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COMPANION DIAGNOSTICSAT THE SITE LEVELA Practical Guide for CRAs and CoordinatorsHow to navigate CDx workflows, specimen handling, eligibility decisions,and documentation at an oncology trial site.CRACoordinatorResearch NurseKCLEAGENICS MEDICAL INC. · kclgmedical.com · CPD SuitablePK
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Welcome slide. This training deck is designed for CRAs, research nurses, and site coordinators who need a practical understanding of companion diagnostics (CDx) at the trial site level — not the regulatory science, but the operational workflow.1PK
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What Is a Companion Diagnostic?The one-line definition your whole team needs to know"A companion diagnostic is a test that must be done before a patient can receive a specific drug.Without a positive result, the patient cannot be enrolled — it is required, not optional."COMPANION DIAGNOSTIC (CDx)Result is REQUIRED before the drug can be givenRegulated as Class III device — FDA PMA approvalDrug label says the CDx is essentialNegative result = patient is ineligible for that drugExamples: EGFR test for osimertinib, HER2 for trastuzumabCOMPLEMENTARY DIAGNOSTICResult is USEFUL but not mandatory for prescribingMay use 510(k) or De Novo pathway (lower bar)Drug label says the test "may help" decisionsNegative result does not automatically excludeExamples: some PD-L1 tests in specific settingsPK
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Explain the core concept simply: the CDx result is a gate — the patient cannot proceed without it. Most site staff have a vague sense of what biomarker testing is but may not understand the regulatory weight of a CDx. The "required vs useful" framing lands quickly.2PK
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The CDx Workflow: 8 Steps from First Contact to EnrolmentEvery step has a documentation requirement01Identify CDx requirementsbefore patient contact02Confirm consentbefore collecting specimen03Source or collectthe specimen04Label, package &ship per lab manual05Track specimen &monitor TAT06Route result to PIfor review07Document in sourcerecord & eCRF08Screen failure:document & notifyPK
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Walk through each step. Emphasise Step 02 (consent before specimen) and Step 06 (PI must review, not coordinator). These two steps generate the most inspection findings.3PK
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Specimen Types: What the Lab Manual Is Really Telling YouSpecimen TypeCDx Use CaseKey RequirementsCommon ErrorsFFPE Tissue BlockTissue NGS, IHC (HER2, PD-L1)≥20–30% tumour; age limit ~3–5 yrsBlock too old; wrong block sentUnstained FFPE SlidesWhen block unavailable; IHC assays10–25 slides, 4–5 µm; charged slidesToo few slides; wrong blockPlasma (ctDNA)Liquid biopsy CDx (e.g., EGFR)Streck BCT tubes; ship ≤96 h; no EDTAEDTA tubes; delay in shippingWhole BloodGermline BRCA; MSI confirmationEDTA tube; 8–10 mL; ambientHaemolysed; mislabelledFresh BiopsyIf archival fails QC; serial biopsyFormalin immediately; ≥2 cores; rush pathSaline instead of formalin⚠ Always check the lab manual — the exact tube type, volume, and shipping temperature are specimen-specific. Using the wrong collection tube is one of the top 6 CDx errors.PK
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Focus on the "Common Errors" column — these are the most actionable points for training. The EDTA vs Streck tube distinction for plasma is particularly important as it is easy to miss and leads to specimen rejection.4PK
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Local Lab vs Central Lab: Know the DifferenceUsing the wrong lab for eligibility is a protocol deviationCENTRAL LAB (Sponsor-Designated)✓Performs the validated, FDA-approved CDx assay✓Required for eligibility determination in most trials✓CLIA/CAP certified; accredited for the specific assay⏱Turnaround: 7–14 days (tissue NGS); 5–7 days (plasma)📋Ship per lab manual; retain tracking number⚠Result must be on file before enrolment is confirmedLOCAL LAB (Site Pathology)⚠May NOT be the FDA-approved CDx assay⚠Cannot substitute for central lab result for eligibility✓Faster turnaround: 48–72 hours?Sometimes permitted for PRE-SCREENING only📋Check protocol: is local testing permitted at all?📋If permitted: document which result is being used and whyPK
