Statistical Considerations
|
|
- David Douglas
- 5 years ago
- Views:
Transcription
1 Version 1.3 Effective date: 21 May 2012 Author: Approved by: Dr Ranjit Lall, Research Fellow Statistician Dr Sarah Duggan, CTU Manager Revision Chronology: Effective Date Version May 2012 Version April 2010 Version st January 2008 Reason for change Bi-annual review: Web site link updated. Format change Bi-annual review: Web site link updated Bi-annual review: Format change. Version 1.0 March 2006 Page 1 of 5
2 1. Purpose The purpose of this Standard Operating Procedure (SOP) is to detail the statistical input into the conduct of a clinical trial. 2. Background Access to statistical expertise is essential before and during the entire trial procedure. This should commence with designing the protocol and end with completion of the final report. 3. Procedure 3.1 Who? This SOP has been written primarily for the statistician who will be assisting in the conduct of a trial. 3.2 When? Statistical input should be provided throughout the entire trial. 3.3 How? Planning and preparation of a new trial After agreement on the objectives of the trial, a statistician must critically review the entire first draft of the protocol with special attention being made to: objective of the trial (endpoints) and an a priori rationale for the target differences between treatments which the trial is being designed to detect; trial design e.g. parallel groups, crossover design; Criteria for evaluation and definition of end-points; e.g. response rate, quality of life assessment and methods of computation and calculation; Registration and randomisation of patients (stratification factors), procedures and practical arrangements. In the case of a blinded trial the protocol must state the conditions for which the code may/must be broken. A system is required enabling access to the treatment of individual subjects in case of emergency. The system must only permit access to treatment code of one subject at a time. If the code is broken this must be justified. Measures to avoid bias Statistical considerations for the protocol Sample size, taking into account clinical and scientific information and professional judgement on the clinical significance of differences that could be detected. Power Significance Statistical methods Page 2 of 5
3 Interim analysis: the possibility and circumstances of these, along with their frequency, must be specified. Early stopping rules (generalised) The statistician must review the final version of the protocol. After the approval of the protocol, the statistician should review the case report forms (CRFs) and the implemented registration/randomisation procedures Statistical Analysis Plan See SOP 21 Statistical Analysis Plan The Statistical Analysis Plan (SAP) should be produced following the guidelines detailed in the Statistical Analysis Plan SOP. Any deviations from the final SAP should be described and justified in the final report of the trial Statistical Analysis The analysis of the trial must be carried out or confirmed by an identified, appropriately qualified and experienced Statistician. Prior to any analysis the trial statistician should perform an initial data freeze of the trial database and place it on a secure specific directory (i.e. create a non-dynamic dataset). The trial statistician should be responsible for importing data into their preferred validated statistical package (e.g. SAS, Stata, S-Plus, SPSS, BMDP), SAS being the current standard. Prior to analysing the data, the statistician must carry out validation checks on the data quality and integrity (e.g. range checks, outliers, missing observations) as detailed in the SAP. The trial statistician should refer any data queries arising during the analysis to the trial co-ordinator and/or data manager (as appropriate) for investigation or resolution. The trial/data manager should amend the current (dynamic) database and the statistician should delete their initial data freeze and perform a re-freeze of the current database. Steps 1-4 may be repeated until data queries are satisfied before the final data lock. The trial statistician is responsible for the statistical programmes for analyses, which include appropriate exploratory annotation throughout. The final version will be placed in the Statistical Analysis Plan Master file. The trial statistician is responsible for running the statistical programmes to carry out analyses. Results should be discussed with the Chief Investigator as appropriate. Statistical results should be reported according to the CONSORT guidelines. (A link to these is available via the clinical trials unit website at Page 3 of 5
