Trial Management: Trial Master Files and Investigator Site Files

Size: px
Start display at page:

Download "Trial Management: Trial Master Files and Investigator Site Files"

Transcription

1 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 maintaining study documentation and records to ensure systematic practice and compliance with research legislation. Kayte Russell, NIHR GCP Facilitator and Bonnie Teague, Research Manager Reviewed: Kayte Russell, Bonnie Teague 20 th April 2017 In Consultation With: Approved and Date: References and Bibliography: By Associated Trust Policies: Applicable To: For Use By: V1.0 Research Governance Committee 23 rd February 2012 V2.0 Research Committee 27 th April 2017 Research governance framework (2005) E6 Document; A pocket guide to clinical practice version 3 December 2014 Data Protection act. MHRA Good Clinical Practice Guide Q14: Development and Management of Trust Policy R&D009: Research Auditing and Monitoring R&D013: Research Study Close-Down and Archiving R&D005: Conducting Drug Trials in NSFT All Trust staff working on approved research studies in the NSFT. All Trust staff working on approved research studies in the NSFT All sponsoring organisations for which NSFT is a participating site R&D officers, monitors and auditing personnel. Reference R&D008 Number: Version: 2.0 Published V1.0 1 st March 2012 Date: V st April 2017 Review Date: 3 years Equality Completed 21 st April Assessment: Implementation and Monitoring The policy will be uploaded to the Trust policy library and research pages. It will be implemented through research induction, training and supported by associated guidance. The updated policy will apply to all studies receiving confirmation of capacity and capability from NSFT Research Office from 1 st May Page 1 of 11

2 Review and Amendment Log Version Reasons for Development/Review Date Description of Change(s) V1.0 To develop standardised research trial management practice across NSFT. 23 rd February 2012 N/A V2.0 To respond to recent updates in legislation and update terminology. 21 st April ) Removed guidance wording/suggestions and appendices 2) Updated legislation references and bibliography. 3) Simplified and standardised language and terminology. 4) Included electronic site file management statement. Page 2 of 11

3 1.0 Introduction 1.1 This standard operating policy stipulates administrative requirements for the management of information generated from approved research studies, where NSFT is acting as the sponsor organisation, or as a participating research site on external research. 1.2 The key to good research management and quality assurance is documenting all essential study information. The ICH Good Clinical Practice (ICH GCP section 8 and UK CT regulation 31A), which covers all types of research, states that the essential documents that are to be filed are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. 1.3 There is a requirement to ensure that All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification. (Guide on Good Practice for Data Management of Chief Investigators of research sponsored by UCL 2010) 1.4 The management of Clinical Trials of Investigational Medicinal Products (CTIMPs) is supported by the Medicines for Human use (Clinical trials) amendment regulations 2006, which legally requires a Trial Master File is set up for each clinical trial. The Research Governance framework (2005) which covers all clinical research with the exception of CTIMPs, requires transparency and accurate record-keeping in the conduct of research. 2.0 Purpose 2.1 The purpose of this Standard Operating Procedure (SOP) is to inform people involved in conducting clinical research in NSFT, the procedures for setting up and maintaining research study documentation in accordance with current legislation and frameworks. 2.2 The SOP will clarify the duties and responsibilities for quality research management, via the use of study trial files (Trial Master File and Investigator Site Files) and associated documentation. 3.0 Definitions and Abbreviations Case Report Forms (CRFs): A record of data collected for the specific purposes of clinical research, completed using source data. CRFs are used to collect data generated for a trial subject, in accordance with the protocol, during the course of their participation in a trial. They also ensure compliance with regulatory requirements. CRFs can be in paper, optical or electronic format, depending on the needs of the study protocol, but all should be dated and version controlled. Chief Investigator (CI): The lead researcher who has overall responsibility and oversight for the conduct of the research study across all sites, including maintaining study documentation. Clinical Trial of an Investigational Medicinal Product (CTIMP) A Clinical Trial of an Investigational Medicinal Product (CTIMP) is defined in the Medicines for Human Use (Clinical Trial) Regulations 2004 as any investigation in human subjects, other than a non interventional trial intended: To discover or verify the clinical, pharmacological or other pharmocodynamic effects of one or more medicinal products To identify one or more adverse effects of these medicinal products Page 3 of 11

