Investigator Site File Index (Medical Devices)
|
|
- Ursula Hoover
- 5 years ago
- Views:
Transcription
1 Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol (Clinical Investigation Plan) Current version plus all previous versions (or provide file note to detail location of previous versions) and any amendments Previous versions should be clearly marked as such with Signed copy of the protocol signature page 2. Investigator Brochure (if non-ce Current version plus previous versions (or provide file note to marked) detail location of previous versions) and any amendments Instructions for use (if CE marked) Previous versions should be clearly marked as such with 3. Study Documents 3.1 Participant information sheets 3.2 Informed consent form(s) (master copies) 3.3 Participant invitation letters 3.4 GP letter 3.5 Diaries / Questionnaires 3.6 Adverts / posters 3.7 Participant contact cards Master copies of current versions plus all previous versions and amendments Previous versions should be clearly marked as such with 3.8 Decoding procedures for blinded investigations (if applicable) 4. Centre Agreements and Finance Current and previous procedure for decoding / unblinding participants if applicable to the investigation 4.1 Clinical Study Agreement / Signed legal agreement between sponsor and investigator / Financial agreement site(s) Financial agreements (if separate from legal agreement) 4.2 Sponsorship and indemnity letters / Evidence of sponsorship and indemnity from the manufacturer insurance certificates (if appropriate) or NHS indemnity if applicable 5. Regulatory approval (where required) Regulatory authority notification correspondence and approval Amendment applications & related approvals Effective Date 22/Mar/2017 Page 1 of 5
2 6. Research Ethics approval Ethics committee applications and all correspondence through to opinion / approval Ethics committee review board attendance Amendment applications & related approvals (new versions of s from 1, 2, 3 should be filed in the appropriate section, copies do not need to be filed here) Safety Annual / Final reports 7. HRA and local confirmation of HRA applications through to approval capacity Include correspondence and approval for amendments (new versions of s from 1, 2, 3 should be filed in the appropriate section, copies do not need to be filed here) 8. Informed Consent Forms (signed Original signed and dated informed consent form and originals) participant information s must be kept here for all screened and enrolled participants Please file in alphabetical order 9. Study Logs 9.1 Participant Screening Log To all participants who entered pre-trial screening 9.2 Participant Enrolment Log A chronological list of all participants enrolled into the study, and their study status 9.3 Participant Identification Log and A complete list of the names of all study participants and Randomisation list (if applicable) their corresponding participant number allocated to them on enrolment in the study. The list verifies whether randomisation has been followed if applicable 10. Site Staff 10.1 Signature & Responsibility / Signatures & delegated responsibilities of staff authorised to Delegation Log at each investigation work on the study by the Principal Investigator site To be updated with any changes to staff or responsibilities 10.2 CVs Original signed and dated version of key staff on the delegation log 10.3 Training Records Evidence that investigators and site staff have been trained in the use of the investigational device or the duties assigned to them in the delegation log Evidence of GCP training 11. Data Collection 11.1 Template Case Report Form (CRF) Master copy of CRF Effective Date 22/Mar/2017 Page 2 of 5
3 Current version plus previous versions 11.2 CRF completion guidelines Current version plus previous versions 11.3 Completed CRF Signed, dated and completed CRF s 11.4 Source s All s created and maintained at the site that substantiate integrity of the trial data and participant 12. SOPs Study specific SOPs and guidelines (other than 11.2 and 15.2) 13. Investigational device 13.1 Shipping records All s that verify the physical possession of the device Documents to include shipment dates, batch numbers and method of shipment of investigational device 13.2 Accountability logs All s that reconcile the shipping, receipt and distribution records held by the Sponsor for each site 13.3 Device deficiency forms Document all deficiencies. Forms may be part of the CRF 13.4 Confirmation of adequacy of equipment if relevant to the investigation 13.5 Documentation of investigational device return or disposal 14. Laboratory / technical procedures (if applicable) 14.1 Laboratory or technical