Clinical Data Management and Integrity Whether the Data Can Carry the Answer
What data management owns and how the work is actually done: the data lifecycle and where failures live, record integrity beyond reciting ALCOA+, source data and instrument design, queries and the discrepancy that cannot be reconciled, audit trails as an inspector reads them, external data and safety reconciliation, coding and standards, database lock and unblinding, and how integrity failures are found in distributions rather than in records. Jurisdiction-neutral.
30 lessons, about 154 minutes. Free, in your language.
What Data Management Owns
Record Integrity and ALCOA+
Source Data and the Case Report Form
Designing the Data Collection Instrument
Queries and Discrepancy Management
Audit Trails and Electronic Records
External Data and Reconciliation
Coding and Data Standards
Database Lock
How Data Integrity Failures Are Found
Free courses What Data Management Actually Owns The Data Lifecycle, From Source to Lock Who Does What: Sites, Sponsors, Vendors and Statistics Attributable, Legible, Contemporaneous, Original, Accurate Complete, Consistent, Enduring, Available What Original Means When the Original Is Electronic What Counts as Source, and Who Decides The Case Report Form and Its Relationship to Source Direct Entry and the Disappearing Source The Form Is an Instrument, Not a Document Edit Checks: What They Catch and What They Create Fields That Produce Unusable Data What a Query Is For Writing a Query a Site Can Actually Answer The Discrepancy That Cannot Be Reconciled What an Audit Trail Must Record Electronic Signatures and System Validation What an Inspector Does With an Audit Trail External Data and the Transfer Specification The Safety Reconciliation Participant-Reported and Device Data Medical Coding: Turning Words Into Counts Data Standards and Why They Are a Regulatory Question Derived Variables and the Rules That Make Them What Lock Actually Commits You To Blinding, Unblinding, and the Sequence That Protects the Result Unlocking, and What It Costs The Shapes a Data Integrity Failure Takes How They Are Actually Found Building a Culture Where the Honest Answer Is Easiest All clinical research training