Data Characteristics
SMO (Site Management Organization) policy and SOP (Standard Operating Procedure) data originates from regulations and guidelines published by the National Medical Products Administration (NMPA). It also includes operational procedures, quality management system documents, training materials, and project execution documents created by SMO companies based on these regulations. These documents are typically in PDF, Word, or Excel formats. They are highly structured or semi-structured.
National regulations are revised or supplemented annually. Internal SOPs are reviewed and updated quarterly or semi-annually based on regulatory changes, business developments, or quality control requirements. Document content covers the entire clinical trial process. This includes ethical review, investigator meetings, subject recruitment, informed consent, adverse event reporting, data management, and document archiving. Common administrative fields include version numbers, effective dates, revisers, approvers, and document numbers. Medical terminology, units of measurement (e.g., mg, ml, times/day), and time units (e.g., days, weeks, months) are also present.
Constraints on Deployment and Upgrade
The structured and semi-structured nature of SMO policy and SOP documents imposes specific requirements on document parsing and knowledge chunking. For example, PDF documents may contain headers, footers, tables of contents, chapter titles, figures, and body text. This requires precise parsing strategies to avoid redundant information or loss of critical data.
The update frequency of documents necessitates efficient version management and incremental updates in the knowledge base. This ensures real-time accuracy of question-answering content. The large number of specialized terms and units of measurement requires high semantic understanding accuracy from the model. This prevents incorrect answers due to word confusion or misinterpretation of units.
Compliance requirements for these documents make the traceability and reliability of question-answering results critical. Every answer must link to specific source documents and original passages. Processing these characteristics requires sufficient computing resources in the deployment environment to support complex document preprocessing and model inference. The upgrade process must also consider data migration and model compatibility.
Configuration Settings
| Configuration Item | Recommended Value | Rationale |
|---|---|---|
UPLOAD_FILE_MAX_SIZE | 200 MB | SMO policy documents are often large; this ensures all files can be uploaded. |
PARSE_FILE_TIMEOUT_SECONDS | 600 seconds | Addresses time-consuming parsing of complex PDFs, preventing timeouts. |
Chunk size (Chunk Length) | 800–1200 characters | Preserves context integrity and maintains semantic coherence. |
Recall count (Recall Count) | Top 8 entries | Increases the probability of recalling relevant passages for long documents with multiple semantics. |
Similarity threshold (Similarity Threshold) | 0.75 | Ensures precision of recalled content and filters out irrelevant information. |
Rerank result count (Reranked Return Count) | Top 3 entries | Focuses on the most relevant key information, improving answer efficiency. |
Common Mistakes
- After an upgrade, some document content is incompletely extracted or appears garbled. This happens because the new text extraction module has insufficient compatibility with the encoding or format of older documents.
- After a system upgrade, account login fails with a password error. This occurs when user authentication information is not correctly synchronized or encryption methods change during database migration.
- During deployment, some containers continuously fail to start. Logs show port conflicts or insufficient file permissions. This is due to improper port mapping or storage volume permission configurations in the deployment environment.
How to Verify Configuration
- Upload SMO policy documents in various formats (PDF, Word, Excel). Check if they parse correctly and generate knowledge points. Verify the completeness of key fields and content.
- Ask questions about core SOP content. Validate the accuracy of the answers. Check if the answers correctly cite the original source and corresponding version numbers.
- Simulate high-concurrency access. Observe system response speed and stability. Ensure smooth question-answering services during peak business hours.
- Perform incremental updates regularly. Upload revised SOP documents. Confirm that updated content is correctly identified and indexed, and that old version data remains unaffected.
These values are common starting points and should be measured against specific samples.
Question material comes from public community discussions. Configuration values are common starting points and should be measured against your own samples. Verified on 2026-09-21.