reference ranges (local and/or central) if relevant to the investigation 14.2 Laboratory Accreditation / validation certificates (local and/or central) if relevant to the investigation 15. Adverse Events Document all equipment maintenance and calibration Documents the proper disposal or return of materials where required Current plus previous laboratory or technical reference ranges Previous reference ranges should clearly be marked as such with reference to being superseded with date of the new Current plus previous accreditation or validation certificates to perform the required test(s). Previous certificates should clearly be marked as such with reference to being superseded with date of the new 15.1 Serious adverse event (SAE) form Master copies of current versions plus previous version. Effective Date 22/Mar/2017 Page 3 of 5
4 15.2 SAE completion guidelines Current version plus previous versions Completed SAE forms Original completed AE / SAE forms 15.4 Notification of SAE s Notification to the regulatory authorities & research ethics committees of SAE s and other safety issues 15.5 SAE updates Safety report updates (or provide file note to detail location) 15.6 SAE correspondence Any other SAE correspondence (or provide file note to detail location). This should include notifications from sponsor to all investigators of safety information 16. Deviations All protocol or SOP deviations reports Completed deviation log 17. Monitoring 17.1 Site initiation report All ation relating to the site initiation visit and final report 17.2 Training ation Documentation of study centre and / or in-house training 17.3 Monitoring plan Details of monitoring guidelines and source data verification plan 17.4 Monitoring Log Documentation of study centre and / or in-house monitoring 17.5 Monitoring Reports Final signed monitoring reports 17.6 Monitoring correspondence Any correspondence relating to monitoring 18. Investigator meetings 18.1 Agendas 18.2 Presentations 18.3 Minutes 18.4 Attendance log Documentation of study initiation training 18.5 Investigator meeting correspondence Any correspondence relating to investigator meetings 19. Close-Out 19.1 Notification of investigation close out Letter confirming close out of the site to the ethics committee to the EC by PI or Sponsor 19.2 Notification of investigation close out Letter confirming close out of the site to the regulatory Effective Date 22/Mar/2017 Page 4 of 5
5 to the regulatory authorities by PI or Sponsor, where required 19.3 Statistical analyses and End of Study Report 19.4 Site close out and End of Study correspondence 20. Miscellaneous authorities (where required) To the results and interpretation of the trial Any correspondence relating to site close out and end of study 20.1 Notes to files Examples of miscellaneous items that could be included in this section Publications 20.3 Disclosures of conflicts of interest Document any conflicts of interest and any updates or amendments 20.4 Audit certificate (if applicable) Certificate of audit conduct where applicable 21. Correspondence 21.1 All correspondence All correspondence not relating to s 4,5,6,7,15,16,17,18,19,20 Effective Date 22/Mar/2017 Page 5 of 5
Investigator Site File Index (CTIMP)
Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol Current version plus all previous versions (or provide file note to detail location of previous
More informationTrial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products
1 Trial Master File / Investigator Site File Index Clinical Trials of Investigational Medicinal Products SECTION TITLE DOCUMENTS 1. Contact List Including details of relevant study site staff, responsible
More informationESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
Assemble Essential Documents in Trial Master File (TMF) Appendix 1 ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 8.2 Before the Clinical Phase of the Trial Commences During this planning stage
More informationStandard Operating Procedure
Standard Operating Procedure Number: UM/UoM TMF/SOP08/6.0 Title: The Creation and Maintenance of Trial Master Files and Essential Documentation Version: 6.0 () Effective Date: Author: Mrs Catherine Barrow
More informationStudy Files and Filing
Study Files and Filing The current version of all Hillingdon Hospital R&D Guidance Documents and Standard Operating Procedures are available from the R&D Intranet and Internet sites: www.ths.nhs.uk/departments/research/research.htm
More informationTrial Master File. SOP No. SOP 7
Trial Master File SOP Title Trial Master File SOP No. SOP 7 Author Consultation Departments Date approved Julia Farmery Lincolnshire Clinical Research Facility, Research and Development, Trust consultants
