SITE FILE MANAGEMENT

Size: px
Start display at page:

Download "SITE FILE MANAGEMENT"

Transcription

1 SITE FILE MANAGEMENT STANDARD OPERATING PROCEDURE NO SOP 08 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES: To describe the procedure for the maintenance of essential documents and investigator site file at a research study site. POLICY AUTHOR: Katie Helm; Research & Development Facilitator Page 1 of

2 BACKGROUND With the large volume of documentation required for each clinical trial, a standard filing system is necessary. From receipt of a research proposal / outline protocol, documentation for each study should be kept in a specific study file with a dedicated member of staff responsible for maintaining and updating the file. Some sponsors may provide the Investigator Site File for specific studies, however, non-commercial studies often do not. ICH Good Clinical Practice (ICH-GCP) guidelines define the study documents to be filed as essential documents those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. Whilst demonstrating compliance with ICH GCP, the filing of the study documents in an orderly, timely manner also greatly assists the smooth running of the study and any future audit or inspection. Other essential documents should be maintained according to local policy which adheres to the Records management NHS Code of Practice. These may include medical notes and other source documentation (See SOP 07 Data collection and entry). PURPOSE To be used to describe the procedure for the maintenance of clinical trials of investigational medicinal product (CTIMP) essential documents and investigator site files at a research study site in line with GCP Guidelines and MHRA requirements. PROCEDURE Who? The Investigator site file must be established and maintained by: The research practitioner responsible for the general conduct of the study e.g. research nurse, trial co-ordinator or research administrator Page 2 of

3 Any other person, as delegated by the Principal Investigator (PI) and recorded on the delegation of duties log for the study (see SOP 09: Roles, responsibilities and delegation of duties in trials). When? An investigator site file should be prepared as soon as an outline protocol is available. The file should be actively maintained and updated from this time until the study is formally closed. It may be that early documentation and correspondence may be kept in a different format than a site file but should be kept and then transferred to the site file once established. A note to file must be included where documents are not stored in the site file to highlight alternative location. The contents of the site file should be archived according to local procedures and SOP 10: Study closure and archiving. How? Setting up an investigator site file It is important to know, as early as possible whether a site file will be provided for the study. Depending on the type of study and sponsor, a site file may be: Completely prepared by the sponsor for initiation of the study o Maintained and kept up to date by site staff Suggested index supplied by Sponsor and documents sent in electronic format o Documents printed and filed appropriately o Maintained and kept up to date by site staff No suggested site file from sponsor o Site staff should produce a site file index in line with the LCFT Audit tool o Documents printed and filed appropriately o Maintained and kept up to date by site staff Page 3 of

4 Maintaining an investigator site file It is the responsibility of the PI or their delegate (e.g. research practitioner) to ensure that all essential documents have been collated prior to study initiation and that the Investigator site file is maintained throughout the study. This will ensure good version control and maintenance of all essential documents and prevent over or under- filing for the study. Documentation required may differ between commercial and non-commercial research and Clinical trials of Investigational Medicinal Products (CTIMPs) and non- CTIMPs, with the level of documentation required for each study generally being determined by the sponsor. If any documents are filed separately from the site file, this should be recorded by a file note detailing where such documents are filed (e.g. pharmacy and laboratory documentation) and include a date and signature. An investigator site file may consist of more than one volume, if so the files should be labelled numerically, the total number of existing files must also be indicated and updated as required e.g. file 1 of 5. All relevant correspondence should be retained however some documents may be stored electronically only. This may be specified by the sponsor. If documentation is stored electronically, a file note in the site file should confirm the location of such. The site file should be stored in a secure place, with restricted access. Restricted access may vary according to location, but should always be inaccessible to non Trust staff and patients and ideally be only accessible to those working on the study and listed on the delegation of duties log. It may be stored in a locked filing cabinet or cupboard. Discussions relating to storage of such documentation should be discussed as part of the study set up, giving consideration to the amount of documentation that will increase as the study continues. Page 4 of