4 The results of the analyses should be presented in a manner likely to facilitate the interpretation of their clinical importance. Estimates of the magnitude of the treatment effects or differences and confidence intervals should be quoted, rather than placing sole reliance on significance testing. The statistician is responsible for producing open and closed (i.e. confidential) statistical reports as required. The open report will be endorsed by the inhouse Trial Management Group for typographical or analytical errors. The final version is signed and dated by the statistician(s) involved and placed in the Trial Results Master file. All closed reports and patient data should be kept confidential (e.g. locked in filing cabinet). Statistical Analysis Master File: This should include the statistical analysis plan and specify the location of all electronic files contained in the SAP master file Interim analyses Objectives An interim analysis includes any examination of the data during the course of a trial for which results are presented for one or more treatment groups. The interim analysis CTAP should provide a comprehensive and detailed description of the methods of analysis and presentation of the data. Interim analyses should follow the same procedure as a final analysis Procedures Any changes, e.g. unplanned interim analysis, must be justified and fully documented in the final statistical report. If appropriate, the interim analysis should also state the method of unblinding. This must ensure that the conduct of the trial is not comprised. The SAP for the interim analysis/analyses should clearly state the reasons for the interim analysis (e.g. ethical (including safety or efficacy) or to provide information for trial management). The plan should also consider whether there is likely to be sufficient power to satisfy the trial objectives. The plan should also state which committees review full or summarised (e.g. blinded) reports of the interim analysis results. Any restriction on circulation should be defined Trial results The Trial Results Master File is a file which includes all documents produced: Independent Data Monitoring Committee reports, abstracts, final paper(s) and summary reports from other analyses such as planned interim analyses. Both files (Statistical Analysis Plan Master file and Trial Results Master file) are the responsibility of the trial statistician Missing data The handling of any missing data within clinical trials is an important consideration, as failure to identify properly the influences of the missing data Page 4 of 5
5 may cause bias and possibly nullify the value of the obtained results, as their validity will be questionable. The number of incomplete variables, the patterns and the frequency of any missing data in all outcome variables and covariates should be investigated. Any retrievable data should be collected prior to analyses (see SOP 15 Data Management). If possible, record any potential reasons for the missing data that will help to determine the type of missing data; that is, whether it is Missing Completely at Random (MCAR), Missing at Random (MAR) or Missing Not at Random (MNAR). The mechanism that resulted in the missing data should be investigated as far as possible, by comparing the characteristics of cases with complete data with those with incomplete data. A decision is required regarding the most appropriate method for handling the missing data. Justifications for this choice should be provided. Complete case analysis uses only the complete cases, and, therefore, is always inefficient, even when the estimates are unbiased as the data are MCAR. Imputation fills in the incomplete data with plausible values, based on the strengths of the associations with the observed data, thus allowing all cases to be analysed and reducing the non-response bias. When imputation is considered appropriate, multiple imputation will generally be preferred over single imputation as it properly accounts for the uncertainty in the imputed values, especially when missing data exists in more than one variable. The method and model used for imputation, together with the statistical programme used should be clearly specified. All missing data methods have underlying and often untestable assumptions. Therefore, the sensitivity of the results to these assumptions and also other model specifications should be investigated. Some data may require their own specific algorithms for imputing missing data (e.g. the SF-12 scale). These algorithms should be stated and referenced in the SAP. List of abbreviations CRF Case Report Form MAR Missing at Random MCAR Missing Completely at Random MNAR Missing Not a Random SAP Statistical Analysis Plan SOP Standard Operating Procedure Page 5 of 5
Standard Operating Procedure for Statistical Reports
Reports_V01.doc Page 1 of 6 Standard Operating Procedure for Statistical Reports SOP ID Number: Effective Date: 22/01/2010 Version Number & Date of Authorisation: V01,15/01/2010 Review Date: 22/01/2012
More informationTrial Protocol. Version 1.2. Effective date: 18 May Dr Sarah Duggan, CTU Manager. V May 2010 Update web links.