More informationSTANDARD OPERATING PROCEDURE. STH Researcher. Investigator Site File
Research Department STANDARD OPERATING PROCEDURE STH Researcher SOP History CSUH 00/016 SOP Number A116 Created STH Research Department (TL) Reviewed by STH Research Department (AL) 06 August 2009 Superseded
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. 17. Study Close Down
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 17. Study Close Down According to ICH Good Clinical Practice (GCP)
More informationHuman Research Protection Program Good Clinical Practice Guidance for Investigators Regulatory File Essential Documents
Guidance for s Regulatory File Essential s All principal investigators must maintain a regulatory binder or file system, which contains all study documentation. These records may be reviewed at the time
More informationLouise Brook Clinical Trials Quality Monitor. Date
Details: Author: Louise Brook Clinical Trials Quality Monitor SOP Pages: 12 Version No. of replaced SOP: Effective date of replaced SOP: NA NA Approval: Version No: of the SOP being approved. Name of person
More informationLOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE. Loughborough University (LU) Research Office
LOUGHBOROUGH UNIVERSITY RESEARCH OFFICE STANDARD OPERATING PROCEDURE Loughborough University (LU) Research Office SOP 1024 LU Study Closedown and End of Study Reporting for NHS Research Sponsored by Loughborough
More informationStandard Operating Procedures (SOP) Research and Development Office
Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Essential Documentation and Creation and Maintenance of Trial Master File SOP Number: 13 Version Number: 2.0 Supercedes:
More informationRegulatory Binder: Set-up and Maintenance
Regulatory Binder: Set-up and Maintenance Introduction Federal and state regulations, institutional policy, and good clinical and research practices require investigators to maintain documents related
More informationESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL
ESSENTIAL DOCUMENTS DURING THE CLINICAL CONDUCT OF THE TRIAL THIS INFORMATION SHEET (ISR-RG-014) HAS BEEN TAKEN DIRECTLY FROM THE ICH- GUIDELINE* WITH ADDITIONAL COMMENTS ADDED BY THE RESEARCH GOVERNANCE
More informationRESEARCH AUDIT Standard Operating Procedure
Reference Number: UHB 236 Version Number: 2 Date of Next Review: 17 th Oct 2020 Previous Trust/LHB Reference Number: N/A RESEARCH AUDIT Standard Operating Procedure Introduction and Aim As a legal Sponsor
More informationSTUDY DOCUMENTS. DOCUMENT NO.: CR007 v4.0. Marise Buçukoğlu ISSUE DATE: 07 MAR 2017 EFFECTIVE DATE: 21 MAR INTRODUCTION
STUDY DOCUMENTS DOCUMENT NO.: CR007 v4.0 AUTHOR: Marise Buçukoğlu ISSUE DATE: 07 MAR 2017 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research & Development (ACCORD) is a joint office
More informationStandard Operating Procedure
Standard Operating Procedure Title: Clinical Site Monitoring Status: PRIVATE Author Name: Audrey Strader Approver Name: Christine Kubiak Document no.: CSM 02 Effective date: 11/01/2016 Review Date (if
More informationSTANDARD OPERATING PROCEDURE SOP 410. Set up and Initiation of an Investigator Site
STANDARD OPERATING PROCEDURE SOP 410 Set up and Initiation of an Investigator Site Version 1.2 Version date 4.01.2017 Effective date 5.07.2017 Number of pages 13 Review date July 2019 Author Role NNUH
More informationThe European Medicines Agency Inspections ANNEX IV TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA:
The European Medicines Agency Inspections London, 20 September 2007 EMEA/INS/GCP/197221/2005 Procedure no.: INS/GCP/3/IV ANNEX IV TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: SPONSOR
More informationIndex of Standard Operating Procedures for all research Sponsored by the UHL
University Hospitals of Leicester NHS Trust () Index of Standard Operating Procedures for all research Sponsored by the March Please note that with effect from 2015, all SOPs and Appendices use the same
More informationIndex of Standard Operating Procedures for all research Sponsored by the UHL
University Hospitals of Leicester NHS Trust () Index of Standard Operating Procedures for all research Sponsored by the October Please note that with effect from 2015, all SOPs and Appendices use the same
More informationResearch Study Close-down and Archiving Procedures
Title: Research Study Close-down and Archiving Procedures Outcome Statement: To inform researchers of the process for closing down research studies, retaining and storing research materials in the Trust.
More informationCode break is also known as breaking the blind and involves un-blinding a participant so that the treatment allocation is made known.