5 Version control (See guidance document GD 03: Document Control) is imperative and superceded documents should be clearly marked as superceded by the new version, signed and dated. The PI may be required to do this for documents such as protocol, investigator brochure and safety reports as evidence that they are aware of the new version and accept that to be the current one which they will then adhere to. Superceded versions that have been used since the site was set up should be maintained this may be electronically if a file note states this and these documents can be printed off if requested. If any errors are made they need to be: - scored through the error not scribbled, with one line - initial and date the error and re write the intended comment/ data, as near as possible or if there is no space they can circle a number 1, 2 etc. and at the bottom of the page draw the circled number and add comment there. In the event of an error, a file note needs to be completed (Appendix A). The file note should: Include the study/subject it refers to Be signed and dated by the individual who is writing it Be legible Include a clear explanation and specify the reason for the error/ omission/ discrepancy it aims to address. Avoid using one-size-fits-all notes when providing details. Overuse of a blanket statement will take away from the value of a note to file. Be one-size-fits-all only when the error/ omission/ discrepancy is the result of a single, re-occurring oversight/ erroneous practice (e.g. failure to provide subject with a signed/dated copy of the consent form) or when it refers to a general practice such as the filing of regulatory documents in alternate locations/ electronically. Include any corrective action or follow-up when applicable. Be filed with the document, subject file or behind the study binder tab to which it applies. Page 5 of

6 Source documents may also be regarded as essential documents for the conduct of a research study. OTHER RELATED PROCEDURES, POLICIES, LEGISLATION OR GUIDANCE SOP 10: Study closure and archiving SOP 09: Roles, responsibilities and delegation of duties SOP 07: Data management LCFT Audit tool APPENDICES Appendix A: Sample File Note GLOSSARY ICH Good Clinical Practice (ICH-GCP) Principal Investigator (PI) Page 6 of

7 APPENDIX A SAMPLE FILE NOTE Study Title From To Re Description of error and corrective action taken Date Signature Page 7 of

Version Control of Study Specific Documents

Version Control of Study Specific Documents SOP Title Version Control of Study Specific Documents SOP No. SOP 10 Author Consulted Departments Lead Manager Sign and Print Name Julia Farmery Revision V2.0: Sarah Fahy Lincolnshire Clinical Research

More information

Standard Operating Procedure. Data Management. Adapted with the kind permission of University Hospitals Bristol NHS Foundation Trust

Standard Operating Procedure. Data Management. Adapted with the kind permission of University Hospitals Bristol NHS Foundation Trust Data Management REFERENCE: VERSION NUMBER: 2.1 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: Clinical Trials Manager; Clinical Trials Officer REVIEWED BY: R&I Senior Team APPROVED BY: Deputy Director

More information

STANDARD OPERATING PROCEDURE

STANDARD OPERATING PROCEDURE STANDARD OPERATING PROCEDURE Title Reference Number Document Version Control SOP-QMS-002 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January 2018 Author(s)

More information

LOUGHBOROUGH 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 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 information

JRO RMG RSS SOP 12. Standard Operating Procedure (SOP) for Study Closedown and Archiving

JRO RMG RSS SOP 12. Standard Operating Procedure (SOP) for Study Closedown and Archiving Office Location: 1 st Floor Maple House 149 Tottenham Court Road London W1T 7DN Joint Research Office Tel No. 0845 1555 000 Web-sites: www.uclh.nhs.uk; www.ucl.ac.uk/jro Postal Address: UCL, Gower Street

More information

Standard Operating Procedure. SOP effective: 06 February 2017 Review date: 06 February 2019

Standard Operating Procedure. SOP effective: 06 February 2017 Review date: 06 February 2019 Standard Operating Procedure SOP number: SOP full title: SOP-JRO-26-001 Data Management SOP effective: 06 February 2017 Review date: 06 February 2019 SOP author signature: SIGNED COPY HELD WITHIN THE NJRO

More information

Cancer Clinical Trials Centre Standard Operating Procedure

Cancer 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 information

Chapter 10: Regulatory Documentation

Chapter 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 information

SOP08: Standard Operating Procedure for Archiving at Trial Closure

SOP08: Standard Operating Procedure for Archiving at Trial Closure SOP08: Standard Operating Procedure for Archiving at Trial Closure Authorship Team: Sarah Gaze, Mel Storey & Ian Russell for Joint SOP Group on Trial Administration (viz Angela Evans, Hayley Hutchings,