Trial Version 1.2 Effective date: 18 May 2010 Reviewed by: Approved by: Claire Daffern, QA Manager Dr Sarah Duggan, CTU Manager Revision Chronology: Effective Date Reason for change V1.2 18 May 2010 Update
More informationQuality Control in Clinical Trials Blinding, Clinical Event Committees, Core Labs, and Data Standards
Quality Control in Clinical Trials Blinding, Clinical Event Committees, Core Labs, and Data Standards Roxana Mehran Columbia University Medical Center Cardiovascular Research Foundation Disclosures Research
More informationHow To Design A Clinical Trial. Statistical Analysis. Gynecologic Cancer InterGroup
How To Design A Clinical Trial Statistical Analysis Andrew Embleton PhD student/medical Statistician MRC Clinical Trials Unit at UCL At what points do you need to consider statistics? At what points do
More informationDealing with Missing Data: Strategies for Beginners to Data Analysis
Dealing with Missing Data: Strategies for Beginners to Data Analysis Rachel Margolis, PhD Assistant Professor, Department of Sociology Center for Population, Aging, and Health University of Western Ontario
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Statistical Validation of Clinical Trial Protocols and Case Report Forms SOP number: ST 001 SOP category: Statistics
More informationGood Practice in PMA Submissions for Efficient Regulatory Decision Making
Good Practice in PMA Submissions for Efficient Regulatory Decision Making Rajesh Nair, Ph.D. FDA/CDRH August 21, 2014 Outline Highlights and impact of MDUFA III on review clock Frequently encountered issues
More informationStandard Operating Procedure. SOP effective: 19 February 2016 Review date: 19 February 2018
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-18-002 Randomisation and Code Breaking SOP effective: 19 February 2016 Review date: 19 February 2018 SOP author signature: SIGNED COPY HELD
More informationPROTOCOL DRAFTING GUIDE
MUHC Research Ethics Board (Neurosciences & Psychiatry) Comité d éthique de la recherche du MUHC (Neurosciences & psychiatrie) PROTOCOL DRAFTING GUIDE LIST OF ITEMS TO BE INCLUDED IN A PROTOCL FOR RESEARCH
More informationOFFICE FOR RESEARCH PROCEDURE PROTOCOL & INVESTIGATIONAL BROCHURE, CONTENT, DESIGN, AMENDMENTS & COMPLIANCE
OFFICE FOR RESEARCH PROCEDURE PROTOCOL & INVESTIGATIONAL BROCHURE, CONTENT, DESIGN, AMENDMENTS & COMPLIANCE 1. Purpose: To describe the procedures related to the development of protocol and investigational
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 informationRDSOP28 Randomisation and Unblinding in Clinical Trials of an Investigational Medicinal Product (CTIMPs)
RDSOP28 Randomisation and Unblinding in Clinical Trials of an Investigational Medicinal Greater Manchester Mental Health NHS Foundation Trust Title of Standard Operating Procedure: Document Summary: Document
More informationSession 4: Statistical considerations in confirmatory clinical trials II
Session 4: Statistical considerations in confirmatory clinical trials II Agenda Interim analysis data monitoring committees group sequential designs Adaptive designs sample size re-estimation Phase II/III
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 informationInvestigator Site File Index (CTIMP)
Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol Current version plus all previous versions (or provide file note to detail location of previous
More informationStandard Operating Procedure Research Governance
Research and Enterprise Standard Operating Procedure Research Governance Title: Development, Review and Amendment: Study Protocol SOP Reference Number: QUB-ADRE-002 Date prepared 28 May 2008 Version Number:
More informationInvestigator Site File Index (Medical Devices)
Study Title: Site Name/Number: REC Reference Number: Sponsor Reference Number: EudraCT Number: 1. Protocol (Clinical Investigation Plan) Current version plus all previous versions (or provide file note
More 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 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 informationWhat s New in GCP? FDA Draft Guidance Details FIH Multiple Cohort Trials
Vol. 14, No. 10, October 2018 Happy Trials to You What s New in GCP? FDA Draft Guidance Details FIH Multiple Cohort Trials While multiple, concurrently accruing patient cohorts in first-in-human (FIH)
More informationArchives of Scientific Psychology Reporting Questionnaire for Manuscripts Describing Primary Data Collections
