AIDS CLINICAL TRIALS GROUP (ACTG)
|
|
- Mervin Jordan
- 5 years ago
- Views:
Transcription
1 AIDS CLINICAL TRIALS GROUP (ACTG) Network Standard Operating Procedure Title Specimen Archiving Approval Process for ACTG Non-priority Protocols SOP number ACTG-145 Effective: 10/15/2018 Version 7.0 Last reviewed: 09/17/2018 Originator ACTG Network Coordinating Center Page 1 of PURPOSE This Standard Operating Procedure (SOP) describes procedures to be followed to identify specimens and acquire approval for specimen archiving from non-priority AIDS Clinical Trials Group (ACTG) protocols. 2.0 SCOPE This SOP directly affects all specimens collected and stored for ACTG protocols. Multiple groups within the ACTG are involved in the specimen archiving approval process including, but not limited to, ACTG protocol teams, Laboratory Science Group (LSG), Data Management Center (DMC), Repository Advisory Group (RAG), Transformative Science Group (TSG), and Scientific Agenda Steering Committee (SASC). 3.0 DEFINITIONS ACTG: AIDS Clinical Trials Group ACTG non-priority eligible studies: Protocols that have been concluded for 5 years or more, with analysis concluded, and are considered by the Scientific Agenda Steering Committee (SASC) and Transformative Science Group (TSG) as eligible for specimen archiving at the ACTG specimen biorepository and at the clinical research sites. ACTG concluded studies: Protocols in which the participants are off study, data entry screens are closed, and all analysis is concluded. Archiving: Identification, organization, and collection of specimens from ACTG nonpriority eligible studies to be stored at the Biorepository. Biorepository: Collects, processes, stores, and distributes biological specimens to support scientific investigations. DMC: Data Management Center Institutional Review Board (IRB): A group formally designated to protect the rights, safety, and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. LDM: Laboratory Data Manager LSG: Laboratory Science Group RAG: Repository Advisory Group, a cross-network oversight committee for site, laboratory, and biorepository specimen logistics. SASC: Scientific Agenda Steering Committee SDAC: Statistical and Data Analysis Center TSG: Transformative Science Group
2 Page 2 of RESPONSIBILITIES 4.1 Laboratory Science Group (LSG) The LSG generates an initial report of eligible studies. This list becomes the list of studies eligible for archiving, which is reviewed by the Repository Advisory Group (RAG). Sends Archiving Notification to the protocol chairs regarding what protocol (and what corresponding sub-studies) specimens have been recommended for archiving. Reviews and summarizes protocol chair responses and shares with the Data Management Center (DMC). Communicates with Transformative Science Group (TSG) for review and approval of specimen archiving plans (protocols with specimen types and time point selections). Notifies the Scientific Agenda Steering Committee (SASC) when TSG approval has been granted. Creates and tracks relevant specimen archiving documentation. Summarizes specimen archiving plans for approval by the Network Laboratory Center Principal Investigator. Provides network leadership with specimen archiving information as needed. 4.2 Repository Advisory Group (RAG) Reviews the list of protocols identified for specimen archiving. Discusses and resolves issues concerning archiving plans during monthly conference calls. 4.3 Data Management Center (DMC) Proposes specimen types and time points to be saved for each study that meets the criteria to be archived. Prepares and sends specimen shipping requests for sites to ship to the ACTG biorepository, and tracks the progress of those shipments. Prepares specimen destruction lists for the ACTG biorepository. 4.4 Protocol Chair(s) Grants permission to initiate the archiving process for the study by selecting one of the following archiving options: Allows all specimens to be destroyed Allows the DMC to select the specimen type and time points for archiving Requests specific specimen type(s) and/or time points for archiving 4.5 Statistical and Data Analysis Center (SDAC) Assigns a statistician, as needed, to work with the Laboratory Data Manager (LDM) to develop a list of specimens (i.e., participant identifiers and specimen dates) to be archived per study. 4.6 Transformative Science Group (TSG) The TSG reviews and provides written approval of specimen disposition plans (based on responses received from protocol chairs and input from the DMC and RAG).