4 To study absorption, excretion or distribution of medicinal products with a view of ascertaining the safety or efficacy of such products. Since May 2004 when the Trial Regulations came into force, CTIMPs have been regulated by the Medicines and Healthcare Products Regulatory Agency (MHRA) who needs to give explicit authorisation for a CTIMP to be conducted in addition to the standard approvals required for clinical studies. This is termed Clinical Trial Authorisation or CTA. Essential Documents: Essential documents are those documents which individually or collectively permit the evaluation of the conduct of a trial and the quality of the data produced. (ICH GCP manual pg 21) and should be kept in a secure but accessible manner, they should be legible, accurate and with a clear description as to it s purpose. Examples of essential documents include: Case report forms Delegation of Duties Log signed by all research staff and agreed by the Principal Investigator. Serious adverse events/reactions (SAE s/sar s) Suspected Unexpected Serious Adverse Events (SUSAR s) Protocols Investigational Brochures Patient information leaflets Amendments to documents and protocols Communication Pharmocological documentation This list is not an exhaustible list of what could be regarded as essential. Further information can be found in Appendix A. GCP: Good Clinical Practice. Good clinical practice is a set of internationally-recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. [Definition from EU Directive 2001/20/EC, article 1, clause 2] Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate. MHRA: Medicines and Healthcare Products Regulatory Authority. The MHRA's Good Clinical Practice (GCP) Inspectorate is part of the Inspection, Standards and Enforcement Division of the MHRA. The function of the GCP Inspectorate is to assess the compliance of organisations with UK and EU legislation relating to the conduct of clinical trials in investigational medicinal products. This is achieved through carrying out inspections of sponsor organisations that hold clinical trial authorisations (CTA) or organisations that provide services to clinical trial sponsors (host organisations). Principal Investigator (PI): The named researcher who has delegated responsibility for the conduct and oversight of the research study at each individual participating research site. Research Team Member: A research practitioner employed by the research team, Trust or research body to carry out specific allocated duties pertaining to the particular study. Page 4 of 11

5 Investigator Site File (ISF): This file is held with the PI on each specific participating trial site. An Investigator Site File should offer a comprehensive, accurate and auditable story of the trial at the participating site. (ICH GCP manual pg 21) In some studies in the NSFT where localities and teams work on studies independently there may be a number of files that would be regarded as Site Specific Files. In such cases an individual should be nominated to be responsible for the maintenance of the file and all the relevant documentation available. Source Data: Source data are all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the clinical trial. Source data are contained in source documents (original records or certified copies). Source documents are original documents and records where study data are first recorded e.g. hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists and pharmacy dispensing records. Source documents are considered "Essential Documents" that allow evaluation of the clinical trial and ensure the quality of the data and serve to certify Sponsor and CI compliance with GCP and regulatory requirements. The process referred to as Source Data Verification (SDV) is an evaluation of the data recorded in the data collection tool against the source documents. Trial Master File (TMF): A master file kept by the study sponsor or CI. It contains all the essential documents and correspondence for the study. Whilst TMF guidelines are directed towards CTIMP trials, Non-CTIMP studies should also follow the standard outlined and is specified by the ICH GCP when it refers to a Trial Master File as being for all studies, not only clinical trials. (ICH GCP manual pg 21) 4.0 Duties and Responsibilities 4.1 Sponsor: The organisation with overall responsibility and oversight for the conduct of the clinical trial. The sponsor will arrange for indemnity, regulatory and Study approvals to be in place by the start of the study, will set-up and provide full trial documentation and study training to local research teams, will ensure that appropriate emergency reporting procedures are in place, will provide study medication to be sent to local Pharmacy sites where required, will perform comprehensive monitoring and audit functions throughout the study by arrangement with local teams. Some of these functions may be delegated to members of the research team. 4.2 Chief Investigator (CI): The lead researcher with responsibility for the conduct of the clinical trial across all research sites, including but not limited to the following areas. Qualifications and agreements (Good Clinical Practice (GCP) Training, delegation of trial-related duties) Adequate Resources to conduct the overall study time, funding, demonstrate ability to recruit (via pilot etc) Medical care of trial subjects: A qualified clinician, who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical decisions On-going communication with Ethics/MHRA/R&D throughout trial (amendments, annual reports etc) Ensure full compliance with protocol and document deviations and submit amendments to Ethics and R&D. Investigational Product (if applicable) - responsible for IMP accountability at site/s (can be assigned to appropriate pharmacist) Randomization Procedures and Unblinding responsible for following trial s randomization and blinding/unblinding procedures (if applicable) Informed consent responsible for following GCP guidelines on informed consent Records and Reports follow GCP guidelines on Case Report Forms and source documentation, maintenance of trial documentation, financial agreements and archiving Page 5 of 11

