SECURE DATA OFFICE: AN INDEPENDENT TEAM THAT CAN COME TO THE RESCUE IN BLINDED TRIALS
|
|
- Sherman Crawford
- 5 years ago
- Views:
Transcription
1 SECURE DATA OFFICE: AN INDEPENDENT TEAM THAT CAN COME TO THE RESCUE IN BLINDED TRIALS Annelies Van Zeveren, PhD Project Manager Biometrics and Medical Affairs SGS Life Science Clinical Research PhUSE US Connect 2018
2 OVERVIEW n Introduction n Secure Data Office tasks Randomisation Data The Pharmacokinetic (PK) Data flow Other unblinding data streams Cleaning of unblinding data Deliver blinded result transfers Deliver data to unblinded teams n Conclusion 2
3 OVERVIEW n Introduction n Secure Data Office tasks Randomisation Data The Pharmacokinetic (PK) Data flow Other unblinding data streams Cleaning of unblinding data Deliver blinded result transfers Deliver data to unblinded teams n Conclusion 3
4 INTRODUCTION n Double blind study: Subject and investigator are unaware of treatment status Parties without access to unblinding data: subjects, investigators, Data Management, Statistics, PK analysts, sponsor Parties with access to unblinding data: pharmacists, bio-analytical lab, unblinded CRA n Unblinding data: Any data that can unblind the study n Downside: Treatment information, Pharmacokinetic & Immunogenicity data Biomarkers.. Unblinding data is not cleaned Delay in clinical database lock or unblinding data are not included in lock Crunched timelines for some parts of the analysis 4
5 Who should handle randomisation data and other unblinding data (e.g. PK, biomarker, immunogenicity data)?
6 SD OFFICE n Dedicated team, physically separated from other study team members n Separate databases and secure server locations n Clearly defined processes in SOPs and WIs 6
7 OVERVIEW n Introduction n Secure Data Office tasks Randomisation Data The Pharmacokinetic (PK) Data flow Other unblinding data streams Cleaning of unblinding data Deliver blinded result transfers Deliver data to unblinded teams n Conclusion 7
8 RANDOMISATION DATA n Generation of randomisation lists Documented randomisation list specifications By SAS programmers with statistical background Distribution to required recipients n Support and handle of unblinding data in IWRS system n Creation of SDTM dataset containing randomisation information based on following input Subject information: from data management Receive randomisation information: from external vendor or internally created 8
9 PK DATA FLOW n PK data (Identifiers and results): Bio-analytical lab SDO n Blinded transfers: SDO DM n Cleaning is performed by DM n DM delivers clean PC file to SDO Contains CRF and sample tracking data Without results n SDO delivers clean PC file with results to include at time of database lock 9
10 1 Central lab 3 Ship sample and shipping list BAN lab Ship sample, req. Form and shipping list Investigational site Transfer ST file for reconciliation Transfer SAMPID file Transfer Results file ZOOM 1 Capture ecrf data into clinical database 5 Data management 7 Send identifier file Send clean PC without concentrati ons 6 SD Office Create merged PC 9 Complete PK flow Send locked Clinical database Create PP dataset NCA output file NCA input file Clinical Pharmacology, Pharmacometrics 10
11 1 Central lab 3 Ship sample and shipping list BAN lab Ship sample, req. Form and shipping list Investigational site Transfer ST file for reconciliation Transfer SAMPID file Transfer Results file Capture ecrf data into clinical database 5 Data management 7 Send identifier file Send clean PC without concentrati ons 6 SD Office Creation of PC dataset Create merged PC 9 11
12 1 Central lab 3 Ship sample and shipping list BAN lab Ship sample, req. Form and shipping list Investigational site Transfer ST file for reconciliation Transfer SAMPID file Transfer Results file Capture ecrf data into clinical database 5 Data management 7 Send identifier file Send clean PC without concentrati ons 6 SD Office Create merged PC 9 Complete PK flow Send locked Clinical database Create PP dataset ZOOM 2 12 NCA output file NCA input file Clinical Pharmacology, Pharmacometrics 11 12
