Details: Approval: Distribution & Storage:
|
|
- Donna Long
- 5 years ago
- Views:
Transcription
1 Details: Author: Neville Young Quality Assurance Manager SOP Pages: Version No. of replaced SOP: Effective date of replaced SOP: NA NA Approval: Version No: of the SOP being approved. Name of person approving this SOP. Date Signature of the person approving this SOP. 1.0 Dr Derek Norfolk Associate Director of R&D Leeds Teaching Hospitals NHS Trust 1.0 Clare Skinner Faculty Head of Research Support University of Leeds Distribution & Storage: Distribution to All Research Staff conducting or assisting with a CTIMP trial within Leeds Teaching Hospital NHS Trust Location of Document Paper: Electronic: Quality Assurance, Research and Development, Leeds General Infirmary I:\QA\1_SPONSOR_LEEDS_DOCUMENTS\SOPs/ R&D website Page 1 of 7
2 CONTENTS Contents Page 2 Section A - Introduction Page 3 Section B - Applicability Page 3 Section C - Glossary Pages 3-4 Section D A Researchers Guide to Sample Collection and Management Pages Planning your Sample Collection Pages 4 2 Sample Collection Page 4 3 Sample Transport Pages 4 4 Sample Receipt & Storage Pages 4 5 Processing Page Equipment Maintenance Page 6 7 Temperature Records Page 6 8 Reagents Page 6 9 Data Handling Page6 10 Contracts Page 6 11 Quality Assurance & Quality Control Page 6-7 Section E - References Page 8 Section F - Definitions Page 9 Page 2 of 7
3 Please note: This SOP should be used and followed in conjunction with other LTHT SOPs developed for researchers to support study set up and management. These can be found on the LTHT website or by contacting R&I directly..?????. For clinical trials where Leeds is not the trial Sponsor you may use these SOPs as guidance, but refer to any Sponsor SOPs for further information. Section A Introduction 1.1 This Standard Operating Procedure (SOP) acts as a guide for all researchers, to aid with the collection and management of Samples for analysis when conducting a Clinical Trial of an Investigational Medicinal Product (CTIMP) within Leeds Teaching Hospitals Trust (LTHT) and the University of Leeds (UoL). 1.2 The collection and management of is essential for evaluation and validation of clinical findings, observations, and other activities during a clinical trial. Documentation and use of systems to collect and manage will substantiate the integrity of the trial data results. This SOP serves to ensure quality by requesting that all are collected, stored and analysed in a demonstrable manner such that high quality data generated can be confirmed by audit and inspection 1.3 This SOP will provide specific support to the protocol on how to collect & process consistently and how equipment and processes with Labs should be maintained to ensure high quality outcomes. This SOP is applicable to all CTIMPs sponsored by LTHT or UoL. At the end of the SOP you will also find general advice, tips and rules. Section B Applicability 1.1 This SOP is applicable to all CTIMPs being conducted within LTHT / UoL. 1.2 All members of research staff involved in running CTIMPs who collect process or analyse trials including, but not restricted to: Chief and Principal Investigators, Research Nurses and laboratory staff. 1.3 The Investigator has ultimate responsibility for ensuring that all applicable study site staff adheres to this SOP. Section C Glossary Audit Trail A trial Sample Confidentiality Documentation that allows reconstruction of the course of events Any sample of tissue (saliva, blood, plasma, urine etc) collected from a participant in a clinical trial for analysis within that trial. Prevention of disclosure, to other than authorised individuals, of a sponsor s proprietary information or of a subjects Page 3 of 7
4 Source Data Source Documents identity All information in original records and certificated copies of original records of clinical findings, observations or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained within source documents. Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files and records kept at pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial. Section D A researchers guide to Sample Collection & Management 1.0 Planning your Sample Collection When setting up where trial are to be collected and analysed it is important to consider the following; 1.1 Sample Type - collected within a CTIMP fall into two categories; Samples collected for Routine (standard care) analysis Samples collected for specific trial related analysis which may occur in a 3rd party laboratory All relevant information regarding sample type, collection, analysis and storage can be located in the protocol. 1.2 Storage If the are to be stored for any length of time then you should consider where they will be stored, how they will be transported, and storage conditions (for transport and at destination). 1.3 Analysis do you have assurance that the analysis will be accurate, equipment should be serviced and calibrated, software should be up to date and validated, SOPs should be in place to described how equipment and software is used. 1.4 Contracts where are being transported to a 3 rd party laboratory not managed by the sponsor or site of collection, a contract should be in place between Page 4 of 7
