How this reference is written, checked, and corrected

Most pages here are reference material — what a regulation requires, how a standard defines a term, how two tools differ. They are produced by an editorial process that combines drafting, primary-source verification, and review, rather than by a single named author writing an opinion piece.

Attaching a person’s name to that would imply an individual authored and vouches for each page personally. That would not be true, and inventing author personas to satisfy a ranking heuristic is precisely the practice search guidance warns against. So pages carry the CASRAI Editorial Board byline, which is accurate: a real, accountable editorial function within a real organisation, reachable at [email protected].

Where a named individual genuinely did write or review a page — for example a working group member contributing to a standards explainer — that person is credited by name on the page, with an ORCID iD where they have one.

Claims are graded by what backs them, in this order:

• Primary source. The regulation, standard, or specification itself — the CFR text, the ICH or ISO document, the EU regulation, the standards body’s own publication. Where a specific clause is load-bearing, the page cites the clause.
• Authoritative secondary source. A regulator’s own guidance, a standards body’s explanatory material, or a peer-reviewed methods paper.
• Reported. Corroborated across independent, credible secondary sources but not confirmed against the primary text — usually because the primary document is paywalled or not machine-retrievable. Pages say so where this applies rather than presenting it as settled.

Numbers, dates, thresholds, and clause references are the claims most likely to be wrong and most costly if they are, so they get the strictest treatment: if a figure cannot be tied to a primary source, the page omits it rather than approximating it.

It is not legal, regulatory, clinical, or financial advice. Compliance obligations turn on jurisdiction, institutional policy, and the specifics of a study or facility. Pages describe how a requirement generally works so a reader can ask their compliance office, IRB, or counsel the right question — not so they can substitute a web page for that conversation.

Regulations change. Every page carries a last-updated date; treat anything time-sensitive as needing confirmation against the current official text.

If something here is wrong, tell us and it gets fixed. Email [email protected] with the page URL and what is incorrect — a pointer to the correct primary source is the fastest route to a change.

Substantive corrections update the page and its last-modified date. Where a correction materially changes what the page previously asserted, the change is noted on the page rather than made silently.