The single most important thing to understand about a RIQA finding: Every RIQA finding is a statement about whether a reported analytical result reproduces from submitted data under the declared methodology. It is not a statement about biological truth, scientific validity, regulatory compliance, or research misconduct. These are fundamentally different things.
RIQA performs independent analytical result reconstruction — a specific and deliberately narrow form of verification. For each engagement, RIQA starts from the raw or processed data the submitter provides, applies the statistical methodology the submitter declares, and determines whether the reported outputs (fold changes, p-values, frequencies, hazard ratios, risk scores, quality measure rates) can be reproduced from those inputs under that method.
This is a computational and methodological evaluation. RIQA asks: given what you submitted, do your reported results follow from your declared method? That is the scope of the question. Nothing broader.
RIQA findings apply only to the materials submitted and the methodology declared at the time of the audit. They do not extend retroactively to earlier versions of an analysis, to related studies not submitted, or to future work building on the audited results.
A RIQA finding is one of the following:
Critical reading guidance. The following statements are never valid interpretations of a RIQA finding, regardless of severity. Anyone citing a RIQA audit report in any context — internal, editorial, institutional, legal, or regulatory — should be aware of these limits.
- An allegation of fraud, misconduct, or data fabrication
- A determination that a biological or clinical conclusion is false
- A regulatory compliance determination of any kind
- A legal finding or evidence in any legal proceeding
- An opinion on the scientific merit or novelty of the work
- A finding that the experiment was conducted incorrectly
- A statement about the quality of the wet-lab or clinical work
- Evidence that any person acted improperly or negligently
- A reproducibility statement about submitted data and declared methodology
- A traceability statement about how completely the analysis was disclosed
- A flag for items the submitter should clarify, document better, or re-derive
- A methodological consistency assessment against declared analytical choices
- A structured quality assurance input for author pre-submission review
- A record of what RIQA could and could not independently reproduce
The distinction between "this result does not reproduce from submitted data" and "this result is wrong" is fundamental. A result may fail to reproduce because of a documentation gap, a software version difference, a methodological choice not fully disclosed, or a genuine error — RIQA cannot distinguish between these causes without additional information from the submitter. RIQA's role is to identify the discrepancy and ask for clarification, not to render a verdict.
RIQA's scope is explicitly bounded. The following are outside RIQA's current audit scope and are disclosed in every audit report:
- Primer efficiency calibration (qPCR; assumes 100% efficiency)
- Amplification curve or melt curve inspection
- Re-gating from raw FCS files (flow cytometry)
- Compensation matrix verification
- geNorm/NormFinder reference gene stability ranking
- Paired, longitudinal, or mixed-effects statistical designs
- Judgement of biological correctness of reported findings
- Verification of wet-lab or clinical procedures
- Regulatory compliance determinations (FDA, CMS, IRB)
- Audit of underlying source systems or EHR data
- PHI de-identification verification
- Adjudication of clinical endpoint disagreements
- Fraud detection or misconduct investigation
- Legal or expert witness services of any kind
Current framework limitations are version-specific. Each audit report includes a limitations appendix documenting what was and was not within scope for the specific module version used in that engagement.
RIQA audit reports are designed to support the following uses:
- Author pre-submission review. Identifying methodological or reporting gaps before journal submission, allowing the research group to address them proactively.
- Internal quality assurance. Institutional or group-level QA programs evaluating the completeness and reproducibility of analytical workflows.
- Grant proposal support. Providing independent verification of preliminary data statistical conclusions for inclusion in NIH and other funding applications.
- Pre-NDA or pre-regulatory submission review. Sponsor-side assurance that reported endpoints reproduce under independent reconstruction before regulatory filing. RIQA reports in this context support internal QA, not regulatory submission packages.
- Editorial or peer-review support. Providing methodological transparency documentation to journals or editors who request independent analytical verification.
Uses that require caution. RIQA audit reports should not be cited as evidence of regulatory compliance, used in legal proceedings as expert testimony, or used to publicly allege misconduct by any named individual or organization. The appropriate response to a material RIQA finding is re-analysis and methodological clarification — not public disclosure or institutional complaint without independent expert review.
The appropriate response to each finding severity level is:
- Material. Re-analyze the underlying data using the declared methodology and identify the source of the discrepancy. Where re-analysis confirms the original number, provide a methodological clarification explaining the analytical basis of the disagreement. Do not revise reported conclusions without understanding and documenting the source of the discrepancy.
- Moderate. Disclose the methodological choice and its rationale in the methods section. Consider whether the finding affects the strength of any stated conclusion and revise accordingly.
- Minor. Incorporate better documentation in future submissions. No retrospective change to the present work is typically required unless the gap is identified as more significant through re-review.
- Informational. No action required. Note the recommendation for future analytical practice.
RIQA audit reports produced through formal engagements are confidential to the submitting party. RIQA LLC does not publish, share, or disclose the contents of any engagement audit report without the express written consent of the submitting party.
Demonstration case studies published on riqassure.com use synthetic data constructed for illustrative purposes. No real engagement data, real study results, or real organization information is included in any publicly available RIQA demonstration material.
Submitters who wish to publicly reference or cite their RIQA audit report — for example in a manuscript methods section or a grant application — may do so at their discretion. RIQA LLC will provide written confirmation of audit completion and overall outcome upon request for inclusion in such references.
Every RIQA audit report identifies the specific framework version under which it was produced (e.g. RIQA-qPCR Livak v1.1, RIQA-Flow Herzenberg v1.1). The scope of findings, concordance standards, and severity classifications applied in any audit are those documented for that specific version.
Framework updates may change concordance thresholds, add new finding types, or expand audit scope. A report produced under v1.1 should be interpreted using the v1.1 methodology documentation, not any later version. RIQA maintains version-specific methodology documentation for all production framework versions.
Questions about the interpretation of a specific RIQA audit finding, the scope of a particular framework version, or the appropriate use of a RIQA report should be directed to:
RIQA LLC
Attn: Framework Interpretation
contact@riqassure.com
riqassure.com
Chicago, Illinois
RIQA LLC is committed to providing clear, prompt responses to interpretation questions from submitters, collaborators, and editors. We typically respond within two business days.