5 the sponsor and the 3 rd part laboratory. This contract should describe mutually agreed quality standards for the handling and management of the. 1.5 Training It is important that all lab personnel have received the appropriate training for the task they will be undertaking and that this training is recorded. Please note if monitored/audited/inspected ALL relevant information regarding the sample life history must be provided including records of how it was transported and where it was stored in order to ensure a full audit trail of each sample can be produced. 2.0 Sample Collection Individuals collecting or receiving as part of a CTIMP should have appropriate assurance in place to confirm that study has been approved by the host organisation, and that consent has been taken from the patient prior to any trial procedure taking place. This included screening and baseline tests.. Samples should be collected as described in the protocol, collection vessels may be supplied Samples may undergo preliminary manipulation at site eg centrifugation, refrigeration if so local equipment used should have appropriate servicing and calibration records available for review. 3.0 Sample Transport If are collected for routine standard care analysis they should be processed and transported to local laboratories in line with local standards procedures. Trial may have a different coloured request forms to identify them as trial specific. Samples being transported to a 3 rd party location must be collected, packaged and transported as described in the protocol. If the protocol is unclear then reference should be made to the contractual agreement between the sponsor and the 3 rd party laboratory to establish the mode of transport. If uncertainly remains please contact the sponsor directly. If a courier is needed to transport please retain evidence of transport including collection and delivery sign off. Temperature specific couriered should use a tag system to supply evidence that have not exceeded the agreed temperature during transit. 4.0 Sample receipt and Storage 3 rd party laboratories receiving should have robust systems in place to receive and process in a timely and efficient manner. For instance an electronic database to catalogue, laboratory staff should have access to appropriate labels for an expected number of. Research teams should seek assurance through the contract with the laboratory that these processes meet the needs of the type of sample collected and transport to the laboratory. Page 5 of 7
6 5.0 Processing Documented systems and processes, often in the form of SOPs should be in situ at the laboratories detailing how are processed and how equipment used to support this activity. 6.0 Equipment Maintenance Equipment in 3 rd party laboratories, including computers and software, should be serviced, maintained and validated in accordance with, as a minimum standard, the manufactures recommendations. Clear records of servicing and calibration checks should be available. For instance are volumetric devises calibrated before servicing to confirm accuracy over the intervening period since a previous service? 7.0 Temperature Records Where trial are stored in fridges and freezers an appropriate log of regular temperature reading should be maintained to provide assurance on the quality of storage conditions of clinical trial AND reagents (antibodies) used to analyse them. Where appropriate, suitable alarms and back up systems should be in place to mitigate against equipment or power failures. Any temperature variations or failures should be recorded and managed according to the local laboratory SOPs. 8.0 Reagents. Reagents used in laboratories in the analysis of clinical trial should be subject to a robust Quality Control process to ensure that they are received into the laboratories in a state fit for purpose and are stored and used appropriately. These QC processes should be documented. 9.0 Data Handling 3 rd Party laboratories producing data for clinical trial must have systems and processes in place to ensure data is recorded and transferred accurately. That appropriate QC is undertaken on the data. Data produced in laboratories may be termed source data and appropriate steps must be taken to ensure that this data is stored appropriately for the duration of the trial. All sample related data should be appropriately anonymised so as not to breach patient confidentiality Contracts Contracts with 3 rd party labs should describe the standards the laboratory will be working to. They do not need to detail all written procedures but should reference the standards at which the laboratory expects to work. Please discuss these agreements with the QA team early in the approval process. If you are working with academic partners in the University you may still need a contract to be in place this may only be to describe the standards agreed Quality Assurance and Quality Control Page 6 of 7
