Biobank Workflow
Integrated Management of Biobank
Biobank Management
Biobank management covers the whole life cycle of samples, and its core process includes standardised inbound and outbound management mechanism.
Sample Accession Process
In the admission process, the applicant (clinical department/project leader) should first submit the 'Application for Biological Sample Admission' and supporting materials such as research proposal, and then enter the approval process after the sample bank comprehensively evaluates the scientific value, ethical compliance and feasibility of the project; for the approved project, the applicant should further submit the standardised collection plan (including the details of collection, transportation and handling), and sign an 'Agreement on Admission' with the sample bank to clarify the implementation of informed consent and the process of consumables receipt; in the final process, both parties will jointly verify the samples and sign a standardised admission and discharge mechanism. The applicant shall further submit a standardised collection plan (including collection and transportation and handling rules) and sign the 'Agreement on Accession' with the sample bank to specify the implementation of informed consent and the process of consumables collection; in the final stage, both parties shall jointly verify the sample information and complete the 'Registration Form for Accession', which shall be digitally archived according to the coding rules of 'Hospital Code + Organ Code + Water Number + Specimen category + Tube Section Number', and the samples which do not pass the audit will be issued with the 'Notice of Rejection', which will state the specific reasons.
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Sample Release Process
With regard to the process of release, the applicant should submit the 'Release Application Form' with departmental approvals and ethical approvals 14 working days in advance, and after reviewing the significance of the research and compliance by the sample bank, the project that passes the audit needs to sign the 'Release Agreement' to define the relationship between rights and responsibilities, and then the staff locates and verifies the target samples and collaborates with the applicant to confirm the information in the inventory and simultaneously completes the signing of the 'Release Registration Form' and the handover of the entity. In order to guarantee the effectiveness of sample use tracking, the applicant is required to submit a sample application progress report 1/3/6 months after the release of samples, forming a closed-loop management to continuously optimise the allocation of resources in the database.
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Metadata Management
Metadata management integrates patients' clinical data (case system collection and follow-up records) and histological data through a unified identifier system to ensure the uniqueness of the association between the biospecimen bank and the database.
Data Accession Process
In the process of data accession, firstly, the data demand department submits the 'Application for Data Accession to the Biospecimen Bank' (the data associated with the already accessed samples can be exempted from application, but the application should be submitted for the case of signing the informed consent form without actually donating the samples); subsequently, the management personnel of the biospecimen bank conducts a comprehensive assessment of the scientific research value of the project, the reasonableness of the data, and the accessibility of the data, and issues the 'Notice of Rejection of Data Accession' with an explanation of the reasons if the data passes the audit. If the data do not pass the audit, the 'Notice of Rejection of Data Entry' will be issued and the reasons will be explained; the data that pass the audit will be entered into the database in strict accordance with the specifications, and the data will be sorted and filed and filled in the 'Biological Sample Database Data Entry Registration Form' after the completion of the audit, and the whole process will be carried out through the review of the legality of data and ethical compliance.
Data Accession Related Documents Download
Data Release Process
The management of data release requires the user department to submit the 'Application for Data Release from the Biological Sample Bank' with ethical approvals, and in the process of audit, it is necessary to go through the double checking of the department of data source and the biological sample bank (including the matching of data and samples, and the assessment of the research value and feasibility); if the data do not pass the audit, the 'Notice of Rejection of Data Release' will be issued; after the audit is passed, the staff will organise the data according to the requirements and archive the data, and the data will be ultimately transferred to the database through on-site copying or encrypted transmission by the personnel designated by the applicant. After passing the audit, the staff will arrange the data according to the requirements and archive them, and finally the applicant will designate the personnel to obtain the data through on-site copying or encrypted transmission, and at the same time, fill in the Data Release Registration Form to complete the handover.