1. INTRODUCTION This SOP has been produced in accordance with Medicines for Human Use (Clinical Trials) Regulations 2004. This SOP will outline the procedure for breaking the study code in a NUH sponsored
More informationOFFICE FOR RESEACH PROCEDURE. Site Initiation and Close-out
OFFICE FOR RESEACH PROCEDURE Site Initiation and Close-out 1. Purpose: To describe the procedures related to site initiation and close-out of a clinical trial. 2. Scope: Applicable to all phases of clinical
More informationAnnex IV to guidance for the conduct of good clinical practice inspections sponsor and CRO
23 August 2017 EMA/431267/2016 Annex IV to guidance for the conduct of good clinical practice inspections sponsor Adopted by GCP Inspectors Working Group (GCP IWG) 29 November 2017 Keywords GCP inspection,
More informationCompliance Program Guidance Manuals (CPGMs) -1-
Inspector s Preparation for a CI Inspection: FDA Compliance Program & the Records Inventory Jean Toth-Allen, Ph.D. APEC GCP Inspection Workshop May 28, 2008 Compliance Program Guidance Manuals (CPGMs)
More informationMulti-Site Coordination Process. Drafted by: Ester Dimayuga Page 1 of 18
Multi-Site Coordination Process Drafted by: Ester Dimayuga Page 1 of 18 MULTI-SITE COORDIATIO (MSC) REGULATOR PROCESS CTO-Regulatory notifies MSC of trial with UMCC as coordinating center MSC prepares
More informationFDA Sponsor and Investigator Responsibility Checklist
FDA Sponsor and Investigator Responsibility Checklist Principal Investigator: Study Name: CPHS #: IND/IDE #: Name of IND/IDE holder: The following checklist is created based on the Sponsor and Investigator
More informationDate: 21 st May 2014 Version: 5 Page 1 of 11. Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May 2014
Date: 21 st May 2014 Version: 5 Page 1 of 11 STANDARD OPERATING PROCEDURE FOR MONITORING CLINICAL TRIALS (NWORTH 3.07) Approvals Principal Author Name D. Skelhorn Signature: D. Skelhorn Date: 22 nd May
More informationOnce notified of the end of trial, a Research Manager, on behalf of the Sponsor, will contact the CI to arrange a close down monitoring visit.
1. INTRODUCTION This SOP has been produced in accordance with the requirements of The Medicines for Human Use (Clinical Trials) Regulations 2004, Medicines for Human Use (Clinical Trials) Amendment Regulations
More informationTopics summarised in this presentation are: method for defining quality level you want meaning of external controls quality assurance activities
Topics summarised in this presentation are: method for defining quality level you want meaning of external controls quality assurance activities audit, audit report and CAPA 1. QUALITY must be guaranteed,
More informationConducting Clinical Trials of Investigational Medicinal Products
Title: Outcome Statement: Written By: Reviewed By: Conducting Clinical Trials of Investigational Medicinal Products Researchers in the Trust and research partners will be informed about the procedures
More informationAudit and Regulatory Inspection Nopanan Yaibuathes Clinical Research and Compliance Manager Roche Thailand Ltd.
Audit and Regulatory Inspection Nopanan Yaibuathes Clinical Research and Compliance Manager Roche Thailand Ltd. Copyright 2009 - Pharmaceutical Research & Manufacturers Association 1 Overview Audit ICH-GCP,
More informationResearch Study Amendments
REFERENCE: VERSION NUMBER: 3.2 EFFECTIVE DATE: 05-02-18 REVIEW DATE: 05-02-20 AUTHOR: Clinical Trials Manager; Clinical Trials Officer REVIEWED BY: R&I Senior Team APPROVED BY: Deputy Director of Research
More informationJoint Research Office
Office Location: 1 st Floor Maple House 149 Tottenham Court Road London W1T 7DN Joint Research Office Tel: 020 3447 5557 Fax: 020 3447 9937 Website: www.uclh.nhs.uk; www.ucl.ac.uk; www.ucl.ac.uk/jro Postal
More informationSite Initiation and Activation
Site Initiation and Activation Clinical Trials SOP Reference ID: Noclor/Spon/S05/01 Version Number 1.0 Effective Date: 23 rd February 2016 It is the responsibility of all users of this SOP to ensure that
More informationSPONSOR INVESTIGATIONAL MEDICINAL PRODUCT (IMP) MANAGEMENT
SPONSOR INVESTIGATIONAL MEDICINAL PRODUCT (IMP) MANAGEMENT DOCUMENT NO.: GS010 v1.0 AUTHOR: Vikki Young ISSUE DATE: 28 MAY 2018 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research &
More informationSource Documents and Regulatory Binders October 6, 2016