6 Progress Reports provide written summaries to Ethics (annually or more frequently if requested) and sponsor and Ethics and R&D regarding substantial changes to trial Serious Adverse Events (SAEs)- responsible for ensuring all SAEs reported to sponsor Premature Termination or Suspension of Trial Responsible for ensuring trial subjects, institution sponsor, Ethics and R&D are promptly informed if trial ends prematurely or is suspended Final Report ensure that final report provided to institution, Ethics and R&D, regulatory authorities and sponsor 4.3 Principal Investigator (PI): The lead researcher with delegated responsibility for the conduct of the clinical trial aligned with the responsibilities of the chief investigator (listed above) across the local site only. The PI will report any adverse events or serious adverse events to the sponsor/ci, will be responsible for the set-up and conduct of the study at the local site and ensure that all trial documentation and appropriate training has been received and passed onto the study team. Duties will include set-up and maintenance of trial documentation, patient identification and recruitment, patient follow-up, arrangement and collection of prescribed study medication from Pharmacy and ensuring that the study is being conducted to study protocol, trust policy and GCP standards. 4.4 Local Research Team: The local research team, as named on approval documentation, have delegated duties from the CI and PI to conduct the clinical trial at the local site. Duties will include set-up and maintenance of trial documentation, patient identification and recruitment, patient follow-up, arrangement and collection of prescribed study medication from Pharmacy and ensuring that the study is being conducted to study protocol, trust policy and GCP standards 4.5 Research and Development (R&D): Ensure that the trial is being conducted to be compliant to approved protocol, GCP and Trust policies, and undertake local research audits of clinical trials where appropriate. The host NHS organisation is required to have procedures in place for conducting the trial in accordance with Good Clinical Practice and the Clinical Trials Regulations, including: Adequate training for all site staff and adequate training records; Ensuring clarity of roles and responsibilities (e.g. contracts and agreement, delegation log) Appropriate knowledge of the trial and quality systems in all peripheral departments (e.g. laboratories, radiology, medical records); Ensure systems and facilities are fit for purpose (e.g. computer systems, equipment) Conducting the trial in accordance with the protocol, including: informed consent; reporting of adverse events / reactions as per protocol (and urgent safety measures); unblinding procedures; and IMP accountability at the trial site; and Adequate trial documentation and archiving of trial documentation. Page 6 of 11

