Templates to be used in Project management and in Clinical Trial Monitoring
Bibliographic record
Abstract
We have developed several documents to be used within the SMA-TB project. From these, we have generated (as part of the SMA-TB Capacity-building toolkit) several templates which others can adapt and use for Project management monitoring and Clinical Trial Monitoring for their projects. This has been done in the context of SMA-TB WP1 (Task 1.1.) and WP4 (task 4.4.) The list of the templates included are: Templates for Project management: Deliverable template Standard Operating Procedure (SOP) template Word document template Project impact report template Templates for Clinical Trial Monitoring: Central Monitoring Report template Site Initiation Visit Checklist template Monitoring Site Visit Checklist template Monitoring Close-Out Site Visit Checklist and Report template Templates for Clinical Trial performance: Delegation of Responsibilities Log template Training Log template Screening Log template Enrolment Log template Investigational Medical Product Dispensing and Accountability Log template Serious Adverse Event Reporting form template Code Break Inquiry template Code Break Report template Meeting attendance template Protocol Deviation tracker template Informed Consent tracker template
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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 | 0.108 | 0.304 |
| Meta-epidemiology (narrow) | 0.002 | 0.003 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.009 | 0.006 |
| Science and technology studies | 0.002 | 0.002 |
| Scholarly communication | 0.008 | 0.007 |
| Open science | 0.005 | 0.006 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.142 | 0.173 |
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".