Nonclinical Data Exchange Standard

 

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.