7 5.0 Research Trial File Management 5.1 Research Site Staff All members of the research study team involved in trial management should be trained and competent to perform the duties delegated and agreed, as evidenced by the delegation of duties, research CV and training log. 5.2 Site Files Prior to study start, a nominated member of the research team is required set up a Study research file containing all essential documentation and templates. Study research files should be maintained in accordance with the Research Site File Index (Appendix 1). Further guidance for the contents of the file can be found in the E6 ICH-GCP booklet and in NSFT Research Training and guidance. 5.3 Electronic Site File Management Study documentation which is required to be regularly updated may be kept electronically on secure trust servers. All procedures need to ensure that processes are in place for the protection of the study data, including encryption, password protection and limited access to delegated members of the research team. A study may use electronic methods of data capture (i.e. ecrfs) providing that the device used is secure and in accordance with Trust ICT Data protection policies. 5.4 Confidentiality and data protection. All research study documentation should be regarded as sensitive information therefore should be kept securely and in line with data protection act principles. Identifiable information related to study participants should be stored separately to non-identifiable information with the exception of protected electronic participant logs (see Section 5.3). Access to the files should be restricted to members of the research team with delegated authority in line with the study approved protocol and delegation of duties log. 5.5 Maintaining Trial Master Files and Investigator Site Files During the Trial Period. The process of updating the TMF and Investigator Site File should be an ongoing response to the progress of the trial. This should include any amendments to documents such as protocol and ethical approval, and management of adverse events. This documentation should serve as an auditable record of the management of the trial, and to evidence and ensure legislation and protocols are adhered to in a timely and accurate manner in all aspects of the study. Accurate and comprehensive maintenance involves documentation that details every aspect of the study, including Case Report forms and source data verification. Page 7 of 11

8 5.5.1 Amendments and Version control Amended documents should be approved through the appropriate channels such as ethics, R&D and regulatory authorities before implementation and disseminated as soon as possible to all participating research sites and teams Accuracy All data should be comprehensive and accurate. It should be auditable against the source data and to be of equal quality. Source data is regarded as the origin of information and should be of a standard that enables the date to be transferred to Research documentation accurately and legibly Transparency No data related to the research study is to be deleted or hidden. Any changes or mistakes are required to be recorded and explained. Any deliberate attempt to falsify or hide information, including prior mistakes, will be investigated under the Research Integrity policy. 5.6 Research Auditing Research site files and all associated documentation are required to be made available to research auditors and monitors upon request. 5.7 Archiving Trial Master and Investigator Site Files. Following study close-down, all study files need to be archived in accordance with Sponsor requirements. Archiving cannot proceed until permitted by the sponsor. Monitoring Statement Aspects of the policy to be monitored Compliance of research teams to the Policy Monitoring method Self-Audit toolkit, research audits. Individual/Tea m responsible for monitoring Research and Development- Audit Team and Quality Lead Frequency 10% of all research studies plus 1 month survey post set-up for all studies. Findings: Group/Commi ttee that will receive the findings/moni toring report NSFT Research Committee. Action: Group/Commi ttee responsible for ensuring actions are completed NSFT Research Committee. Page 8 of 11

9 Appendix 1: Trial Master File/Investigator Site-File Index Template R&D008 Appendix 1 This index gives a suggested guide to the order of site file documentation. Mandatory documents required for all studies are marked with a * before the document name. All documentation listed below is mandatory for CTIMPs. Core Study Documentation *Approved Protocol Financial aspects of the trial (if applicable) Insurance/indemnity (if non-nhs sponsor) Signed agreements between involved parties (if applicable) Study initiation visit report (if applicable) *Approval documents *Study contact sheet *Delegation of duties and signatures log *Research Team CVs *Training certificates *Sample case report forms/outcome measures *Amendments *Information given to potential participants (Approved Templates) Participant Specific Information *Participant logs (can be saved electronically and location referenced with site file) *Informed consent Forms *Mental Capacity status *Screening assessments *Completed CRFs (CRFs may not be available to the local site if ecrfs are in use) *Source data *File notes *Participant communication Page 9 of 11 All studies HRA Ethics R&D Confirmation of Capability and Capacity Must include 24/7 safety reporting details if relevant to study. Should be signed by all research team members. Amendment notification and approvals. PIS Consent forms Any other written information Advertisement for participant recruitment Recruitment Screening Completed copies in separate file To be kept with completed Informed Consent forms or location referenced via file note. Include blood tests, questionnaires In a separate file This may be test results/outcome measures Document any errors, omissions, corrections, protocol deviations GP letters Appointment letters Communication sheets documenting adverse events, willingness to continue Telephone logs

