HTTP Interface and External Systems for CRO Regulatory

Data Characteristics in This Category

Contract Research Organizations (CROs) prepare regulatory submission documents. This process involves diverse data types. These include clinical trial protocols, ethics committee approvals, informed consent forms, case report forms (CRFs), trial data (e.g., lab results, imaging reports), statistical analysis reports, and various regulatory documents and guidelines. Data exists in a hybrid format, both structured (e.g., database records, XML files) and unstructured (e.g., Word documents, PDF reports, images).

Data sources are extensive. They include sponsors, research institutions, third-party laboratories, and public information from regulatory bodies. Data update frequencies vary. Clinical trial data may update daily or weekly. Regulatory documents update irregularly. Document structures are complex. A complete Clinical Study Report (CSR), for example, can have dozens of chapters and hundreds of pages. It contains numerous tables, charts, and cross-references. Field and unit standardization is strict. Compliance with ICH, FDA, NMPA, and other international and domestic regulatory standards is essential. Requirements are clear for drug generic names (INN), dosage units (mg, g, mL), and time points (D1, W4, M6).

Constraints Imposed by These Characteristics on "HTTP Interface and External Systems"

CRO regulatory submission data characteristics impose multiple constraints on HTTP interfaces and external systems. First, a large volume of unstructured documents, such as PDF clinical study reports and Word ethics approvals, requires the interface to efficiently upload, parse, and extract content. This is especially true for recognizing complex tables and charts.

Second, diverse data sources and uncertain update frequencies require the interface to support flexible data retrieval strategies. Examples include scheduled incremental updates of specific database tables or on-demand API queries for the latest regulatory documents. Strict standardization of structured data, such as drug generic names and dosage units, requires the interface to perform rigorous format validation during data transmission and reception. This prevents submission failures due to data inconsistencies.

Document internal cross-references and version management require external systems to transmit metadata via the interface. Examples include document version numbers and revision history. This ensures reference accuracy and traceability. Finally, sensitive clinical trial data demands high security for the interface. Authentication mechanisms (e.g., OAuth2.0, API Key) and encrypted data transmission (HTTPS) are critical to meet data privacy and compliance requirements.

Configuration Guidelines

Configuration Item	Recommended Value	Rationale
`UPLOAD_FILE_MAX_SIZE`	`500 MB`	CRO submission documents often contain many images and charts. Individual file sizes can be large.
`PARSE_FILE_TIMEOUT_SECONDS`	`600 seconds`	Parsing large PDF or Word documents takes a long time. Sufficient timeout is necessary.
`chunk_size`	`800–1200 characters`	Balances semantic integrity and LLM processing window. Avoids excessive splitting or overly long contexts.
`overlap_size`	`100 characters`	Ensures context continuity and handles key information across paragraphs.
`maxContext`	`32000 token`	Addresses the need for long text contexts with complex logic and multiple references in submission documents.
`API_KEY_ROTATION_PERIOD`	`90 days`	Enhances security, aligning with the high data security requirements in the CRO industry.

Three Common Mistakes

Symptom: After uploading a large PDF document, the system remains unresponsive for a long time or returns a parsing failure. Reason: The PARSE_FILE_TIMEOUT_SECONDS configuration is too short. It cannot complete complex document parsing within the allotted time.
Symptom: Drug names or dosage units synchronized by an external system via HTTP interface do not match those stored in FastGPT. Reason: The interface does not strictly validate data types and formats for incoming data fields. This leads to discrepancies during data writing.
Symptom: Calling an external API to retrieve the latest regulatory documents returns a 401 or 403 error. Reason: The API key is expired or permissions are insufficient. The Authorization header or API Key parameter is not configured correctly according to the external system's authentication requirements.

How to Confirm Correct Configuration

Upload a PDF document over 100MB containing complex tables and charts. Confirm it parses successfully and its content is retrievable.
Simulate an external system sending a request with structured data via HTTP. Check if the data format and units in the corresponding fields in the FastGPT knowledge base match expectations.
Configure an HTTP request for an external API. For example, call the public database interface of the NMPA official website. Check if it can retrieve data and process the response normally.

Note: The values provided are common starting points. Measure against your own 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.