13 CREATION OF PK INPUT FILES AND PP DATASET Create merged PC 9 Data management Send locked Clinical database 10 SD Office Create PP dataset 13 NCA output file 12 NCA input file Creation of PP dataset Clinical Pharmacology, Pharmacometrics 11 13
14 Without SD Office CREATION OF PK/PD INPUT FILES BY SDO Database lock Start programming input file Final PK/PD input (NCA/ NONMEM) file ready PK/PD modeling Results Issues in DB? DB re-opening With SD Office Start programming input file Issues in DB? Solved before DB lock Database lock PK/PD modeling Results Time Gain Final PK/PD input (NCA/ NONMEM) file ready 14
15 OTHER UNBLINDING DATA STREAMS: LAB DATA n Similar to PK data stream n Only unblinding analytes via SDO n SDTM domains: LB, PD, IS n DM unblinded at release Yes: combine LB parts by DM No: combine LB parts and release by SDO 15
16 OTHER UNBLINDING DATA STREAMS: PROTOCOL DEVIATIONS n Identification of unblinding protocol deviations (usually medication kit errors) Protocol deviation defined as Any medication kit misallocation Only treatment misallocations Medication kit number unblinding? Y SD Office involved SD Office involved N Detection of medication kit misallocations by data management SD Office involved 16
17 OTHER UNBLINDING DATA STREAMS: PROTOCOL DEVIATIONS n Assigned medkit = planned data n Dispensed medkit = actual data n Reconciliation of planned and actual data by SDO n SDO creates part of the DV domain: Deviations related to medkit or treatment misallocations 17
18 CLEANING OF UNBLINDING DATA n Only if cleaning of the unblinding content is required n Cleaning requirements: in secure data handling plan n Cleaning Checks are: Defined Documented Programmed Validated Ran n Review output of checks n Write and follow up queries: blinded/unblinded 18
19 DELIVER BLINDED RESULT TRANSFERS TO BLINDED TEAMS n PK data (Identifiers and results), other unblinding data: external vendor SDO n Blinded transfers: SDO Data Management (DM) n Cleaning is performed by DM n Results transfer with dummy identifiers/scrambled: SDO Statistics, PK analysts: dry runs 19
20 DELIVER DATA TO UNBLINDED TEAMS n PK data (Identifiers and results), other unblinding data: external vendor SDO n Blinded transfers: SDO Data Management (DM) n Cleaning is performed by DM n Results transfer with real production data: SDO Safety commitee, DRC, Statistical Support Group (SSG) 20
21 OVERVIEW n Introduction n Secure Data Office tasks Randomisation Data The Pharmacokinetic (PK) Data flow Other unblinding data streams Cleaning of unblinding data Deliver blinded result transfers Deliver data to unblinded teams n Conclusion 21
22 CONCLUSION n Role of SD Office Create randomisation lists and datasets Clean data before database lock PK data Medication kit misallocations Other unblinding data Prepare input files for PK/PD analysis upfront -> analysis can start earlier n Results Time gain after database lock Higher quality Unblinded data available before database lock for DRC, SSG, dry runs Off the critical path and key results can be met 22
23 THANK YOU FOR YOUR ATTENTION Questions? Meet us at the SGS booth 5 clinicalresearch@sgs.com EUROPE: AMERICAS: JOIN THE SCIENTIFIC COMMUNITY CONNECT ON LINKEDIN 23
24 Agriculture, Food and Life Clinical Research Annelies Van Zeveren Project Director Biometrics and Medical Affairs SGS Belgium NV Phone: Life Science Fax: Generaal De Wittelaan 19a bus 5 annelies.vanzeveren@sgs.com 2800 Mechelen Web : Belgium Meet us at the SGS booth 5 clinicalresearch@sgs.com EUROPE: AMERICAS: JOIN THE SCIENTIFIC COMMUNITY CONNECT ON LINKEDIN 24
AUTOMATED SDTM CREATION AND DISCREPANCY DETECTION JOBS: THE NUMBERS TELL THE TALE. Joris De Bondt PhUSE Conference Oct 2014
AUTOMATED SDTM CREATION AND DISCREPANCY DETECTION JOBS: THE NUMBERS TELL THE TALE Joris De Bondt PhUSE Conference 2014 12-15 Oct 2014 OUTLINE n Setting the scene SGS Conversion Center SDTM data sources
More informationEDC integrations. Rob Jongen Integration Technology & Data Standards
EDC integrations Rob Jongen Integration Technology & Data Standards Past, Present and Future Past (10 years back) Few sources, all on paper Source data copied on paper CRF Data entry from CRF to clinical
More informationHow to write ADaM specifications like a ninja.