Source Documents and Regulatory Binders October 6, 2016 Lisa Wilson, Regulatory Lead, Clinical Trials Office and Mark Alger, CRC, Clinical Trials Office Essential Documents AKA: the stuff in the Reg Binder
More informationPOST-IRB APPROVAL FDA DRUG (IND) SPONSOR AND INVESTIGATOR RESPONSIBILITY (21 CFR312)
POST-IRB APPROVAL FDA DRUG (IND) SPONSOR AND INVESTIGATOR RESPONSIBILITY (21 CFR312) Purpose: Investigators who initiate and submit an IND application to the FDA assume the responsibilities of both the
More informationStandard Operating Procedures (SOPs) for. Clinical Research Personnel Part 16. Summary
Standard Operating Procedures for Clinical Research Personnel Part 16 Wendy Bohaychuk and Graham Ball GCRP Consultants, Lakehurst General Delivery, Ontario, Canada KOL 2JO Summary This is the 16th in a
More informationSponsor/Investigator Responsibilities
Sponsor/Investigator Responsibilities Marian Serge, RN Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health Food and Drug Administration Marian.Serge@fda.hhs.gov
More informationInvestigator s Responsibility
Investigator s Responsibility Introduction Investigator s Qualifications Clinical Trial Agreement Adequate Resources Medical Care of Trial Subjects Communication with IRB/IEC Study Initiation Patient Recruitment
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. 14. Amendments to Research Studies
Basildon and Thurrock University Hospitals NHS FT Research & Development APPROVED STANDARD OPERATING PROCEDURE FOR RESEARCH 1. BACKGROUND 14. Amendments to Research Studies Amendments are changes made
More informationIMP Management and Accountability
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More informationSource And Regulatory Documentation for DMID Clinical Studies
Source And Regulatory Documentation for DMID Clinical Studies Walt Jones RN, MPH Nurse Consultant Clinical Monitoring Coordinator OCRA, DMID, NIAID November, 2007 Source Data Defined All information in
More informationECTU Central Office SOP ECTU_TM_17 Management of Trial (IMP) Supplies
ECTU Central Office SOP ECTU_TM_17 Management of Trial (IMP) Supplies SOP number: ECTU TM 17 Signature Date Authored by: Holly Ennis, Trial Manager 6 th Sept 2017 Reviewed by: Laura Forsyth, Trial Manager
More informationStandard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies. SOP Number: UoA-NHSG-SOP-010 Version No: 2
Standard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies SOP Number: UoA-NHSG-SOP-010 Version No: 2 Author: Date: 27 th March 2015 (Carole Edwards, Lead Research
More informationRegulatory Binder Guidance
Regulatory Binder Guidance What is the purpose of a regulatory binder? Achieve and maintain regulatory compliance Ensure protection of human subjects and high standards of research Guidance for organization
More informationFRAMEWORK OF CHARACTERISTICS OF A QUALIFIED SITE TEAM: How Does Yours Measure Up?
FRAMEWORK OF CHARACTERISTICS OF A QUALIFIED SITE TEAM: How Does Yours Measure Up? The following framework of characteristics focuses on attributes that are within the control of investigators and their
More informationConducting and reporting a GCP Inspection. Gunnar Danielsson Medical Products Agency
Conducting and reporting a GCP Inspection Gunnar Danielsson Medical Products Agency Preparation for an inspection Inspection plan Create worksheets for the inspection general project specific study specific
More informationDocument Title: Site Recruitment and Initiation for Papworth Sponsored Studies
Document Title: Site Recruitment and Initiation for Papworth Sponsored Studies Document Number: SOP015 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For
More informationTrial Committees SOP Number: 47 Version Number: 2.0 Effective Date: 01/02/2017 Review Date: 01/02/2019
Standard Operating Procedures (SOP) for: Trial Committees SOP Number: 47 Version Number: 2.0 Effective Date: 01/02/2017 Review Date: 01/02/2019 Author: Reviewer: Reviewer: Authorisation: Name / Position:
More informationThe EFGCP Report on The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Bulgaria
The Procedure for the Ethical Review of Protocols for Clinical Research Projects in Europe (Update: April 2011) Bulgaria Question 1: What laws or regulations apply to an application for conducting a clinical
More informationStandard Operating Procedure. GCP Auditing of Research Studies
