Clinical Standards Hub
Non-profit Community HubNot affiliated with CDISC/SASContributions Welcome

AI Tools for Community

Select a specialized agent to assist with your clinical programming workflow.

Important: Independent Validation Required

All content generated by AI tools on this platform should be validated independently before using in real clinical projects. AI-generated code, specifications, and documentation may contain errors, hallucinations, or logic gaps. Always review outputs against your study protocol, SAP, and company SOPs before incorporating into production environments.

Code & Prompt Studio

The original toolkit. Build detailed LLM prompts, generate SAS/Python code, or convert legacy code between languages.

Launch Tool

Automated Specs Creator

Reverse engineer your code. Paste a derivation script (SAS/Python) and get a formatted Define.xml style mapping specification.

Launch Tool

Logic Explainer

Get professional documentation of complex macros or scripts. Focuses on business logic and data flow, not syntax.

Launch Tool

Raw Dataset Generator

Upload eCRF specs (Excel) and generate linked SAS raw datasets with 5 subject scenarios — screen failure, ongoing, completed, discontinued, and follow-up.

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New

TS Domain Generator

Generate a complete CDISC Trial Summary (TS) domain. Enter core study parameters, AI expands to 30-40 rows with QC verification, then download as Excel.

Launch Tool
New

Spec-to-Code Generator

Upload your SDTM or ADaM mapping specification (Excel) and generate a complete derivation program in SAS, R, Python, or SQL. Specs are chunked by target dataset and processed by AI.

Launch Tool

Best Papers AI

Explore PHUSE and PharmaSUG best papers. Select papers, ask GPT-4.1 mini for summaries and comparisons, and turn award-winning ideas into practical clinical-programming experiments.

Launch Tool

Regulatory Chatbot

Open the Regulatory page's AI assistant for questions about FDA submission guidance, CDISC standards, ICH guidelines, and study data requirements.

Launch Tool
Pilot

ARS-CORE Workbench

Dedicated pilot workspace for mock-shell design, ADaM metadata, cross-spec validation, future AI code generation, execution, CORE validation, and final packaging.

Launch Tool
New

Synthetic Data Generator

Dedicated workbench for importing an eCRF spec, deterministically generating 5 subjects (one per disposition status) as raw datasets, mapping raw to SDTM, and gating every pass through a clinical-trial golden-rule engine.

Launch Tool

How to Use Each Tool

Guidelines and expectations for best results

Code & Prompt Studio

What to Expect

  • Generate production-ready SAS, Python, or R code for SDTM, ADaM, and TLF domains
  • Convert code between languages (e.g., SAS ↔ Python) while preserving clinical logic
  • Build structured prompts for clinical programming tasks

How to Use

Select a mode (Generate, Convert, or Prompt Builder), choose your language and domain, describe your task clearly, and submit. The more specific your prompt, the better the output.

Automated Specs Creator

What to Expect

  • Generates a Define.xml-style mapping specification table from your code
  • Identifies variable names, labels, types, lengths, origins, and derivation logic
  • Best suited for well-structured derivation programs

How to Use

Paste your SAS or Python derivation code into the input box and submit. The tool will analyze the code and produce an HTML specification table that you can copy into your documentation.

Logic Explainer

What to Expect

  • Produces a header summary of overall objective and data flow
  • Adds inline comments explaining business logic and derivation rules
  • Focuses on 'why' (clinical context) rather than 'what' (syntax)

How to Use

Paste any clinical programming code (macros, derivations, etc.) and submit. The output is the original code annotated with professional inline comments. All output is valid runnable code.

Raw Dataset Generator

What to Expect

  • Generates complete SAS DATA steps for each CRF page in your uploaded eCRF specification
  • Creates 5 linked subjects with clinically realistic scenarios (screen failure, ongoing, completed, discontinued, follow-up)
  • Uses exact variable names, labels, and types from your spec

How to Use

Upload your eCRF specification Excel file, provide a study name, and submit. The tool reads all sheets/pages and generates SAS code with proper LENGTH, LABEL, and FORMAT statements. Best used for generating test data during study start-up.

TS Domain Generator

What to Expect

  • Generates 30-40 TS parameter rows from your core study inputs
  • AI infers standard parameters (INTMODEL, STYPE, TTYPE, NARMS, etc.) from study context
  • QC agent verifies all TSPARMCD values against CDISC Controlled Terminology
  • Editable table lets you review, modify, add, or delete rows before export

How to Use

Fill in the core study fields (Study ID, Drug, Phase are required). Optionally add dictionary versions. Click Generate — the AI creates the full TS dataset. Review the editable table, make corrections, then download as .xlsx.

Spec-to-Code Generator

What to Expect

  • Reads your mapping specification Excel file with columns: Source, Target, Variable, Label, Type, Length, Logic
  • Chunks spec rows by target dataset and sends them to GPT-4o-mini for code generation
  • Generates a single consolidated program in your choice of SAS, R, Python, or SQL
  • Implements every variable derivation listed in your spec with proper comments

How to Use

Select SDTM or ADaM, choose your output language, upload your spec Excel file (download the sample template if needed), select sheets, and click Generate. The tool produces a complete derivation program you can copy or download.