Poster PP06 How to write ADaM specifications like a ninja. Caroline Francis, Independent SAS & Standards Consultant, Torrevieja, Spain ABSTRACT To produce analysis datasets from CDISC Study Data Tabulation
More informationExamining Rescue Studies
White Paper Examining Rescue Studies Introduction The purpose of this White Paper is to define a Rescue Study, outline the basic assumptions, including risks, in setting up such a trial based on DATATRAK
More informationFrom ODM to SDTM: An End-to-End Approach Applied to Phase I Clinical Trials
PhUSE 2014 Paper PP05 From ODM to SDTM: An End-to-End Approach Applied to Phase I Clinical Trials Alexandre Mathis, Department of Clinical Pharmacology, Actelion Pharmaceuticals Ltd., Allschwil, Switzerland
More informationRDC Roles and Responsibilities RDC has several basic roles that are available to users that enter, update, review and approve data. Site User Data Entry Responds to queries Principal Investigator Reviews
More informationOne Project, Two Teams: The Unblind Leading the Blind
ABSTRACT PharmaSUG 2017 - Paper BB01 One Project, Two Teams: The Unblind Leading the Blind Kristen Reece Harrington, Rho, Inc. In the pharmaceutical world, there are instances where multiple independent
More informationesource Initiative ISSUES RELATED TO NON-CRF DATA PRACTICES
esource Initiative ISSUES RELATED TO NON-CRF DATA PRACTICES ISSUES RELATED TO NON-CRF DATA PRACTICES Introduction Non-Case Report Form (CRF) data are defined as data which include collection and transfer
More informationBioInformatics A Roadmap To Success. Data Management Plans. Wes Rountree Associate Director of Data Management Family Health International
BioInformatics A Roadmap To Success Data Management Plans Wes Rountree Associate Director of Data Management Family Health International What is a Data Management Plan? A document that describes how clinical
More informationPurpose: To describe the requirements for managing IP at the clinical site
Title: Investigational Product Management Topic: Management of IP Effective Date: March 16, 2016 Approved By: Rita Hanson, M.D. Senior VP/Chief Medical Officer Purpose: To describe the requirements for
More informationCDASH Standards and EDC CRF Library. Guang-liang Wang September 18, Q3 DCDISC Meeting
CDASH Standards and EDC CRF Library Guang-liang Wang September 18, 2014 2014 Q3 DCDISC Meeting 1 Disclaimer The content of this presentation does not represent the views of my employer or any of its affiliates.
More informationBest Practices for E2E DB build process and Efficiency on CDASH to SDTM data Tao Yang, FMD K&L, Nanjing, China
PharmaSUG China 2018 - Paper 73 Best Practices for E2E DB build process and Efficiency on CDASH to SDTM data Tao Yang, FMD K&L, Nanjing, China Introduction of each phase of the trial It is known to all
More informationHow to review a CRF - A statistical programmer perspective
Paper DH07 How to review a CRF - A statistical programmer perspective Elsa Lozachmeur, Novartis Pharma AG, Basel, Switzerland ABSTRACT The design of the Case Report Form (CRF) is critical for the capture
More informationUNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE
UNIVERSITY OF LEICESTER, UNIVERSITY OF LOUGHBOROUGH & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES University of Leicester (UoL)
More informationPharmaSUG Paper PO03
PharmaSUG 2012 - Paper PO03 Streamlining Regulatory Submission with CDISC/ADaM Standards for Nonstandard Pharmacokinetic/Pharmacodynamic Analysis Datasets Xiaopeng Li, Celerion Inc., Lincoln, NE (USA)
More informationAutomate Clinical Trial Data Issue Checking and Tracking
PharmaSUG 2018 - Paper AD-31 ABSTRACT Automate Clinical Trial Data Issue Checking and Tracking Dale LeSueur and Krishna Avula, Regeneron Pharmaceuticals Inc. Well organized and properly cleaned data are
More informationPharmaSUG Paper PO22
PharmaSUG 2015 - Paper PO22 Challenges in Developing ADSL with Baseline Data Hongyu Liu, Vertex Pharmaceuticals Incorporated, Boston, MA Hang Pang, Vertex Pharmaceuticals Incorporated, Boston, MA ABSTRACT
More informationPharmaSUG 2014 PO16. Category CDASH SDTM ADaM. Submission in standardized tabular form. Structure Flexible Rigid Flexible * No Yes Yes
ABSTRACT PharmaSUG 2014 PO16 Automation of ADAM set Creation with a Retrospective, Prospective and Pragmatic Process Karin LaPann, MSIS, PRA International, USA Terek Peterson, MBA, PRA International, USA
More informationAn Introduction to Analysis (and Repository) Databases (ARDs)
An Introduction to Analysis (and Repository) TM Databases (ARDs) Russell W. Helms, Ph.D. Rho, Inc. Chapel Hill, NC RHelms@RhoWorld.com www.rhoworld.com Presented to DIA-CDM: Philadelphia, PA, 1 April 2003
More informationIRT & ecoa: The Good, The Bad & The Ugly YPrime, inc. All Rights Reserved
