SOP16: Standard Operating Procedure for Establishing Sites and Centres - Site Setup
|
|
- Caitlin McGee
- 5 years ago
- Views:
Transcription
1 SOP16: Standard Operating Procedure for Establishing Sites and Centres - Site Setup Authorship Team: Leanne Quinn for Joint SOP Group on Trial Processes (viz Ian Russell, Anne Seagrove, Jemma Hughes, Yvette Ellis) Approved by WWORTH JMG (Ian Russell in chair) Signature Date of Approval 0 Version Record Version Number Effective Date Reason for Change 0 20 Apr 2009 Derived from SOP approved by NWORTH Apr 2009 Reviewed by JSOPG on 1 st May May 2009 Changes made by LQ following JSOPG meeting Jul 2009 Changes made by LQ following review meeting Aug 2009 Changes made by LQ following JMG meeting Jul 2009 Approved in principle at JMG following reviewer s comments Oct 2009 Changes made by LQ following review by Stefan Siebert May 2010 Minor formatting amendments Jul 2011 Egs in practice - RefraMED, SAFER 2, CONSTRUCT. Prepare SOP for JSOPG. MS Jul 2011 Amendments following JSOPG meeting. MS & LQ Sept 2011 Amendments following JSOPG meeting LQ Sept 2011 Approved for use by JMG May 2014 Remove training log post JSOPG discussion - MS & CS WWORTH-SOP16SitesetupV Page 1 of 12 Not guaranteed if printed
2 1 Table of Contents 0 Version record Table of Contents Glossary Introduction Purpose Roles and Responsibilities Procedure Procedure Flow Chart Site Selection Site Approvals Site Initiation Organising site visit Site Documentation Site Visit and Training Following the initiation visit Site Activation Training plan References Related SOPs...12 WWORTH-SOP16SitesetupV Page 2 of 12 Not guaranteed if printed
3 2 Glossary The full Glossary is in Swansea University H drive/documents/526- WWORTH/Development Group/Glossary. 3 Introduction Standard Operating Procedures (SOPs) are succinct formal documents designed to achieve consistency in specified trial functions by specifying standard practice in performing those functions (GCP 1.55 & 5.1.1(1). While SOPs should cite relevant legislation & regulations, and key references & evidence, they need not expound theory. WWORTH SOPs are written in compliance with regulatory requirements - The Research Governance Framework, EU Clinical Trial Directive, ICH Good Clinical Practice and Internal Guidelines NHS guidelines/policies/clinical governance. All SOPs will distinguish regulatory requirements between Clinical Trials Involving Medicinal Products (CTIMPs) and other research (non-ctimps). This document forms part of the set of SOPs of the West Wales Organisation for Rigorous Trials in Health - WWORTH. It describes the roles, responsibilities and actions of the individuals involved in site / centre identification, assessment, recruitment, set-up, initiation and activation.. For the purpose of this SOP, the term site will be taken to include centres too. Prior to a site being activated and starting participant recruitment, a site visit by the Trial Manager (TM) and other WWORTH team members may be required to prepare the site for participant recruitment. This should take place when all regulatory and ethics approvals for that specific site are obtained see WWORTH SOP14 Ethics RG approval and WWORTH SOP15 MHRA Approval. 4 Purpose To describe the process of study site identification, assessment, recruitment, set-up, initiation and activation, and who should perform those tasks. 5 Roles and Responsibilities An assessment of potential investigator(s) and institution(s) should be carried out to determine the suitability of that site to participate in the study. Accountable to the sponsor, it is the responsibility of the Chief Investigator (CI) or WWORTH to ensure appropriate sites are selected to participate in a study WWORTH-SOP16SitesetupV Page 3 of 12 Not guaranteed if printed
4 (see WWORTH SOP31 Sponsorship and Adoption), with the exception of commercial studies where it is the norm for the sponsor to have this responsibility. The CI is accountable to the sponsor for the participating sites. The CI can delegate the roles as indicated below: The Trial Manager (TM) / Trial Co-ordinator (TC) should: Ensure that all regulatory approvals for a site are obtained before a site visit and training takes place. Arrange a visit or if not practical video, audio or Skype can be used. Ensure all site team members (including pharmacy for CTIMPS) understand the study and its procedures. Ensure all site team members have received training in the principles of GCP. Obtain signatures; PI to trial protocol, all signatures on a delegation log and any SOPs (or modified procedures) used. A list of agreed SOPs should be sent to the site with a statement to say that WWORTH will work to these SOPs and request sign up by the site to the SOPs (MOPs). Confirmation via is acceptable. Ensure that all site team members that are to be involved in the study have signed the delegation log and provided their CV to demonstrate that they are qualified by training and experience to perform delegated study tasks. Ensure that the TSF contains all essential documentation and information that is particular to that site and may affect the running of the study (e.g. local laboratory reference ranges, accreditation certificates) and copy it to the TMF (see WWORTH SOP03 Master Site File). Ensure each site has sufficient copies of the study documentation (e.g. Trial Site File (TSF), Case Report Form (CRF), Investigator s Brochure (IB) (see WWORTH SOP03 Master Site File). Obtain the PI s signature to allow direct access to all trial-related source data or documents for the purpose of monitoring and auditing, WWORTH-SOP16SitesetupV Page 4 of 12 Not guaranteed if printed
