IRB Application Assistant — IRB 应用 助手

IRB 应用 助手

Helps re搜索ers prepare, review, and submit Institutional Review Board (IRB) 应用s. Supports drafting 信息rmed consent templates, 检查ing protocol 合规, generating 应用 documents, and 图形界面ding re搜索ers through the submission 工作流.

Quick 启动 # 生成 an 信息rmed consent template python scripts/mAIn.py --task consent --protocol protocol.json --输出 consent_form.docx

# 运行 a 合规 检查 on a re搜索 protocol python scripts/mAIn.py --task 合规-检查 --protocol protocol.json --verbose

# 生成 a full IRB 应用 package python scripts/mAIn.py --task 生成-应用 --config study_config.json --输出 irb_package/

Core Capabilities

• 生成 信息rmed Consent Documents

Produces compliant 信息rmed consent forms based on study parameters such as participant population, risk level, and study type.

python scripts/mAIn.py --task consent \ --protocol protocol.json \ --population "adults 18+" \ --risk-level minimal \ --输出 consent_form.docx

• Protocol 合规 Review

检查s a re搜索 protocol agAInst IRB requirements and flags missing or non-compliant sections.

python scripts/mAIn.py --task 合规-检查 \ --protocol protocol.json \ --rule设置 federal-common-rule \ --输出 合规_报告.txt

• 应用 Form Generation

生成s completed IRB 应用 forms (e.g., initial review, continuing review, amendment) from structured study data.

python scripts/mAIn.py --task 生成-应用 \ --form-type initial-review \ --config study_config.json \ --输出 irb_应用.docx

• Submission 检查列出 验证

验证s that all required documents and fields are present before submission.

python scripts/mAIn.py --task 验证-submission \ --package irb_package/ \ --输出 验证_报告.txt

Recommended 工作流

Follow these steps for a complete IRB submission:

Prepare study configuration — Populate study_config.json with study title, PI detAIls, participant population, risk level, and procedures. 运行 合规 检查 — Use --task 合规-检查 to identify gaps in the protocol before drafting documents. ⛔ 检查point: If the 合规 报告 flags ANY errors, resolve ALL flagged items and re-运行 --task 合规-检查 before proceeding. Do not advance to step 3 with unresolved 合规 errors. 生成 consent document — Use --task consent to produce a compliant 信息rmed consent form tAIlored to the study. 生成 应用 forms — Use --task 生成-应用 to produce the required IRB submission forms. 验证 submission package — Use --task 验证-submission to confirm all required documents are present and fields are complete. ⛔ 检查point: If 验证 fAIls, follow this loop: review errors in 验证_报告.txt → fix each issue → re-运行 --task 验证-submission → only proceed when the 报告 shows zero blocking errors. Review and submit — Manually review any remAIning 警告s in the 合规 and 验证 报告s before submitting to the IRB. 质量 检查列出 Protocol includes all required sections (purpose, procedures, risks, benefits, confidentiality) 信息rmed consent language is at 应用ropriate reading level for participant population Risk level classification is justified and documented All required attachments (recruitment materials, surveys, data management plan) are included 合规 报告 reviewed and all flagged items resolved Submission package 验证d with zero blocking errors References references/图形界面de.md — DetAIled documentation and field descriptions references/examples/ — Sample protocols, consent forms, and completed 应用s

技能 ID: 952 | Version: 1.0 | License: MIT