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RBQM READINESS CHECK

RBQM Readiness Check

Answer based on how your organisation currently operates. This is not a personal knowledge test or a trial-specific risk assessment.

01Governance & roles
02CtQ & quality by design
03Risk management
04Metrics & responses
05Data & monitoring
06Execution & improvement

About 5–7 minutes · 18 questions · Basic results without registration

The basic check is calculated in your browser and resets on reload. Only answers you choose to save are linked to your account. Do not enter confidential or participant-level information.

Method and references

An OrioNex self-assessment informed by ICH E6(R3) quality and risk management principles. It is not an official ICH instrument or compliance certification.

Unknown and not applicable responses are excluded from scores. A domain score is not shown when fewer than two items can be scored. Scores with different response coverage are not directly comparable.

Version 1.0 · 2026-10-20 · ICH E6(R3), Annex 1 §3.10–3.11

ORIONEX MEMBERSHIP

About membership

Register using email verification and save readiness results to your account. Saved reports can be downloaded or deleted in your member account.

You can use the basic RBQM readiness check now without registration.

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Privacy and use of this site

The basic check is calculated in your browser. Profiles and readiness responses you choose to save are stored in your member account. Unsaved answers are lost on reload. Enquiry form entries are not stored on a server. Your language preference may be stored in this browser. If you choose to discuss your results, their summary is temporarily held in this browser session to populate the enquiry page and is deleted when read there. If you send an enquiry email, its contents are delivered to OrioNex for handling your request. Member authentication and storage use the Supabase Seoul project; verification emails use the Resend Tokyo sending region. Profile information is retained during member service use and deleted when withdrawal or deletion requests are processed. Marketing consent is optional and can be changed in your account. Read the detailed notice on the membership page. For privacy enquiries, contact contact@orionex-ai.com.

Use of this site

The readiness check is an OrioNex educational and improvement tool. It does not replace a regulatory compliance determination, audit or certification. Decisions for actual clinical trials require review of trial-specific risks and applicable requirements.