3 Page 3 of 6 If concerns arise, the TSG will communicate with the RAG, via the LSG, to resolve any issues. 4.7 ACTG Biorepository Destroys specimens and consolidates inventory for archived studies. 5.0 PROCEDURES 5.1 LSG Generates List of Eligible Studies The LSG generates a list of non-priority studies eligible for archiving: protocols that have been concluded for 5 years or more, with analysis concluded, and are considered by the Scientific Agenda Steering Committee (SASC) and Transformative Science Group (TSG) as eligible for specimen archiving at the ACTG specimen biorepository and at the clinical research sites. 5.2 RAG Reviews and Approves List of Eligible Protocols The LSG sends the list of non-priority studies to the members of the RAG. If concerns arise, they are discussed during the monthly RAG conference call. The RAG chair provides written approval for the list of proposed studies for archiving to the LSG. 5.3 Archiving Notifications The LSG generates protocol archiving notifications and relevant specimen inventory reports for each study. Archiving notifications with the reports (generated from DMC portal) are sent to the protocol chairs (Appendix I - Sample Archiving Notification Template). Protocol chairs may decide to discard all specimens or choose to proceed with arching. 5.4 DMC Selects Specimen Types and Time Points If the protocol chairs choose to archive the study, the DMC will review their response together with the available inventory and propose an archive plan for each study. This includes the specimen types, time points, and number of aliquots to save (usually four or less). 5.5 TSG Approves Specimen Archiving Plans The LSG generates a summary for each TSG to review specimen archiving plans based on responses received from protocol teams and DMC input on specimens. (Appendix II - TSG Notification of Archiving Review and Approval Template). The TSG will provide concerns and/or approval for specimen archiving plans to the LSG. If concerns arise, they are discussed during the monthly RAG conference call and resolved with the TSG (and protocol teams, if necessary). 5.6 SASC Notification The LSG will provide notification to the SASC of archiving plans (including DMC and TSG input) once TSG approvals are granted. If concerns arise, they are discussed during the monthly RAG conference call and resolved with the TSG (and protocol teams, if necessary).
4 Page 4 of Final Archiving Approval The LSG will generate an Archiving Approval summary document for the Network Lab Center Principal Investigator to approve. This summary contains relevant information such as the date of initial RAG approval, list of protocols, protocol team responses, DMC selection of specimen types and time points, and TSG approval. If concerns arise, they are discussed during the monthly RAG conference call and resolved with the Network Lab Center Principal Investigator. The Network Lab Center Principal Investigator provides written approval. 5.8 DMC Generates Shipment and Destroy Inventory Lists The DMC generates and distributes inventory lists for each clinical research site, which identify the specimens to ship to the biorepository. The DMC also generates and distributes an inventory list for the biorepository, which identifies specimens for long-term storage or destruction. When all specimens for a study have been shipped to the biorepository, the DMC will notify the LSG. The LSG will then inform the sites to destroy the remaining specimens for that study. Specimens that are testing remnants, located at closed or defunded laboratories, or collected from defunded international sites will not be requested for shipment and may be added to the Destroy Inventory list. 5.9 Regular Status Updates The DMC and biorepository destroy specimens and consolidate inventory for archived studies according to the DMC instructions. The DMC and biorepository will provide regular updates to the RAG and the ACTG Network Lab Central Principal Investigator Document Retention The LSG will store relevant documents and records in the ACTG portal for the RAG. Revision Summary Item Section Version Date Reason for Revision All sections 6.0 to 7.0 8/8/2018 All sections have been content updated to reflect the new process for specimen archiving and SASC directives on communication with the ACTG TSGs and SASC.
5 APPENDIX I SAMPLE ARCHIVING NOTIFICATION TEMPLATE Page 5 of 6 Date: Month Day, 2018 To: Protocol Chair, Protocol Co-Chair, and Protocol Vice Chair From: Grace Aldrovandi, MD, ACTG Laboratory PI Subject: ACTG XXX or A5XXX Protocol Archiving Notification The AIDS Clinical Trials Group (ACTG) Repository Advisory Group (RAG) has identified the protocol ACTG XXX or A5XXX (Full Study Title) as a candidate for archiving. As a study chair of the protocol, please complete the form by clicking the link below: rbodwcnref1zw/viewform. You will be asked to choose from the following options: 1) allow the remaining specimens to be destroyed, 2) allow the Data Management Center (DMC) to select the specimen type and time points, or 3) request specific specimen type(s) and/or time points to be archived. ACTG XXX or A5XXX has approximately ##### specimens in storage at the Biomedical Research Institute (BRI) Repository and ##### specimens in storage at the study sites. For additional information, refer to the attached specimen inventory reports. The completed form is due Month Day, After the due date, there is no guarantee that specimens will be saved in the repository for future use. If you choose to archive any specimens, your request will be sent to the Transformative Science Group (TSG) for review and approval. Please direct archiving questions to the RAG Coordinator, Heather Brand (hbrand@s- 3.com), and LDMS Project Coordinator, Alex Benns (benns@fstrf.org), at the DMC. Cc: Network Lab PI RAG Chair Sender Lab Science Group Manager FSTRF/DMC
