Shared vocabularies for research administration.

CONSORT Flow Diagram for Randomised Trials

Human Cell Atlas (HCA)

An international, open-science consortium, founded in 2016 and convened by the Broad Institute, the Wellcome Sanger Institute, and Wellcome, that aims to create comprehensive reference maps of every cell type in the human body using single-cell and spatial genomics. The HCA is a distributed research collaboration organized into national/regional networks and topic-specific Biological Networks (not a repository, funder, or formal legal entity), coordinated by an Organizing Committee and Working Groups, publishing data and analysis tools through the HCA Data Portal for free public reuse under its own network-level standards.

Reverse Causality

Reverse causality (also called reverse causation) is the error of assuming a relationship between two variables, X and Y, runs from X to Y when the true causal arrow runs the opposite way -- from Y to X -- or, in the general case, runs both ways at once as a feedback loop. It requires no third variable: the mistake is not that some lurking factor is driving both X and Y (that is confounding), it is that the direction assigned to a real relationship between X and Y is simply backwards. Observing that X and Y are correlated, or even that X was measured before Y, does not establish that X causes Y -- it is equally consistent with Y's own prior trajectory having produced X, which is common whenever both variables are stable traits or slow-moving processes capable of influencing each other over time.

Vivli (concept)

A non-profit, independent clinical-trial data-sharing platform that hosts a searchable catalogue of individual participant-level data (IPD) from completed clinical trials and mediates researcher access to it through a structured, multi-stage request-and-review process rather than open download. Approved researchers analyze the data inside a browser-based secure research environment; the underlying files are never downloaded to the researcher's own machine. Vivli grew out of a project at the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women's Hospital and Harvard, and launched publicly in July 2018.

PharmGKB (Now ClinPGx): The Pharmacogenomics Knowledgebase

ClinPGx (the renamed, relaunched successor to PharmGKB, the Pharmacogenomics Knowledgebase) is the NIH-funded, Stanford-hosted resource that curates the evidence linking specific genetic variants to drug response -- clinical annotations, dosing guidelines, and drug-label pharmacogenomic annotations -- and now brings PharmGKB's original knowledgebase together with CPIC's dosing guidelines and PharmCAT's genotype-to-phenotype annotation tool under one platform at clinpgx.org (pharmgkb.org now redirects there). What makes a gene-drug relationship a PharmGKB/ClinPGx entry specifically is that the resource's own curation team has reviewed the evidence and published a structured clinical annotation with an assigned level of evidence under a stable, citable identifier -- not merely that a primary study reported the association.

Authorised Prescriber (AP) Scheme (TGA, Australia)

The Authorised Prescriber (AP) Scheme is one of two pathways under Australia's Therapeutic Goods Act 1989 (Cth) letting a medical practitioner lawfully supply an unapproved therapeutic good (one not on the Australian Register of Therapeutic Goods for the intended use) outside a formal clinical trial. It applies when a single named practitioner needs standing authority to prescribe that good to an entire class of patients with a defined medical condition under their ongoing care -- as opposed to the Special Access Scheme (SAS), which covers a single patient or a specific small group per request. Becoming an Authorised Prescriber requires endorsement from a Human Research Ethics Committee or relevant specialist college (or, for products with an established history of use, direct TGA application), and carries an ongoing obligation to report patient numbers to the TGA roughly every six months.