5 Activate the study site to begin participant recruitment. The PI s are responsible for a specific site and can delegate this role to the site trial co-ordinator. The Trial Data Manager s (TDM) role (with support from IT specialist) is to ensure training is received for all aspects of randomisation, data collection, CRF completion and/or input of electronic data. See WWORTH SOP24 Randomisation and WWORTH SOP22a Data Collection Management. The Trial Unit Manager has responsibility of ensuring study site set-up is in keeping with the principles of GCP. Site Staff need to understand their role and have an awareness of the duties of others in the team and read and understand applicable trial related documents as directed by the TM. 6 Procedure This section describes the responsibilities and procedures for identification, assessment, site recruitment, site setup, initiation and activation. WWORTH-SOP16SitesetupV Page 5 of 12 Not guaranteed if printed
6 6.1 Procedure Flow Chart 6.2 Identification and assessment of potential investigator(s) and institution(s) is carried out by CI or delegated person. Confidentiality agreements may need to be in place before the release of any study documentation 6.3 Ethics approval, sponsorship, funding, research governance approvals are agreed for the trial as a whole. Site-specific ethics and regulatory approvals are obtained Sites may be added after full regulatory approvals are in place, although this would be a substantial amendment for CTIMPS only and site specific ethics and regulatory approvals would be required prior to the site being initiated A date for a site initiation visit is arranged if required Site documentation TC and TM, TDM and IT specialist visit the site, 1) meet the PI and discuss clinical aspects, obtain his/her signature on the protocol 2) train staff on data collection and entry 3) for CTIMP, train pharmacy staff 4) train any other staff involved in trial-specific documentation (lab / imaging etc) 5) obtain signatures to a delegation log TC and TM records any site-specific details or issues likely to affect the trial A record of the visit, including answers to any questions raised, is filed and copy sent to the PI & CI 6.5 Site activated to begin participant recruitment 6.5 Following activation monitoring visits should be carried out as stated in the monitoring plan. If any problems are identified then a monitoring visit should be carried out as soon as possible WWORTH-SOP16SitesetupV Page 6 of 12 Not guaranteed if printed
7 6.2 Site Selection The CI is responsible for selecting appropriate investigator(s) and institution(s) for a study, in collaboration with WWORTH. Thorough site selection ensures that study resources are directed towards motivated, qualified staff, with the potential to recruit eligible participants and conduct the study within the context of relevant regulations and timelines. Potential investigator(s) and institutions(s) will be assessed to confirm their suitability to participate in the study. Confidentiality agreements may need to be signed by the potential investigator before protocols are issued to sites, especially in commercial research. Assessments may include; willingness to participate, approval turn around, the qualifications and training needs of site staff, potential to recruit participants and adequate facilities to conduct the study. Site suitability may be assessed in the form of a feasibility questionnaire or a feasibility site visit by the trial research team. Investigator specifications may include: Medical specialty Patient population Experience Facilities required (e.g. laboratories, treatment units, access to freezer and centrifuge Human Resources, either designated research nurse/ professional or other explicit arrangements like Network Staff) Staff Geographic location Recruitment If a site visit is carried out this should be documented in the form of a written pre-study report so feedback is provided to the site and sponsor. 6.3 Site Approvals Local approval procedures for potential sites should be discussed and clarified at the earliest possible stage. Favourable opinion must be sought by each site (where appropriate) from ethics, competent authorities, NHS Health Board and other relevant bodies, prior to the site initiation and activation for participant recruitment (see WWORTH SOP14 Ethics RG Approval and WWORTH SOP15 MHRA Approval). Copies of all approval documents should be sent to the CI or WWORTH for filing in the TMF (see WWORTH SOP03 Master Site File). Participating Site agreements must also be in place before site initiation, activation and recruitment. This is a written, dated and signed agreement between the WWORTH-SOP16SitesetupV Page 7 of 12 Not guaranteed if printed
8 sponsor and site that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. A suite of Model agreements have been developed by the UKCRC to streamline the Research Governance Process and can be accessed at: wnloads.aspx 6.4 Site Initiation After regulatory and ethics approval has been secured and before a site opens to participant recruitment to the full or pilot study, the TM should organise a site visit or video-conference and if this is not possible, an audio conference to inform and train all site staff involved in the study, to ensure that they have a thorough understanding of the study procedures. The TM will develop a thorough understanding of each specific site s local practice which may affect participant recruitment. A site may be considered initiated once: All essential documents and approvals are in place. Site staff are familiar with study requirements and their role and responsibilities The site has been provided with documentation, equipments and or training to enable site staff to conduct the study. For a CTIMP, study drug is available to the site. Study drug can only be released to the site after all approvals are in place. During an initiation visit the study protocol, protocol procedures, important elements of the running of the study, inclusion/exclusion criteria, CRF completion and queries are clarified. The visit may also provide the opportunity to obtain essential documentation for the TMF (see WWORTH SOP03 Master Site File). The TM may provide the site with a TSF Organising site visit The TM will organise the site visit and training date. This should include all site team members where possible: Principal Investigator Co Investigator(s) Local Coordinator(s) Local collaborator(s) WWORTH-SOP16SitesetupV Page 8 of 12 Not guaranteed if printed