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-16-003 GCP Auditing of Research Studies SOP effective: 09 June 2017 Review date: 09 June 2019 SOP author signature: SIGNED COPY HELD WITHIN
More informationConfirming Research Study Capacity and Capability
Title: Outcome Statement: Written By: Confirming Research Study Capacity and Capability Researchers will be informed about the procedures and requirements for obtaining permission to conduct a research
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Training and Development SOP-QMS-007 Version Number 2 Issue Date 15 Apr 2016 Effective Date 26 May 2016 Review Date 26 May 2018 Author(s) Reviewer(s)
More informationGCP Basics - refresher
p. 01 GCP Basics - refresher Agenda: p. 02 Brief History of GCP GCP Regulations Principles of ICH E6 Sponsor Responsibilities Computer Systems Common Compliance Issues Brief History of GCP 3 Brief History
More informationGuidelines for Setting Up a Regulatory Binder
Guidelines for Setting Up a Regulatory Binder Prepare for an audit Georgamaly Estronza, MS UPR - Medical Sciences Campus IRB Administrator - Compliance Officer Email: georgamaly.estronza@upr.edu Introduction
More informationPharmacovigilance and safety reporting for sponsored ATIMPs/CTIMPs
Joint Research Management Office (JRMO) Standard Operating Procedure (SOP) for: Pharmacovigilance and safety reporting for sponsored ATIMPs/CTIMPs SOP Number: 26a Version Number: 13.0 Effective Date: 31
More informationISRCTN: EudraCT Number: Sponsor Protocol Number: UCL 08/0350. Pharmacy Manual
The StAmP Trial: A Proof of Principle, double blind, Randomised Placebo-Controlled, Multi Centre Trial of Statins to Ameliorate Early Onset Pre-eclampsia. ISRCTN: 23410175 EudraCT Number: 2009-012968-13
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Maintaining Study Files SOP-RES-014 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January 2018 Author(s)
More informationInspections: an academic perspective
Inspections: an academic perspective Patricia Henley Quality and Governance Manager Head, Research Governance & Integrity Office London School of Hygiene & Tropical Medicine Email: patricia.henley@lshtm.ac.uk
More informationStandard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies. SOP Number: SOP-QA-9 Version No: 1
Standard Operating Procedure: Obtaining Informed Consent from Competent Adults for Research Studies SOP Number: SOP-QA-9 Version No: 1 Author: Date: 1-9-15 (Carole Edwards, Lead Research Nurse, NHS Grampian)
More informationSTUDY CLOSURE AND ARCHIVING
STUDY CLOSURE AND ARCHIVING DOCUMENT NO.: CR009 v2.0 AUTHOR: Lynn Smith ISSUE DATE: 15 August 2016 EFFECTIVE DATE: 29 August 2016 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research
More informationRDSOP16 Writing a GCP Compliant Protocol for Non-CTIMPs. Greater Manchester Mental Health NHS Foundation Trust
RDSOP16 Writing a GCP Compliant Protocol for Non-CTIMPs Greater Manchester Mental Health NHS Foundation Trust Title of Standard Operating Procedure: RDSOP16 Writing a GCP Compliant Protocol for Non-CTIMPs
More informationRegulatory and ethical requirements in medical device studies. Finland
Regulatory and ethical in medical device studies Finland SECTIONS A.Type of research SECTIONS A.Type of research We have differentiated 8 types of research: Medical device alone with CE mark use within
More informationMarie-Claire Good, RG and GCP Manager James Rickard, Deputy Chief Pharmacist Technical Services Cheryl Lawrence, Senior Research Pharmacist
Standard Operating Procedures (SOP) for: IMP Management BH/QMUL Sponsored CTIMPs SOP Number: 42a Version Number: 3.0 Effective Date: 14 th August 2017 Review Date: 14 th August 2019 Author: Reviewer: Reviewer:
More informationGood Clinical Practice
Clinical Site Monitoring DMID/ICSSC 10/7/08 1 Monitoring ICH E6 5.18.1 The purpose of monitoring is to ensure that: The rights and well-being of subjects are being protected The data are accurate, complete
More informationStandard Operating Procedure. Vendor Management
REFERENCE: VERSION NUMBER: 2.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: Clinical Trials Manager, Contracts & Quality Management Officer REVIEWED BY: Research & Innovation Group APPROVED BY:
More information4.2. Investigator Regulatory Binder: Files, usually a binder, maintained by the investigator at the investigative site.