What we would like to share: Overview of the concept of IRT and ecoa integration Benefits and challenges of scanning in an integrated system Using an integrated system for drug accountability and reconciliation
More informationLeveraging Study Data Reviewer s Guide (SDRG) in Building FDA s Confidence in Sponsor s Submitted Datasets
PharmaSUG 2017 - Paper SS09 Leveraging Study Data Reviewer s Guide (SDRG) in Building FDA s Confidence in Sponsor s Submitted Datasets Xiangchen (Bob) Cui, Min Chen, and Letan (Cleo) Lin, Alkermes Inc.,
More informationDiscrepancy Statuses In OC RDC PDF Discrepancy Management Window:
Discrepancy Statuses In OC RDC PDF Discrepancy Management Window: While working in OC RDC, you will encounter discrepancies with various assigned statuses on the Discrepancy Management window. The statuses
More informationPooling Clinical Data: Key points and Pitfalls. October 16, 2012 Phuse 2012 conference, Budapest Florence Buchheit
Pooling Clinical Data: Key points and Pitfalls October 16, 2012 Phuse 2012 conference, Budapest Florence Buchheit Introduction Are there any pre-defined rules to pool clinical data? Are there any pre-defined
More informationStandard Operating Procedure Clinical Data Management
P-CTU-010 Standard Operating Procedure Topic area: Data Management and Statistics Based on SCTO Matrix: Not applicable Identification number: P-CTU-010 Version: /- Valid from: 01.06.2014 Review and Approval
More informationOC RDC 4.6. User Guide
OC RDC 4.6 Read-Only User Guide Version 1.0 Page 1 of 25 TABLE OF CONTENTS ACCESSING OC RDC...3 Steps for Obtaining Access...3 Logging On...4 Password Changes...5 Computer System and Security...5 VIEWING
More informationStandard Operating Procedure. SOP effective: 06 February 2017 Review date: 06 February 2019
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-26-001 Data Management SOP effective: 06 February 2017 Review date: 06 February 2019 SOP author signature: SIGNED COPY HELD WITHIN THE NJRO
More informationMichael Duvenhage / Tarun Bhatnagar. 08 Aug 2018
Michael Duvenhage / Tarun Bhatnagar 08 Aug 2018 Agenda Dataflow and regional collection strategies (3 options) Data Management Tasks Data collection hot zone considerations Data sharing agreements Safety
More informationDiscrepancy Management
Discrepancy Management While working in OC RDC, you will encounter discrepancies with various assigned statuses. The description of each type of status is listed below. Unreviewed This is the Unreviewed
More informationOC RDC HTML User Guide
CRA - Monitor OC RDC 4.5.3 HTML User Guide Page 1 of 46 TABLE OF CONTENTS Accessing OC RDC Steps for Access Logging On Change Password Computer and System Security Study and Site 3 4 5 5 6 Navigating OC
More informationClinical trial data management technology Guide
annex Clinical trial data management technology Guide I. Overview Clinical Trial Data quality is evaluated on the basis of clinical trial results. In order to ensure accurate and reliable results of clinical
More informationTips on Creating a Strategy for a CDISC Submission Rajkumar Sharma, Nektar Therapeutics, San Francisco, CA
PharmaSUG 2015 - Paper IB09 Tips on Creating a Strategy for a CDISC Submission Rajkumar Sharma, Nektar Therapeutics, San Francisco, CA ABSTRACT A submission to FDA for an NDA (New Drug Application) or
More informationUser Guide 16-Mar-2018
16-Mar-2018 This document is freely distributable Identification Authors Name Organization Title TMF User Guide and Implementation Guide Sub-Team Version History Version Steering Committee Approval Date
More informationPaper FC02. SDTM, Plus or Minus. Barry R. Cohen, Octagon Research Solutions, Wayne, PA
Paper FC02 SDTM, Plus or Minus Barry R. Cohen, Octagon Research Solutions, Wayne, PA ABSTRACT The CDISC Study Data Tabulation Model (SDTM) has become the industry standard for the regulatory submission
More informationA Simple Interface for defining, programming and managing SAS edit checks
Paper PP07 A Simple Interface for defining, programming and managing SAS edit checks Virginie Freytag, Clin Data Management, Rouffach, France Michel Toussaint, Clin Data Management, Rouffach, France ABSTRACT
More informationDiscrepancy Management
Discrepancy Management Oracle Clinical Discrepancy Statuses IN OC RDC Discrepancies tab: While working in OC RDC Classic, you will encounter discrepancies with various assigned statuses on the Discrepancies
More informationD4.2 Data Management System
D4.2 Data Management System 116019 - RESCEU REspiratory Syncytial virus Consortium in EUrope WP4 Prospective data collection Lead contributor Other contributors Louis Bont (3 UMCU) l.bont@umcutrecht.nl
More informationImplementing targeted Source Data Verification (SDV) Strategy in idatafax
