FAIRsharing record for: WHO Guidelines for good clinical practice (GCP) for trials on pharmaceutical products
Bibliographic record
Abstract
This FAIRsharing record describes: The purpose of these Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO TRS 850 - Annex 3) is to set globally applicable standards for the conduct of such biomedical research on human subjects. They are based on provisions already promulgated in a number of countries, including Australia, Canada, European Community countries, Japan, Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) and the United States. These provisions inevitably vary somewhat in content and emphasis, but all are consonant with regard to the prerequisites to be satisfied and the principles to be applied as a basis for assuring the ethical and scientific integrity of clinical trials. Indeed, they have provided a formal basis for mutual recognition of clinical data generated within the respective countries.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.019 | 0.136 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.005 | 0.011 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.010 | 0.006 |
| Open science | 0.004 | 0.006 |
| Research integrity | 0.005 | 0.004 |
| Insufficient payload (model declined to judge) | 0.277 | 0.205 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".