More information

Standard Operating Procedure. SOP full title: Sponsor processes for reporting Suspected Unexpected Serious Adverse Reactions

Standard Operating Procedure. SOP full title: Sponsor processes for reporting Suspected Unexpected Serious Adverse Reactions Standard Operating Procedure SOP number: SOP full title: SOP-JRO-03-003 Sponsor processes for reporting Suspected Unexpected Serious Adverse Reactions SOP effective: 23/05/2017 Review date: 23/05/2019

More information

SOP-QA-32 V2. Document History Version Description of update Date Effective 1 Change of number for Q-Pulse

SOP-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 information

BioInformatics A Roadmap To Success. Data Management Plans. Wes Rountree Associate Director of Data Management Family Health International

BioInformatics A Roadmap To Success. Data Management Plans. Wes Rountree Associate Director of Data Management Family Health International BioInformatics A Roadmap To Success Data Management Plans Wes Rountree Associate Director of Data Management Family Health International What is a Data Management Plan? A document that describes how clinical

More information

UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE

UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES University of Leicester (UoL)

More information

Title: Non-Commercial Study Archiving of Investigator Site file and Pharmacy Site File (if applicable)

Title: Non-Commercial Study Archiving of Investigator Site file and Pharmacy Site File (if applicable) Title: Non-Commercial Study Archiving of Investigator Site file and Pharmacy Site File (if applicable) SOP Number and Version: UCLH SOP 10, Version 2.1 Effective Date: Review Date: 06/09/2020 For Trust-wide

More information

STANDARD 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. 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 information

EUROPEAN MEDICINES AGENCY (EMA) CONSULTATION

EUROPEAN MEDICINES AGENCY (EMA) CONSULTATION EUROPEAN MEDICINES AGENCY (EMA) CONSULTATION Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical

More information

Data validation and database lock down for RFL sponsored studies Document Number: 037

Data validation and database lock down for RFL sponsored studies Document Number: 037 Data validation and database lock down for RFL sponsored studies Document Number: 037 Version: 1 Ratified by: Committee Date ratified: 30 September 2014 Name of originator/author: Directorate: Department:

More information

General Guidance for Maintaining a Regulatory Binder

General 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 information

Signature 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 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 information

Introduction. Lesson 1 Access and Basic Navigation

Introduction. Lesson 1 Access and Basic Navigation Introduction Hello and Welcome to PRA s etmf Basics for External Users This tutorial is designed to provide you with a basic overview of PRA s etmf 3 System that you will be using to access your Trial

More information

The Lilly Safety Mailing Process

The Lilly Safety Mailing Process The Lilly Safety Mailing Process 1 After this presentation you will be able to: Define Safety Mailings and the type of adverse events that trigger safety mailings. Define Principal Investigator (PI) and

More information

ELECTRONIC SITE DELEGATION LOG (esdl) USER MANUAL

ELECTRONIC 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 information

Standard Operating Procedure Clinical Data Management

Standard 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 information

Purpose: To describe the requirements for managing IP at the clinical site

Purpose: 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 information

Trial Cost Analysis Trial: Knee Surgery Study Sponsor: Principal Investigator: Hillary Resendes Total Enrollment: 8

Trial 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 information

Elements of Data Management

Elements of Data Management Elements of Data Management Disclaimers: The views in this presentation represent those of the presenter and not necessarily those of Bayer, CVM, SQA or KSU. Names used in examples are fictional and not

More information

Standard Operating Procedure. Preparation, Review and Approval of Clinical Research Standard Operating Procedures and Work Instructions

Standard 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 information

BRANDMAN UNIVERSITY INSTITUTIONAL REVIEW BOARD Continuing Review Request/Closure Report

BRANDMAN 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 information

ELECTRONIC CASE REPORT FORM

ELECTRONIC CASE REPORT FORM ELECTRONIC CASE REPORT FORM User Requirements & Settings Version 3.9 User Requirements & Settings v 3.9 TABLE OF CONTENT AIM OF THE DOCUMENT... 3 GLOSSARY... 3 REFERENCES... 3 1. INTRODUCTION... 4 2. HARDWARE