(Based on APA Journal Article Reporting Standards JARS Questionnaire) 1 Archives of Scientific Psychology Reporting Questionnaire for Manuscripts Describing Primary Data Collections JARS: ALL: These questions
More informationBios 6648: Design & conduct of clinical research
Bios 6648: Design & conduct of clinical research Section 3 - Essential principle (randomization) 3.4 Trial monitoring: Interim decision and group sequential designs Bios 6648- pg 1 (a) Recruitment and
More informationArchives of Scientific Psychology Reporting Questionnaire for Manuscripts Describing Primary Data Collections
(Based on APA Journal Article Reporting Standards JARS Questionnaire) 1 Archives of Scientific Psychology Reporting Questionnaire for Manuscripts Describing Primary Data Collections JARS: ALL: These questions
More informationImplementing Current Regulatory Guidance: An Industry Perspective
Implementing Current Regulatory Guidance: An Industry Perspective European Statistical Meeting: Advances in the Treatment of Missing Data November 18, 2011 Brussels Mouna Akacha, Novartis Pharma AG Basel
More informationQuality Assurance in Clinical Trials Introduction
Quality Assurance in Clinical Trials Introduction Doctor Catherine CORNU, Lyon clinical Investigation Centre EUDIPHARM December 2012 1 Delphine TEPPE-CROITROU - Catherine CORNU (Hospices Civils de Lyon)
More informationAuthor Signature: Date: 11 October 2017 The author is signing to confirm the technical content of this document
MELBOURNE CHILDREN S TRIALS CENTRE (MCTC) Guideline document title: Developing, amending and complying with research protocols Version: 2.0 Author: Melbourne Children s Trials Centre (MCTC) Author Signature:
More informationEisuke Hida & Yuki Ando Biostatistics group Pharmaceuticals and Medical Devices Agency
Eisuke Hida & Yuki Ando Biostatistics group Pharmaceuticals and Medical Devices Agency This is not an official PMDA guidance or policy statement. No official support or endorsement by the PMDA is intended
More informationCurrent State of Endpoint Adjudication in Device Trials Academic View
HARVARD MEDICAL SCHOOL Current State of Endpoint Adjudication in Device Trials Academic View CSRC/MDEpiNet Device Adjudication March 11, 2016 Donald E. Cutlip, MD Harvard Clinical Research Institute Smith
More informationGuideline on good pharmacovigilance practices (GVP)
9 October 2017 EMA/813938/2011 Rev 3* Guideline on good pharmacovigilance practices (GVP) Module VIII Post-authorisation safety studies (Rev 3) Date for coming into effect of first version 2 July 2012
More informationGuideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/813938/2011 Guideline on good pharmacovigilance practices (GVP) Module VIII Post-authorisation safety studies Draft finalised by the Agency in collaboration with Member States and submitted
More informationQuality Assurance in Clinical Trials
Quality Assurance in Clinical Trials Doctor Catherine CORNU, Lyon clinical Investigation Centre EUDIPHARM December 5th, 2011 1 Introduction: quality in clinical research in human subjects Regulatory requirements:
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 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 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 informationImplications for Investigator Initiated Trials (IITs)- Risk Based Approaches in Managing Clinical Trials
Implications for Investigator Initiated Trials (IITs)- Risk Based Approaches in Managing Clinical Trials Lisa Marie Saldanha Senior Director & Head Academic Research & Delivery Solutions Real World Insights
More informationData Quality and Integrity: From Clinical Monitoring to Marketing Approval
Data Quality and Integrity: From Clinical Monitoring to Marketing Approval Nancy Detich, Ph.D., C.C.R.P. Senior Scientist, Clinical Strategy 18 November 2010 1 Objectives Identify the importance of accuracy,
More informationR&D Administration Manager. Research and Development. Research and Development. NHS Staff Trust-Wide THIS IS A CONTROLLED DOCUMENT
Document Title: Document Number: Research Protocol Design for Papworth Sponsored Studies SOP019 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by:
More informationThis document provides guidelines for unblinding participants enrolled in IMPAACT clinical trials.
APPENDIX I UNBLINDING PROCEDURES... 1 I.1 Purpose... 1 I.2 Scope... 1 I.3 Definitions... 1 I.3.1 Blinding... 1 I.3.2 Unblinding... 2 I.3.3 Open-label or Unblinded Study... 2 I.4 Roles and Responsibilities...