Implementing targeted Source Data Verification (SDV) Strategy in idatafax Sadia Yousuf Research Coordinator, Population Health Research Institute DFUG 2017, Orlando, Florida Source Data Verification (SDV)
More informationTaming the SHREW. SDTM Heuristic Research and Evaluation Workshop
Taming the SHREW SDTM Heuristic Research and Evaluation Workshop September 13, 2013 Carlo Radovsky 2 Overview Introductions The Backstory CDISC IntraChange History of a Rule The Challenge Discuss Amongst
More informationUsing EDC System: Benefits, Considerations, and Challenges. March 20, 2012
Benefits, Considerations, and Challenges March 20, 2012 A Quick Introduction of Merck Serono Oldest pharmaceutical company Four R&D Hubs, Geneva, Darmstadt, Boston and Beijing Focus on oncology, neurodegenerative,
More informationPharmaSUG Paper SP09
PharmaSUG 2013 - Paper SP09 SAS 9.3: Better graphs, Easier lives for SAS programmers, PK scientists and pharmacometricians Alice Zong, Janssen Research & Development, LLC, Spring House, PA ABSTRACT Data
More informationGeneral Guidance for Maintaining a Regulatory Binder
General Guidance for Maintaining a Regulatory Binder Study documentation should be well organized, providing a complete and thorough history from protocol development to study completion. Maintaining a
More informationTrial Cost Analysis Trial: Knee Surgery Study Sponsor: Principal Investigator: Hillary Resendes Total Enrollment: 8
Total Site Resources Available Coordinator Rate = $50.00 CRA Rate = $45.00 Investigator Rate = $300.00 Site Director Rate = $65.00 Trial Participation Fees Administration Institutional IT Fee $500.00 IRB
More informationHow a Metadata Repository enables dynamism and automation in SDTM-like dataset generation
Paper DH05 How a Metadata Repository enables dynamism and automation in SDTM-like dataset generation Judith Goud, Akana, Bennekom, The Netherlands Priya Shetty, Intelent, Princeton, USA ABSTRACT The traditional
More informationCDASH MODEL 1.0 AND CDASHIG 2.0. Kathleen Mellars Special Thanks to the CDASH Model and CDASHIG Teams
CDASH MODEL 1.0 AND CDASHIG 2.0 Kathleen Mellars Special Thanks to the CDASH Model and CDASHIG Teams 1 What is CDASH? Clinical Data Acquisition Standards Harmonization (CDASH) Standards for the collection
More informationSDTM Implementation Guide Clear as Mud: Strategies for Developing Consistent Company Standards
Paper CD02 SDTM Implementation Guide Clear as Mud: Strategies for Developing Consistent Company Standards Brian Mabe, UCB Biosciences, Raleigh, USA ABSTRACT Many pharmaceutical companies are now entrenched
More informationImplementation of Data Cut Off in Analysis of Clinical Trials
PharmaSUG 2018 DS19 Implementation of Data Cut Off in Analysis of Clinical Trials Mei Dey, AstraZeneca, USA Ann Croft, ARC Statistical Services Ltd, UK ABSTRACT Interim analysis can result in key decisions
More informationLex Jansen Octagon Research Solutions, Inc.
Converting the define.xml to a Relational Database to enable Printing and Validation Lex Jansen Octagon Research Solutions, Inc. Leading the Electronic Transformation of Clinical R&D PhUSE 2009, Basel,
More informationStandardising The Standards The Benefits of Consistency
Paper DH06 Standardising The Standards The Benefits of Consistency Nathan James, Roche Products Ltd., Welwyn Garden City, UK ABSTRACT The introduction of the Study Data Tabulation Model (SDTM) has had
More informationStandard Operating Procedure. Data Management. Adapted with the kind permission of University Hospitals Bristol NHS Foundation Trust
Data Management REFERENCE: VERSION NUMBER: 2.1 EFFECTIVE DATE: 28-03-18 REVIEW DATE: 28-03-20 AUTHOR: Clinical Trials Manager; Clinical Trials Officer REVIEWED BY: R&I Senior Team APPROVED BY: Deputy Director
More informationThe Wonderful World of Define.xml.. Practical Uses Today. Mark Wheeldon, CEO, Formedix DC User Group, Washington, 9 th December 2008
The Wonderful World of Define.xml.. Practical Uses Today Mark Wheeldon, CEO, Formedix DC User Group, Washington, 9 th December 2008 Agenda Introduction to Formedix What is Define.xml? Features and Benefits
More informationReducing SAS Dataset Merges with Data Driven Formats
Paper CT01 Reducing SAS Dataset Merges with Data Driven Formats Paul Grimsey, Roche Products Ltd, Welwyn Garden City, UK ABSTRACT Merging different data sources is necessary in the creation of analysis
More informationDemystifying Laboratory Data Reconciliation. The issues at hand
Demystifying Laboratory Data Reconciliation Heather M. Irish and Huiming (Sam) Tu Premier Research Group, plc The issues at hand Why lab data is a necessary evil Why lab data gives us nightmares Holes
More informationWhy organizations need MDR system to manage clinical metadata?