7 The laboratory may have accreditation (which should be up to date and available for review) describing the QA and QC processes within the laboratory. These should work independently but with direct reference to each other. The accuracy of all lab processes should be subject to a proportionate level of QC. The QA process is different and should address whether the labs quality systems are operating effectively. If the QA systems are operating effectively they will minimise the possibility of QC uncovering any discrepancies, but where they are identified should aid rapid identification of problems and support solutions. Quality Management systems should be present in any laboratory managing clinical trial to provide a level of assurance for the sponsor. Section E References MHRA Good Clinical Practise Guide 2012 Chapter 13 E6 Guideline for Good Clinical Practise version 2.1 August 2011 Section F CTIMP GCP LTHT MHRA QA R&D REC SOP QA QC Definitions Clinical Trial of an Investigational Medicinal Product Good Clinical Practise Leeds Teaching Hospitals Trust Medicines and Healthcare products Regulatory Agency Quality Assurance Research and Development Research Ethics Committee Standard Operation Procedure Quality Assurance Quality Control Page 7 of 7
Louise Brook Clinical Trials Quality Monitor. Date
Details: Author: Louise Brook Clinical Trials Quality Monitor SOP Pages: 12 Version No. of replaced SOP: Effective date of replaced SOP: NA NA Approval: Version No: of the SOP being approved. Name of person
More informationOFFICE FOR RESEACH PROCEDURE. Site Initiation and Close-out
OFFICE FOR RESEACH PROCEDURE Site Initiation and Close-out 1. Purpose: To describe the procedures related to site initiation and close-out of a clinical trial. 2. Scope: Applicable to all phases of clinical
More informationStudy Management SM STANDARD OPERATING PROCEDURE FOR Specimen Management
Study Management SM 308.01 STANDARD OPERATING PROCEDURE FOR Specimen Management Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick M. Schnell, MD, FACP
More informationQuality Assurance QA STANDARD OPERATING PROCEDURE FOR FDA or Pharmaceutical Sponsored Audits
Quality Assurance QA 601.01 STANDARD OPERATING PROCEDURE FOR FDA or Pharmaceutical Sponsored Audits Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Maintaining Study Files SOP-RES-014 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January 2018 Author(s)
More information1.4 Applicable Regulatory Requirement(s) Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended
More informationSPONSOR INVESTIGATIONAL MEDICINAL PRODUCT (IMP) MANAGEMENT
SPONSOR INVESTIGATIONAL MEDICINAL PRODUCT (IMP) MANAGEMENT DOCUMENT NO.: GS010 v1.0 AUTHOR: Vikki Young ISSUE DATE: 28 MAY 2018 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research &
More informationStandard Operating Procedures Guidelines for Good Clinical Practice
SOP # CRSC-105 Effective Date 10-22-2013 Version # 1 Version Date 7-30-2013 Standard Operating Procedures Guidelines for Good Clinical Practice Purpose: This SOP outlines the steps required to follow FDA
More informationRESEARCH AUDIT Standard Operating Procedure
Reference Number: UHB 236 Version Number: 2 Date of Next Review: 17 th Oct 2020 Previous Trust/LHB Reference Number: N/A RESEARCH AUDIT Standard Operating Procedure Introduction and Aim As a legal Sponsor
More informationSource Documents and Regulatory Binders October 6, 2016
Source Documents and Regulatory Binders October 6, 2016 Lisa Wilson, Regulatory Lead, Clinical Trials Office and Mark Alger, CRC, Clinical Trials Office Essential Documents AKA: the stuff in the Reg Binder
More informationInvestigator Site File Index (CTIMP)
Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol Current version plus all previous versions (or provide file note to detail location of previous
More informationIndex of Standard Operating Procedures for all research Sponsored by the UHL
University Hospitals of Leicester NHS Trust () Index of Standard Operating Procedures for all research Sponsored by the October Please note that with effect from 2015, all SOPs and Appendices use the same
More informationR&D Administration Manager. Research and Development. Research and Development. NHS Staff Trust-Wide THIS IS A CONTROLLED DOCUMENT
Document Title: Document Number: Research Protocol Design for Papworth Sponsored Studies SOP019 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by:
More informationResearch Study Close-down and Archiving Procedures
Title: Research Study Close-down and Archiving Procedures Outcome Statement: To inform researchers of the process for closing down research studies, retaining and storing research materials in the Trust.
