1 Introduction
The purpose of this standard is to specify the format, content and
method of exchange of non-clinical data to ensure data sharing and
collaboration between different organizations. This standard applies to
non-clinical data exchange involving drug development, approval and
supervision.
2. Terms and
Definitions
2.1 Non-clinical data: refers to data generated in the process of drug
development, approval and supervision, but not used in clinical trials,
including but not limited to data on pharmacodynamics, pharmacokinetics,
toxicology, quality control, etc.
2.2 Data exchange: refers to the activities of sharing and obtaining
non-clinical data between different organizations.
3. Non-clinical data
exchange standards
3.1 Data format: Non-clinical data should adopt common data formats,
such as CSV, Excel, JSON, etc., to ensure the readability and parsability of
the data.
3.2 Data content: Non-clinical data should include the following:
3.2.1 Test names and identifiers: Specify the name, number, and other
identifiers for each test.
3.2.2 Experimental design: Describe key information such as the
experimental design plan, experimental animal species, administration route,
dosage, etc.
3.2.3 Test results: Provide test results on pharmacodynamics,
pharmacokinetics, toxicology, etc., including charts, statistical data, etc.
3.2.4 Data analysis: Preliminary analysis and interpretation of the test
results, including the reliability, consistency and processing of outliers of
the data.
3.2.5 Quality standards: Provide test-related quality standards, such as
the health status of experimental animals, concentration and stability of
dosing solutions, etc.
3.3 Data exchange method: Non-clinical data exchange should use secure
electronic transmission methods, such as FTP, SFTP, HTTPS, etc., to ensure the
confidentiality, integrity and availability of data.
4. Non-clinical data
exchange process
4.1 The data provider and recipient should reach a data exchange agreement
to clarify the scope, purpose and responsibilities of data sharing.
4.2 The data provider should send non-clinical data to the recipient in accordance with the
specified data format and content.
4.3 After receiving the data, the recipient should verify and verify the
data to ensure the integrity and accuracy of the data. If necessary, the
provider can be asked to supplement or correct data.
4.4 The receiving party shall use non-clinical data in accordance with
the purpose and scope of use specified in the agreement, and take necessary
confidentiality measures.
5. Documentation and
management
5.1 Non-clinical data exchange activities should be documented,
including data exchange protocols, data sending and receiving records, etc.
5.2 Document records should be saved and managed in accordance with
regulatory requirements to ensure traceability and accessibility of records.
6. Standardized reference guides and best practice recommendations refer
to the guidelines and specifications issued by relevant international and
national drug regulatory agencies, as well as best practice recommendations
issued by industry associations, to ensure standardization and compliance of
non-clinical data exchange.
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