More informationRisk-Based Monitoring: How Can It Be Implemented For More Effective Study Oversight
Risk-Based Monitoring: How Can It Be Implemented For More Effective Study Oversight Lisa Marie Saldanha Senior Director & Head of Operations Real World Insights Asia Singapore Research & Ethics Conference
More informationTrial oversight SOP for HEY-sponsored CTIMPs
R&D Department Trial oversight SOP for HEY-sponsored CTIMPs Hull And East Yorkshire Hospitals NHS Trust 2010 All Rights Reserved No part of this document may be reproduced, stored in a retrieval system
More 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 informationSTANDARD OPERATING PROCEDURE SOP 320. Developing a Research Protocol
STANDARD OPERATING PROCEDURE SOP 320 Developing a Research Protocol Version 2.1 Version date 26.03.2017 Effective date 26.03.2017 Number of pages 14 Review date April 2019 Author NNUH UEA Joint Research
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 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 informationPhUSE Single Day Event 2009, Frankfurt
Risk Based Approach Applied to the Validation of Report Objects PhUSE Single Day Event 2009, Frankfurt Christoph Ziegler, F. Hoffmann La Roche AG, Basel, Switzerland Agenda Introduction Definition of Risk
More informationELEMENTS OF A DATA MONITORING PLAN
ELEMENTS OF A DATA MONITORING PLAN Definitions Data Monitoring: The regular evaluation of data and documentation collected during a study to ensure both adherence to the approved investigative plan and
More informationSWOG ONCOLOGY RESEARCH PROFESSIONAL (ORP) MANUAL STUDY PROTOCOL CHAPTER 14 REVISED: OCTOBER 2015
THE STUDY PROTOCOL The study protocol is a written document detailing how a clinical trial is conducted. The elements of a protocol include: 1. Trial design and organization; 2. Study objectives; 3. Background
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 informationSecure Interim Analysis Data Access. Management with ACES. Eric J. Silva, Cytel, Inc. Steven Ketchum, Ph.D., Sunesis Pharmaceuticals
Secure Interim Analysis Data Access and Automated DMC/DSMB Management with ACES Eric J. Silva, Cytel, Inc. Steven Ketchum, Ph.D., Sunesis Pharmaceuticals Introductions: Today s Speakers Eric J. Silva Manager,
More informationDMC membership experience. P.Bauer Basel May 2016
DMC membership experience P.Bauer Basel May 2016 EMA GUIDELINE ON DATA MONITORING COMMITTEES Clinical trials frequently extend over a long period of time. Thus, for ethical reasons it is desirable to ensure
More informationMRC. Clinical Trials. Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS. Medical Research Council
MRC Clinical Trials Series MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 Medical Research Council MRC GUIDELINES FOR GOOD CLINICAL PRACTICE IN CLINICAL TRIALS 1998 MRC GUIDELINES FOR
More informationSOP24: Standard Operating Procedure for Randomisation
SOP24: Standard Operating Procedure for Randomisation Authorship Team: Alan Watkins for Joint SOP Group on Trial Techniques (viz Bridget Wells, Kerina Jones, Moira Morgan, Sian Davies, Sinead Brophy, Steve
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 informationEnd-to-End Management of Clinical Trials Data
End-to-End Management of Clinical Trials Data A Revolutionary Step Toward Supporting Clinical Trials Analysis Over the Next Decades of Clinical Research WHITE PAPER SAS White Paper Table of Contents Introduction....
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 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 informationReflection paper on the use of extrapolation in the development of medicines for paediatrics
1 2 3 9 October 2017 EMA/199678/2016 4 5 6 Reflection paper on the use of extrapolation in the development of medicines for paediatrics Draft Draft agreed by Biostatistics Working Party September 2017
More informationThe role of the Clinical Trials Unit Emma Hall PhD CStat Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU)
in partnership with The role of the Clinical Trials Unit Emma Hall PhD CStat Institute of Cancer Research Clinical Trials and Statistics Unit (ICR-CTSU) CTRad Clinical Trials Workshop 14/10/2014 What is
More informationMarcia Brackman, Data Scientist Eli Lilly and Company
k Marcia Brackman, Data Scientist Eli Lilly and Company Adaptive Design: A clinical study design that uses accumulating data to decide how to modify aspects of the study as it continues, without undermining
More informationAchieves International Standards
Rising to Excellence How a China CRO Achieves International Standards Helen Yin, VP & GM Tigermed-MacroStat Minzhi Liu, GM, MacroStat July 7 th, 2012 1 Outline Selecting excellent staff Training staff
More informationFDA S DRAFT GUIDANCE ON MULTIPLE ENDPOINTS IN CLINICAL TRIALS: OVERVIEW, RECEPTION AND NEXT STEPS. John Scott, Ph.D. FDA/CBER 5 October 2017
FDA S DRAFT GUIDANCE ON MULTIPLE ENDPOINTS IN CLINICAL TRIALS: OVERVIEW, RECEPTION AND NEXT STEPS John Scott, Ph.D. FDA/CBER 5 October 2017 Disclaimer 2 This presentation reflects the views of the author
More informationGood Clinical Practice Inspections Expectations for Compliance with Sponsor Responsibilities, Part II
Good Clinical Practice Inspections Expectations for Compliance with Sponsor Responsibilities, Part II IMB Clinical Trials Seminar, 19 th June 2012 Ms. Sinead Curran GCP/Pharmacovigilance Inspector 22/06/2012