9 Pharmacist (for CTIMPS only) and any others relevant to the success of recruitment e.g. clinicians, laboratory staff, data managers, network staff. Relevant team members from CI or WWORTH should attend: Trial Team If appropriate an IT specialist if the site selection processes have identified IT issues or if the study requires electronic data capture Site Documentation Ensure all sites are provided with or create their own TSF (see WWORTH SOP03 Master Site File) and receive the CRF, Investigator Brochure or SmPc (if appropriate) and pharmacy file (if appropriate). Check that all local forms and relevant approvals (Site Specific Assessment, research governance, finance) are in TSF. All documentation to be version controlled and dated (see WWORTH SOP01b Document Control) Site Visit and Training Ideally arrange the visit and training to include training of the local coordinator and any other key staff. Training can also be organised at a central site. Presentation checklist should include the following: Trial procedure discussed Aims of trial Primary and secondary endpoints Inclusion/exclusion criteria Data collection, including CRFs or electronic data capture Inform when monitoring visits will take place GCP SOP or MOP training Pharmacovigilance If a CTIMP, discuss with PI and pharmacist the prescription of IMP, WWORTH-SOP16SitesetupV Page 9 of 12 Not guaranteed if printed
10 storage, and labelling of the medication and documentation of received, prescribed and destroyed IMP (see WWORTH- SOP04trialsupplieslabelling) Discuss any trial-specific lab procedures and check equipment is appropriate freezer temperatures, centrifuge speeds, calibration certificates etc. TSF maintenance Investigator and local co-ordinator responsibilities Informed Consent Randomisation Process Source Data Archiving Each PI. Co-Investigator, Local Collaborator must be qualified by education, training and experience and must have adequate resources to conduct the study properly [1]. For CTIMPs, it is a legal requirement for all site research staff with patient contact to be GCP trained and for non-ctimps it is best practice for all research staff to be GCP trained. GCP training would be repeated every 2 years or sooner if procedures, guidance or legislation change. Qualifications and training needs analysis would be one of the requirements of site selection. Evidence of qualifications and training of site research staff would be requested usually in the form of current curriculum vitae (CV) and would be requested by CI to store in the Trial Master File (TMF). Study-specific training may be required (eg questionnaire administration, CRF completion, specific intervention) but it is not the intention of this SOP to cover this type of training. This would be covered by study specific operating procedures and discussed at the site initiation visit if appropriate see WWORTH SOP02 Training Following the initiation visit The CI or trial team should submit a written report to the PI summarising what was discussed during the initiation visit, and should include action points and resolution of site queries. This should then be filed in the WWORTH-SOP16SitesetupV Page 10 of 12 Not guaranteed if printed
11 TMF/TSF and any outstanding actions that arose from the initiation visit should be addressed promptly by the PI or a member of their team. 6.5 Site Activation Once the site has been initiated and all necessary documentation and training has been completed, an or fax is sent from the CI to formally inform the PI that they have been activated and that recruitment can commence at the site. Confirmation of the receipt of the notice of activation should be sent by the PI and this is filed in the TMF. Following activation, monitoring visits should be carried out as stipulated in the monitoring plan (see WWORTH SOP17 Monitoring). 7 Training plan All WWORTH staff involved with trials must undertake the appropriate generic and trial-specific training to ensure that they meet with the specific employers mandatory training requirements and the specific requirements of the trial. For example, for SU staff, all new employees must attend induction, fire and safety training (as well as role-specific training courses, e.g. laboratory safety). For new staff, additional training requirements should be identified alongside the specific role requirements and the WWORTH Unit Manager should make provision for the new staff member to attend the necessary courses as soon after appointment as is practicably possible. It is the responsibility of the WWORTH Unit Manager (alongside the CI or TM) to identify all the SOPs that are relevant to a specific trial and in which the new member of staff should be trained. The WWORTH UM or the SOP author will provide group training for trial staff and/or one-to-one training, as required for new staff in relation to the specific SOPs identified. Training records should be filed both by the main employer and the staff member, in accordance with the specific employer requirements. Trial specific training should be filed in TMF or TSF as appropriate and every individual involved in a trial should have an individual training record (see WWORTH SOP02 Training). Where the tasks specified in the individual SOPs are delegated to WWORTH staff, CIs/PIs or TMs, these delegated staff must ensure that they have attended a training course on GCP and keep up-to-date through attending refresher courses. It is the responsibility of the CI/PI to ensure that all staff allocated duties on the study delegation log template of responsibilities are suitably trained in the activities linked to those duties (see WWORTH SOP16 Site Setup, Appendix 9 and Appendix 10). Each trial should maintain a central training log and ensure that WWORTH WWORTH-SOP16SitesetupV Page 11 of 12 Not guaranteed if printed