POLICY #: RCO-203 Page: 1 of 7 1. POLICY STATEMENT: Essential regulatory documents will be on maintained for research sponsored by or conducted at Dana-Farber/Harvard Cancer Center (DF/HCC) to assure compliance
More informationClinical Trial Basics:
Clinical Trial Basics: Components and Responsibilities Pre-Award Aida Nana Ama Manu, Project Coordinator Four Main Components Non-Disclosure Agreements Institutional Review Board Application Clinical Trial
More informationStandard Operating Procedure for Archiving
Standard Operating Procedure for Archiving SOP name: NWORTH07/19 archiving Version 2 Authorship Team: Angela Gliddon & Rhiannon Whitaker Meeting date reviewed 16 th April 2008 Designated NWORTH member
More informationEnd of Study Notification, Close-Out and Reporting Sponsored Research. Noclor/Spon/S11/01. SOP Reference ID:
End of Study Notification, Close-Out and Sponsored Research SOP Reference ID: Noclor/Spon/S11/01 Version Number 1.0 Effective Date: 6 th June 2016 It is the responsibility of all users of this SOP to ensure
More informationObjectives Discuss the importance of proper data collection. Identify the types of data collected for clinical trials. List potential source documents
Data Management in Clinical Trials Introduction to the Principles and Practice of Clinical Research January 24, 2011 Diane St. Germain, RN, MS, CRNP Nurse Consultant Division of Cancer Prevention National
More informationCompliance and Quality Monitoring: What, Why, When, and How
Compliance and Quality Monitoring: What, Why, When, and How Jeanna Julo, BA, BA, CCRP Assistant Director, Clinical Data Management & Quality Controls, Auditing & Training Research Institute, University
More informationGCP INSPECTION FINDINGS Singapore Research Ethics Conference 2018
1 GCP INSPECTION FINDINGS Singapore Research Ethics Conference 2018 Sumitra Sachidanandan GCP Inspection Consultant Clinical Trials Branch Health Products Regulation Group Health Sciences Authority Singapore
More informationRD SOP32 Gaining MHRA Approval
RD SOP32 Gaining MHRA Approval Version Number: 1.0 Name of originator/author: Dr Lloyd Gregory Name of responsible committee: R&I Committee Name of executive lead: Medical Director & Director of Quality
More informationViews of a Clinical Study Report
Out-of-(CSR)-Body Experiences Tips on Assembling Appendices, Datasets, and CRFs Susan C Sisk, PhD, RAC 1 Views of a Clinical Study Report OR Photos courtesy of Leigh Vaughan and RAPS, 2008 2 Topics Process
More informationSally Burtles, Director of Research Services & Business Development
Standard Operating Procedures (SOP) for: Process for Researchers - Amendments for Sponsored Studies (including halting studies and early termination) SOP Number: 17c Version Number: 2.0 Effective Date:
More informationStandard Operating Procedures
Standard Operating Procedures 4.7.2 Unblinding Version V2.3 Author/s Approved B Fazekas, S Kochovska D Currow Effective date 28/02/2018 Review date 31/12/2019 DO NOT USE THIS SOP IN PRINTED FORM WITHOUT
More informationStandard Operating Procedures Guidelines for Good Clinical Practice
SOP # CRSC-105 Effective Date 10-22-2013 Version # 1 Version Date 7-30-2013 Standard Operating Procedures Guidelines for Good Clinical Practice Purpose: This SOP outlines the steps required to follow FDA
More informationDate: 23 rd December 2014 Version 5 Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03)
Page 1 of 8 STANDARD OPERATING PROCEDURE FOR TRIAL INITIATION AND SITE SET UP (NWORTH 3.03) Approvals Principal Author Name: D. Skelhorn Signature: D. Skelhorn Date: 22/12/2014 Quality Assurance Officer
More informationUNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH SUPPORT OFFICE
UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH SUPPORT OFFICE STANDARD OPERATING PROCEDURES University of Leicester (UoL) Research Governance
More informationQuality Assurance QA STANDARD OPERATING PROCEDURE FOR FDA or Pharmaceutical Sponsored Audits
Quality Assurance QA 601.01 STANDARD OPERATING PROCEDURE FOR FDA or Pharmaceutical Sponsored Audits Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick
More informationDocument Number: SOP/RAD/SEHSCT/003 Page 1 of 9 Version 2.0
Standard Operating Procedures (SOP) Research and Development Office Title of SOP: Archiving Study Documents SOP Number: 3 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August
