Data Quality & Technology

Data integrity, system validation, interoperability, and operational controls.

Laboratory Units: Preserve Original Results Before Standardizing

A clinical trial laboratory crosswalk for converting units, preserving source results and ranges, and separating missing metadata from assay comparability.

Oct 2411 minBy Ran Chen

Blank ruled cards on oxblood and navy folders, with a smaller card at the lower right and a brass-colored stylus on a warm paper surface.

Data Quality & Technology

ODM Version Changes: When to Quarantine a Clinical Data Transfer

Decide whether to accept or quarantine an ODM transfer by checking its version, schema, header, metadata dependencies and required audit information.

Oct 2112 minBy Ran Chen

Illustrated archival-records still life with two envelopes, blank paper, a punched paper ribbon and a brass magnifier over an empty checklist.

Data Quality & Technology

CDISC QRS: Match the Instrument to the Published Supplement

Map clinical outcome assessments to CDISC QRS domains, track SDTM version dependencies, pin controlled terminology packages, and separate supplement publication from usage rights.

Oct 1814 minBy Ran Chen

Research still life on parchment: an open ruled workbook with checkbox columns, a blank clipped index card, a stopwatch resting on a hand-drawn walking-course sketch, a pencil, a circular stamp mark, and a wax-sealed envelope

Data Quality & Technology

FDA CGM Data Submission: Tracing Sensor Epochs to the Final Analysis Dataset

How FDA's May 2026 CGM technical specifications link SDTM LB epochs, ADCGM phantom rows and ADCGMEN completeness variables, and what the SAP must lock first.

Oct 1224 minBy Ran Chen

An unbranded white disc on parchment beside a pen trace that runs onto graph paper and breaks off at a brass pin on an oxblood thread, with a stack of blank cards at upper right.

Data Quality & Technology

Wearable Endpoints: Separating Non-Wear Time From True Inactivity

How clinical trial teams choose wearable non-wear rules, define valid days, and distinguish missing observations from intercurrent events.

Oct 914 minBy Ran Chen

Unbranded charcoal activity sensor band resting beside blank folded cream paper on a wooden desk.

Data Quality & Technology

Endpoint Data Before Database Lock: A Reconciliation Checklist

Which endpoint data must be reconciled and evidenced before a clinical database lock, who signs each row, and how unlock and unblinding stay controlled.

Oct 821 minBy Ran Chen

Still life on a wooden desk: a navy cloth-bound casebook closed with a strap and a plain oxblood wax seal, a grey stopwatch, two small vials with blank labels, a tablet with its screen off, and a parchment checklist with empty ruled rows.

Data Quality & Technology

Withdrawal From a Trial: Separating New Collection From Retained Data

How trial teams timestamp a withdrawal boundary, keep endpoint data already collected in an FDA-regulated database, and stop only the collection the participant has refused.

Oct 323 minBy Ran Chen

Editorial still life of a closed oxblood protocol binder and filed parchment records separated from a collection tray holding a powered-off handheld device and sealed specimen tube.

Data Quality & Technology

Endpoint Queries: Correcting Data Without Leading the Respondent

How data management teams query an endpoint discrepancy without supplying the answer, and what to do when the site confirms the original value.

Oct 221 minBy Ran Chen

Still life of an open blank protocol binder, a blank slip marked only with a charcoal stroke, a pencil, a brass magnifier, and a face-down unbranded diary on a wooden desk.

Data Quality & Technology

Reconciling eCOA and EDC: Participant, Visit, and Timestamp Conflicts

Resolve eCOA and EDC participant, visit, and timestamp conflicts using prespecified cross-reference keys, visit-window rules, and originator change controls under ICH E6(R3) and EMA guidelines.

Sep 2524 minBy Ran Chen

Still life of two parallel paper card stacks linked by an oxblood thread beside a protocol visit schedule, an unbranded tablet showing abstract color blocks, and an analog desk clock

Data Quality & Technology

Validating Computerized Systems That Capture Endpoints: Risk-Based Evidence Beyond Part 11

A practical framework for clinical development and quality teams to validate computerized systems capturing trial endpoints—distinguishing platform qualification from protocol configuration under FDA 2024 and EMA 2023 guidelines.

Sep 620 minBy Ran Chen