12 has access to that log, not least to integrate the logs of staff who work on more than one trial. Similarly trials should ensure that each site maintains a local training log, not least to integrate the logs of staff who work for more than one sponsor. This SOP will have a training plan and log to monitor training. In principle the trainer should be one of the authors. Training will be in two stages. First training in the principles of that SOP will take place during monthly meetings of JSOPGs. Second training in using that SOP in practice will take the form of regular supervision by an experienced trialist, culminating in approval of that SOP. WWORTH core staff should be involved in the training process. Both trainer and trainee will sign the log (see WWORTH SOP02 Training) to confirm that training is complete. To help individual staff record training for the purpose of their Continuing Professional Development, and help individual trials and WWORTH record training for quality assurance, WWORTH will aggregate training logs by individual within trial. 8 References 1. ICH Harmonised Tripartite Guideline for Good Clinical Practice (1996) Related SOPs WWORTH SOP01b Document Control WWORTH SOP02 Training WWORTH SOP03 Master Site File WWORTH SOP04 Trial Supplies Labelling WWORTH SOP14 Ethics RG Approval WWORTH SOP17 Monitoring WWORTH SOP22a Data Collection Management WWORTH SOP24 Randomisation WWORTH-SOP16SitesetupV Page 12 of 12 Not guaranteed if printed
SOP18b: Standard Operating Procedure for Preparing for External Audit and Inspection
SOP18b: Standard Operating Procedure for Preparing for External Audit and Inspection Authorship Team: Jemma Hughes, Tina Morgan, for Joint SOP Group on Trial Processes (viz Leanne Quinn, Ian Russell, Anne
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Site Selection and Initiation SOP number: TM-005 SOP category: Trial Management Version number: 04 Version date: 10 July
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Site Selection and Initiation SOP number: TM 005 SOP category: Trial Management Version number: 03 Version date: 19 December
More informationJoint R&D Support Office SOP S-2011 UHL
UNIVERSITY OF LEICESTER & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES Joint R&D Support Office SOP S-2011 UHL Site Initiation for
More informationStandard Operating Procedure INVESTIGATOR OVERSIGHT OF RESEARCH. Chief and Principal Investigators of research sponsored and/or hosted by UHBristol
Standard Operating Procedure INVESTIGATOR OVERSIGHT OF RESEARCH SETTING FOR STAFF ISSUE Trustwide Chief and Principal Investigators of research sponsored and/or hosted by UHBristol Oversight of research
More informationSite Closedown Checklist for UoL Sponsored CTIMP Studies
Site Closedown Checklist for UoL Sponsored CTIMP Studies Site Information Site: Study Title: UoL study number: Centre name: Investigator: Date of Visit: Date of Report Date Responses due by: List of site
More informationTrial set-up, conduct and Trial Master File for HEY-sponsored CTIMPs
R&D Department Trial set-up, conduct and Trial Master File for HEY-sponsored CTIMPs Hull And East Yorkshire Hospitals NHS Trust 2010 All Rights Reserved No part of this document may be reproduced, stored
More informationTrial Management: Trial Master Files and Investigator Site Files
Title: Outcome Statement: Written By: Trial Management: Trial Master Files and Investigator Site Files Staff working on research studies in NSFT will be informed about the requirements of setting up and
More informationDocument Title: Site Selection and Initiation for RFL Sponsored Studies Document Number: 026
Document Title: Site Selection and Initiation for RFL Sponsored Studies Document Number: 026 Version: 1.1 Ratified by: Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department:
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Sponsorship SOP-RES-001 Version Number 3 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s) Teresa
More informationTRAINING REQUIREMENTS FOR RESEARCH STAFF, INCLUDING GOOD CLINICAL PRACTICE (GCP)
Reference Number: UHB 317 Version Number: 1 Date of Next Review: 7th July 2019 Previous Trust/LHB Reference Number: N/A TRAINING REQUIREMENTS FOR RESEARCH STAFF, INCLUDING GOOD CLINICAL PRACTICE (GCP)
More informationSTANDARD OPERATING PROCEDURE SOP 325
STANDARD OPERATING PROCEDURE SOP 325 STUDY START UP ACTIVITIES FOR CLINICAL RESEARCH TRIALS Version 1.4 Version date 28.03.2017 Effective date 28.03.2017 Number of pages 7 Review date April 2019 Author
More informationMHRA Findings Dissemination Joint Office Launch Jan Presented by: Carolyn Maloney UHL R&D Manager
MHRA Findings Dissemination Joint Office Launch Jan. 2012 Presented by: Carolyn Maloney UHL R&D Manager Purpose of presentation To feed back abridged findings from March 2011 MHRA Statutory Systems Inspection
More informationSOP19a & 19b: Standard Operating Procedure for (a) Safety Monitoring (especially Pharmacovigilance) & (b) Urgent Safety Measures
SOP19a & 19b: Standard Operating Procedure for (a) Safety Monitoring (especially Pharmacovigilance) & (b) Urgent Safety Measures Authorship Team: Anne Seagrove, Melanie Storey, Ian Russell for Joint SOP
More informationStandard Operating Procedure. Essential Documents: Setting Up a Trial Master File. SOP effective: 19 February 2016 Review date: 19 February 2018