6 Page 6 of 6 APPENDIX II TSG NOTIFICATION OF ARCHIVING REVIEW AND APPROVAL TEMPLATE Date: Month Day, 2018 To: TSG Chair, TSG Vice Chair, and NCC Coordinator From: ACTG Laboratory Science Group Subject: Please Respond: TSG Notification of Archiving Review and Approval Per the Scientific Agenda Steering Committee (SASC), as of July 10, 2018, the AIDS Clinical Trials Group (ACTG) Transformative Science Group (TSG) is being asked to review and approve the proposed specimen types and time points to be archived. The TSG can also choose to destroy all specimens for any of the protocols listed, or provide its own proposed specimen types and time points to be archived. The ACTG Repository Advisory Group (RAG) has identified the following protocols as candidates for specimen archiving. Please see the attached spreadsheet. We have separated the protocols by Responders and Non-responders (Protocol Chairs that have responded and not responded to the Protocol Archiving Notifications). TSG Chairs will choose one of the following selections for the Responders: 1) Approve Protocol Chair specimen types and time points to be archived. 2) Approve Specimen Destruction for all specimens. 3) Approve Data Management Center (DMC)-suggested specimen types and time points to be archived. 4) Have TSG give an alternative suggestion for specimen types and time points to be archived. TSG Chairs will choose one of the following selections for the Non-responders: 1) Approve Specimen Destruction for all specimens. 2) Approve DMC-suggested specimen types and time points to be archived. 3) Have TSG give an alternative suggestion for specimen types and time points to be archived. Please direct archiving questions to the RAG Coordinator, Heather Brand (hbrand@s- 3.com), and LDMS Project Coordinator, Alex Benns (benns@fstrf.org), at the DMC. Cc: Network Lab PI RAG Chair Sender Lab Science Group Manager FSTRF/DMC
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
SOP details SOP title: Document Control SOP number: GE-003 SOP category: General Version number: 03 Version date: 17 April 2018 Effective date: 17 May 2018 Revision due date: 17 May 2021 NEWCASTLE CLINICAL
More informationGuidelines for Safety EQA Monitoring, Data and Communication Flow
ACTG, IMPAACT and HVTN HPTN and MTN Guidelines for Safety EQA Monitoring, Data and Communication Flow PT Step PNL Affiliated NL SMILE DCLOT LAB 100% 1 Enters No problems noted in the PTPT System. 80-100%
More informationSection 14 - Study Reporting Plan
Section 14 - Study Reporting Plan The MTN-026 Statistical and Data Management Center (SDMC) Staff are listed below. Job Role Name Email Address Protocol Statistician Elizabeth Brown erbrown@fredhutch.org
More informationCertification Standing Committee (CSC) Charter. Appendix A Certification Standing Committee (CSC) Charter
Appendix A A1 Introduction A1.1 CSC Vision and Mission and Objectives Alignment with Boundaryless Information Flow: Our vision is a foundation of a scalable high integrity TOGAF certification programs
More informationUser Guide for DCP Consortia 2012
AQuIP On line Accrual Reporting System (OARS) User Guide for DCP Consortia 2012 This User Guide provides an introduction to the AQuIP On line Accrual Reporting System (OARS) for the Division of Cancer
More informationCompleting & Submitted the IRB Approval of Human Subjects Form
Completing & Submitted the IRB Approval of Human Subjects Form All areas of the form should be completed. Once completed it must be submitted to the IRB by sending it to the EU IRB Chairperson. The following
More informationGuide to Status Only Annual Reviews and Re-appointments
Guide to Status Only Annual Reviews and Re-appointments Using Web Forms and LaserFiche Discovery Commons April 2016 Table of Contents Guide to Status Only Annual Reviews and Re-appointments... 0 Laserfiche
More informationIRB RESEARCH REPOSITORY COMPLIANCE PROGRAM: Repository Protocols and FAQs
IRB RESEARCH REPOSITORY COMPLIANCE PROGRAM: Repository Protocols and FAQs Compliance Deadline: August 31, 2011 Kathryn Schuff, MD, MCR Andrea Johnson, JD IRB Co-Chair Regulatory Specialist, ORIO Agenda
More informationVQA PROFICIENCY TESTING INVESTIGATION REPORT PROCEDURE
VQA PROFICIENCY TESTING INVESTIGATION REPORT PROCEDURE 1. Purpose 1.1. This procedure will establish the process for identifying, tracking, completing and investigating the existence of problems that result
More informationChapter 10: Regulatory Documentation
Table of Contents Chapter 10: Regulatory Documentation... 10-1 10.1 Regulatory Requirements:... 10-1 10.2 Ongoing Regulatory Documents:... 10-4 10.3 After study completion or termination of the trial...