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 informationAttachment B: A Guideline for Writing a Clinical Protocol for CPRN
Attachment B: A Guideline for Writing a Clinical Protocol for CPRN This document provides guidelines for protocol submission. It is only guidance, and the format in which you choose to present the information
More informationPublic release of clinical information in drug submissions and medical device applications
Public release of clinical information in drug submissions and medical device applications Health Products and Food Branch March 10, 2017 Health Canada is the federal department responsible for helping
More informationDFG. Proposal Preparation Instructions. Clinical Trials Draft Proposals. DFG form /14 page 1 of 8
form 17.03 10/14 page 1 of 8 Proposal Preparation Instructions Clinical Trials Draft Proposals form 17.03 10/14 page 2 of 8 Please write your proposal in English and use the Draft Proposal Template ( form
More informationTENCENT HOLDINGS LIMITED
Terms of Reference of Audit Committee TENCENT HOLDINGS LIMITED (the Company ) Audit Committee Composition, terms of reference and responsibilities Definition 1. For the purposes of these terms of reference:
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 informationGUIDELINES ON MEDICAL DEVICES
EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Cosmetics and Medical Devices MEDDEV 2.7/4 December 2010 GUIDELINES ON MEDICAL DEVICES GUIDELINES ON CLINICAL INVESTIGATION:
More informationECPAG Effectively Communicating Pharmacometric Analysis Results & Implications
3KDUPDFRPHWULF$QDO\VLV3ODQV 7HFKQLFDO5HSRUWV ECPAG 2006 Effectively Communicating Pharmacometric Analysis Results & Implications -LOO)LHGOHU.HOO\ 933KDUPDFRPHWULF6HUYLFHV &62 &RJQLJHQ&RUSRUDWLRQ $GMXQFW$VVLVWDQW3URIHVVRU
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 informationClinical trial databases are a crucial investment in clinical research. Part 4 - The "Life" of a Data Manager - Project Manager for the Database
Clinical trial databases are a crucial investment in clinical research Part 4 - The "Life" of a Data Manager - Project Manager for the Database Speakers: M.Duvenhage K. Laras S. Erari 12 Oct 2018 Overview
More informationReflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples
1 2 3 26 August 2010 EMA/INS/GCP/532137/2010 GCP Inspectors Working Group 4 5 6 Reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples Draft Adoption
More informationAuthor Signature: Date: 10 October 2017 The author is signing to confirm the technical content of this document
SOP Title: Investigator s Brochure Content, Design, Amendments, Filing & Distribution Author: Clinical Research and Development Office (CRDO) Author Signature: Date: 10 October 2017 The author is signing
More informationPosition Description Clinical Research Associate
Job title Location ALLG Clinical Trial Centre, Richmond Reporting to Direct: ALLG Program Manager Indirect: ALLG Business Manager, ALLG CEO Main purpose of position Central coordination and data management
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 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 informationREGISTERED CANDIDATE AUDITOR (RCA) TECHNICAL COMPETENCE REQUIREMENTS
REGISTERED CANDIDATE AUDITOR (RCA) TECHNICAL COMPETENCE REQUIREMENTS 1. Context After completion of the recognised training contract, a period of specialisation is required, appropriate to the level required
More informationGUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION
EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE-GENERAL Consumer goods Cosmetics and Medical Devices MEDDEV 2.7.2 December 2008 GUIDELINES ON MEDICAL DEVICES GUIDE FOR COMPETENT AUTHORITIES IN
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 informationAdaptive Model-Based Designs in Clinical Drug Development. Vlad Dragalin Global Biostatistics and Programming Wyeth Research
Adaptive Model-Based Designs in Clinical Drug Development Vlad Dragalin Global Biostatistics and Programming Wyeth Research 2007 Rutgers Biostatistics Day February 16, 2007 Outline Definition and general
More informationDevelopment and Implications of a Redacted Clinical Trial Protocol for Posting Online With the Published Manuscripts
Development and Implications of a Redacted Clinical Trial Protocol for Posting Online With the Published Manuscripts Namit Ghildyal, Yvette Ng, Craig Tendler, Chris H. Takimoto, Susan Glasser Janssen Research
More informationCommon CSR Template Mapped to ICH E3 and CORE Guidance
Common CSR Template Mapped to ICH E3 and CORE Guidance ICH E3 CORE Common CSR Rationale 1. TITLE PAGE 1. TITLE PAGE TITLE PAGE Per CORE, title page does not 2. SYNOPSIS 2. SYNOPSIS SYNOPSIS require a Heading
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Medical Technologies Evaluation Programme
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Medical Technologies Evaluation Programme Sponsor submission of evidence: Evaluation title: Sponsor: Date sections A and B submitted: Date section C submitted:
More informationData Monitoring Committees (DMC)
Data Monitoring Committees (DMC) Mario Chen, PhD Advanced Biostatistics and RCT Workshop Office of AIDS Research, NIH ICSSC, FHI Goa, India, September 2009 1 Overview Why monitor data? When a DMC is needed?