More information

User Guide 16-Mar-2018

User 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 information

SAFE USE OF MOBILE PHONES AT WORK POLICY

SAFE USE OF MOBILE PHONES AT WORK POLICY SAFE USE OF MOBILE PHONES AT WORK POLICY Links to Lone Working Policy, Personal Safety Guidance, Lone Working Guidance, Information Governance Policy Document Type General Policy Unique Identifier GP31

More information

THE TRIAL MASTER FILE

THE TRIAL MASTER FILE THE TRIAL MASTER FILE CONFIDENCE IN PROVIDING TMF FOR REGULATORY INSPECTION OR LEGAL DISCOVERY EXECUTIVE SUMMARY FOR EXL PHARMA S 2ND EUROPEAN TRIAL MASTER FILE SUMMIT LONDON OCTOBER 22 23, 2013 CONTENTS

More information

Vaccine data collection tool Oct Functions, Indicators & Sub-Indicators

Vaccine 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 information

Request for Feedback. Manizhe Payton, MPH. Director Office of Clinical Site Oversight Division of AIDS February 22, 2017

Request for Feedback. Manizhe Payton, MPH. Director Office of Clinical Site Oversight Division of AIDS February 22, 2017 Request for Feedback Manizhe Payton, MPH Director Office of Clinical Site Oversight Division of AIDS February 22, 2017 Background European Medicines Agency (EMA) inspected 2 clinical research sites in

More information

Source Documentation Standards for DMID Clinical Studies. Version Nov-2005

Source Documentation Standards for DMID Clinical Studies. Version Nov-2005 Source Documentation Standards for DMID Clinical Studies Version 2.0-21-Nov-2005 1 Source Data Defined All information in original records and certified copies of original records. necessary for the reconstruction

More information

1. STRATEGIC PLANNING

1. STRATEGIC PLANNING RAC (EU) EXAMINATION SUBJECTS & FORMAT The European RAC Examination is a knowledge-based examination addressing European Union laws, regulations, policies and guidelines affecting medical RAC devices,

More information

Informed Consent and the Consent Form

Informed Consent and the Consent Form Informed Consent and the Consent Form What is informed consent? What does the process look like? Who can obtain consent? Where can I find more information? Consent Form Informed Consent They are NOT the

More information

Standard Operating Procedure (SOP) Research and Development Office

Standard Operating Procedure (SOP) Research and Development Office Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Case Report Forms SOP Number: 5 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August 2015

More information

Welcome Membership Update Sub-group / Initiatives update Investigator TMF Clarifications Sub-artifacts Observational Studies Exchange Mechanism

Welcome Membership Update Sub-group / Initiatives update Investigator TMF Clarifications Sub-artifacts Observational Studies Exchange Mechanism 11 February 2019 While we are waiting for attendees to join and the host to start the meeting, all lines will be muted. Please stay on the call. You can unmute yourself when you want to talk! Welcome Membership

More information

Birmingham Community Healthcare NHS Foundation Trust. 2017/17 Data Security and Protection Requirements March 2018

Birmingham Community Healthcare NHS Foundation Trust. 2017/17 Data Security and Protection Requirements March 2018 1.0 Executive Summary Birmingham Community Healthcare NHS Foundation Trust 2017/17 Data Security and Protection Requirements March 2018 The Trust has received a request from NHS Improvement (NHSI) to self-assess

More information

NN CS 704 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR DATA BACKUP, RECOVERY, AND CONTINGENCY PLANS

NN CS 704 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR DATA BACKUP, RECOVERY, AND CONTINGENCY PLANS NN CS 705 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR DATA BACKUP, RECOVERY, AND CONTINGENCY PLANS SOP: NN CS 705 Version No. 2.0 Effective Date: 21Oct2016 DATA BACKUP, RECOVERY, AND CONTINGENCY

More information

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

NEWCASTLE 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 information

Procedure re-written. (i.e. All staff with responsibility for the creation, use and management of organisational responsibility)

Procedure re-written. (i.e. All staff with responsibility for the creation, use and management of organisational responsibility) Standard Operating Procedure Title of Standard Operation Procedure: Corporate Records Management Procedure Reference Number: ECT002863 Version No: 2.0 Supersedes Versions No: 0.1 Amendments Made: Procedure