More informationAQuIP On-line Accrual Reporting System (OARS) User Guide for DCP Consortia 2012
AQuIP On-line Accrual Reporting System (OARS) User Guide for DCP Consortia 2012 This User Guide provides an introduction to the AQuIP On-line Accrual Reporting System (OARS) for the Division of Cancer
More informationOnline Reliance System FAQs
Online Reliance System FAQs Table of Contents Online Reliance System FAQs... 1 When should the Online Reliance System be used?...3 Who can use the Online Reliance System?...3 Do I have to use the Online
More informationPurpose: To describe the requirements for managing IP at the clinical site
Title: Investigational Product Management Topic: Management of IP Effective Date: March 16, 2016 Approved By: Rita Hanson, M.D. Senior VP/Chief Medical Officer Purpose: To describe the requirements for
More information5 Data processing tables, worksheets, and checklists
5 Data processing tables, worksheets, and checklists 1 2 WS 5.1 Data system worksheet (DataSys.WS) When: Prior to start of data collection Who: Personnel in the coordinating center Purpose: To establish
More information9 PROTOCOL DEVELOPMENT AND MODIFICATIONS Capsule Development and Review... 3
9 PROTOCOL DEVELOPMENT AND MODIFICATIONS... 1 9.1 Capsule Development and Review... 3 9.1.1 Development... 3 9.1.2 Scientific Committee Review... 4 9.1.3 Scientific Leadership Group Review... 5 9.2 Concept
More informationUniversity of California, San Francisco Helen Diller Family Comprehensive Cancer Center Policy and Procedure. PRMS Amendment Submission Policy
University of California, San Francisco Helen Diller Family Comprehensive Cancer Center Policy and Procedure PRMS Amendment Submission Policy PRMS Procedure for Submitting Institutional Protocol Amendments
More informationIRB RESEARCH REPOSITORY COMPLIANCE PROGRAM. FAQs: Designing and Managing Repositories. Compliance Deadline: August 31, 2011
IRB RESEARCH REPOSITORY COMPLIANCE PROGRAM FAQs: Designing and Managing Repositories Compliance Deadline: August 31, 2011 Susan Bankowski, MS, JD IRB Chair Kathryn Schuff, MD, MCR IRB Co-Chair Agenda Review
More informationDocumentation for Non-Medical Research Ethics Board Researchers Full Board and Delegated Board Review
Documentation for Non-Medical Research Ethics Board Researchers Full Board and Delegated Board Review July 23, 2013 Office of Research Ethics If you run into any difficulties or have questions about Romeo,
More informationIncident Reporting SOP
1.0 Commercial in Confidence 10-Aug-2006 1 of 6 Incident Reporting SOP Document No: SOP_0106 Prepared by: David Brown Date: 10-Aug-2006 Version: 1.0 1.0 Commercial in Confidence 10-Aug-2006 2 of 6 Document
More informationOffice of Human Research
Office of Human Research JeffTrial End-User Training Document Regulatory Coordinator Training for Non-Oncology personnel Office of Human Research 8/16/2013 Ver. 1.0 Contents The REG Role: Completing Basic
More informationLOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE. Loughborough University (LU) Research Office SOP 1027 LU
LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE Loughborough University (LU) Research Office SOP 1027 LU Process for Writing Study Protocols for NHS Research Sponsored by Loughborough
More informationirb.unm.edu
IRBNet Submission Instructions The purpose of this document is to provide IRBNet submission instructions for UNM researchers using IRBNet. Please contact the Office of the IRB for assistance: irb.unm.edu
More informationDF/HCC Operations for Human Research Subject Registration Procedures
1. BACKGROUND: This document outlines the appropriate procedures for subject registration and other registration situations that may arise. To quickly locate a specific topic, please use the hyperlinks
More informationeprmc User Manual For Investigators and Research Staff
eprmc User Manual For Investigators and Research Staff Table of Contents How to Get an Account... 3 Logging In... 3 Overview of the eprmc Database... 4 Searching for a Protocol... 5 Adding a New Protocol...
More informationThe Material Transfer Agreement: It s a Give and Take Understanding MTAs at Northwestern University
The Material Transfer Agreement: It s a Give and Take Understanding MTAs at Northwestern University Anne K. Grace, Ph.D. Senior Contract and Grant Officer Office for Sponsored Research, Chicago Campus
More informationBuck-IRB Amendment User Guide
Office of Research Buck-IRB Amendment User Guide Office of Responsible Research Practices 1960 Kenny Road, Columbus, OH 43210-1016 Institutional Review Board General Guidance for Amendments: The Start
More informationStandard Operating Procedure. Preparation, Review and Approval of Clinical Research Standard Operating Procedures and Work Instructions
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-35-001 Preparation, Review and Approval of Clinical Research Standard Operating Procedures and Work Instructions SOP effective: 11 July
More informationDF/HCC Operations for Human Research Project Initiation Meeting
1. BACKGROUND: This procedure applies to all DF/HCC studies that require RIO EDC developed Electronic Case Report Forms (ecrfs), principally Investigator Sponsored Trials (ISTs.) 2. ASSOCIATED DF/HCC POLICIES:
More informationWISER. Protocol Creation, Activation, and Management TRAINING MANUAL. Wake Integrated Solution for Enterprise Research. For Oncology Studies
WISER Wake Integrated Solution for Enterprise Research Protocol Creation, Activation, and Management For Oncology Studies TRAINING MANUAL Version June 11, 2018 WELCOME to WISER! Navigation and Home Page
More informationKuali Research User Guide: Create a Protocol Amendment, Renewal or Event
Kuali Research User Guide: Create a Protocol Amendment, Renewal or Event Version.0: November 06 Purpose: To create an amendment, renewal or event on an existing IRB Protocol document. Trigger / Timing
More informationCoeus Extension IRB Administrative Process Grant Exemption/Expedited Approval (Initial Protocol or Amendment)
Coeus Extension IRB Administrative Process Grant Exemption/Expedited Approval (Initial Protocol or Amendment) Complete the following steps only when ALL Reviewers have indicated Grant Exemption AND there
More informationInformation Sheet for Scientific Approvers
1 Information Sheet for Scientific Approvers This document will provide you with the basic instructions for your role as a scientific approver in OSIRIS. All listed approvers have been designated by their
More informationSOP-QA-32 V2. Document History Version Description of update Date Effective 1 Change of number for Q-Pulse
Title: Effective Date: 1-4-17 Review Date: 1-4-20 Author: Gary Cooper, Named Archivist QA Approval: Richard Cowie, QA Manager Approver: Prof Maggie Cruickshank, R&D Director Approved by QA: N/A Document
More informationSTREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR / STUDENT
Rev: 06/2017 STREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR / STUDENT In This Document Protocol Application (Exempt and Expedited/Full Board Review)...2 NIH Certificate (Required)... 2 Logging In...