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-06-003 Essential Documents: Setting Up a Trial Master File SOP effective: 19 February 2016 Review date: 19 February 2018 SOP author signature:
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Delegated Responsibilities in Research Projects SOP Number: 11 Version Number: 2.0 Supercedes: 1.0 Effective date: August
More informationUnofficial copy not valid
Page 2 (9) CONTENTS 1. PURPOSE... 3 2. DEFINITIONS... 3 3. RESPONSIBILITY... 3 4. INVESTIGATOR SELECTION... 3 4.1 Identification of Investigator s... 3 4.2 Initial Contacts... 4 4.3 Distribution of Pre-Study
More informationACTIONS/PSOP/001 Version 1.0 Page 2 of 6
1. The purpose of the Pharmacy Site File To enable the designated trust pharmacy to fulfil its role and exercise appropriate control over all aspects of study medication handling, an accurately maintained
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Study Management and Handover SOP-RES-012 Version Number 3 Issue Date 19 th April 2017 Effective Date 2 nd June 2017 Review Date 2 nd June 2019 Author(s)
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Routine Project Audit SOP Number: 6 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August
More information1. INTRODUCTION 2. SCOPE 3. PROCESS
1. INTRODUCTION This document describes the procedure for establishing and maintaining records for staff training and complies with the principles of good clinical practice (GCP) for clinical trials of
More informationResearch Staff Training
REFERENCE: VERSION NUMBER: 3.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: Research Infrastructure Manager REVIEWED BY: Research & Innovation Group APPROVED BY: Deputy Director of Research CONTROLLER:
More informationDocument Title: Investigator Site File. Document Number: 019
Document Title: Investigator Site File Document Number: 019 Version: 1.1 Ratified by: R&D Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department: Name of responsible individual:
More informationInvestigator Site File Standard Operating Procedure (SOP)
Investigator Site File Standard Operating Procedure (SOP) DOCUMENT CONTROL: Version: 1 Ratified by: Quality and Safety Sub Committee Date ratified: 30 January 2017 Name of originator/author: Research Nurse
More informationVersion Number: 004 Controlled Document Sponsor: Controlled Document Lead:
Chief Investigators and Principal Investigators in Research Policy CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Policy Governance To set out the responsibilities of
More informationSOP-QA-28 V2. Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head of School
Title: Effective Date: 1-4-17 Review Date: 1-4-20 Author: Richard Cowie, QA Manager QA Approval: Richard Cowie, QA Manager Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head
More informationSTANDARD OPERATING PROCEDURE SOP 715. Principles of Clinical Research Laboratory Practice
STANDARD OPERATING PROCEDURE SOP 715 Principles of Clinical Research Laboratory Practice Version 1.2 Version date 13.11.2015 Effective date 24.04.2017 Number of pages 9 Review date June 2018 Author Role
More informationStandard Operating Procedures (SOP) Research and Development Office
Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Maintaining Training Records SOP Number: 20 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date:
More informationDocument Title: GCP Training for Research Staff. Document Number: SOP 005
Document Title: GCP Training for Research Staff Document Number: SOP 005 Version: 2 Ratified by: Version 2, 04/10/2017 Page 1 of 13 Committee Date ratified: 26/10/2017 Name of originator/author: Directorate:
More informationHertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust
Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust STANDARD OPERATING PROCEDURE FOR RESEARCH Definition of Responsibilities for Externally
More informationGCP: Investigator Responsibilities. Susan Tebbs Nicola Kaganson
GCP: Investigator Responsibilities Susan Tebbs Nicola Kaganson Investigator Responsibilities Qualifications & agreements Resources Responsibilities to the subject Ethics The protocol The IMP & randomisation
More informationSOP MONITORING & OVERSIGHT OF RESEARCH ACTIVITY. Contact Jess Bisset, Research Operations Manager x20227
SOP MONITORING & OVERSIGHT OF RESEARCH ACTIVITY SETTING FOR STAFF QUERIES Trust wide All staff involved in research Contact Jess Bisset, Research Operations Manager x20227 Guidance 1. Introduction In accordance
More informationThis Agreement dated DD/MM/YYYY (the Effective Date ) is between
Clinical Trial Delegation of Sponsorship Responsibilities to Chief This Agreement dated DD/MM/YYYY (the Effective Date ) is between Nottingham University Hospitals NHS Trust, Derby Road, Nottingham, NG7
More informationMonitoring Clinical Trials
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 informationOnce the feasibility assessment has been conducted the study team will be notified via (Appendix 3) of the outcome and whether the study is;
1. INTRODUCTION 2. SCOPE Feasibility assessments will ascertain any operational concerns about a research study which may delay NHS Permission or cause issues with study delivery. By conducting an assessment
More informationSTANDARD OPERATING PROCEDURE SOP 710. Good Clinical Practice AUDIT AND INSPECTION. NNUH UEA Joint Research Office. Acting Research Services Manager
STANDARD OPERATING PROCEDURE SOP 710 Good Clinical Practice AUDIT AND INSPECTION Version 1.3 Version date 27.02.2018 Effective date 3.03.2018 Number of pages 10 Review date February 2020 Author Role Approved
More informationResearch Governance Framework 2 nd Edition, Medicine for Human Use (Clinical Trial) Regulations 2004