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This is the most common source of confusion on site. Many sites have capable local labs and assume the local result is sufficient. Emphasise: the protocol and lab manual are the definitive guide. If uncertain, ask the sponsor or CRA before proceeding.5PK
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Eligibility Decision: Who Does WhatCDx result arrives at the site — this is what happens nextCOORDINATOR / NURSEReceives CDx report from portal/email/faxFiles report in patient source record immediatelyNotifies PI or sub-I that result is availableEnters raw CDx data in eCRF per sponsor instructionsDoes NOT confirm eligibility independentlySUB-INVESTIGATOR (Delegated)Reviews CDx result against eligibility criterionConfirms result meets protocol requirementCountersigns eligibility assessment formCommunicates decision to coordinatorMust be listed on delegation log for eligibility reviewPRINCIPAL INVESTIGATORHolds ultimate responsibility for eligibility accuracyReviews and signs the eligibility checklistEnsures CDx result, date, and assay are recordedAuthorises enrolment / randomisationApproves screen failure documentation if CDx negativeRULE: A coordinator or nurse confirming eligibility without PI/sub-I countersignature is a regulatory finding. Always get the countersignature before entering enrolment in the eCRF.PK
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This slide addresses the most common inspection finding related to CDx: eligibility confirmed by someone who was not delegated that authority. Make it concrete — if a coordinator receives the CDx report and emails the sponsor to confirm eligibility without a PI signature, that is a finding.6PK
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Screen Failure: When the CDx Result Is NegativeWhat to do, what to document, and what to check firstTRUE NEGATIVE RESULT→Patient does not meet the key eligibility criterion→Check protocol: is a reflex test permitted?→(e.g., tissue biopsy if plasma was negative)→If no reflex: document screen failure in source record→Record screen failure reason and CDx result date→Update screen failure log→Notify sponsor per protocol reporting requirements→PI countersignature required on screen failure formASSAY FAILED (Not a True Negative)→Insufficient tumour content → specimen rejected by lab→Not the same as a negative biomarker result→Check lab report for reason code (QNS, low TC, etc.)→Protocol may allow repeat specimen collection→Document assay failure as a separate finding→If repeat specimen: follow same collection workflow→Notify sponsor — some trials need AE/deviation report→Do NOT record as screen failure due to CDx negativePK
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Distinguish clearly between a true negative result and an assay failure. Site teams often document an assay failure as a "CDx screen failure" — which is incorrect and can skew the trial's screen failure rate data. Assay failure is a separate event that may allow repeat testing.7PK
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The 6 Most Common CDx Errors at Trial SitesAll are preventable — all appear at FDA and sponsor inspectionsCRITICAL1CDx collected before consentThe biopsy or blood draw happens before the patient signs the ICF. Even verbal agreement is not enough.CRITICAL2Wrong assay usedLocal lab test used instead of the protocol-required central CDx assay. Invalidates the eligibility result.HIGH3CDx report not in source docsEligibility form references the result but no lab report is filed. A CRA or inspector will raise a query.HIGH4Archival tissue outside age windowBlock older than the protocol's limit (e.g., >5 years) used without a sponsor waiver.MEDIUM5Wrong tube for plasma CDxEDTA tube used instead of Streck BCT for ctDNA. The sample is rejected; delay in eligibility.MEDIUM6Eligibility confirmed without PI sign-offCoordinator reviews CDx and confirms eligibility in eCRF before PI countersigns the eligibility form.PK
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Walk through each error and ask: "Has anyone seen this at your site?" Most teams will recognise at least 2–3. The consent-before-specimen error is especially important because it has patient safety and ethical implications beyond just a regulatory finding.8PK