More information

FDA Audit Preparation

FDA 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 information

Version 11, JAN2017. Regulatory Document Approval Parameters for WebDCU TM POINT. People Document Collection REGULATORY REQUIREMENTS

Version 11, JAN2017. Regulatory Document Approval Parameters for WebDCU TM POINT. People Document Collection REGULATORY REQUIREMENTS Regulatory Approval Parameters for WebDCU TM Collection Person Role CV Study Drug Recipient, Secondary SC within document 5 yrs. from effective Required for all site personnel who are directly involved

More information

Comprehensive Accreditation Manual for Critical Access Hospitals

Comprehensive Accreditation Manual for Critical Access Hospitals Comprehensive Accreditation Manual for Critical Access Hospitals Table of Changes CAMCAH, June 2010 Standard, element of performance, and scoring changes in this update include the following: Clarifications

More information

Data Integrity: Technical controls that demonstrate trust

Data Integrity: Technical controls that demonstrate trust WHITE PAPER 80077 Data Integrity: Technical controls that demonstrate trust Using Chromeleon 7 Chromatography Data System for enhanced data integrity Author Shaun Quinn, Marketing Manager Informatics and

More information

Reviewers Guide on Clinical Trials

Reviewers Guide on Clinical Trials Reviewers Guide on Clinical Trials Office of Research Integrity & Compliance Version 2 Updated: June 26, 2017 This document is meant to help board members conduct reviews for Full Board: Clinical Trial

More information

Keele Clinical Trials Unit

Keele Clinical Trials Unit Keele Clinical Trials Unit Standard Operating Procedure (SOP) Summary Box Title Randomisation SOP Index Number SOP 32 Version 3.0 Approval Date 31-Jan-2017 Effective Date 14-Feb-2017 Review Date January

More information

Severn Trent Water. Telecommunications Policy and Access Procedure

Severn Trent Water. Telecommunications Policy and Access Procedure Severn Trent Water Telecommunications Policy and Access Procedure Contents STW Telecommunications Policy: 5-12 Health and Safety: 13-18 Access Procedures:19-30 2 STW LSH Sites Access Policy [Controlled

More information

Use of Controlled Substances in Research

Use of Controlled Substances in Research Use of Controlled Substances in Research A Tutorial on Regulatory Requirements and the Emory University Policy 7.25 Research Use of Controlled Substances Emory University, Office of Compliance Tutorial

More information

European Medicines Agency Standard Operating Procedure

European Medicines Agency Standard Operating Procedure European Medicines Agency Standard Operating Procedure Title: Procedure to be followed by the EMEA in case of mechanical, programme, electronic or communication failure, which prevents a Sender from generating

More information

Electronic Data Capture (EDC) Systems and Part 11 Compliance

Electronic Data Capture (EDC) Systems and Part 11 Compliance Electronic Data Capture (EDC) Systems and Part 11 Compliance Office of New Animal Drug Evaluation Center for Veterinary Medicine Society of Quality Assurance Gaylord Hotel, Washington DC March 28, 2017

More information

Wayne State University

Wayne State University Wayne State University Office of Environmental Health & Safety Controlled Substances Program Why is Wayne State doing this? In 2011, a survey of our laboratories revealed that some were not adhering to

More information

The SPECTRUM 4.0 Acquisition Procedure

The SPECTRUM 4.0 Acquisition Procedure The SPECTRUM 4.0 Acquisition Procedure Contents 1. What is the SPECTRUM 4.0 Acquisition Procedure? 2. The Acquisition Procedure and Accreditation 3. Why is the Acquisition Procedure important? 4. When

More information

Use of and Instant Messaging (IM) Policy

Use of  and Instant Messaging (IM) Policy Use of Email and Instant Messaging (IM) Policy Name of Author and Job Title: Mike Cavaye, IT & Digital Consultant Name of Review/Development Body: IT Services Ratification Body: Quality and Safety Group

More information

SOP Owner: Finance Last Reviewed/Update Date: 10/05/2015. Petty Cash Reimbursement on Grants Standard Operating Procedure

