDE June 2011 - Version 1 INTRODUCTION The Central Database of Handicaps (CDH) was introduced in 2009 to assist Golf Clubs in the administration of their
STANDING PROCEDURES FOR PARA TAEKWONDO COMPETITION AT THE PARALYMPIC GAMES
STANDING PROCEDURES FOR PARA TAEKWONDO COMPETITION AT THE PARALYMPIC GAMES IN FORCE AS OF JANUARY 1, 2018 STANDING PROCEDURES Table of contents Article 1 Purpose 2 Article 2 Competition area 4 Article
Supersedes Document Dated: 7/7/11. SOP: RR 401 Version No.: 07 Version Date: 9/8/15 EXPEDITED REVIEW 1. POLICY
1. POLICY Steering Committee approved / Effective Date: 9/9/15 An expedited review procedure consists of a review of research involving human subjects by an IRB Chair or by one or more experienced reviewers
Navy Guidance and Tips for Using DOEHRS-IH Ventilation NAVY & MARINE CORPS PUBLIC HEALTH CENTER
Navy Guidance and Tips for Using DOEHRS-IH Ventilation NAVY & MARINE CORPS PUBLIC HEALTH CENTER October 2010 Purpose This document is a supplemental Navy guide to the DOEHRS Student Guide/User Manual Version
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD PROCEDURES FOR FULL BOARD REVIEW
UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD PROCEDURES FOR FULL BOARD REVIEW I. PURPOSE This document outlines the required elements of Institutional Review Board (IRB)
UNITED STATES OLYMPIC COMMITTEE. USOC ATHLETE ADVERTISING WAIVER SYSTEM User Guide October 25, 2017
USOC ATHLETE ADVERTISING WAIVER SYSTEM User Guide October 25, 2017 2 TABLE OF CONTENTS Advertising Guidance 3-4 What You Need to Start Submitting...5 Signing Up..6-9 User Dashboard Overview..10-13 Logging
Netball'WA'Dra,'Governance'Model' 'V1' Proposed'Model,'Member'&'Par=cipant'Categories' Netball'WA'Regional'Offices'&'Associa=ons' ' Document'1'
Netball'WA'Dra,'Governance'Model' 'V1' Proposed'Model,'Member'&'Par=cipant'Categories' Netball'WA'Regional'Offices'&'Associa=ons' ' Document'1' 1 Netball WA Governance & Membership Review Draft Governance
Missouri Lottery Periodic Rule Review July 1, 2017 June 30, 2018
Title 12 Amendment Is necessary? Is obsolete? Does overlap, s? accomplish Can be modified Division 40 State Lottery Chapter 10 General Considerations 12 CSR 40 10.010 Definitions Jun. 30, 2018 Yes No No
Pepperdine University eprotocol - IRB Student Investigator User Guide
Pepperdine University eprotocol - IRB Student Investigator User Guide 1 Welcome to eprotocol the online IRB system for Pepperdine University. To begin creating an online IRB application, please login to
AS/NZS :2013. Training and certification of occupational divers AS/NZS :2013. Part 2: Surface supplied diving to 30 m
AS/NZS 2815.2:2013 Australian/New Zealand Standard Training and certification of occupational divers Part 2: Surface supplied diving to 30 m AS/NZS 2815.2:2013 AS/NZS 2815.2:2013 This Joint Australian/New
The Race Director. Race Director Go [RACE DIRECTOR GO] This document describes the implementation of Race Director Go with a beginning to end example.
![The Race Director. Race Director Go [RACE DIRECTOR GO] This document describes the implementation of Race Director Go with a beginning to end example.](/thumbs/80/81747710.jpg "The Race Director. Race Director Go [RACE DIRECTOR GO] This document describes the implementation of Race Director Go with a beginning to end example.")
2018 The Race Director [RACE DIRECTOR GO] This document describes the implementation of with a beginning to end example. Contents Intro... 3 1 Setup... 3 Combining Race Director Divisions... 3 Creating
Welcome. Mid Leinster Chairman Yvonne MacSweeney
Welcome Mid Leinster Chairman Yvonne MacSweeney Mid Leinster District Handicap Secretaries Meeting 2017 Carlow Golf Club 25 th February 2017 Chairman of CONGU : Paula O Flaherty Agenda 1. Know your Handicap
IRB 7. Network for Clinical Research Professionals (NCRP) Seminar June 18, 2013
IRB 7 Network for Clinical Research Professionals (NCRP) Seminar June 18, 2013 What is IRB 7? IRB 7 is a new electronic IRB solution from Huron Consulting Group Same underlying software as eprost, but
GHSA Swimming/Diving POP School User s Guide
GHSA Swimming/Diving POP School User s Guide Purpose The GHSA has implemented a web-based system for the reporting of Swimming and Diving Proof of Performance that replaces the previous system that was