NHG Human Tissue Bank Policy, SOPs & Templates

NHG Human Tissue Bank Policy
Proper Conduct of Tissue Bank SOPs & Templates

These are a set of guidelines and templates developed by NHG Tissue Compliance Committee to provide detailed procedures on conducting tissue banking activities in accordance with applicable guidelines and regulations (e.g. HBRA). You may adapt and modify these guidelines and templates to suit your individual tissue banking activities.

These documents are strictly for internal circulation among NHG Staff and Authorized personnel only.
* Access to these files is Restricted (NHG Intranet access required).

NHG Human Tissue Bank Policy

1601-A02 NHG Policy for Tissue Banks

Proper Conduct of Tissue Bank (PCT) SOPs

1501-A01 Prep Maintaining and Communicating PCT SOPs

1501-A02 Responsibilities of the Tissue Bank and Tissue Collection Team

1501-A03 Training and Education

1501-B01 Pre-Initiation of Tissue Banking Activities

1501-B02 Interaction with NHG Tissue Compliance Committee

1501-B03 Documentation

1501-B04 Quality Management of Tissue Banks and Tissue Collections

1501-B05 Data Management

1501-B06 Release of Tissue Specimens

1501-B07 Closure of Tissue Bank and or Tissue Collection

1501-C01 Informed Consent Form and Process Requirements

1501-C02 Donor Recruitment

1501-C03 Donor Management

1501-C04 Management of Incidental Findings

1501-C05 Human Tissue Specimen

Checklist

1502-01 NHG Tissue Bank Review Checklist

1502-02 Eligibility Checklist

Logs

1503-01 Tissue Responsibility and Delegation Log

1503-02 Tissue Bank SOP Communication Log

1503-03 Donor Screening and Enrollment Log

1503-04 Donor Identification log

1503-05 Specimen Inventory Log

1503-06 Temperature Log

1503-07 Specimen Destruction Log

1503-08 Tissue Team Meeting Attendance Log

1503-09 Human Tissue Informed Consent Form Information Tracking Log

1503-10 Untoward Occurrence/ Serious Adverse Event Tracking Log

1503-11 Non-Compliance / Protocol Deviation Tracking Log

Forms

1504-02 Training Record Form

1504-03 Laboratory Request Form

1504-04 Tissue Specimen Request Form

1504-05 Tissue Specimen Retrieval Form

1504-06 Withdrawal of Participation Form

1504-07 Custodian Self-Assessment Form

1504-08 Tissue Collection Activity Self-Assessment Form

Templates

1505-01 Tissue File Contents Template

1505-02 Corrective Action and Preventive Action Plan (CAPA) Template

1505-03 Letter of Undertaking for Leftover Tissues

Other Resources

1506-01 NHG Information Sheet for Tissue Donors (Incidental Finding)

1506-02 A Quick Guide for Setting Up and Managing a Tissue Bank

1506-03 Witness requirement flow chart

1506-04 HBRA Human Tissue Banking regulations and NHG Tissue Bank Policies Index

1506-05 NHG Guidance To Store And Use Leftover Human Tissue for Future Research

1506-06 Introduction to Tissue Bank Quality Management Audit

1506-07 Introduction to Tissue Quality Management Site Initiation Visit

* Access to these files is Restricted (NHG Intranet access required).