Data Characteristics in this Category
Data for registration dossier preparation in SMO (Site Management Organization) primarily comes from clinical trial protocols, ethics committee approvals, investigator brochures, informed consent forms, case report forms (CRFs), and various SOPs (Standard Operating Procedures) and regulatory guidelines. These documents are typically in PDF, Word, or scanned image formats. Regulatory guidelines are revised periodically, SOPs may be adjusted due to project or process optimizations, and clinical trial documents are dynamically generated and updated as trials progress. Regulatory guidelines usually have clear chapters and articles, while SOPs have fixed formats and version control information. Common fields and units include medical terminology, dosage units (e.g., mg, ml), time units (e.g., days, weeks), and various biostatistical indicators (e.g., p-value, CI).
Constraints Imposed by These Characteristics on Knowledge Base Retrieval and Recall
The diversity of SMO data requires the knowledge base to handle multiple file formats, with OCR capabilities for scanned documents being crucial. The structured nature of regulations and SOPs necessitates refined text segmentation strategies to ensure precise, article-level recall, avoiding large sections of irrelevant content. Dynamically updated trial documents demand incremental updates and version management from the knowledge base to ensure the timeliness and accuracy of retrieval results. The presence of medical terminology and measurement units requires vector models to have stronger domain-specific semantic understanding, reducing recall bias caused by synonyms or abbreviations. Furthermore, the rigorous nature of registration dossiers means high demands for the accuracy and traceability of retrieval results, requiring verification via metadata or original document links.
Configuration Guidelines
| Configuration Item | Suggested Value | Rationale |
|---|---|---|
UPLOAD_FILE_MAX_SIZE | 500 MB | Accommodates large PDF files and scanned documents containing images, ensuring successful uploads. |
Chunk size (Segment Length) | 300–500 characters (characters) | Matches the granularity of regulatory articles and SOP steps, preventing incomplete semantics or redundancy from segments that are too long or too short. |
Recall count (Number of Retrieved Items) | 8–12 entries (items) | Balances comprehensive recall with avoiding excessive noise, improving the efficiency of subsequent re-ranking. |
Similarity threshold (Similarity Threshold) | Calibrated by actual measurement | Given the specialized nature of SMO data, different thresholds must be evaluated against test sets for their impact on accuracy and recall rates. |
Rerank result count (Number of Re-ranked Items) | 3–5 entries (items) | Focuses on the most relevant core information, reducing the workload for engineers and improving efficiency. |
PARSE_FILE_TIMEOUT_SECONDS | 600 seconds (seconds) | Handles time-consuming complex PDF parsing or OCR recognition, preventing parsing interruptions. |
Three Common Mistakes
- When uploading documents with Chinese filenames, the knowledge base system displays garbled filenames. This occurs because the file upload interface or backend storage service does not correctly handle UTF-8 encoding.
- Retrieval results contain a large amount of irrelevant or outdated SOP content. This is due to the knowledge base lacking effective version management mechanisms or having overly large segmentation granularity.
- Queries for specific medical terms yield inaccurate or missing recall results. This typically happens because the vector model has insufficient understanding of specialized terminology in the biomedical domain, or the knowledge base does not adequately cover relevant synonyms.
How to Verify Configuration
- Select typical regulatory articles, SOP snippets, and trial report content for retrieval tests. Check the relevance, completeness, and ranking of recall results.
- Upload files with Chinese names, special characters, and various formats (PDF, Word, scanned images). Verify that file upload and parsing function correctly, and check the
file status. - Perform retrievals for different versions of the same SOP. Confirm that the knowledge base can distinguish and recall the latest or specified version, or that version information is reflected in the retrieval results.
- Upload a batch of documents containing specific medical terms and measurement units via the API. Then, use these terms to query and assess whether the recall results accurately cover them.
The values provided 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.