More informationELECTRONIC SITE DELEGATION LOG (esdl) USER MANUAL
Version 1.0 24May16 ELECTRONIC SITE DELEGATION LOG (esdl) USER MANUAL - Table of Contents - 1. INTRODUCTION... 3 Background... 3 Purpose of the Site Delegation Log... 3 TNCC Contacts... 3 2. SYSTEM REQUIREMENTS...
More informationFDA Audit Preparation
Duke University Office of Audit, Risk and Compliance (OARC) FDA Audit Preparation Margaret M. Groves, JD, CRA, CCRP, CHRC Associate Compliance Officer for Human Subject Research Compliance (HSRC) External
More informationResearcher User Manual
Researcher User Manual Post-Review Application Management Cloning Applications, Creating and Managing Events Audience: Principal Investigators & Project Team Members Updated: December 1, 2016 Checkpoint
More informationUser Manual myescreen.com web portal for MultiCare Occupational Medicine Clients
User Manual myescreen.com web portal for MultiCare Occupational Medicine Clients escreen MANUAL008 Revised 3/8/10 Important Numbers Your escreen Client ID # 9803- escreen client services 1-800-881-0722,
More informationeprotocol - Protocol Management System (PMS) Reviewer User Guide Version 2.0
eprotocol - Protocol Management System (PMS) Reviewer User Guide Version 2.0 Last Updated: 05/18/2011 Product Version: 2.0.16 eprotocol - PMS - Reviewer User Guide 2 Table of Contents 1. INTRODUCTION 3
More informationTrialSearch v2.0 User Guide
TrialSearch v2.0 User Guide Revised August 2016 by Robin Richardson Contents 1.0. Introduction to TrialSearch... 3 2.0. Searching or Browsing Studies... 3 2.1. Locating Trials and Viewing Trial Details
More informationVaccine data collection tool Oct Functions, Indicators & Sub-Indicators
data collection tool Oct. 2011 A. National Regulatory System RS01: Legal framework for establishment of a regulatory system, mandate and enforcement power for each function RS01.01: Legislation or and
More informationPage 1/6 MEMORANDUM. DATE: 7 July Faculty & Graduate Students. John Allen, Melissa Soenke, & Jeff Greenberg
MEMORANDUM Page 1/6 DATE: 7 July 2010 TO: FROM: RE: Faculty & Graduate Students John Allen, Melissa Soenke, & Jeff Greenberg INTRODUCTORY PSYCHOLOGY STUDENT SURVEY To all Mass Survey contributors: This
More informationPolicies and Procedures for CTIA Authorized Testing Laboratories
Policies and Procedures for CTIA Authorized Testing Laboratories Revision 1.1 June 2012 CTIA Certification Program 1400 16 th Street, NW, Suite 600 Washington, DC 20036 e-mail: certification@ctia.org Telephone:
More informationClick. IRB Study Submission Guide
Click IRB Study Submission Guide October 2016 Table of Contents Logging In... 3 Creating a New Study... 4 Finding More Information... 5 Editing a Study... 5 Checking the Study for Errors... 6 Submitting
More informationSetting the Stage for Automatic Disposition
Setting the Stage for Automatic Disposition Susan Cisco Director, Gimmal Education Code: MO01-4025 1 Learning Objectives Upon completion of this session, participants will be able to: 1. Define an information
More informationCancer Clinical Trials Centre Standard Operating Procedure
Controlled Document - do not download/save/print/photocopy Cancer Clinical Trials Centre Standard Operating Procedure SOP No.: 17 Title: Archiving Current Version No.: 3.3 Reviewed & Endorsed by STH Research:
More informationPCORI Online: Awardee User Guide Research Awards
PCORI Online: Awardee User Guide Research Awards Updated as of 1/31/18 1 Table of Contents Section 1: Introduction to PCORI Online... 3 1.1 Getting Started - Tips for Using PCORI Online... 4 1.2 Logging
More informationABBOTT INFORMATICS STARLIMS BIOREPOSITORY INDUSTRY LIMS SPECIFICATION DOCUMENT
ABBOTT INFORMATICS STARLIMS BIOREPOSITORY INDUSTRY LIMS SPECIFICATION DOCUMENT VERSION 2.0 SEPTEMBER 18, 2017 INTRODUCTION The purpose of this document is to list the main functionality and features available
More informationPTP Registration: Credit Card
Page 1/7 PTP Registration: Credit Card 1. Visit www.aatcc.org/test/proficiency/#register. 2. To register and pay for AATCC Proficiency Testing Programs by credit card, click Register online. To pay by
More informationUVMClick IRB Study Submission Guide
UVMClick IRB Study Submission Guide September 2018 Table of Contents How to Login 3 How to Create a New Study 4 Find More Information 5 How to Edit a Study 6 Check the Study for Errors 7 Submit the Study
More informationSUBMITTING A NEW IBC PROJECT APPLICATION (INITIAL)
SUBMITTING A After you have established and activated your username and password, you can begin to create an IBC application in IRBNet. To start building a new IBC application, you must first CREATE A
More informationDISCOVR-e USER MANUAL. Vanderbilt University Human Research Protection Program
DISCOVR-e USER MANUAL Vanderbilt University Human Research Protection Program Table of Contents Introduction and Overview... 3 Log into the System... 4 Investigator Dashboard... 5 Submitting a New Study...