PharmaSUG 2018 - Paper SS-17 Why organizations need MDR system to manage clinical metadata? Abhinav Jain, Ephicacy Consulting Group Inc. ABSTRACT In the last decade, CDISC standards undoubtedly have transformed
More informationStandard Operating Procedure. SOP full title: Sponsor processes for reporting Suspected Unexpected Serious Adverse Reactions
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-03-003 Sponsor processes for reporting Suspected Unexpected Serious Adverse Reactions SOP effective: 23/05/2017 Review date: 23/05/2019
More informationPreparing the Office of Scientific Investigations (OSI) Requests for Submissions to FDA
PharmaSUG 2018 - Paper EP15 Preparing the Office of Scientific Investigations (OSI) Requests for Submissions to FDA Ellen Lin, Wei Cui, Ran Li, and Yaling Teng Amgen Inc, Thousand Oaks, CA ABSTRACT The
More informationData Collection & Management
Data Collection & Management Investigator Meetings 1 st and 2 nd September 2016 - London and Leeds Jamie Godsall Data Manager, BCTU CRF return rates Form Time point Forms expected Forms received Percentage
More informationCost-Benefit Analysis of Retrospective vs. Prospective Data Standardization
Cost-Benefit Analysis of Retrospective vs. Prospective Data Standardization Vicki Seyfert-Margolis, PhD Senior Advisor, Science Innovation and Policy Food and Drug Administration IOM Sharing Clinical Research
More informationDocument Version: 1.0. Purpose: This document provides an overview of IBM Clinical Development v released by the IBM Corporation.
Release Notes IBM Clinical Development Release Date: 17 August 2018 Document Version: 10 OVERVIEW Purpose: This document provides an overview of IBM Clinical Development released by the IBM Corporation
More informationAutomation of SDTM Programming in Oncology Disease Response Domain Yiwen Wang, Yu Cheng, Ju Chen Eli Lilly and Company, China
ABSTRACT Study Data Tabulation Model (SDTM) is an evolving global standard which is widely used for regulatory submissions. The automation of SDTM programming is essential to maximize the programming efficiency
More informationChapter 10: Regulatory Documentation
Table of Contents Chapter 10: Regulatory Documentation... 10-1 10.1 Regulatory Requirements:... 10-1 10.2 Ongoing Regulatory Documents:... 10-4 10.3 After study completion or termination of the trial...
More informationSAS Training BASE SAS CONCEPTS BASE SAS:
SAS Training BASE SAS CONCEPTS BASE SAS: Dataset concept and creating a dataset from internal data Capturing data from external files (txt, CSV and tab) Capturing Non-Standard data (date, time and amounts)
More informationStandard Operating Procedure (SOP) OPTIMISE II Database User Guide SOP 007
` Standard Operating Procedure (SOP) OPTIMISE II Database User Guide SOP 007 Authors: Priyanthi Dias & Ann Thomson Authorisation: Rupert Pearse (Chief Investigator) Scope To provide guidance on the data
More informationAUTOMATED CREATION OF SUBMISSION-READY ARTIFACTS SILAS MCKEE
AUTOMATED CREATION OF SUBMISSION-READY ARTIFACTS SILAS MCKEE AGENDA 1. Motivation 2. Automation Overview 3. Architecture 4. Validating the System 5. Pilot Study Results 6. Future State Copyright 2012-2017
More informationAdvanced Data Visualization using TIBCO Spotfire and SAS using SDTM. Ajay Gupta, PPD
Advanced Data Visualization using TIBCO Spotfire and SAS using SDTM Ajay Gupta, PPD INTRODUCTION + TIBCO Spotfire is an analytics and business intelligence platform, which enables data visualization in
More informationJohannes Ulander. Standardisation and Harmonisation Specialist S-Cubed. PhUSE SDE Beerse,
Towards better data Johannes Ulander Standardisation and Harmonisation Specialist S-Cubed PhUSE SDE Beerse, 2017-11-28 Agenda What is data? Current state of submissions Introduction to linked data and
More informationBay Area CDISC Network: PhUSE Working Group for Inspection Site Selection Data Standards
Bay Area CDISC Network: PhUSE Working Group for Inspection Site Selection Data Standards Patricia Gerend Genentech, Inc., A Member of the Roche Group 30 April 2015 Agenda Page 2 Introduction to PhUSE Working
More informationInForm Functionality Reference Manual for Sites. Version 1.0
InForm Functionality Reference Manual for Sites Version 1.0 1-Mar-2012 2012 by Merck & Co., Inc., Whitehouse Station, New Jersey, USA All Rights Reserved No part of this book may be reproduced in any form
More informationPhUSE Paper SD09. "Overnight" Conversion to SDTM Datasets Ready for SDTM Submission Niels Mathiesen, mathiesen & mathiesen, Basel, Switzerland