Title: Outcome Statement: Research Auditing and Monitoring Procedures Researchers in the Trust and research partners will be informed about the requirements and procedures involved in research audit and
More informationGood Clinical Practice: A Ground Level View
Good Clinical Practice: A Ground Level View Jeanna Julo, BA, BA, CCRP Assistant Director, Clinical Data Management & Quality Controls, Auditing & Training Clinical Research Administration Research Institute,
More informationAuditing of Clinical Trials
Version 1.2 Effective date: 3 September 2012 Author: Approved by: Claire Daffern, QA Manager Dr Sarah Duggan, CTU Manager Revision Chronology: Effective Date Version 1.2 3 Sept 2012 Version 1.1 12 May
More informationStandard Operating Procedures
Standard Operating Procedures 5.7 Site Initiation Version V1.0 Author/s Approved B Fazekas, S Kochovska D Currow Effective date 30/09/2017 Review date 30/09/2019 DO NOT USE THIS SOP IN PRINTED FORM WITHOUT
More informationOFFICE FOR RESEACH PROCEDURE. Documentation of Investigational Site Qualifications, Adequacy of Resources and Training Records
OFFICE FOR RESEACH PROCEDURE Documentation of Investigational Site Qualifications, Adequacy of Resources and Training Records 1. Purpose: To describe the procedures related to the appropriate documentation
More informationKeele Clinical Trials Unit
Keele Clinical Trials Unit Standard Operating Procedure (SOP) Summary Box Title SOP Index Number SOP 21 Version 4.0 Approval Date Effective Date Non-Compliance: Deviations and Serious Breaches of GCP and/or
More informationStandard Operating Procedure (SOP) for Reporting Serious Breaches in Clinical Research
Standard Operating Procedure (SOP) for Reporting Serious Breaches in Clinical Research For Completion by SOP Author Reference Number PHT/RDSOP/002 Version V2.0 07 Apr 2016 Document Author(s) Document Reviewer(s)
More informationStandard Operating Procedure Research Governance
Research and Enterprise Standard Operating Procedure Research Governance Title: Research Governance Audit SOP Reference Number: QUB-ADRE-08 Date prepared 7 August 008 Version Number: Final v -6.0 Revision
More informationStorage and Archiving of Research Documents SOP 6
Storage and Archiving of Research Documents SOP 6 SOP Title Storage and Archiving or Research Documents (Formerly Storage and Archiving Requirements ) SOP No. SOP 6 Author Consulted Departments Lead Manager
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number End of Study Report SOP-RES-027 Version Number 2 Issue Date 15 Apr 2016 Effective Date 26 May 2016 Review Date 26 May 2018 Author(s) Reviewer(s) Natalie
More informationR. Fay, Research Governance & GCP Manager K. Mahiouz, Clinical Trials Facilitator E. Clough, R&D Governance Operations Manager
Standard Operating Procedures (SOP) for: BH/QMUL Sponsorship of CTIMPs, ATMPs and Clinical Trials of non- CE marked Medicinal Devices Process for Researchers SOP Number: 11a Version Number: V1.0 Effective
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Urgent Safety Measures SOP-RES-022 Version Number 1 Issue Date 30 th April 2014 Effective Date 28 th May 2014 Review Date 28 th May 2016 Author(s) Reviewer(s)
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Risk Assessment SOP-RES-002 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s)
More informationRisk Assessment and Monitoring
Version 1.3 Effective date: 25 May 2012 Author: Approved by: Claire Daffern, QA Manager Dr Sarah Duggan, CTU Manager Revision Chronology: Effective Date Version 1.3 25 May 2012 Version 1.2 29 January 2010
More informationDocument Number: 006. Version: 1. Date ratified: Name of originator/author: Heidi Saunders, Senior Portfolio Coordinator
including Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs (Clinical Trials of Investigational Medicinal Products) Document Number: 006 Version: 1 Ratified
More informationInformed Consent SOP Number: 25 Version Number: 6.0 Effective Date: 1 st September 2017 Review Date: 1 st September 2019
Standard Operating Procedures (SOP) for: Informed Consent SOP Number: 25 Version Number: 6.0 Effective Date: 1 st September 2017 Review Date: 1 st September 2019 Author: Reviewer: Reviewer: Authorisation:
More informationSTH Researcher. Recording of research information in patient case notes
STANDARD OPERATING PROCEDURE STH Researcher Recording of research information in patient case notes SOP History None SOP Number A108 Created Research Department (AL) SUPERSEDED Final 1.3 Version 3.5 Date
More informationSetting up a Clinical Trial
York Foundation Trust R&D Unit SOP Pharm/S45 Setting up a Clinical Trial IT IS THE RESPONSIBILITY OF ALL USERS OF THIS SOP TO ENSURE THAT THE CORRECT VERSION IS BEING USED All staff should regularly check
More informationCorporate. Research Governance Policy. Document Control Summary
Corporate Research Governance Policy Document Control Summary Status: Version: Author/Owner/Title: Approved by: Ratified: Related Trust Strategy and/or Strategic Aims Implementation Date: Review Date:
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Recording and Reporting Deviations, Violations, Potential Serious Breaches, Serious Breaches and Urgent Safety Measures
More informationSponsor Responsibilities. Roles and Responsibilities. EU Directives. UK Law
EU Directives Pharmacovigilance Legislation, SOPs and Reporting Louise Boldy, Governance & Safety Manager David Martin, Pharmacovigilance Monitor EU Legislation 2001/20/EC 2005/28/EC EudraLex Vol 10 UK
More informationM. Rickard, Research Governance and GCP Manager R. Fay Research Governance and GCP Manager Elizabeth Clough, Governance Operations Manager
Standard Operating Procedures (SOP) for: Pharmacovigilance and Safety Reporting for Sponsored non-ctimps SOP Number: 26b Version 2.0 Number: Effective Date: 29th November 2015 Review Date: 3 rd December