More informationGeneral Guidance for Maintaining a Regulatory Binder
General Guidance for Maintaining a Regulatory Binder Study documentation should be well organized, providing a complete and thorough history from protocol development to study completion. Maintaining a
More informationIntroduction to ARFMS. (Animal Research Facility Management Software)
Introduction to ARFMS (Animal Research Facility Management Software) Agenda 1. Overview Existing active protocols Course Access Users & Teams IACUC Viewing of AUPs assigned 2. Creation of New AUP Filling
More informationTrial Cost Analysis Trial: Knee Surgery Study Sponsor: Principal Investigator: Hillary Resendes Total Enrollment: 8
Total Site Resources Available Coordinator Rate = $50.00 CRA Rate = $45.00 Investigator Rate = $300.00 Site Director Rate = $65.00 Trial Participation Fees Administration Institutional IT Fee $500.00 IRB
More informationVersion GENESIS HEALTH SYSTEM. Institutional Review Board (IRB) IRBNet User s Guide
Version 1 7-1-2012 GENESIS HEALTH SYSTEM Institutional Review Board (IRB) IRBNet User s Guide G E N E S I S H E A L T H S Y S T E M I N S T I T U T I O N A L R E V I E W B O A R D IRBNet User s Guide Genesis
More informationExecutive Committee Meeting
Executive Committee Meeting To hear the meeting, you must call in Toll-free phone number: 1-866-740-1260 Access Code: 2201876 For international call in numbers, please visit: https://www.readytalk.com/account-administration/international-numbers
More informationDocument Version: 1.0. Purpose: This document provides an overview of IBM Clinical Development v released by the IBM Corporation.
Release Notes IBM Clinical Development Release Date: 17 August 2018 Document Version: 10 OVERVIEW Purpose: This document provides an overview of IBM Clinical Development released by the IBM Corporation
More informationBRANDMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD Continuing Review Request/Closure Report
BRANDMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD Continuing Review Request/Closure Report Instructions: Please complete all sections of this form and submit with attached documents, forms, and/or explanations
More informationIBC Reviewer User Guide
IBC Reviewer User Guide Key Solutions, Inc. 2803 Lakeview Ct. Fremont, CA 94538 www.keyusa.com Software version 2.5.43.0 Document Version 1.0 Copyright 2016 Key Solutions 2002-2016 Key Solutions, Inc.
More informationSTREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS
STREAMLYNE GUIDE FOR STUDENTS/PRINCIPAL INVESTIGATORS Rev: 01/2017 In This Document Logging In... 1 Creating a New Protocol... 2 Revising a Returned Protocol... 7 Submitting an Amendment or Renewal Application...
More informationDATA PRESERVATION AND SHARING INITIATIVE. 1. Aims of the EORTC QLG Data Repository project
DATA PRESERVATION AND SHARING INITIATIVE 1. Aims of the EORTC QLG Data Repository project The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group Data Repository project
More informationWeill Research Gateway
Table of Contents The - What is the? - Logging In to WRG - The WRG Homepage Conflicts of Interest - What are Conflicts of Interest? - Submitting your Conflicts Survey - Submitting a Travel Disclosure -
More informationStandard Operating Procedure Clinical Data Management
P-CTU-010 Standard Operating Procedure Topic area: Data Management and Statistics Based on SCTO Matrix: Not applicable Identification number: P-CTU-010 Version: /- Valid from: 01.06.2014 Review and Approval
More informationELECTRONIC RESEARCH STUDY APPLICATION (ERSA) INITIAL APPLICATION GUIDEBOOK. (Version date 03/03/2006)
ELECTRONIC RESEARCH STUDY APPLICATION (ERSA) INITIAL APPLICATION GUIDEBOOK (Version date 03/03/2006) Table of Contents ERSA Home Page and Login 3 CRC Desktop 4 Creating a: New Study Application 5 Amendment
More informationDecember CTMS Site Management. User Reference Guide
December 2016 CTMS Site Management User Reference Guide Trademarks DCRI is a registered trademark of Duke University. Cognos is a registered trademark of Cognos, Incorporated. Chrome is a trademark of
More informationReliability Coordinator Procedure PURPOSE... 1
No. RC0550 Restriction: Table of Contents PURPOSE... 1 1. RESPONSIBILITIES... 2 1.1.1. CAISO RC... 2 1.1.2. RC Working Groups... 2 1.1.3. Operationally Affected Parties... 2 1.1.4. RC Oversight Committee...
