How does it help with document readability?

The skill specifically guides the creation of lay-language summaries and consent forms, targeting an 8th-grade reading level to ensure participant comprehension.

Can I use this for multi-site studies?

Yes, it includes provisions for single-IRB (sIRB) arrangements and documentation required for multi-site coordination under the 2018 Common Rule revision.

Does this skill handle FDA-regulated studies?

Yes, the skill is designed to meet requirements for both the Common Rule (45 CFR 46) and FDA-regulated research under 21 CFR Parts 50 and 56.

Does it generate HIPAA documentation?

Yes, it assists in drafting HIPAA Authorizations, Waivers of Authorization, and Limited Data Set agreements for research involving protected health information.

IRB Submission Writer

Name: IRB Submission Writer
Author: lev-os

bylev-os

•

生产力与工作流

Drafts comprehensive IRB submission packages, protocol summaries, and informed consent forms compliant with federal regulations.

This skill equips Claude to manage the complex documentation required for Institutional Review Board (IRB) submissions in clinical and human-subjects research. It guides users through intake scoping, determines the appropriate review category (Exempt, Expedited, or Full Board), and generates compliant protocol summaries and informed consent documents according to 45 CFR 46 and 21 CFR 50/56 standards. By encoding regulatory requirements and risk-benefit analysis frameworks, it helps researchers and regulatory affairs professionals minimize submission delays and ensure ethical compliance from the first draft.

主要功能

01Automated drafting of Informed Consent Forms (ICF) including all 8 required regulatory elements

02Regulatory classification assistance for Exempt, Expedited, and Full Board reviews

03Generation of lay-language protocol summaries and structured risk-benefit analyses

04Preparation of HIPAA authorizations, waivers, and Data Use Agreements (DUA)

05Comprehensive pre-submission quality audits and checklist verification

062 GitHub stars

使用场景

01Drafting amendments and continuing review documents for ongoing trials

02Creating participant-facing recruitment materials, scripts, and advertisements

03Preparing initial ethics applications for new clinical research or behavioral studies

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add lev-os/agents writing-irb-submissions

For use in Claude.ai and ChatGPT

主要功能

01Automated drafting of Informed Consent Forms (ICF) including all 8 required regulatory elements

02Regulatory classification assistance for Exempt, Expedited, and Full Board reviews

03Generation of lay-language protocol summaries and structured risk-benefit analyses

04Preparation of HIPAA authorizations, waivers, and Data Use Agreements (DUA)

05Comprehensive pre-submission quality audits and checklist verification

062 GitHub stars

使用场景

01Drafting amendments and continuing review documents for ongoing trials

02Creating participant-facing recruitment materials, scripts, and advertisements

03Preparing initial ethics applications for new clinical research or behavioral studies