More informationResearch & Development. Case Report Form SOP. J H Pacynko and J Illingworth. Research, pharmacy and R&D staff
Department Title of SOP Research & Development Case Report Form SOP SOP reference no: R&D GCP SOP 03 Authors: Current version number and date: J H Pacynko and J Illingworth Version 2, 01.02.18 Next review
More informationStandard Operating Procedure
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-07-004 Recording, managing and reporting Adverse Events for Clinical Trials of Investigational Medicinal Products and trials of Advanced
More informationGCP INSPECTION CHECKLIST
(This list is not all inclusive; item may be added &/or deleted as per the Study/Site/Sponsor/Lab) I. General. Name and address of the clinical trial site Tel. No. & e- mail:. Date of Inspection. Inspection
More informationJoint Statement on the Application of Good Clinical Practice to Training for Researchers
Joint Statement on the Application of Good Clinical Practice to Training for Researchers HRA, MHRA, Devolved Administrations for Northern Ireland, Scotland and Wales v1.1 12/10/17 Summary This joint statement
More informationMANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS
MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS DOCUMENT NO.: CR010 v4.0 AUTHOR: Heather Charles ISSUE DATE: 01 September 2016 EFFECTIVE DATE: 15 September 2016 1 INTRODUCTION 1.1 The Academic
More informationClinical Trial Readiness Checklist October 2014
The clinical trial readiness checklist is a tool which can help new and experienced researchers prepare for upcoming clinical studies. It is designed to be a quick reference to ensure that you have the
More informationKeele Clinical Trials Unit
Keele Clinical Trials Unit Standard Operating Procedure (SOP) Summary Box Title Safety Reporting and Pharmacovigilance SOP Index Number SOP 20 Version 4.0 Approval Date 31-Jan-2017 Effective Date 14-Feb-2017
More informationSOP: New Revised Reviewed Effective Date: 08 October Approved by : Supervisor/Manager Risk/Ethics Sr. Mgmt Committees Board/Councils
Title: Assessment of Study Feasibility Manual: RI MUHC Policies and Procedures Human Research SOPs Originating Dept/ Service: RI MUHC Division of Clinical Research SOP: New Revised Reviewed Effective Date:
More informationMEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS Memorandum of understanding between MHRA, COREC and GTAC
MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS 2004 Memorandum of understanding between MHRA, COREC and GTAC 1. Purpose and scope 1.1 Regulation 27A of the Medicines for Human Use (Clinical Trials)
More informationNN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION
NN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION SOP: NN SS 401 Version No.: 2.0 Effective Date: 21Oct2016 SITE SELECTION AND QUALIFICATION Supercedes Document:
More informationMarie-Claire Rickard, Governance and GCP Manager Jimena Lovos, Quality Assurance Manager Elizabeth Clough, R&D Governance Operations Manager
Standard Operating Procedures (SOP) for: Reporting of Serious Breaches of or the Trial Protocol SOP Number: 037 Version Number: 5.0 Effective Date: 17/6/16 Review Date: 17/6/18 Author: Reviewer: Reviewer
More informationRisk Assessment. Version Number 1.0 Effective Date: 21 st March Sponsored Research
Risk Assessment Sponsored Research SOP Reference ID: Noclor/Spon/S03/01 Version Number 1.0 Effective Date: 21 st March 2016 It is the responsibility of all users of this SOP to ensure that the correct
More informationSTANDARD OPERATING PROCEDURE SOP 205
STANDARD OPERATING PROCEDURE SOP 205 Adverse Events: Identifying, Recording and Reporting for CTIMPs Sponsored by the Norfolk and Norwich University Hospital NHS Foundation Trust Version 2.3 Version date
More informationResearch & Development Quality Manual
Title: Effective Date: 1-4-17 Review Date: 1-4-20 Author: Richard Cowie, QA Manager Version: 3 Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head of School Document History
More informationStandard Operating Procedure:
Standard Operating Procedure: Preparation and Submission of Annual Progress Reports for all Research Projects and Development Safety Update Reports SOP Number: SOP-QA-21 Version No: 1 Author: Date: 1-9-15
More informationCOMPETENCY FRAMEWORK
COMPETENCY FRAMEWORK Theresa Ledger Lead Nurse Research and Development Clinical Research Facility Sheffield C:\Documents and Settings\Robertus\My Documents\Mariann\CRF\CRF Portfolio and Competency Template_DRAFT
More informationDocument Title: Study Data SOP (CRFs and Source Data)
Document Title: Study Data SOP (CRFs and Source Data) Document Number: SOP047 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D
More information1. Introduction, purpose of this Standard Operating Procedure (SOP)
SOP-CTN-001- Clinical Trial Network - General Organisation and Principles European Society of Anaesthesiology Details Document Type Document name Ref # Version Effective from Review date Owner Prepared
More informationSafety Reporting in Clinical Research Policy Final Version 4.0
Safety Reporting in Clinical Research Policy Final Version 4.0 Category: Summary: Equality Assessment undertaken: Impact Policy The Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent
More informationStudy Monitoring Plan Template
Study Monitoring Plan Template Sponsor Reference Number: Study Title: Principal Investigator: Study Centre: The Sponsor risk assessment form and the trial risk based monitoring strategy appendices 2 &
More informationSTANDARD OPERATING PROCEDURE 24. Training Records
STANDARD OPERATING PROCEDURE 24 Version: 1.4 Issue Date: 07 February 2018 Effective Date: 21 February 2018 Review Due: 21 February 2020 Author: Jill Wood, QA Manager WCTU WCTU Reviewers: Sponsor Reviewers:
More information1. Introduction, purpose of this Standard Operating Procedure (SOP)
