What medical reporting standards are supported?

It supports a wide range of standards including CARE (case reports), ICH-E3 (clinical study reports), CONSORT (trial flow diagrams), and standard medical formats like SOAP and H&P.

Can this skill generate visual aids for reports?

Yes, it has a mandatory requirement to include at least one AI-generated schematic, such as a patient timeline or diagnostic algorithm, using the scientific-schematics tool.

Is it suitable for regulatory submissions to the FDA?

Yes, the skill is designed to follow ICH-GCP and FDA-compliant structures for Serious Adverse Event (SAE) reports and Clinical Study Reports (CSR).

How does the clinical-reports skill handle patient privacy?

The skill includes specialized de-identification logic to remove or alter the 18 HIPAA-defined identifiers, ensuring that generated reports are compliant with privacy regulations.

Clinical Report Writing & Regulatory Documentation

Name: Clinical Report Writing & Regulatory Documentation
Author: K-Dense-AI

byK-Dense-AI

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235

Content Management

Generates comprehensive, regulatory-compliant clinical reports, diagnostic summaries, and medical documentation following international standards like CARE and ICH-E3.

About

The Clinical Reports skill empowers medical writers and healthcare professionals to draft precise, standardized documentation ranging from journal-ready case reports to complex clinical study reports (CSR). It integrates deep knowledge of regulatory frameworks such as HIPAA, FDA, and ICH-GCP while enforcing the inclusion of visual aids via scientific schematics to improve data communication. Whether you are documenting patient progress via SOAP notes or preparing Serious Adverse Event (SAE) reports, this skill ensures accuracy, privacy through automated de-identification, and adherence to professional medical guidelines.

Key Features

Support for clinical trial documentation including SAE and DSMB reports
235 GitHub stars
Integrated scientific schematic generation for clinical progression and workflows
Standardized templates for radiology, pathology, and laboratory reports
Automated HIPAA-compliant de-identification of 18 patient identifiers
Full compliance with CARE, ICH-E3, and CONSORT guidelines

Use Cases

Preparing clinical study reports (CSR) for FDA or other regulatory submissions
Automating clinical documentation such as SOAP notes, H&P, and discharge summaries
Drafting peer-reviewed case reports for medical journal submissions

About

Key Features

Support for clinical trial documentation including SAE and DSMB reports
235 GitHub stars
Integrated scientific schematic generation for clinical progression and workflows
Standardized templates for radiology, pathology, and laboratory reports
Automated HIPAA-compliant de-identification of 18 patient identifiers
Full compliance with CARE, ICH-E3, and CONSORT guidelines

Use Cases

Preparing clinical study reports (CSR) for FDA or other regulatory submissions
Automating clinical documentation such as SOAP notes, H&P, and discharge summaries
Drafting peer-reviewed case reports for medical journal submissions