Clinical & GCP
Clinical quality and good clinical practice govern the integrity of trial data and patient safety information. This pillar covers GCP data integrity, validation of EDC, IRT, eTMF and CTMS systems, and the integrity of pharmacovigilance and safety data.
15 articlesSource Data, SDV, and ALCOA in Clinical Trials: Getting the Site Records Right
How clinical source data, certified copies, source data verification, and ALCOA principles work at the investigator site, and the monitoring and inspection findings that come from getting them wrong.
Clinical Data Management: EDC Build, Edit Checks, Database Lock, and CDISC Standards
A working guide to clinical data management for GxP quality professionals: CRF design, EDC build and validation, edit checks, query management, UAT, database lock, and the CDISC SDTM/ADaM/Define-XML standards that feed a regulatory submission.
eConsent and Decentralized Trial Technology: Validation and Part 11 Compliance
How to validate eConsent and decentralized clinical trial systems, preserve informed-consent integrity, and meet Part 11 and Annex 11 expectations for ePRO, wearables, and televisits.
The Trial Master File: eTMF Structure, the DIA Reference Model, and Inspection Readiness
How to build and run an electronic Trial Master File that survives a GCP inspection: the DIA TMF Reference Model, completeness and timeliness metrics, QC processes, and what inspectors actually look for.
Good Laboratory Practice (21 CFR 58) for Nonclinical Safety Studies
How 21 CFR Part 58 and OECD GLP principles govern nonclinical safety studies through the study director, the study plan and final report, an independent Quality Assurance Unit, archiving, and computerized-system data integrity.
GMP for Investigational Medicinal Products: Phase-Appropriate Quality and IMP Release
How GMP applies to clinical-trial supplies: phase-appropriate controls, evolving specifications, IMP labelling, randomisation and blinding, and QP certification of investigational batches.
ICH E6(R2)/E6(R3) Good Clinical Practice: The Foundation of Clinical Trial Quality
A working account of ICH E6 GCP: the principles, sponsor and investigator and IRB/IEC responsibilities, essential documents, the R2 risk-based addendum, and the R3 rewrite. Built for people who run, monitor, audit, or inspect clinical trials.
ICH E8(R1) and E9: Quality by Design and Statistical Principles in Clinical Trials
How E8(R1) critical-to-quality factors, quality-by-design protocol thinking, and the E9(R1) estimands framework connect statistical planning to clinical data integrity, with worked examples and inspection-finding patterns.
Pharmacovigilance and Safety Data: GVP and Data Integrity After Approval
How individual case safety reports, expedited and periodic reporting, signal detection, and a validated safety database carry GxP data integrity obligations into the postmarketing phase.
Protocol Deviation Management in Clinical Trials
How protocol deviations are defined, classified, reported to the IRB/EC, captured in the CSR, trended, and assessed for data impact, so the program prevents unmanaged and unreported deviation findings.
Risk-Based and Centralized Monitoring of Clinical Trials
How to design and run a risk-based monitoring program for clinical trials, including the central, remote, and on-site mix, key risk indicators, the monitoring plan, and reduced source data verification.
Maintaining the Blind and Controlling Unblinding
How to plan, hold, and break the blind in a clinical trial without corrupting the result: the blinding plan, system and role controls, emergency code-break, accidental-unblinding handling, the firewall around the unblinded statistician, unblinding at database lock, and the records inspectors check.
Clinical Statistical Programming and TLF Validation
How double programming, ADaM dataset and TLF validation, end-to-end traceability, version control, and the SAP linkage produce tables, listings, and figures that can be reproduced and defended in an inspection.
GCP Audits and Regulatory Inspections: Sponsor, Site, and Vendor Audit Programs
How to build and run a GCP audit program across sponsor systems, investigator sites, and vendors, and how to prepare for and survive an FDA BIMO or EMA GCP inspection.
Sponsor Oversight of CROs and Vendors
How a sponsor delegates clinical trial tasks to CROs and vendors while keeping responsibility, and what defensible oversight looks like to an inspector.