Details Document Type Document name Ref # Version Effective from Review date Owner Prepared by Reviewed by Approved by Superseded documents Relevant regulations/legislation/guidelines/reference Standard
More informationResearch Adverse Event and Safety Reporting Procedures Outcome Statement: Title:
Title: Research Adverse Event and Safety Reporting Procedures Outcome Statement: Research Teams will be able to correctly identify and report Adverse Events and complete Annual Safety Reports for research
More informationGovernance %%.4- r2&% Queen s University Belfast. Standard Operating Procedure Research Governance. r2.aoc7. Research and Enterprise
Queen s University Belfast Research and Enterprise Standard Operating Procedure Research Governance Title: Delegation of Responsibilities SOP Reference QUB-ADRE-005 Date prepared 23 June 2008 Number: Version
More informationCancer Research UK Clinical Trials/Research Unit Glasgow. Quality System
Cancer Research UK Clinical Trials/Research Unit Glasgow Quality System BEATSON WEST OF SCOTLAND CANCER CENTRE POLICY ON THE AWARENESS AND TRAINING OF STAFF MANAGING PATIENTS WITHIN THE CONTEXT OF A CLINICAL
More informationThe GCP Perspective on Study Monitoring
The GCP Perspective on Study Monitoring Heidi Judge, CCRP Sr. Clinical Trials Project Manager Clinical Trials Network and Institute Massachusetts General Hospital 1 Overview Monitoring Basics Who, What,
More informationResearch Policy. Date of first issue: Version: 1.0 Date of version issue: 5 th January 2012
Research Policy Author: Caroline Mozley Owner: Sue Holden Publisher: Caroline Mozley Date of first issue: Version: 1.0 Date of version issue: 5 th January 2012 Approved by: Executive Board Date approved:
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Safety Reporting in CTIMPs and ATMPs SOP number: TM-003 SOP category: Trial Management Version number: 04 Version date:
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Corrective and Preventative Action SOP-QMS-008 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s)
More informationDocument Title: File Notes. Document Number: 024
Document Title: File Notes Document Number: 024 Version: 1.2 Ratified by: Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department: Name of responsible individual: Rachel
More informationDocument Title: Document Number:
including Document Title: Document Number: Version: 2.0 Ratified by: Committee Date ratified: 25/01/2018 Name of originator/author: Directorate: Department: Name of responsible individual: Rachel Fay Corporate
More informationEuropean Medicines Agency Inspections ANNEX V TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: PHASE I UNITS
European Medicines Agency Inspections London, 23 July 2008 EMEA/INS/GCP/197215/2005 Procedure no.: INS/GCP/3/V ANNEX V TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: PHASE I UNITS GCP
More informationCLOSE OUT VISIT REPORT (NO CRF TO MONITOR)
Date: Page: 1 of 8 CLOSE OUT VISIT REPORT (NO CRF TO MONITOR) Protocol: PI Name: PI Address: Date of Visit: Monitor(s): Other Sponsor Personnel Present: Site Personnel Present at Visit (include names and
More informationProcedure For Training In Use Of Human Tissue Obtained For Research Purposes
Reference Number: UHB 137 Version Number: 2 Date of Next Review: 11 TH Oct 2019 Previous Trust/LHB Reference Number: Procedure For Training In Use Introduction and Aim The Human Tissue Act 2004 (HT Act)
More informationDetails: Approval: Distribution & Storage: Pharmacovigilance for Researchers for UoL / LTHT Sponsored CTIMPs. Standard Operating Procedure
Details: Author: Razwan Mahroof - QA Clinical Trials Monitor SOP Pages: 10 Version No. of replaced SOP: 1.0 Effective date of replaced SOP: 04 December 2015 Approval: Version No: of the SOP being approved.
More informationGaining NHS Trust R&D Approvals
Version 1.1 Effective date: 1 October 2012 Author: Approved by: Claire Daffern, QA Manager Dr Sarah Duggan, CTU Manager Revision Chronology: Effective Date Reason for change Version 1.1 1 October 2012
More informationGuidance for the Tripartite model Clinical Investigation Agreement for Medical Technology Industry sponsored research in NHS Hospitals managed by
Guidance for the Tripartite model Clinical Investigation Agreement for Medical Technology Industry sponsored research in NHS Hospitals managed by Contract Research Organisations (CRO mcia, 2011 version)
More informationStudy Start-Up SS STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV)
Replaces previous version 203.01: 01 July 2014 Study Start-Up SS 203.01 STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV) Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature
More informationReference Number: UHB 253 Version Number: 1 Date of Next Review: 22/01/2018 Previous Trust/LHB Reference Number: SR-RG-015
Reference Number: UHB 253 Version Number: 1 Date of Next Review: 22/01/2018 Previous Trust/LHB Reference Number: SR-RG-015 Safety Reporting in CTIMPs Standard Operating Procedure Introduction and Aim The
More informationmanaging or activities.
STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit TITLE: Site Initiation Visit 1. PURPOSE SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec2013 1.1 This
More informationStandard Operating Procedure (SOP)
Standard Operating Procedure MANAGEMENT OF BREACHES IN RESEARCH SETTING AUDIENCE ISSUE Trustwide for research sponsored by UHBristol All research staff involved in UH Bristol sponsored research This SOP
More informationStandard Operating Procedure (SOP) for Reporting Urgent Safety Measures in Clinical Research
Standard Operating Procedure (SOP) for Reporting Urgent Safety Measures in Clinical Research For Completion by SOP Author Reference Number PHT/RDSOP/006 Version V1.1 07 Apr 2016 Document Author(s) Document
More information