Is it suitable for clinical trial documentation?

Absolutely, it supports ICH-E3 standards for Clinical Study Reports (CSR), Serious Adverse Event (SAE) reporting, and DSMB reports.

What standards does it follow for case reports?

It strictly follows the CARE (CAse REport) guidelines, ensuring structured abstracts, detailed patient info, and chronological clinical findings.

Does this skill handle HIPAA compliance?

Yes, it includes built-in protocols for the de-identification of the 18 HIPAA identifiers to ensure patient privacy in all generated documentation.

Can it generate visual diagrams for medical reports?

Yes, the skill mandates at least one AI-generated scientific schematic per report, such as patient timelines, diagnostic algorithms, or CONSORT flow diagrams.

Clinical Report Writing

Name: Clinical Report Writing
Author: Sologa

bySologa

Content Management

Generates comprehensive, regulatory-compliant clinical reports and medical documentation with integrated scientific schematics.

About

This skill empowers healthcare professionals and researchers to produce high-quality clinical documentation ranging from CARE-compliant case reports to complex clinical study reports (CSR). It automates the structured reporting process while ensuring strict adherence to HIPAA, FDA, and ICH-GCP standards. A unique feature is the mandatory integration of scientific schematics, providing visual clarity through AI-generated patient timelines, diagnostic algorithms, and CONSORT flow diagrams to enhance data interpretation and professional presentation.

Key Features

Regulatory-ready clinical trial documentation including ICH-E3 and SAE reports
Automated de-identification of 18 HIPAA-protected health identifiers
0 GitHub stars
Integrated AI-generated visual schematics for clinical progression and workflows
Structured diagnostic reporting for radiology, pathology, and lab results
CARE guidelines compliance for peer-reviewed case reports

Use Cases

Generating structured radiology or pathology reports based on clinical findings
Drafting clinical case reports for journal submission with visual timelines
Preparing serious adverse event (SAE) reports for regulatory clinical trial submission

About

Key Features

Regulatory-ready clinical trial documentation including ICH-E3 and SAE reports
Automated de-identification of 18 HIPAA-protected health identifiers
0 GitHub stars
Integrated AI-generated visual schematics for clinical progression and workflows
Structured diagnostic reporting for radiology, pathology, and lab results
CARE guidelines compliance for peer-reviewed case reports

Use Cases

Generating structured radiology or pathology reports based on clinical findings
Drafting clinical case reports for journal submission with visual timelines
Preparing serious adverse event (SAE) reports for regulatory clinical trial submission