Topic

protocol-design

Protocol language that makes endpoint intent operational.

Changing Trial Endpoints: When Is an Adaptation Defensible?

Assess a proposed trial endpoint change using prespecification, operating characteristics, information access, and applicable amendment procedures.

Oct 2213 minBy Ran Chen

Open navy notebook with blank pages beside a plain wax-sealed envelope, glass partition, brass clock, and pen in warm window light.

Endpoint Strategy

Core Outcome Sets: Check Scope Before Adopting the Minimum List

How a protocol team can screen core outcome sets in the COMET database, check scope, development and currency, and document the adoption decision.

Oct 1919 minBy Ran Chen

Illustrated still life of an open oxblood protocol binder with a blank ruled grid under a brass magnifying lens, beside a pocket watch, drafting dividers and a pen on a navy desk mat

Estimands & Statistics

ICH E19: What Safety Data Should Your Trial Still Collect?

Define retained safety data, justified CRF reductions, regional exceptions and escalation plans under ICH E19 for qualifying late-stage trials.

Oct 1615 minBy Ran Chen

Illustrated still life of an unbranded navy protocol binder, blank paper with an oxblood page marker, and a fountain pen on a parchment surface

Endpoint Strategy

ICH M11 Protocol Endpoints: Writing Definitions That Can Be Executed and Reported

How clinical trial teams write executable endpoint definitions in ICH M11 Section 3, integrating SPIRIT-Outcomes elements and aligning Sections 1.3, 7, 8, and 10.

Sep 1821 minBy Ran Chen

An open unbranded paper protocol notebook and an unmarked schedule grid sheet on warm parchment alongside a closed oxblood binder and a dark fountain pen on a wooden desk.

Endpoint Strategy

ICH E8(R1) Critical-to-Quality Endpoints: Protocol Design Rules

A methodological guide to identifying critical-to-quality endpoint factors under ICH E8(R1) and locking definitions, estimands, and feasibility before protocol freeze.

Sep 1219 minBy Ran Chen

Editorial still life of study planning materials with an oxblood binder, measurement caliper, and blank card on warm parchment

Measurement & Operations

MedConsumablesGuide: Reviewing Trial Kit Substitutions Before Collection

A clinical trial guide for reconciling protocol and lab-manual identity when offered substitute collection kits, separating transport compliance from endpoint assay comparability.

Sep 1019 minBy Ran Chen

Editorial still life of two unbranded closed collection boxes, a blank unlined card, closed oxblood and navy notebooks, and an unlabelled tube on parchment under window light

Estimands & Statistics

PharmaDossier: Mapping Coverage Gaps to Trial Treatment Interruptions

A structured clinical trial guide for documenting therapy identity, supply responsibility, and actual exposure when routine-care or background regimens encounter insurance coverage delays before biostatisticians classify an intercurrent event.

Sep 1020 minBy Ran Chen

Editorial still life of a closed muted-navy folio, a closed oxblood notebook, and a blank unlined cream card set apart on warm parchment under natural window light

eCOA & Digital Endpoints

EClinCloud eCOA Change Control: What a Protocol Amendment Must Resolve Before Release

A practical release framework for endpoint and data management leads: separating eCOA measurement alterations from schedule and configuration changes under 21 CFR 312.30, 21 CFR 56.108, final PFDD Guidance 3, and EMA Annex 2.10.

Sep 720 minBy Ran Chen