Paper SD09 "Overnight" Conversion to SDTM Datasets Ready for SDTM Submission Niels Mathiesen, mathiesen & mathiesen, Basel, Switzerland ABSTRACT This demonstration shows how legacy data (in any format)
More informationSAS CLINICAL SYLLABUS. DURATION: - 60 Hours
SAS CLINICAL SYLLABUS DURATION: - 60 Hours BASE SAS PART - I Introduction To Sas System & Architecture History And Various Modules Features Variables & Sas Syntax Rules Sas Data Sets Data Set Options Operators
More informationALEA instructions for Local Investigators
ALEA instructions for Local Investigators This document provides instructions, guidelines and background information for Local Investigators (LI) regarding the Electronic Data Capture (EDC) system of ALEA,
More informationStandards Metadata Management (System)
Standards Metadata Management (System) Kevin Lee, MarkLogic COPYRIGHT 2015 MARKLOGIC CORPORATION. ALL RIGHTS RESERVED. Agenda Regulatory Requirement on Clinical Trial Standards(i.e., CDISC and ectd) Standards
More informationKey. General. Host Account Functionality. Included, no-cost Not Included Add-on/Low cost $ Add-on/High cost $$$
Key Included, no-cost Not Included Add-on/Low cost $ Add-on/High cost $$$ General X Cost $ $ $$$ $$$ Complete cross-functionality between native mobile app and web-based system Ability to create host accounts
More informationData Edit-checks Integration using ODS Tagset Niraj J. Pandya, Element Technologies Inc., NJ Vinodh Paida, Impressive Systems Inc.
PharmaSUG2011 - Paper DM03 Data Edit-checks Integration using ODS Tagset Niraj J. Pandya, Element Technologies Inc., NJ Vinodh Paida, Impressive Systems Inc., TX ABSTRACT In the Clinical trials data analysis
More informationLegacy to SDTM Conversion Workshop: Tools and Techniques
Legacy to SDTM Conversion Workshop: Tools and Techniques Mike Todd President Nth Analytics Legacy Data Old studies never die Legacy studies are often required for submissions or pharmacovigilence. Often
More informationRelease Notes IBM Clinical Development v (formerly eclinicalos) Release Date: 03 February 2017
Development v201710 Document Version: 10 Release Notes IBM Clinical Development v201710 (formerly eclinicalos) Release Date: 03 February 2017 OVERVIEW Purpose: This document provides an overview of IBM
More informationCRA OC RDC Classic User Guide
CRA OC RDC Classic User Guide Version 1.0 Page 1 of 37 TABLE OF CONTENTS Accessing OC RDC Steps for Access 3 Logging On 3 Change Password 5 Change Study 5 Laptop and System Security 6 Navigating OC RDC
More informationTopics Raised by EFPIA. Webinar on Policy Jun 2017, FINAL. Presentation
Topics Raised by EFPIA Webinar on Policy 70 29 Jun 2017, FINAL Presentation Definition of listings out of scope of Phase 1 Examples Topics to discuss Previously submitted studies in scope Reiterating EFPIA
More informationAdvanced Visualization using TIBCO Spotfire and SAS
PharmaSUG 2018 - Paper DV-04 ABSTRACT Advanced Visualization using TIBCO Spotfire and SAS Ajay Gupta, PPD, Morrisville, USA In Pharmaceuticals/CRO industries, you may receive requests from stakeholders
More informationAnnual Report 2017 (Jan. Dec.) April 3, 2018 Japan CRO Association
Annual Report 2017 (Jan. Dec.) April 3, 2018 Japan CRO Association 1 JCROA 2017 Total Number of Members: 37 companies Regular Member: 16 companies Supporting Member: 21 companies (Note) * The business
More informationCDISC SDTM and ADaM Real World Issues
CDISC SDTM and ADaM Real World Issues Washington DC CDISC Data Standards User Group Meeting Sy Truong President MXI, Meta-Xceed, Inc. http://www.meta-x.com Agenda CDISC SDTM and ADaM Fundamentals CDISC
More informationStudy Data Reviewer s Guide Completion Guideline
Study Data Reviewer s Guide Completion Guideline 22-Feb-2013 Revision History Date Version Summary 02-Nov-2012 0.1 Draft 20-Nov-2012 0.2 Added Finalization Instructions 10-Jan-2013 0.3 Updated based on
More informationTraceability Look for the source of your analysis results
Traceability Look for the source of your analysis results Herman Ament, Cromsource CDISC UG Milan 21 October 2016 Contents Introduction, history and CDISC Traceability Examples Conclusion 2 / 24 Introduction,
More informationInForm for Primary Investigators Performing esignature Only (v4.6) Narration
InForm for Primary Investigators Performing esignature Only (v4.6) Narration Page 1: Title Slide No narration Page 2: Welcome Welcome to the InForm for Primary Investigators Performing esignature Only
More informationReporting & Visualisation : D un Dun standard maison au format CDISC 02/02/2016 CDISC GUF 1