More informationSt. Luke s University Health Network
Page 1 of 6 PURPOSE: This standard operating procedure (SOP) serves as a companion to the Standard Operating Procedure for Data Management. The St. Luke s University Health Network (SLUHN) Clinical Trials
More informationIMP Management and Accountability
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More informationStandard Operating Procedure (SOP) for the Development, Management & Control of Research-Related SOPs
Standard Operating Procedure (SOP) for the Development, Management & Control of Research-Related SOPs For Completion by SOP Author Reference Number Version Document Author(s) Document Reviewer(s) PHT/RDSOP/001
More informationCOMBINED RISK ASSESSMENT
COMBINED RISK ASSESSMENT DOCUMENT NO.: GS002 v3.0 AUTHOR: Lorn Mackenzie ISSUE DATE: 04 AUG 2017 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research & Development (ACCORD) is a joint
More informationIndex of Standard Operating Procedures for all research Sponsored by the UHL
University Hospitals of Leicester NHS Trust () Index of Standard Operating Procedures for all research Sponsored by the March Please note that with effect from 2015, all SOPs and Appendices use the same
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. 14. Amendments to Research Studies
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 14. Amendments to Research Studies Amendments are changes made
More informationSTANDARD OPERATING PROCEDURE SOP 725 CAPACITY, CAPABILITY AND RISK ASSESSMENT OF TRIALS HOSTED BY NNUH
STANDARD OPERATING PROCEDURE SOP 725 CAPACITY, CAPABILITY AND RISK ASSESSMENT OF TRIALS HOSTED BY NNUH Version 1.0 Version date 13.12.2016 Effective date 13.12.2016 Number of pages 9 pages Review date
More informationStandard Operating Procedure. SOP effective: 23 July 2015 Review date: 23 July 2017
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-12-002 Archiving Clinical Research Documents SOP effective: 23 July 2015 Review date: 23 July 2017 SOP author signature: SIGNED COPY HELD
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Non Compliance and Serious Breach Reporting SOP-RES-017 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov
More informationGood Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations
Good Clinical Practice (GCP): how does a laboratory that supports a clinical trial ensure compliance with these Regulations 9th edition of Synevo Clinical Research Symposium. 17 th November 2017 Bucharest.
More informationTrial Master File. SOP No. SOP 7
Trial Master File SOP Title Trial Master File SOP No. SOP 7 Author Consultation Departments Date approved Julia Farmery Lincolnshire Clinical Research Facility, Research and Development, Trust consultants
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. 17. Study Close Down
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 17. Study Close Down According to ICH Good Clinical Practice (GCP)
More informationOnce notified of the end of trial, a Research Manager, on behalf of the Sponsor, will contact the CI to arrange a close down monitoring visit.
1. INTRODUCTION This SOP has been produced in accordance with the requirements of The Medicines for Human Use (Clinical Trials) Regulations 2004, Medicines for Human Use (Clinical Trials) Amendment Regulations
More informationAdopted by GCP Inspectors Working Group (GCP IWG) 29 November 2017
13 June 2017 EMA/431270/2016 Annex VII to guidance for the conduct of good clinical practice inspections bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials Adopted by
More informationUse of computerised equipment, software and systems in clinical research
Standard Operating Procedures (SOP) for: Use of computerised equipment, software and systems in clinical research SOP Number: 38a Version Number: 1.0 Effective Date: 21/3/16 Review Date: 21/8/17 Author:
More informationManagement and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility
Management and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility Document Detail Document type Standard Operating Procedure CRF-STU-SOP-1: Management and Accountability
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Archiving and the Destruction of Records SOP-RES-028 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January
More informationTrial oversight SOP for HEY-sponsored CTIMPs
R&D Department Trial oversight SOP for HEY-sponsored CTIMPs Hull And East Yorkshire Hospitals NHS Trust 2010 All Rights Reserved No part of this document may be reproduced, stored in a retrieval system
More informationStandard Operating Procedure. Vendor Management