10 Additional Study Reporting and Procedures *Randomisation process (if randomised trial only) *Un-blinding process (if randomised trial only) *Safety reporting *Monitoring/audit reports Interim analysis reports *Annual reports *All other communication Records of retained body fluids/tissue samples Final close out report *All superseded documents s SAE report forms Evidence of being sent to REC if required ( SAR s) AE s (communication sheet) Initial/Notification Feedback Follow up s Minutes Records of retained body fluids/tissue samples and labels Final close out report All former versions of approved documentation should be kept securely. CTIMP specific Investigator s brochure or Summary of Product Characteristics (SmPC). Medical/Laboratory/technical procedure/test Normal value ranges for Medical/Laboratory/technical procedure/test Sample of labels Instructions for storing and handling or Investigational medicinal product and trial related materials Copy of card given to participants re: safety reporting Shipping/postage records Samples of labels and packaging Certificates of analysis of investigational products shipped Records of retained body fluids/tissue samples Final close out report All superseded documents All additional documentation is mandatory for CTIMPs. Certification Calibration certificates/arrangements Contracts Quality control Includes the proper storage, packaging, dispensing and disposition Page 10 of 11

11 Page 11 of 11

Research Governance Framework 2 nd Edition, Medicine for Human Use (Clinical Trial) Regulations 2004

Research 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 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: Routine Project Audit SOP Number: 6 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August

More information

Standard Operating Procedure. Essential Documents: Setting Up a Trial Master File. SOP effective: 19 February 2016 Review date: 19 February 2018

Standard 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 information

Document Title: Investigator Site File. Document Number: 019

Document 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 information

STANDARD OPERATING PROCEDURE SOP 325

STANDARD 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 information

Standard 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. 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 information

Trial set-up, conduct and Trial Master File for HEY-sponsored CTIMPs

Trial 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 information

Document Number: 006. Version: 1. Date ratified: Name of originator/author: Heidi Saunders, Senior Portfolio Coordinator

Document 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 information

Research Adverse Event and Safety Reporting Procedures Outcome Statement: Title:

Research 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 information

Document 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 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 information

Version Number: 004 Controlled Document Sponsor: Controlled Document Lead:

Version 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 information

STANDARD OPERATING PROCEDURE

STANDARD 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 information

STANDARD 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. 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 information

Site Closedown Checklist for UoL Sponsored CTIMP Studies

Site 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 information

SOP-QA-28 V2. Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head of School

SOP-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 information

Document Title: Study Data SOP (CRFs and Source Data)

Document 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 information

Standard Operating Procedure (SOP) for Reporting Serious Breaches in Clinical Research

Standard 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 information

SOP MONITORING & OVERSIGHT OF RESEARCH ACTIVITY. Contact Jess Bisset, Research Operations Manager x20227

SOP 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 information

Document Title: Document Number:

Document 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 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: Delegated Responsibilities in Research Projects SOP Number: 11 Version Number: 2.0 Supercedes: 1.0 Effective date: August

More information

Research Staff Training

Research 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 information

Keele Clinical Trials Unit

Keele 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 information

SOP16: Standard Operating Procedure for Establishing Sites and Centres - Site Setup

SOP16: Standard Operating Procedure for Establishing Sites and Centres - Site Setup 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

More information

Hertfordshire 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 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 information

