Lock decision and open-item log
Give every open decision a latest acceptable date, a triage class and a closure record.
Resources
Templates, references and short guides in one place.
Download team-ready templates, open the Field Guide, check official standards and practise with synthetic study files. Everything is free, needs no login and works without adopting the whole platform.
Library
Find the right kind of help.
Handbook templatesThree templates that go with the written Handbook chapters: lock log, capacity plan, dependency and risk log.Jump to templates →
Field Guide21 short guides that answer “what should I do?”, from study startup to regulatory delivery.Open →
Standards watchA reading list of authoritative FDA, CDISC and ICH sources, with local review status.Open →
Regulatory scenariosGeneralized compressed-timeline situations: authority requests, safety updates, late changes, pooling.Open →
Practice ExchangeGeneralized lessons from delivery situations, and how to contribute your own.Open →
GlossaryShared terminology for cross-functional readiness conversations.Open →
Handbook templates
Templates that go with the written chapters.
Each has synthetic example rows from the chapter and blank rows with date formulas. CSV opens in Excel or Google Sheets and contains no study data.
Capacity plan and assumptions log
Demand lines, supply lines, assumptions, exclusions and change-order triggers in one table.
Dependency, risk and escalation log
Dependencies, risks and issues with latest acceptable dates, responses, triggers and escalation levels.
Checklists
Operational checklists, in Excel and CSV.
Practice files
Synthetic study files for practising with AI.
ZEPHYR-101 is a fictional study. These five files contain no real subjects, sponsors or vendors, and have deliberate problems to find. Use them with the AI workflow builder workflow “Turn study files into an outcome”.
ZEPHYR-101 synthetic study files
Validation findings log, programming and QC tracker, external data transfer log, weekly team notes and a late change request.
Industry guidance & standards
Official references that frequently shape clinical data, analysis, programming, and submission work.
Last reviewed September 2026. These links are a practical reference map, not a determination of which requirement applies to a specific study. Always confirm current agency, sponsor, product, and regional requirements.
Study Data Technical Conformance Guide
FDA technical specifications covering standardized study-data submission considerations, electronic format, validation, traceability, and related topics.
Open FDA guidance ↗Study Data Standards Resources & Data Standards Catalog
Use FDA's resource hub to verify standards that are supported or required and to locate related submission resources.
Open FDA resources ↗Electronic Common Technical Document resources
FDA information for eCTD submission standards, technical conformance guides, regional Module 1, and supported eCTD versions.
Open FDA eCTD resources ↗SDTM v2.0 & SDTMIG v3.4
Foundational model and implementation guidance for standardized clinical tabulation datasets. Verify sponsor and agency-supported versions before implementation.
Open CDISC SDTMIG ↗ADaMIG v1.3 & Conformance Rules v5.0
Analysis dataset structures, conventions, and formal conformance rules supporting analysis-ready and traceable data.
Open CDISC ADaMIG ↗ICH E6(R3) Good Clinical Practice — Annex 1 & Annex 2
Current E6(R3) GCP context. Annex 2 was adopted at ICH Step 4 on 3 June 2026, completing the E6(R3) revision. Confirm regional implementation status before relying on a specific annex.
Open ICH efficacy guidelines ↗ICH E9 & E9(R1)
Statistical principles for clinical trials and the estimand/sensitivity-analysis addendum. Particularly relevant when programming decisions reflect populations, intercurrent events, estimators, and sensitivity analyses.
Open ICH E9(R1) ↗ICH CTD & eCTD v4.0
Harmonized dossier structure plus the current eCTD v4.0 implementation materials. The ICH eCTD v4.0 Implementation Guide v1.7 was endorsed in June 2026; regional Module 1 and implementation rules still apply.
Open ICH eCTD v4.0 ↗Regional regulatory references
Verify the region-specific implementation before building the package.
eCTD, study-data, validation, portal, lifecycle, and regional Module 1 requirements are not globally identical. Use these official agency entry points and confirm the current effective version for the target submission.
Study data & eCTD technical resources
FDA study-data conformance, supported data standards, eCTD technical resources, and related validation/traceability context.
Open FDA study-data resources ↗EU eCTD specifications & implementation
EU Module 1 specifications, validation criteria, harmonised technical guidance, and current eCTD v4.0 implementation materials.
Open EU eSubmission resources ↗Electronic study-data submission guidance
PMDA technical conformance guidance, FAQs, and related information for electronic study-data submissions.
Open PMDA electronic-data resources ↗Electronic filing & eCTD resources
Health Canada guidance, validation rules, Regulatory Enrolment Process information, and eCTD/non-eCTD filing resources.
Open Health Canada filing resources ↗MHRA eCTD submission guidance
Current MHRA guidance on eCTD submission routes, lifecycle expectations, and technical validation for marketing-authorisation activities.
Open MHRA eCTD guidance ↗Australian eCTD regional information
TGA Module 1 and regional technical specifications, validation guidance, and current Australian eCTD implementation resources.
Open TGA regional guidance ↗Verify effective versions before implementation.
A standard can be published without being the version currently required or supported for a particular agency, submission date, sponsor, or program. Treat the links above as entry points and confirm the current effective requirement before building or validating a deliverable.
Do not freeze the reference list in time.
Submission standards and technical specifications evolve. Before using any checklist or example, verify the current FDA Data Standards Catalog, current agency technical guidance, applicable CDISC versions, sponsor standards, and regional requirements.