REFERENCE: VERSION NUMBER: 2.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: Clinical Trials Manager, Contracts & Quality Management Officer REVIEWED BY: Research & Innovation Group APPROVED BY:
More informationUNIVERSITY 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 informationManagement and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility
Management and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility Document Detail Document type Standard Operating Procedure CRF-STU-SOP-1: Management and Accountability
More informationRD SOP32 Gaining MHRA Approval
RD SOP32 Gaining MHRA Approval Version Number: 1.0 Name of originator/author: Dr Lloyd Gregory Name of responsible committee: R&I Committee Name of executive lead: Medical Director & Director of Quality
More informationPhase 1 studies and The Over- Volunteering Prevention System (TOPS)
Research Department STANDARD OPERATING PROCEDURE Phase 1 studies and The Over- Volunteering Prevention System () SOP Number C129 Version Number 1.0 Date effective 18 June 2018 Author Luke Barron Related
More informationDate: 23 rd December 2014 Version 5 Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03)
Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03) Approvals Principal Author Name: D. Skelhorn Signature: D. Skelhorn Date: 22/12/2014 Quality Assurance Officer
More informationStandard Operating Procedure. SOP effective: 21 December 2017 Review date: 21 December 2019
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-12-003 Archiving Clinical Research Documents SOP effective: 21 December 2017 Review date: 21 December 2019 SOP author signature: SIGNED
More informationLOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE. Loughborough University (LU) Research Office
LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE Loughborough University (LU) Research Office SOP 1024 LU Study Closedown and End of Study Reporting for NHS Research Sponsored by Loughborough
More informationStandard Operating Procedure for Archiving
Standard Operating Procedure for Archiving SOP name: NWORTH07/19 archiving Version 2 Authorship Team: Angela Gliddon & Rhiannon Whitaker Meeting date reviewed 16 th April 2008 Designated NWORTH member
More informationGuidance for Industry - Computerized Systems Used in Clinical Trials
Page 1 of 14 Regulatory Information Computerized Systems Used in Clinical Trials Guidance for Industry - Computerized Systems Used in Clinical Trials
More informationComputer System Validation & Backup
REFERENCE: VERSION NUMBER: 1.1 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 of Research
More informationSponsorship of Clinical Research Studies
Sponsorship of Clinical Research Studies Category: Summary: Equality Impact Assessment undertaken: Policy The UK Policy Framework for Health and Social Care 2017 (UKPF) and The Medicines for Human Use
More informationWriting a Protocol for CTIMPs
REFERENCE: VERSION NUMBER: 4.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: REVIEWED BY: APPROVED BY: CONTROLLER: Clinical Trials Manager; Clinical Trials Officer Research & Innovation Group
More informationDocument Title: Site Recruitment and Initiation for Papworth Sponsored Studies
Document Title: Site Recruitment and Initiation for Papworth Sponsored Studies Document Number: SOP015 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For
More informationTopics summarised in this presentation are: method for defining quality level you want meaning of external controls quality assurance activities
Topics summarised in this presentation are: method for defining quality level you want meaning of external controls quality assurance activities audit, audit report and CAPA 1. QUALITY must be guaranteed,
More informationInvestigator Site File Index (Medical Devices)
Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol (Clinical Investigation Plan) Current version plus all previous versions (or provide file note
More informationStandard Operating Procedures (SOP) Research and Development Office
Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Essential Documentation and Creation and Maintenance of Trial Master File SOP Number: 13 Version Number: 2.0 Supercedes:
More informationStandard Operating Procedure. GCP Auditing of Research Studies
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-16-003 GCP Auditing of Research Studies SOP effective: 09 June 2017 Review date: 09 June 2019 SOP author signature: SIGNED COPY HELD WITHIN
More informationNHS Tayside Effective Date: 24/7/2009