SOP Owner: Finance Last Reviewed/Update Date: 10/05/2015. Petty Cash Reimbursement on Grants Standard Operating Procedure Petty Cash Reimbursement on Grants Standard Operating Procedure 1. Purpose WCMC is required by federal regulation to monitor and review any research related costs associated to Grants. All transactions

More information

Use of Synthetic Data in Live Environments

Use of Synthetic Data in Live Environments Use of Synthetic Data in Live Environments Guidance Published 6 th July 2018 Version 1.0 Final Copyright 2018 NHS Digital Contents Introduction 3 General Principles 4 Synthetic Data Naming Convention 4

More information

Data Management Dr Evelyn Flanagan

Data Management Dr Evelyn Flanagan Data Management Dr Evelyn Flanagan e.flanagan@ucc.ie DATA MANAGEMENT OVERVIEW Role of the Data Manager in Clinical Trials General understanding of the principles underpinning data management for clinical

More information

Data Integrity in Clinical Trials

Data Integrity in Clinical Trials Data Integrity in Clinical Trials DIA/ISPE Workshop 06-07 NOV 2014 Tom Haag, Novartis Pharmaceuticals Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual

More information

What is the Northern Ireland ehealth and Care strategy?

What is the Northern Ireland ehealth and Care strategy? What is the Northern Ireland ehealth and Care strategy? The regional ehealth and Care strategy provides a framework and plan for regional coordination and collaboration to further develop ehealth in Northern

More information

INFORMATION SECURITY AND RISK POLICY

INFORMATION SECURITY AND RISK POLICY INFORMATION SECURITY AND RISK POLICY 1 of 12 POLICY REFERENCE INFORMATION SHEET Document Title Document Reference Number Information Security and Risk Policy P/096/CO/03/11 Version Number V02.00 Status:

More information

Protocol Deviations and Protocol Violations Made Simple. Donna Brassil, MA, RN, CCRC Rhonda G. Kost, MD

Protocol Deviations and Protocol Violations Made Simple. Donna Brassil, MA, RN, CCRC Rhonda G. Kost, MD Protocol Deviations and Protocol Violations Made Simple Donna Brassil, MA, RN, CCRC Rhonda G. Kost, MD Objectives Upon completion of this class, the learner will be able to: verbalize the difference between

More information

Castle View Primary School Data Protection Policy

Castle View Primary School Data Protection Policy Castle View Primary School Data Protection Policy Aims The Headteacher and Governors of the school intend to comply fully with the requirements and principles of the Data Protection Act 1998. All staff

More information

3 September

3 September 3 September 2012 Reference: EMA 12007 By e-mail: Silvia.Domingo@ema.europa.eu Dr. Silvia DOMINGO European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB, United Kingdom Subject: epmf Database

More information

How to review a CRF - A statistical programmer perspective

How to review a CRF - A statistical programmer perspective Paper DH07 How to review a CRF - A statistical programmer perspective Elsa Lozachmeur, Novartis Pharma AG, Basel, Switzerland ABSTRACT The design of the Case Report Form (CRF) is critical for the capture

More information

esource Initiative ISSUES RELATED TO NON-CRF DATA PRACTICES

esource Initiative ISSUES RELATED TO NON-CRF DATA PRACTICES esource Initiative ISSUES RELATED TO NON-CRF DATA PRACTICES ISSUES RELATED TO NON-CRF DATA PRACTICES Introduction Non-Case Report Form (CRF) data are defined as data which include collection and transfer

More information

Examining Rescue Studies

Examining Rescue Studies White Paper Examining Rescue Studies Introduction The purpose of this White Paper is to define a Rescue Study, outline the basic assumptions, including risks, in setting up such a trial based on DATATRAK

More information

Statutory Notifications

Statutory Notifications Registration under the Health and Social Care Act 2008 Statutory Notifications Guidance for registered providers and managers of NHS GP and other primary medical services May 2013 Statutory notifications

More information

eprmc User Manual For Investigators and Research Staff

eprmc 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 information

MHRA GMP Data Integrity Definitions and Guidance for Industry March Introduction:

