GCP Quality Control
Overview
This skill provides structured quality control (QC) procedures for GCP (Good Clinical Practice) clinical trial projects. It covers the full lifecycle: pre-study preparation QC, in-study periodic QC, and study close-out QC. The output includes a structured QC report with defect classification and rectification recommendations, plus a defect tracking checklist.
When to Trigger
Trigger this skill when the user requests any of the following:
- GCP质控 / 临床试验质控 / 机构质控
- 对某项目做质控检查
- 生成质控报告 / 质控缺陷清单
- 试验前/中/后质控
- SDV（原始数据溯源）检查
- 知情同意核查
- 入排标准核查
- AE/SAE核查
- 试验药品管理检查
QC Workflow
Step 1: Gather Project Context
Collect the following information from the user before starting QC. If any item is unknown, ask the user:
- Project name and protocol number
- Sponsor (申办方) and CRO (if applicable)
- Investigator (PI) and study site (研究中心)
- Trial phase (I/II/III/IV期 or BE)
- Current stage: pre-study / ongoing / close-out
- Subject enrollment status (已入组人数 / 目标入组人数)
- QC scope: full coverage, or specific phase only
- Any known issues or complaints to focus on
Step 2: Determine QC Phase and Load Checklist
Based on the current trial stage, load the appropriate checklist sections from references/qc-checklist.md:
| Trial Stage | QC Phase | Checklist Sections |
|---|---|---|
| Not yet started | Pre-study QC | Section 1 (all) + Section 2 (partial) |
| Ongoing | In-study QC | Section 2 (all) + Section 3 (partial) |
| Completed/Closing | Close-out QC | Section 3 (all) + Section 4 (all) |
| Any stage | Full coverage QC | All sections |
Read references/qc-checklist.md to get the full checklist items.
Step 3: Execute QC Items
Work through each checklist item systematically. For each item:
- State the check item name and regulatory basis (GCP / protocol / SOP)
- Ask the user to provide the relevant documents or data
- Evaluate compliance: Pass / Fail / N/A
- If Fail, classify the defect using
references/defect-classification.md - Record findings with specific evidence (document name, page, subject ID, visit date)
Defect Classification — read references/defect-classification.md for full criteria:
- Critical (严重缺陷): Affects subject rights, safety, or data reliability. Examples: missing informed consent, unreported SAE, eligibility criteria violation.
- Major (主要缺陷): Deviation from protocol/GCP that impacts data quality or study integrity. Examples: late AE recording, CRF entry errors, drug accountability gap.
- Minor (次要缺陷): Minor deviation with no impact on subject safety or data reliability. Examples: signature date format, minor filing issue.
Step 4: Generate QC Report
After completing all checklist items, generate the output using the template in references/report-template.md. The report includes:
- QC Report (质控报告) — project info, QC scope, summary statistics, findings by category, defect summary, overall assessment, rectification recommendations
- Defect Checklist (缺陷清单) — itemized list of all defects with severity, description, evidence, and recommended corrective action
Read references/report-template.md to get the full report template.
Key Regulatory References
- ICH-GCP E6(R2) — International Council for Harmonisation Good Clinical Practice
- 《药物临床试验质量管理规范》(2020年版) — China GCP
- 《药物临床试验机构监督检查办法（试行）》
- 《药物临床试验数据现场核查要点》
- Project-specific protocol and amendments
- Site-specific SOPs
Important Notes
- When evaluating compliance, always cite the specific regulatory clause or protocol section
- Defect evidence must be specific: subject ID, visit number, document name, page number
- If a checklist item is N/A for the project, state the reason
- Rectification recommendations must be actionable with suggested timelines
- For Critical defects, recommend immediate corrective action (CAPA)
- Maintain objectivity — report findings as observed, do not speculate
Resources
references/
- qc-checklist.md — Full QC checklist organized by trial phase (pre-study, in-study, close-out, document archival). Load this when executing QC items.
- defect-classification.md — Defect severity classification criteria with examples. Load this when classifying findings.
- report-template.md — QC report and defect checklist output templates. Load this when generating the final output.