1. PURPOSE This document describes the procedure for the supply, transport and storage of Investigational Medicinal Product (IMP). This SOP complies with the principles of Good Clinical Practice, Good
More informationRDSOP28 Randomisation and Unblinding in Clinical Trials of an Investigational Medicinal Product (CTIMPs)
RDSOP28 Randomisation and Unblinding in Clinical Trials of an Investigational Medicinal Greater Manchester Mental Health NHS Foundation Trust Title of Standard Operating Procedure: Document Summary: Document
More informationSTANDARD OPERATING PROCEDURE SOP 410. Set up and Initiation of an Investigator Site
STANDARD OPERATING PROCEDURE SOP 410 Set up and Initiation of an Investigator Site Version 1.2 Version date 4.01.2017 Effective date 5.07.2017 Number of pages 13 Review date July 2019 Author Role NNUH
More informationSTUDY CLOSURE AND ARCHIVING
STUDY CLOSURE AND ARCHIVING DOCUMENT NO.: CR009 v2.0 AUTHOR: Lynn Smith ISSUE DATE: 15 August 2016 EFFECTIVE DATE: 29 August 2016 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research
More informationDate: 21 st May 2014 Version: 5 Page 1 of 11. Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May 2014
Date: 21 st May 2014 Version: 5 Page 1 of 11 STANDARD OPERATING PROCEDURE FOR MONITORING CLINICAL TRIALS (NWORTH 3.07) Approvals Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May
More informationInspections: an academic perspective
Inspections: an academic perspective Patricia Henley Quality and Governance Manager Head, Research Governance & Integrity Office London School of Hygiene & Tropical Medicine Email: patricia.henley@lshtm.ac.uk
More informationStandard Operating Procedure. SOP effective: 19 February 2016 Review date: 19 February 2018
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-18-002 Randomisation and Code Breaking SOP effective: 19 February 2016 Review date: 19 February 2018 SOP author signature: SIGNED COPY HELD
More informationStudy Files and Filing
Study Files and Filing The current version of all Hillingdon Hospital R&D Guidance Documents and Standard Operating Procedures are available from the R&D Intranet and Internet sites: www.ths.nhs.uk/departments/research/research.htm
More informationUNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH SUPPORT OFFICE
UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH SUPPORT OFFICE STANDARD OPERATING PROCEDURES University of Leicester (UoL) Research Governance
More informationReflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples
1 2 3 26 August 2010 EMA/INS/GCP/532137/2010 GCP Inspectors Working Group 4 5 6 Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples Draft Adoption
More informationResearch & Development. J Illingworth and S Moffat. Research, pharmacy and R&D staff
Department Title of SOP Research & Development SOP reference no: R&D GCP SOP 08 Authors: Reviewed by Current version number and date: J H Pacynko J Illingworth and S Moffat Version 4, 04.02.19 Next review
More informationConducting Clinical Trials of Investigational Medicinal Products
Title: Outcome Statement: Written By: Reviewed By: Conducting Clinical Trials of Investigational Medicinal Products Researchers in the Trust and research partners will be informed about the procedures
More informationInvestigational Medicinal Product (IMP) Management Standard Operating Procedure
Reference Number: UHB 040 Version Number: 3 Date of Next Review: 26 Apr 2019 Previous Trust/LHB Reference Number: T 363 Standard Operating Procedure Introduction and Aim This procedure is written to support
More informationR&D Administration Manager. Research and Development. Research and Development
Document Title: Document Number: Trial Closure and End of Trial SOP021 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D Administration
More informationR&D Manager Hillingdon Hospital. Revision History Effective Date Reason For Change. recommendations Version no:
Research as a Participating site STANDARD OPERATING PROCEDURE FOR OVERSIGHT SOP No: P08/PF2 V2 Effective Date: 31 st July 2013 Supersedes: P08/PF2 Revision Date: 31 st March 2014 Author: Position: Approved
More informationStandard Operating Procedure
Standard Operating Procedure Number: UM/UoM TMF/SOP08/6.0 Title: The Creation and Maintenance of Trial Master Files and Essential Documentation Version: 6.0 () Effective Date: Author: Mrs Catherine Barrow
More informationSTUDY DOCUMENTS. DOCUMENT NO.: CR007 v4.0. Marise Buçukoğlu ISSUE DATE: 07 MAR 2017 EFFECTIVE DATE: 21 MAR INTRODUCTION