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CDx Source Documentation ChecklistUse this for every patient who undergoes CDx testingInformed consent signed and dated BEFORE specimen collection dateSpecimen collection date, time, type, and collector documented in source recordLab manual version used for specimen handling confirmed and filedShipping manifest and tracking number retained at siteCentral lab CDx report filed in patient source record (original or certified copy)Report includes: assay name, lab name, CLIA/CAP number, accession number, result, dateDate CDx report received at site is documentedPI or sub-I review of CDx result documented with countersignature and dateEligibility form references CDx result with specific value (not just "positive")eCRF CDx fields completed per sponsor data entry instructionsScreen failure: reason documented, sponsor notified, screen failure log updatedAssay failure: repeat specimen plan documented; sponsor notified if requiredPK
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Distribute this as a printed or electronic checklist for site coordinators to use during the screening process. Consider adding it to your site's screening SOP or ICF administration procedure.9PK
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Archival Tissue Requests: Build in 3 WeeksThe most common cause of screening delay is starting this too lateWeek 1Initiate the RequestContact pathology dept where biopsy was performedSubmit tissue request form + patient consent to releaseInclude protocol number and specific block/slides neededConfirm tumour content on original pathology reportWeek 1–2Pathology ReviewOutside pathology retrieves block, reviews tumour contentPrepares unstained slides or releases blockFollow up proactively — one call can save 3–5 daysIf block heavily used, insufficient tissue may require fresh biopsyWeek 2–3Shipping & ReceiptShip to central lab per lab manual (temperature, packaging)Notify lab of incoming shipment; obtain tracking numberCentral lab assesses tumour content before CDx testingIf content insufficient: fresh biopsy required — plan aheadSTART EARLY ────────────────────────────────────────────────────────────── ENROLMENT READYPK
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This slide often generates discussion. Teams that have experienced a 3-week delay because they waited until screening to request archival tissue immediately understand the message. The proactive follow-up point in Week 1-2 is practical gold: one call to the pathology admin can save a full week.10PK
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Key Takeaways for Your Site Team6 things to do differently starting today01Read the lab manual beforescheduling the first screening visitKnow the specimen type, tube, temperature, and lab before you book the patient.02Consent before specimen —every time, no exceptionsThe collection date must be on or after the ICF signature date. Check both dates.03Central lab = eligibility;local lab = pre-screening onlyNever substitute a local lab result for the central CDx result without explicit protocol permission.04Route CDx results to the PIbefore eCRF entryFile the report, notify the PI, wait for countersignature, then enter eCRF. In that order.05Start archival tissue requestsat least 3 weeks before consentThe wait for outside pathology departments is the most predictable delay in the CDx process.06Assay failure ≠ negative result:document them differentlyA rejected specimen is not a screen failure. Check if a repeat specimen is allowed before concluding ineligibility.PK
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Close with this slide and leave it visible for discussion. Ask the team: "Which of these would you change at your site tomorrow?" The goal is not just knowledge transfer but a specific behaviour change.11PK
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KCLEAGENICS MEDICAL INC.Questions or site support?We support sites with CDx specimen logistics, lab coordination,and eligibility documentation review.📧keog@kclgmedical.com📞312-225-3916🌐kclgmedical.com/educationRELATED RESOURCESAdvanced CDx Guide(Regulatory & Validation Depth)edu-companion-diagnostics-oncology.htmlBiospecimen Collectionin Oncology Trialsedu-biospecimen-oncology-trials.htmlICH GCP E6(R3)Complete Site Guideedu-gcp-e6r3-oncology-sites.htmlCDx Site Teams Training Deck(this presentation)CDx-Site-Team-Training-KCLG.pptx© 2026 KCLEAGENICS MEDICAL INC. — GCP ICH E6(R3) Certified · CPD SuitablePK
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Back cover. Leave this on screen during any Q&A at the end of the training session. The contact details allow attendees to follow up directly.12PK
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7/23/19Click to edit Master text stylesSecond levelThird levelFourth levelFifth level‹#›PK
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