Document Title: Research Database Application (ReDA) Document Number: 043

Document Title: Research Database Application (ReDA) Document Number: 043 Document Title: Research Database Application (ReDA) Document Number: 043 Version: 1.1 Ratified by: Committee Date ratified: 23 February 2017 Name of originator/author: Rachel Fay Directorate: Medical

More information

MHRA Findings Dissemination Joint Office Launch Jan Presented by: Carolyn Maloney UHL R&D Manager

MHRA 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 information

Document Title: Research Database Application (ReDA) Document Number: 043

Document Title: Research Database Application (ReDA) Document Number: 043 Document Title: Research Database Application (ReDA) Document Number: 043 Version: 1 Ratified by: Committee Date ratified: 30 September 2014 Name of originator/author: Directorate: Department: Name of

More information

This Agreement dated DD/MM/YYYY (the Effective Date ) is between

This 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 information

STANDARD OPERATING PROCEDURE SOP 715. Principles of Clinical Research Laboratory Practice

STANDARD 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 information

ACTIONS/PSOP/001 Version 1.0 Page 2 of 6

ACTIONS/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 information

Sponsor Responsibilities. Roles and Responsibilities. EU Directives. UK Law

Sponsor 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 information

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

NEWCASTLE 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 information

GCP: Investigator Responsibilities. Susan Tebbs Nicola Kaganson

GCP: 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 information

European Medicines Agency Inspections ANNEX V TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: PHASE I UNITS

European 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 information

Standard Operating Procedure

Standard 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 information

Standard Operating Procedure (SOP)

Standard 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 information

Document Title: GCP Training for Research Staff. Document Number: SOP 005

Document 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 information

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

NEWCASTLE 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 information

STANDARD OPERATING PROCEDURE SOP 205

STANDARD 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 information

Marie-Claire Rickard, RG and GCP Manager Jimena Lovos, Quality Assurance Manager Elizabeth Clough, R&D Governance Operations Manager

Marie-Claire Rickard, RG and GCP Manager Jimena Lovos, Quality Assurance Manager Elizabeth Clough, R&D Governance Operations Manager Standard Operating Procedures (SOP) for: Pharmacovigilance processing for the JRMO SOP Number: 26c Version Number: V1 Effective Date: 5/8/16 Review Date: 5/8/17 Author: Reviewer: Reviewer: Authorisation:

More information

Monitoring Clinical Trials

Monitoring 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 information

Corporate. Research Governance Policy. Document Control Summary

Corporate. 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 information

Study Monitoring Plan Template

Study 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 information

STANDARD OPERATING PROCEDURE

STANDARD OPERATING PROCEDURE STANDARD OPERATING PROCEDURE Title Reference Number Adverse Event Identification, Recording and Reporting in Clinical Trials of Investigational Medicinal SOP-RES-019 Version Number 2 Issue Date 08 th Dec

More information

Governance %%.4- r2&% Queen s University Belfast. Standard Operating Procedure Research Governance. r2.aoc7. Research and Enterprise

Governance %%.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 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: Recording and Reporting Deviations, Violations, Potential Serious Breaches, Serious Breaches and Urgent Safety Measures

More information

Document Title: File Notes. Document Number: 024

Document 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 information

Standard Operating Procedure Research Governance

Standard 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 information

STANDARD OPERATING PROCEDURE

STANDARD 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 information

STANDARD OPERATING PROCEDURE

STANDARD 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 information

M. Rickard, Research Governance and GCP Manager R. Fay Research Governance and GCP Manager Elizabeth Clough, Governance Operations Manager

M. 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 information

Details: Approval: Distribution & Storage: Pharmacovigilance for Researchers for UoL / LTHT Sponsored CTIMPs. Standard Operating Procedure

Details: 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 information

Storage and Archiving of Research Documents SOP 6

Storage 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 information

I2S2 TRAINING Good Clinical Practice tips. Deirdre Thom Neonatal Nurse Coordinator