More informationResearch & Development. J Illingworth and S Moffat. Research, pharmacy and R&D staff
Department Title of SOP Research & Development SOP reference no: R&D GCP SOP 08 Authors: Reviewed by Current version number and date: J H Pacynko J Illingworth and S Moffat Version 4, 04.02.19 Next review
More informationMonitorización del ensayo clínico
Monitorización del ensayo clínico Dr. Salvador Ribas Ribas E-mail: salvador.ribas@gmail.com III CURSO PARA INVESTIGADORES SOBRE NORMAS DE BUENA PRÁCTICA CLÍNICA (BPC) Tenerife, 16 de septiembre 2009 Definition
More informationManagement and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility
Management and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility Document Detail Document type Standard Operating Procedure CRF-STU-SOP-1: Management and Accountability
More informationRegulatory and ethical requirements in medical devices studies. Turkey
Regulatory and ethical in medical devices studies Turkey SECTIONS A.Type of research H. Data Protection SECTIONS A.Type of research H. Data Protection We have differentiated 8 types of research: Medical
More informationWriting a Protocol for CTIMPs
REFERENCE: VERSION NUMBER: 4.0 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: REVIEWED BY: APPROVED BY: CONTROLLER: Clinical Trials Manager; Clinical Trials Officer Research & Innovation Group
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Archiving and the Destruction of Records SOP-RES-028 Version Number 2 Issue Date 08 th Dec 2015 Effective Date 22 nd January 2016 Review Date 22 nd January
More informationImplementing Good Clinical Practice at an Academic Research Institution
Implementing Good Clinical Practice at an Academic Research Institution Maintaining Essential Documents Partners Human Research Quality Improvement (QI) Program Stephen W. Hayes Outline Significance of
More informationRegulatory and ethical requirements in medical devices studies. France
Regulatory and ethical in medical devices studies France SECTIONS A.Type of research SECTIONS A.Type of research We have differentiated 8 types of research: Medical device alone with CE mark use within
More informationPresented by NC TraCS Institute UNC Office of Clinical Trials UNC Network for Research Professionals
ORIENTATION FOR NEW CLINICAL RESEARCH COORDINATORS Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network for Research Professionals Overall Agenda for Orientation Module 1: Introduction
More informationInvestigational Medicinal Product (IMP) Management Standard Operating Procedure
Reference Number: UHB 040 Version Number: 3 Date of Next Review: 26 Apr 2019 Previous Trust/LHB Reference Number: T 363 Standard Operating Procedure Introduction and Aim This procedure is written to support
More informationManagement and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility
Management and Accountability of Investigational Medicinal Products in the King s Clinical Research Facility Document Detail Document type Standard Operating Procedure CRF-STU-SOP-1: Management and Accountability
More informationCOMBINED RISK ASSESSMENT
COMBINED RISK ASSESSMENT DOCUMENT NO.: GS002 v3.0 AUTHOR: Lorn Mackenzie ISSUE DATE: 04 AUG 2017 1 INTRODUCTION 1.1 The Academic & Clinical Central Office for Research & Development (ACCORD) is a joint
More information1 The Clinical Research Coordinator (CRC)... 1
TABLE OF CONTENTS Dedication... iii Introduction... xi 1 The Clinical Research Coordinator (CRC)... 1 Role and Responsibilities of the CRC...1 Personality and Skills... 3 Where Do CRCs Work?... 3 CRC Responsibilities...
More informationStandard Operating Procedure. GCP Auditing of Research Studies. SOP effective: 23rd January 2018 Review date: 23rd January 2020
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-16-005 GCP Auditing of Research Studies SOP effective: 23rd January 2018 Review date: 23rd January 2020 SOP author signature: Signed copy
More informationRegulatory Documentation and Submissions for C2012 Clinical Trials DCP SOP #1
Regulatory Documentation and Submissions for C2012 Clinical Trials DCP SOP #1 Phone: 650.691.4400 Fax: 650.691.4410 Email: regulatory.ccsainc.com COMPLIANCE & STANDARDIZATION Rationale for Revision of
More information