MHRA GMP Data Integrity Definitions and Guidance for Industry March Introduction: MHRA GMP Data Integrity Definitions and Guidance for Industry Introduction: Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This

More information

ENCePP Code of Conduct Implementation Guidance for Sharing of ENCePP Study Data

ENCePP Code of Conduct Implementation Guidance for Sharing of ENCePP Study Data EMA/409316/2010 Revision 2, dated 14 July 2016 European Network of Centres for Pharmacoepidemiology and Pharmacovigilance ENCePP Code of Conduct Implementation Guidance for Sharing of ENCePP Study Data

More information

Electronic Communication of Personal Health Information

Electronic Communication of Personal Health Information Electronic Communication of Personal Health Information A presentation to the Porcupine Health Unit (Timmins, Ontario) May 11 th, 2017 Nicole Minutti, Health Policy Analyst Agenda 1. Protecting Privacy

More information

University of Pennsylvania Institutional Review Board

University of Pennsylvania Institutional Review Board Reliance Agreement Guidance Creating Consent Templates This document provides step by step guidance on how to convert the Penn IRB approved consent form into a consent form template that can be shared

More information

HEALTH AND SAFETY PROGRAM 207 Permit Writer Certification Procedure

HEALTH AND SAFETY PROGRAM 207 Permit Writer Certification Procedure Page 1 of 11 1.0 PURPOSE Axiall, Plaquemine Complex, has developed this procedure to establish guidelines and protocols to certify Safe Work Permit Writers and Confined Space Entry Supervisors. 2.0 SCOPE

More information

Image Exchange Portal

Image Exchange Portal Image Exchange Portal Approved By: Date Approved: 25 th January 2011 Trust Reference: C132/2016 Version: Supersedes: Author / Originator(s): Name of Responsible Committee/Individual: Imaging Clinical Business

More information

Common Statistical Analysis Plan (SAP) Frequently Asked Questions

Common Statistical Analysis Plan (SAP) Frequently Asked Questions Last Updated 4-Nov-2018 Topics 1 Stakeholder Input to Common SAP Template Development... 2 2 Template Content... 2 3 Implementation of the Common SAP template by the Sponsor... 55 4 Updates to the Common

More information

How to Produce a Procedural Document

How to Produce a Procedural Document An Organisation-wide Policy for the Management and Development of Procedural Documents Also known as: How to Produce a Procedural Document Status (Draft/ Ratified): Ratified Date ratified: 15 th May 2013

More information

Office of Human Research

Office 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 information

ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES

ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES ACCREDITATION COMMISSION FOR CONFORMITY ASSESSMENT BODIES ACCREDITATION SCHEME MANUAL Document Title: Document Number: Various Accreditation Schemes ACCAB-ASM-7.0 CONTROLLED COPY Revision Number Revision

More information

October p. 01. GCP Update Data Integrity

October p. 01. GCP Update Data Integrity p. 01 p. 02 p. 03 failures by organizations to: apply robust systems that inhibit data risks, improve the detection of situations where data reliability may be compromised, and/or investigate and address

More information

DATA INTEGRITY (EMA AUGUST 2016)

DATA INTEGRITY (EMA AUGUST 2016) Data integrity Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities.it is a fundamental requirement of the pharmaceutical quality system described in EU

More information

Use Of Mobile Communication Devices Within Healthcare Premises Policy

Use Of Mobile Communication Devices Within Healthcare Premises Policy Use Of Mobile Communication Devices Within Healthcare Premises Policy Co-ordinator: Director of Facilities Reviewer: Working Group chaired by Director of Facilities Approver: GAPF Signature Signature Signature

More information

ONE ID Identity and Access Management System

ONE ID Identity and Access Management System ONE ID Identity and Access Management System Local Registration Authority User Guide Document Identifier: 2274 Version: 1.8 Page 1 Copyright Notice Copyright 2011, ehealth Ontario All rights reserved No

More information

Kuali Coeus Implementation: IRB Progress Report. October 7, 2013

Kuali Coeus Implementation: IRB Progress Report. October 7, 2013 Kuali Coeus Implementation: IRB Progress Report October 7, 2013 IRB Presentation Outline Current State Documentation Future State Process Development KC-IRB24 Protocol Development-Submission Process Process

More information

This procedure applies to all Standard Operating Procedures and Protocols that are generated in the NCSBI Crime Laboratory Forensic Biology Section.