I2S2 TRAINING Good Clinical Practice tips. Deirdre Thom Neonatal Nurse Coordinator I2S2 TRAINING Good Clinical Practice tips Deirdre Thom Neonatal Nurse Coordinator Content Principal investigator (slides 3-5) Delegation and delegation log (slides 6-7) Informed consent (slides 8-15) Data

More information

Document Title: Version Control of Study Documents. Document Number: 023

Document Title: Version Control of Study Documents. Document Number: 023 Document Title: Version Control of Study Documents Document Number: 023 Version: 1.1 Ratified by: Committee Date ratified: 03 OCT 2017 Name of originator/author: Directorate: Department: Name of responsible

More information

managing or activities.

managing 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 information

Safety Reporting in Clinical Research Policy Final Version 4.0

Safety 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 information

Version Number: 003. On: September 2017 Review Date: September 2020 Distribution: Essential Reading for: Information for: Page 1 of 13

Version Number: 003. On: September 2017 Review Date: September 2020 Distribution: Essential Reading for: Information for: Page 1 of 13 CONTROLLED DOCUMENT Reporting Research Incidents and Breaches Policy CATEGORY: CLASSIFICATION: PURPOSE Controlled Number: Document Policy Governance To set out the framework and principles for reporting

More information

Investigator Site File Standard Operating Procedure (SOP)

Investigator 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 information

STANDARD OPERATING PROCEDURE

STANDARD 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 information

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 1 2 31 January 2017 EMA/430909/2016 3 4 5 Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or Draft Adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2017 Adopted

More information

Risk Assessment and Monitoring

Risk 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 information

NN 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 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 information

POLICY ON RESEARCH RELATED ADVERSE EVENT REPORTING

POLICY ON RESEARCH RELATED ADVERSE EVENT REPORTING POLICY ON RESEARCH RELATED ADVERSE EVENT REPORTING CLASSIFICATION TRUST POLICY NUMBER APPROVING COMMITTEE R & D Governance Committee RATIFYING COMMITTEE Quality & Risk Committee DATE RATIFIED October 2009

More information

Reference 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 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 information

Joint R&D Support Office SOP S-2011 UHL

Joint 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 information

COMPETENCY FRAMEWORK

COMPETENCY 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 information

General Administration GA STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility

General Administration GA STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility General Administration GA 102.01 STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility Approval: Nancy Paris, MS, FACHE President and CEO (17 July 2014) (Signature and

More information

Clinical Trial Readiness Checklist October 2014

Clinical 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 information

STANDARD OPERATING PROCEDURE

STANDARD 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 information

Research & Development. Case Report Form SOP. J H Pacynko and J Illingworth. Research, pharmacy and R&D staff

Research & 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 information

MANAGEMENT OF PROTOCOL AND GCP DEVIATIONS AND VIOLATIONS

MANAGEMENT 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 information

Good Clinical Practice: A Ground Level View

Good 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 information

Informed Consent SOP Number: 25 Version Number: 6.0 Effective Date: 1 st September 2017 Review Date: 1 st September 2019

Informed 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 information

MEDICINES FOR HUMAN USE (CLINICAL TRIALS) REGULATIONS Memorandum of understanding between MHRA, COREC and GTAC

MEDICINES 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 information

SOP18b: Standard Operating Procedure for Preparing for External Audit and Inspection

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 information

Research & Development Quality Manual

Research & 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 information

Keele Clinical Trials Unit

Keele 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 information

Quality Assurance in Clinical Research at RM/ICR. GCP Compliance Team, Clinical R&D

Quality Assurance in Clinical Research at RM/ICR. GCP Compliance Team, Clinical R&D Quality Assurance in Clinical Research at RM/ICR GCP Compliance Team, Clinical R&D Slide 1 of 13 What is Quality Assurance? The maintenance of a desired level of quality in a service or product, especially

More information

Once the feasibility assessment has been conducted the study team will be notified via (Appendix 3) of the outcome and whether the study is;