More information(see reminder below) (see reminder below)
Email sent to for approval of request (e.g. submitter submits request to ) Request needs your review and approval (see reminder below) All (including MTAs and CDAs/NDAs for which someone other than the
More informationUser Guide 16-Mar-2018
16-Mar-2018 This document is freely distributable Identification Authors Name Organization Title TMF User Guide and Implementation Guide Sub-Team Version History Version Steering Committee Approval Date
More informationSignature Practices and Technologies for TMF An Industry Overview. Kathie Clark Wingspan Technology Vice President Product Management
Signature Practices and Technologies for TMF An Industry Overview Kathie Clark Wingspan Technology Vice President Product Management 1 Agenda Review of Guidance and Regulations Research Approach Results
More informationInstitutional Animal Care & Use Committee Protocol Review
Institutional Animal Care & Use Committee Protocol Review I. Purpose To describe MSU s IACUC procedures for reviewing new Animal Care and Use Protocols, changes to existing protocols (amendments) and annual
More informationPPD s Guide for External Users Requesting OC RDC Access
Welcome to PPD s guide to obtaining Oracle Clinical Remote Data Capture 4.6.x access. This guide has been written to walk you through the steps you will need to take in order to obtain OC RDC access for
More informationJohn P Buechler NYISO Executive Regulatory Policy Advisor. NPCC Governmental and Regulatory Affairs Advisory Group Meeting Albany, NY
Eastern Interconnection Planning Collaborative Update John P Buechler NYISO Executive Regulatory Policy Advisor NPCC Governmental and Regulatory Affairs Advisory Group Meeting Albany, NY November 30, 2010
More informationSTANDARD OPERATING PROCEDURE SOP 815. Clinical Data Management System LOCKING AND UNLOCKING THE DATABASE. Joint Research Office
STANDARD OPERATING PROCEDURE SOP 815 Clinical Data Management System LOCKING AND UNLOCKING THE DATABASE Version 2.1 Version date 19/06/2017 Effective date 08/08/2017 Number of pages 6 Review date June
More informationPostal Inspection Service Mail Covers Program
Postal Inspection Service Mail Covers Program May 28, 2014 AUDIT REPORT Report Number HIGHLIGHTS BACKGROUND: In fiscal year 2013, the U.S. Postal Inspection Service processed about 49,000 mail covers.
More informationCompliance Verification Program Governance Guide
Compliance Verification Program Governance Guide Version 1.0.0 9/19/2018 Executive Summary LF Networking is offering compliance verification through its OPNFV Verification Program (OVP). The OVP verifies
More informationStep: 9 Conduct Data Standardization
Step: 9 Conduct Data Standardization Version 1.0, February 2005 1 Step Description/Objectives: Step 9, Conduct Data Standardization, is intended to reduce the life cycle cost of data through data integration,
More informationInformation Security Incident Response and Reporting
Information Security Incident Response and Reporting Original Implementation: July 24, 2018 Last Revision: None This policy governs the actions required for reporting or responding to information security
More informationImageNow Retention Policy Manager
ImageNow Retention Policy Manager Getting Started Guide ImageNow Version: 6.7. x Written by: Product Documentation, R&D Date: September 2016 2014 Perceptive Software. All rights reserved CaptureNow, ImageNow,
More informationREVIEW OF MANAGEMENT AND OVERSIGHT OF THE INTEGRATED BUSINESS MANAGEMENT SYSTEM (IBMS) January 16, 2009
APPENDIX 1 REVIEW OF MANAGEMENT AND OVERSIGHT OF THE INTEGRATED BUSINESS MANAGEMENT SYSTEM (IBMS) January 16, 2009 Auditor General s Office Jeffrey Griffiths, C.A., C.F.E. Auditor General City of Toronto
More informationJeffTrial Training Document Protocol Management. Jefferson Coordinating Center for Clinical Research 9/10/2013 Ver. 1.1
JeffTrial Training Document Protocol Management Jefferson Coordinating Center for Clinical Research 9/10/2013 Ver. 1.1 Table of Contents JCCCR Process Flow Diagram... 3 The REG Role, PART I: Entering Basic
More informationPrivacy Breach Policy
1. PURPOSE 1.1 The purpose of this policy is to guide NB-IRDT employees and approved users on how to proceed in the event of a privacy breach, and to demonstrate to stakeholders that a systematic procedure
More informationComplaint Handling Procedure and Escalation Policy
Complaint Handling Procedure and Escalation Policy COPYRIGHT STATEMENT This document is the property of Nottingham Rehab Ltd. and may not, without our express written consent, be copied in whole or in
More information***** ***** June
SLU eirb Investigator Guide Saint Louis University ***** eirb Investigator Submitter Guide ***** Institutional Review Board June 2011 http://eirb.slu.edu Institutional Review Board Saint Louis University
More informationManagement s Response to the Auditor General s Review of Management and Oversight of the Integrated Business Management System (IBMS)
APPENDI 2 ommendation () () 1. The City Manager in consultation with the Chief Information Officer give consideration to the establishment of an IBMS governance model which provides for senior management
More informationALLIANCE CLINICAL RESEARCH PROFESSIONAL INFORMATION SESSION CTSU WEBSITE AND OPEN UPDATES
ALLIANCE CLINICAL RESEARCH PROFESSIONAL INFORMATION SESSION CTSU WEBSITE AND OPEN UPDATES Kendra Godfrey Barrow, BS, CCRP Martha Hering, RN, BA, MHA, CCRP 1 1. CTSU Website Updates 1. Protocol Tab New
More informationThe Common Controls Framework BY ADOBE
The Controls Framework BY ADOBE The following table contains the baseline security subset of control activities (derived from the Controls Framework by Adobe) that apply to Adobe s enterprise offerings.