STUDY DOCUMENTS DOCUMENT NO.: CR007 v4.0 AUTHOR: Marise Buçukoğlu ISSUE DATE: 07 MAR 2017 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research & Development (ACCORD) is a joint office
More informationDocument Title: Handling of drug alerts and recalls of IMPs
Document Title: Handling of drug alerts and recalls of IMPs Document Number: SOP074 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager,
More informationTrial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products
1 Trial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products SECTION TITLE DOCUMENTS 1. Contact List Including details of relevant study site staff, responsible
More informationTemperature Monitoring (Clinical Trials)
York Foundation Trust R&D Unit Standard Operating Procedure Pharm/S48 Temperature Monitoring (Clinical Trials) IT IS THE RESPONSIBILITY OF ALL USERS OF THIS SOP TO ENSURE THAT THE CORRECT VERSION IS BEING
More informationSTANDARD OPERATING PROCEDURE SOP 310
STANDARD OPERATING PROCEDURE SOP 310 DEVELOPMENT OF PARTICIPANT INFORMATION SHEET AND INFORMED CONSENT FORM Version 1.3 Version date 28.03.2017 Effective date 28.03.2017 Number of pages 8 Review date April
More informationControlled Document Number: Version Number: 2 Controlled Document Sponsor: Controlled Document Lead:
University Hospitals Birmingham Policy on Human Tissue in Research NHS Foundation Trust CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Version Number: 2 Controlled Document
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number End of Study Notification and Premature Discontinuation of a Study SOP-RES-025 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016
More informationJOB DESCRIPTION. Position Number various. Job Title Trial Manager. Academic / Service Unit Newcastle Clinical Trials Unit. Effective Date
Job Title Trial Manager Academic / Service Unit Newcastle Clinical Trials Unit Position Number various Effective Date 01.04.2018 Faculty / Central Services Faculty of Medical Sciences Grade F Vacancy Ref
More informationECTU Central Office SOP ECTU_TM_17 Management of Trial (IMP) Supplies
ECTU Central Office SOP ECTU_TM_17 Management of Trial (IMP) Supplies SOP number: ECTU TM 17 Signature Date Authored by: Holly Ennis, Trial Manager 6 th Sept 2017 Reviewed by: Laura Forsyth, Trial Manager
More informationESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL
ESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL THIS INFORMATION SHEET (ISR-RG-014) HAS BEEN TAKEN DIRECTLY FROM THE ICH- GUIDELINE* WITH ADDITIONAL COMMENTS ADDED BY THE RESEARCH GOVERNANCE
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Trial Master File & Investigator Site File SOP number: TM 001 SOP category: Trial Management Version number: 03 Version
More informationStandard Operating Procedure. GCP Auditing of Research Studies. SOP effective: 23rd January 2018 Review date: 23rd January 2020
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-16-005 GCP Auditing of Research Studies SOP effective: 23rd January 2018 Review date: 23rd January 2020 SOP author signature: Signed copy
More informationHRA/Ethics Approval for Health-Related Research
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More informationEnd of Study Notification, Close-Out and Reporting Sponsored Research. Noclor/Spon/S11/01. SOP Reference ID:
End of Study Notification, Close-Out and Sponsored Research SOP Reference ID: Noclor/Spon/S11/01 Version Number 1.0 Effective Date: 6 th June 2016 It is the responsibility of all users of this SOP to ensure
More informationCOMPUTER SYSTEMS VALIDATION
COMPUTER SYSTEMS VALIDATION DOCUMENT NO.: POL007 v1.0 AUTHOR: Lorn Mackenzie ISSUE DATE: 04 AUG 2017 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research & Development (ACCORD) is a joint
More informationSally Burtles, Director of Research Services & Business Development
Standard Operating Procedures (SOP) for: Process for Researchers - Amendments for Sponsored Studies (including halting studies and early termination) SOP Number: 17c Version Number: 2.0 Effective Date:
More informationRESEARCH AND INNOVATION (R&I) Research Capacity and Capability Assessment Guidance
RESEARCH AND INNOVATION (R&I) Research Capacity and Capability Assessment Guidance Title: Prepared for: Author: Purpose of document: Research Capacity, Capability and Delivery Guidance Research & Innovation
More informationStorage of Clinical Trials Materials and Investigational Medicinal Products
York Foundation Trust R&D Unit Standard Operating Procedure Pharm/S47 Storage of Clinical Trials Materials and Investigational Medicinal Products IT IS THE RESPONSIBILITY OF ALL USERS OF THIS SOP TO ENSURE