More informationEvolving Role of the Data Manager
07 November 2016 Evolving Role of the Data Manager 2 Evolution of the Data Manager Role... 2014 2010 Mobility Early 90 s We all simply did it OUR way! No formal measure of data managers' knowledge and
More informationIntroduction to Adaptive Design Roger J. Lewis, MD, PhD
Introduction to Adaptive Design Roger J. Lewis, MD, PhD Financial Disclosures Berry Consultants, LLC Multiple clients U01 Support from National Institutes of Health/NINDS Food and Drug Administration AspenBio
More informationAdaptive Design for Medical Device Development
Adaptive Design for Medical Device Development A guide to accelerate clinical development and enhance portfolio value Executive Summary In May 2015, the FDA released a draft guidance document regarding
More informationA Life-cycle Approach to Dose Finding Studies
A Life-cycle Approach to Dose Finding Studies Rajeshwari Sridhara, Ph.D. Director, Division of Biometrics V Center for Drug Evaluation and Research, USFDA This presentation reflects the views of the author
More informationThis template is to be used by companies willing to submit an overview of relevant
Briefing book template for pharmaceuticals to support a multi-hta Early Dialogue (ED) December 13 th, 2013 This template is to be used by companies willing to submit an overview of relevant information
More informationBIOMETRICS SERVICES ADVISORY DATA OFFICE UNBLINDING SECURE INDEPENDENT TEAM PROGRAM. ADaM TRAINER SAFETY SDTM COMPLIANT TA-EXPERTISE SDTM DATA
BIOMETRICS SERVICES DELIVER UNBLINDED DATASETS TO IDMC SDTM-IG UNBLINDING ADVISORY QUALITY ON TIME DEDICATED DATA SECURE BOARD EMERGENCY PARTNERSHIPTEAM DATA OFFICE UNBLINDING INVESTINGEXPERTISE SHARING
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Creation, Review and Management of Standard Operating Procedures for Research SOP Number: 1 Version Number: 2.0 Supercedes:
More informationSafety Reporting Part 1: For Clinical Trials of Investigational Medicinal Products (CTIMPs)
Part 1: For Clinical Trials of Investigational Medicinal Products (CTIMPs) Version 1.4 Effective date: 1 December 2011 Author: Approved by: Claire Daffern, QA Manager Dr Sarah Duggan, CTU Manager Revision
More informationGuide for Manufacturers and Sponsors on Clinical Investigations Carried Out in Ireland
Guide for Manufacturers and Sponsors on Clinical Investigations Carried Out in Ireland AUT-G0095-1 15 AUGUST 2014 This guide does not purport to be an interpretation of law and/or regulations and is for
More informationMoving Forward. Adaptive Eligibility Criteria, Alternate Trial Designs, and Subgroup Analysis. Elizabeth Garrett-Mayer, PhD
Moving Forward Adaptive Eligibility Criteria, Alternate Trial Designs, and Subgroup Analysis Elizabeth Garrett-Mayer, PhD Eligibility Trade-offs Broad eligibility Pros: Heterogeneous group Can generalize
More informationHeterogeneity Random and fixed effects
Heterogeneity Random and fixed effects Georgia Salanti University of Ioannina School of Medicine Ioannina Greece gsalanti@cc.uoi.gr georgia.salanti@gmail.com Outline What is heterogeneity? Identifying
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 information