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Preface Acknowledgements Common Acronyms Introduction to Clinical Trials Testing in Humans Clinical Trial Protocols Clinical Trial Process The Importance of Clinical Data Management Regulations, Guidance, and ICH E6 (GCP)
Part I: Study Startup
Chapter 1: The Data Management Plan Purpose of Data Management Plans Contents of the DMP Initiating the DMP Approving the DMP Revising the DMP Using DMPs with CROs The Value of Data Management Plans Data Quality and DMPs SOPs for DMPs
Chapter 2: CRF Design Considerations Primary Goals of CRF Design Collecting Required Data: Visits, Forms, & Fields Collecting Analyzable Data Protocol Compliance CRFs Linked to Non-CRF Data Reuse and Refine CRF Modules Data Quality through CRF Design SOPs on CRF Design
Chapter 3: Selecting Edit Checks Identifying Possible Edit Checks Focus on Critical Variables Data Validation/Edit Check Specifications Updating Data Validation Specifications Data Quality through Data Validation SOPs for Data Validation Checks
Chapter 4: EDC Study Build and Release eCRF Build Data Validation/Edit Check Programming EDC Study Testing Release to Production Change Control Data Quality for eCRFs and Edit Checks SOPs on EDC Build
Chapter 5: Planning for Blinded Studies Background on Blinding Maintaining the Blind Accidental Unblinding Unblinded Study Team Members Blinding Impacts Data Quality SOPs and Study Plans for Blinding
Chapter 6: Patient Reported Outcomes Background to Patient Reported Outcomes Licensing PRO Questionnaires Considerations for Electronic Collection Consideration for Paper Instruments Protocol Compliance Budgeting Time and Money Quality Assurance for ePRO SOPs and Study Plans for ePRO
Part II: Study Conduct
Chapter 7: Overseeing eCRF Data Entry Tracking Participants Enrolled Forms Entered vs Forms Expected Tracking Investigator Signatures Monitoring Data Entry Benefits Data Quality SOPs and Plans for Overseeing eCRF Data Collection
Chapter 8: Managing Queries System Queries Manual Queries Tracking Open Queries Quality Control for Queries Using Queries to Improve Quality SOPs and Plans for Managing Queries
Chapter 9: Collecting Adverse Event Data Collecting AEs and SAEs Adverse Event Forms Storing and Cleaning AE Data Coding Adverse Event Terms Reconciling Serious Adverse Events Coding and Reconciliation Approvals Data Quality for AEs SOPs and Study Plans for AE Data
Chapter 10: Managing Lab Data Data Management for Lab Data Lab Test Names Storing Units Lab Reference Ranges Laboratory Identification Central Labs Using Specialty Labs Data Quality for Lab Results SOPs and Study Plans for Processing Lab Data
Chapter 11: Receiving Non-CRF Data Receiving Electronic Files from a Vendor Cleaning Non-CRF Data Managing Blinded Data Data Quality for External Data SOPs and Study Plans for Non-CRF Data
Chapter 12: Data Review Edit Checks vs Data Review Data Review Plan Performing Data Review Planning for Manual Queries Data Quality and Manual Data Reviews SOPs and Study Plans for Data Review
Chapter 13: Risk-Based Quality Management Background A Structure for Risk-Based Quality Management Centralized Monitoring Working with Clinical Operations RBQM is Quality Assurance SOPs and Study Plans for RBQM
Chapter 14: Managing EDC Changes Change Control for Studies eCRF Changes Edit Check Changes Other Study Changes Testing and Approval Impact on Investigator Signatures Changes Associated with a Protocol Amendment Maintaining Data Quality during EDC Study Changes SOPs for EDC Changes
Part III: Study Lock
Chapter 15: Study Lock Core Requirements for Study Lock Final Study Lock Interim Study Lock Data Extract Plans or Specifications Soft Lock Time to Study Database Lock Final Data Quality SOPs and Study Plans for Study Locks
Chapter 16: After Study Lock Post-Lock Activities Unlocking EDC Studies Data Quality and TMF Quality SOPs and Sutdy Plans for Post-Lock and Unlock
Part IV: Necessary Infrastructure
Chapter 17: SOPs for CDM What Is an SOP? SOPs for Data Management Creating SOPs Complying with SOPs SOP on SOPs Quality Assurance through SOP Revisions
Chapter 18: CDM and the TMF TMF Reference Model Reviewing the Study Reference Model Submitting to the TMF TMF QC Supporting Documents, Email, and NTFs Living with the TMF
Chapter 19: Training Minimum Required Training Training Matrices How to Train Training Records Experience and Education Allotting Time for Training SOPs on Training
Chapter 20: User Management Account Management Access Control through Roles Taking Security Seriously SOPs and Guidelines for Accounts
Chapter 21: Developing and Using Standards The Goal and Purpose of Standards\ Industry Standards Where to Start Standards Team Governance Using Standards SOPs for Standards
Chapter 22: Working with Service Providers Data Management CROs The CRO Myth Qualifying CROs Defining Responsibilities Oversight Metrics Oversight During the Trial Resourcing EDC Vendors as CROs Functional Service Providers Benefiting from CROs SOPs for working with CROs
Part V: Using Computerized Systems
Chapter 23: Data Integrity What is Data Integrity? Integrity in the Data Lifecycle Demonstrating Integrity in Transfers Applying Risk Assessments
Chapter 24: Data in EDC Systems Control of Data: Hosting Data Entry by the Sponsor or CRO Need for Data Repositories
Chapter 25: Choosing Vendor Systems Defining Business Needs Initial Data Gathering Extended Demos and Pilots Additional Considerations What is Missing? Qualifying a Vendor Preparing for Implementation
Chapter 26: Implementation Planning Overview and Related Plans Essential Preparation Validation Integration and Extensions Migration of Legacy Data Benefiting from Pilots Assessing SOPs and Other Documents Preparation for Production Successful Implementation
Chapter 27: System Validation What Is System Validation? Systems that Require Validation Validation for Hosted Systems Validation Plan Validation Testing Validation Report Change Control Requirements and Benefits
Chapter 28: Migrating and Archiving Data Regulatory Expectations When to Migrate EDC Migrations Complex Migrations Migration by Re-Entry Audit Trails in Migrations Archiving and Decommissioning Migration and Archive Plans Data Integrity for Migrations and Archives
Chapter 29: EDC Study Rebuilds Circumstances Leading to Rebuilds eCRF and Edit Check Rebuild Moving Data Investigator Signatures Integrated Systems Site Impact Documentation Appendix A: Data Management Plan Template Appendix B: Data Extract Plan Template Appendix C: System Implementation Outline Index