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
SOP details SOP title: Protocol development SOP number: TM 010 SOP category: Trial Management Version number: 03 Version date: 16 December 2016 Effective date: 16 January 2017 Revision due date: 16 January
More informationReview Protocol and Write Comments or Recommend for Approval
Contents: A. The Protocol Review Process B. DMR call to FCR C. DMR/FCR Review Review Protocol and Write Comments or Recommend for Approval A. The Protocol Review Process 1. Once a protocol is submitted
More informationTIES Usage Policies. for University of Pittsburgh. Authors. University of Pittsburgh
TIES Usage Policies for University of Pittsburgh Authors University of Pittsburgh Girish Chavan, MS Elizabeth Legowski, BS Rebecca Crowley Jacobson, MD, MS Table of Contents A. DOCUMENT HISTORY... A-1
More informationICON Laboratory Services, Inc. isite User Guide
ICON Laboratory Services, Inc. isite User Guide TABLE OF CONTENTS Section 1 Introduction and Creating an Account in isite... 2 Section 2 Log In... 3 2.1 Selecting a Study... 3 Section 3 Viewing Lab Reports...
More informationRecords Retention Training
Records Retention Training Purpose LSUHSC-NO must comply with state and federal records retention requirements in order to provide appropriate access to state information to the public and to limit the
More informationArchitecture and Standards Development Lifecycle
Architecture and Standards Development Lifecycle Architecture and Standards Branch Author: Architecture and Standards Branch Date Created: April 2, 2008 Last Update: July 22, 2008 Version: 1.0 ~ This Page
More informationInformational Guide for the NewSTEPs Data Repository
Informational Guide for the NewSTEPs Data Repository Document Contents What is the NewSTEPs Data Repository... 2 What data is being collected?... 2 Why is this data being collected?... 2 How did NewSTEPs
More informationIACUC Module. March 2018
z IACUC Module March 2018 1 Page left intentionally blank 2 Contents Logins Required for Exercises... 4 Navigation Exercises... 6 Log into the Click IACUC Module... 6 Explore the Inbox... 6 Explore Submissions...
More informationClinicalTrials.gov PRS How to Register and Maintain a Record
ClinicalTrials.gov PRS How to Register and Maintain a Record IRB Compliance Program PRS Administrator, Brian Brotzman Human Subjects Office/Institutional Review Board Overview Purpose Rules and Regulations
More informationFedRAMP: Understanding Agency and Cloud Provider Responsibilities
May 2013 Walter E. Washington Convention Center Washington, DC FedRAMP: Understanding Agency and Cloud Provider Responsibilities Matthew Goodrich, JD FedRAMP Program Manager US General Services Administration
More informationCompliance & Certification Phase 2 Path to Certification
Compliance & Certification Phase 2 Path to Certification Jose A. Rodrigo, AT4 wireless 11 November 2014 20 November 2014 AllSeen Alliance 1 Agenda 1. C&C Process Overview 2. Prepare / Apply / Test / Certify
More informationSTREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR Rev. 10/2018. I. Protocol Application & IRB Certification Tutorial...2
STREAMLYNE INITIAL GUIDE FOR PRINCIPAL INVESTIGATOR Rev. 10/2018 I. Protocol Application & IRB Certification Tutorial...2 II. Logging In (Password)... 2 III. Creating a New Protocol Record / Menu Bar...
More informationeirb User Manual for Research Staff
eirb User Manual for Research Staff Version 4 1 10.2016 Table of Contents eirb Access... 3 Log-in to eirb... 4 Overview of the eirb Submission and Review Process... 7 Create a New Application and Specify
More information