This procedure applies to all Standard Operating Procedures and Protocols that are generated in the NCSBI Crime Laboratory Forensic Biology Section. NCSBI Forensic Biology Section QA Manual Appendix J Effective Date: December 23, 2004 Title: PROCEDURE FOR COMPLETION OF QUALITY SYSTEM DOCUMENTS Revision 00 1 PURPOSE This procedure details the content

More information

ACCAB. Accreditation Commission For Conformity Assessment Bodies

ACCAB. Accreditation Commission For Conformity Assessment Bodies ACCAB Accreditation Commission For Conformity Assessment Bodies ACCAB Platinum Plus Accreditation For Certification Bodies, Inspection Bodies, Testing & Calibration Laboratories and Medical Laboratories

More information

ABB Limited. Table of Content. Executive Summary

ABB Limited. Table of Content. Executive Summary 21 CFR Part 11 Electronic Records; Electronic Signatures Guidance for Industry Scope of Application Position Paper: A Summary and Interpretation of the Guidance Note: This document has been prepared based

More information

12/2/2011. Integration of s into the Trial Master File. Russell Joyce. Heath Barrowcliff Consulting Ltd. Disclaimer

12/2/2011. Integration of  s into the Trial Master File. Russell Joyce. Heath Barrowcliff Consulting Ltd. Disclaimer Integration of emails into the Trial Master File Russell Joyce Director & Principal i Consultant t Heath Barrowcliff Consulting Ltd Disclaimer The views and opinions expressed in the following PowerPoint

More information

Issues that Matter Notification and Escalation

Issues that Matter Notification and Escalation Issues that Matter and and Clinical Development Enterprise Occurrences/Situations that require a simple correction, with no effect on clinical development activities, are managed through normal business

More information

Information Sheet for Scientific Approvers

Information 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 information

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

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 information

Using the Resource Packet for Licensed Independent Practitioners

Using the Resource Packet for Licensed Independent Practitioners Using the Resource Packet for Licensed Independent Practitioners Our Responsibilities and Yours Alliance is responsible for conducting routine monitoring of solo and group LIPs that contract with us Providers

More information

MBChB Student E-portfolio Guide Year /18

MBChB Student E-portfolio Guide Year /18 MBChB Student E-portfolio Guide Year 2 2017/18 This document is a step by step guide covering the use of the e- portfolio system and the customised forms that have been created, allowing you to record

More information

Design of Case Report Forms. Case Report Form. Purpose. ..CRF Official clinical data-recording document or tool used in a clinical study

Design of Case Report Forms. Case Report Form. Purpose. ..CRF Official clinical data-recording document or tool used in a clinical study Design of Case Report Forms David W. Mailhot February 23, 2010 Case Report Form..CRF Official clinical data-recording document or tool used in a clinical study PAPER RDC/RDE (Remote Data Capture, Remote

More information

May ORION User Access Procedures

May ORION User Access Procedures May 2018 ORION User Access Procedures Disclaimer The guidance in this document is correct as at the date of publication. The Central Bank regularly issues guidance to ensure compliance by regulated firms

More information

University 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 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 information

Good Computer Validation Practices

Good Computer Validation Practices Good Computer Validation Practices Common Sense Implementation Teri Stokes Ronald C. Branning Kenneth G. Chapman Heinrich J. Hambloch Anthony J. Trill Interpharm Press, Inc. Buffalo Grove, IL Contents

More information

Standard operating procedure

Standard operating procedure Standard operating procedure Title: Procedure for liaising between the EMA, the CHMP and the CTFG on the potential CHMP negative opinion, pre-opinion or post-authorisation withdrawal, suspension or revocation

More information

Guidance for Quality Control (QC) of CTU Study Document(s)

Guidance for Quality Control (QC) of CTU Study Document(s) Document type Keele University Health and Social Care QMS: Guideline Version No. 1.0 Version Date 20 July 2018 SOP index number HSCR-GUI10 Guidance for Quality Control (QC) of CTU Study Document(s) Author(s)

More information