Reporting & Visualisation : D un Dun standard maison au format CDISC Jérémy MAMBRINI Florence WAGER 02/02/2016 CDISC GUF 1 Contents CDISC Implementation ti at SERVIER Reporting & Visualisation using CDISC
More informationOctober p. 01. GCP Update Data Integrity
p. 01 p. 02 p. 03 failures by organizations to: apply robust systems that inhibit data risks, improve the detection of situations where data reliability may be compromised, and/or investigate and address
More informationComprehensive Capabilities Comparison
page 1 of 9 Comprehensive Capabilities Comparison General Key Included, no added cost Add-on/Low cost $ Not Available X Add-on/High cost $$$ Cost $ $ $$$ $$$ Complete cross-functionality between native
More informationHow to clean up dirty data in Patient reported outcomes
Paper DH02 How to clean up dirty data in Patient reported outcomes Knut Mueller, UCB Schwarz Biosciences, Monheim, Germany ABSTRACT The current FDA Guidance for Industry - Patient Reported Outcome Measures
More informationPooling strategy of clinical data
Pooling strategy of clinical data Abraham Yeh, Xiaohong (Grace) Zhang, Shin-Ru Wang, Novartis Pharmaceuticals Corporation, East Hanover, NJ ABSTRACT Pooling of clinical data is used by all pharmaceutical
More informationIntegrated Safety Reporting Anemone Thalmann elba - GEIGY Ltd (PH3.25), Basel
ntegrated Safety Reporting Anemone Thalmann elba - GEGY Ltd (PH3.25), Basel Abstract: Most of the regulatory health authorities approving pharmaceutical products consider the ntegrated Safety Summary to
More informationVersion 11, JAN2017. Regulatory Document Approval Parameters for WebDCU TM POINT. People Document Collection REGULATORY REQUIREMENTS
Regulatory Approval Parameters for WebDCU TM Collection Person Role CV Study Drug Recipient, Secondary SC within document 5 yrs. from effective Required for all site personnel who are directly involved
More informationThis 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.
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 informationStandardizing FDA Data to Improve Success in Pediatric Drug Development
Paper RA01 Standardizing FDA Data to Improve Success in Pediatric Drug Development Case Study: Harmonizing Hypertensive Pediatric Data across Sponsors using SAS and the CDISC Model Julie Maddox, SAS Institute,
More informationArgus to Oracle Clinical SAE Reconciliation. Dipti Kadam. DBMS Consulting 12 October 2010 Argus Focus Group Session 14
Argus to Oracle Clinical SAE Reconciliation Dipti Kadam DBMS Consulting 12 October 2010 Argus Focus Group Session 14 Agenda Background: SAE Reconciliation Benefits of Clinical Data Systems and Safety Data
More informationImproving Metadata Compliance and Assessing Quality Metrics with a Standards Library
PharmaSUG 2018 - Paper SS-12 Improving Metadata Compliance and Assessing Quality Metrics with a Standards Library Veena Nataraj, Erica Davis, Shire ABSTRACT Establishing internal Data Standards helps companies
More informationIntroduction to CDASH
Introduction to CDASH Rhonda Facile, CDISC Melissa Binz, Wyeth Presented by Melissa Binz Director Central Standards Group, Wyeth 1 Introduction to the CDASH Standard Monday, March 16 2009 Welcome and Review
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
SOP details SOP title: Protocol development SOP number: TM 010 SOP category: Trial Management Version number: 03 Version date: 16 December 2016 Effective date: 16 January 2017 Revision due date: 16 January
More informationCRF Design for Data Standards. David A. Scocca
CRF Design for Data Standards David A. Scocca dave_scocca@rhoworld.com CRF Design for Data Standards Controlled Terminology Epochs and Dispositions Dates and Times Free Text Fields Avoiding Unwanted Data
More informationODM The Operational Efficiency Model: Using ODM to Deliver Proven Cost and Time Savings in Study Set-up
ODM The Operational Efficiency Model: Using ODM to Deliver Proven Cost and Time Savings in Study Set-up Mark Wheeldon, CEO, Formedix Bay Area User Group Meeting, 15 th July 2010 Who are we? Proven Business
More informationSAS (Statistical Analysis Software/System)
SAS (Statistical Analysis Software/System) Clinical SAS:- Class Room: Training Fee & Duration : 23K & 3 Months Online: Training Fee & Duration : 25K & 3 Months Learning SAS: Getting Started with SAS Basic
More informationNow let s take a look
1 2 3 4 Manage assets across the end to end life cycle of your studies This includes forms, datasets, terminologies, files, links and more, for example: - Studies may contain the protocol, a set of Forms,
More information