More informationPolicy Checklist. March Date for further review March Name of Policy: Purpose of Policy:
Name of Policy: Purpose of Policy: Directorate responsible for Policy Name & Title of Author: Policy Checklist Policy for the Management of Research and Development To encourage and support a quality Research
More informationMarie-Claire Rickard, RG and GCP Manager Cheryl Lawrence, Senior Research Pharmacist Damien Kelly, Barts Pharmacy Site and Clinical Trials Lead
Standard Operating Procedures (SOP) for: Pharmacy Involvement in Hosted Studies SOP Number: 42b Version Number: 2.0 Effective Date: 23 rd November 2015 Review Date: 2 nd November 2017 Author: Reviewer:
More informationAnnex IV to guidance for the conduct of good clinical practice inspections sponsor and CRO
23 August 2017 EMA/431267/2016 Annex IV to guidance for the conduct of good clinical practice inspections sponsor Adopted by GCP Inspectors Working Group (GCP IWG) 29 November 2017 Keywords GCP inspection,
More informationSource And Regulatory Documentation for DMID Clinical Studies
Source And Regulatory Documentation for DMID Clinical Studies Walt Jones RN, MPH Nurse Consultant Clinical Monitoring Coordinator OCRA, DMID, NIAID November, 2007 Source Data Defined All information in
More informationResearch Governance Policy and Procedure
Research Governance Policy and Procedure Version: 5 Name of originator/author: Name of executive lead: Date ratified: Review date: APPLICABLE TO: All staff. EXECUTIVE SUMMARY Dr Lisa Austin- University
More informationRD SOP27 Implementing a Drug Recall for IMP/NIMP
RD SOP27 Implementing a Drug Recall for IMP/NIMP Version Number: Name of originator/author: Name of responsible committee: Name of executive lead: V3 Dr Andy Mee, R&I Manager and Maxine Syme, R&I Pharmacist
More informationFacility and Equipment Maintenance
Facility and Equipment Maintenance Deborah L. Griffin Manager, Quality Assurance for Cellular Therapies Hillman Cancer Center University of Pittsburgh Cancer Institute University of Pittsburgh Medical
More informationKey changes in new BCSH Transfusion I.T. Guidelines. Debbie Asher EPA Network Transfusion Manager Member, BCSH Guideline Writing Group
Key changes in new BCSH Transfusion I.T. Guidelines Debbie Asher EPA Network Transfusion Manager Member, BCSH Guideline Writing Group Membership Joan Jones Head of Quality, Welsh Blood Service Paul Ashford
More informationThe European Medicines Agency Inspections ANNEX IV TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA:
The European Medicines Agency Inspections London, 20 September 2007 EMEA/INS/GCP/197221/2005 Procedure no.: INS/GCP/3/IV ANNEX IV TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: SPONSOR
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Training and Development SOP-QMS-007 Version Number 2 Issue Date 15 Apr 2016 Effective Date 26 May 2016 Review Date 26 May 2018 Author(s) Reviewer(s)
More informationThe role of the Clinical Trials Unit Emma Hall PhD CStat Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
in partnership with The role of the Clinical Trials Unit Emma Hall PhD CStat Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU) CTRad Clinical Trials Workshop 14/10/2014 What is
More informationAudit and Regulatory Inspection Nopanan Yaibuathes Clinical Research and Compliance Manager Roche Thailand Ltd.
Audit and Regulatory Inspection Nopanan Yaibuathes Clinical Research and Compliance Manager Roche Thailand Ltd. Copyright 2009 - Pharmaceutical Research & Manufacturers Association 1 Overview Audit ICH-GCP,
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Creation, Review and Management of Standard Operating Procedures for Research SOP Number: 1 Version Number: 2.0 Supercedes:
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Audits and Inspections SOP-QMS-004 Version Number 4 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s)
More informationCompetence in Clinical Trials the Regulators Perspective.. (Jennifer Martin Senior GCP Inspector, 9 June 2014)
Competence in Clinical Trials the Regulators Perspective. (Jennifer Martin Senior GCP Inspector, 9 June 2014) Requirements Statutory Instrument 2004/1031 (as amended) Regulation 28(2): The sponsor (and
More informationDATA INTEGRITY IN CLINICAL RESEARCH. Singapore Clinical Research Professional (CRP) Forum 25 August 2017
DATA INTEGRITY IN CLINICAL RESEARCH Singapore Clinical Research Professional (CRP) Forum 25 August 2017 Welcome! David W. Fryrear Senior Director R&D Quality Assurance Joined AbbVie in 2013 Responsibilities
More information