Practical, evidence-grounded education for the professionals who run, monitor, and participate in oncology and haematology clinical trials. From GCP/ICH E6(R3) updates to risk-based monitoring in oncology — built for the realities of site practice.
The cornerstone resources in our education library — high-priority reading for clinical research professionals working in oncology.
New — July 2026
The most significant update to Good Clinical Practice guidance in a decade — from risk-based quality management to critical data identification and remote monitoring. A practical site-level implementation guide.
Monitoring
How RBM replaces traditional 100% SDV, what triggers an on-site visit, how oncology-specific risks (AEs, dose modifications, biospecimen handling) are factored in, and what site documentation should look like.
Covers risk-based quality management, critical data identification, sponsor/site responsibilities, eSource, and remote monitoring. Written for site teams implementing the new guidance.
A structured gap analysis checklist for site quality teams reviewing existing SOPs against new E6(R3) requirements — covering delegation, monitoring, informed consent, and data integrity.
E6(R3) strengthens PI accountability requirements. This article covers delegation log standards, oversight documentation, medical decision authority, and what regulators will look for at inspection.
How to apply ICH E8(R1) Quality by Design and the E9(R1) estimand framework to build robust oncology protocols — covering endpoint selection, eligibility design, biomarker-stratified designs, adaptive trials, and avoiding the protocol amendments that cost $141K–$535K per submission.
What RBM means in practice for an oncology site — how centralized statistical monitoring works, what on-site triggers look like, and how to prepare your team and documentation for remote and hybrid monitoring visits.
How to classify major vs minor deviations, documentation requirements, 48-hour root-cause analysis, CAPA design, and what regulators expect when they review your deviation log at inspection.
Everything a site coordinator needs to prepare before a CRA visit — TMF organisation, source document availability, delegation log currency, equipment calibration records, and eCRF query status.
How upfront biomarker strategy determines whether a trial shows a treatment effect or an artefact — covering companion diagnostics, prospective vs retrospective stratification, and the regulatory expectations for biomarker-defined populations.
A practical guide for coordinators and CRAs on biospecimen collection protocols — PBMC isolation, serum separation, temperature monitoring, IATA shipping, and how to handle time-critical specimens for biomarker assays.
Based on the 2026 Chawla et al. Clinical Cancer Research study: how KRAS-targeted ddPCR detects residual disease in localised PDAC patients classified as ctDNA-negative by standard NGS — and what three survival tiers it reveals.
The complete guide to companion diagnostics — FDA PMA approval pathway (21 CFR 809), analytical and clinical validation standards, CDx co-development timelines with drug NDA/BLA, FoundationOne CDx, liquid biopsy CDx, PD-L1 complexity, and the 4 landmark CDx approvals that redefined oncology trial design.
The operational workflow for site teams — pre-screening steps, specimen collection essentials, local vs central lab, eligibility decision roles, screen failure documentation, the 6 most common CDx errors, and a 12-item source documentation checklist.
Three unresolved controversies — PD-L1 assay fragmentation (concordance κ 0.16–0.52), liquid vs. tissue biopsy (ROME trial: 49% concordance; sensitivity 45% in stage III NSCLC), and single-biomarker vs. comprehensive genomic profiling — examined through 12 primary academic sources with DOI citations for every claim.
How methylation-based liquid biopsy detects 50+ cancer types from a single blood draw — plus what NHS-Galleri (140,000+ participants) and SYMPLIFY (5,461 patients) found, sensitivity by stage (Stage I: 16.8%), positive predictive value, FDA regulatory pathway, and what MCED means for trial eligibility and biomarker strategy.
Oncology trial consent is uniquely complex — patients are often distressed, cognitively fatigued, or facing limited alternatives. This guide covers best practices for consent discussions, documentation standards, capacity assessment, and when re-consent is required under 21 CFR Part 50 and ICH E6(R3).
A systematic checklist covering 21 CFR Part 50 and ICH GCP E6(R3) consent documentation requirements — signature dates, version control, witness requirements, LAR documentation, and eCOA audit trail review.
Electronic informed consent (eConsent) is increasingly used in oncology — particularly for decentralised trial elements. Covers FDA e-consent guidance, IRB approval requirements, accessibility obligations, and audit trail standards.
Resources curated for the specific knowledge gaps and day-to-day challenges of each role in oncology trial operations.
Monitor-focused content covering site qualification, SDV, risk-based monitoring, deviation management, and regulatory inspection readiness.
Leadership-level content covering PI oversight obligations, regulatory accountability, medical decision documentation, and inspection preparation.
Operations-focused resources for patient management, eCRF entry, query resolution, specimen handling, and monitoring visit preparation.
Science-forward resources on trial design, biomarker-driven eligibility, novel therapeutic modalities, and clinical practice implications of emerging trial data.
Commentary and analysis on the trials, assays, and technologies reshaping oncology — written for clinicians and trial professionals.
NHS-Galleri (140,000+), sensitivity by stage, PPV caveats, and what a positive result means in clinical practice.
Read → 10 min · July 2026 Imaging · Trial DataHead-to-head comparison for prostate cancer staging and what it means for biomarker-driven trial eligibility screening.
Read → 8 min · July 2026