Once 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 information

1. INTRODUCTION 2. SCOPE 3. PROCESS

1. 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 information

Standard Operating Procedure (SOP) for Reporting Urgent Safety Measures in Clinical Research

Standard 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

Setting up a Clinical Trial

Setting 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 information

Site Qualification and Training (SQT) INFORMATION AND GUIDANCE SHEET FOR SITE SIGNATURE AND DELEGATION OF RESPONSIBILITIES LOG

Site Qualification and Training (SQT) INFORMATION AND GUIDANCE SHEET FOR SITE SIGNATURE AND DELEGATION OF RESPONSIBILITIES LOG Site Qualification and Training (SQT) INFORMATION AND GUIDANCE SHEET FOR SITE SIGNATURE AND DELEGATION OF RESPONSIBILITIES LOG INFORMATION AND GUIDANCE SHEET FOR THE COMPLETION OF THE SITE SIGNATURE AND

More information

Joint 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 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 information

GCP INSPECTION CHECKLIST

GCP 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 information

STH Researcher. Recording of research information in patient case notes

STH 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 information

TRAINING REQUIREMENTS FOR RESEARCH STAFF, INCLUDING GOOD CLINICAL PRACTICE (GCP)

TRAINING 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 information

R. Fay, Research Governance & GCP Manager K. Mahiouz, Clinical Trials Facilitator E. Clough, R&D Governance Operations Manager

R. 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 information

Auditing of Clinical Trials

Auditing 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 information

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

NEWCASTLE 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 information

Checklist prior to recruiting first patient

Checklist prior to recruiting first patient Pre-Site selection Site Initiation Visit (SIV) What kind of questions should you ask How you should prepare for this visit Delegation logs Training logs ECRF/CRF Checklist prior to recruiting first patient

More information

Roles & Responsibilities of Investigator & IRB

Roles & Responsibilities of Investigator & IRB Roles & Responsibilities of Investigator & IRB Jaranit Kaewkungwal Mahidol University Regulatory & Guidelines Regulatory & Guidelines GCP & Computer / Database Management Systems International Conference

More information

NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES

NEWCASTLE 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: 03 Version date:

More information

Document Title: Informed Consent for Research Studies

Document Title: Informed Consent for Research Studies Document Title: Informed Consent for Research Studies Document Number: SOP003 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D

More information

Standard Operating Procedures (SOP) Research and Development Office

Standard 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 information

Dr. R. Sathianathan. Role & Responsibilities of Principal Investigators in Clinical Trials. 18 August 2015

Dr. R. Sathianathan. Role & Responsibilities of Principal Investigators in Clinical Trials. 18 August 2015 18 August 2015 Role & Responsibilities of Principal Dr. R. Sathianathan Professor of Psychiatry, SRMC, Porur & Former Director, Institute of Mental Health, Chennai Principal Investigators & GOOD CLINICAL

More information

VCU Clinical Research Quality Assurance Assessment

VCU Clinical Research Quality Assurance Assessment VCU Clinical Research Quality Assurance Assessment Principal Investigator Protocol Title Protocol IRB Number Name of Person Completing Assessment Date Assessment was Completed The goal of this assessment

More information

IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES

IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES DOCUMENT NO.: CR012 v2.0 AUTHOR: Raymond French ISSUE DATE: 18 September 2017 EFFECTIVE DATE: 02 October

More information

STANDARD OPERATING PROCEDURE SOP 220. Investigation of allegations of Research Fraud and Misconduct. NNUH UEA Joint Research Office

STANDARD OPERATING PROCEDURE SOP 220. Investigation of allegations of Research Fraud and Misconduct. NNUH UEA Joint Research Office STANDARD OPERATING PROCEDURE SOP 220 Investigation of allegations of Research Fraud and Misconduct Version 1.4 Version date 27.02.2018 Effective date 2.03.2018 Number of pages 8 Review date February 2020

More information