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Human Tissue

Standard Operating Procedures

Receipt, Labelling, Tracking and Storage of Human Tissue

Disposal of Human Tissue

Internal Audit of Human Tissue Authority Licenced Premises, Facilities and Equipment

Recording Human Tissue Act Related Adverse Events

Assessment of Risk to Personnel for the Handling of Human Tissue

Assessment of Risk to Human Tissue

External Transfer and Export of Relevant Material

Import of Relevant Material

Transportation of Human Tissue

Informed Consent for Research

Research Governance: Audit

Complaints from Research Participants

Relevant Research Governance SOPs include

The Ethical Approval of Research

Development, Review and Amendment: Study Protocol

Amendments to Protocols and Essential Documentation

Data management: Collection, Validation and Storage

Maintaining Laboratory Books

Archiving Research Study Documents

Risk Assessment of Research Studies

Forms

HTA Adverse Event Notification Form

Health and Safety Risk Assessment Guidance and Risk Assessment Form

Request for External Transfer or Export of Human Tissue Form

Authority to Import Form

Consent Form Template (Consent forms may vary according to the nature of the study.  The template consent form is suitable for most studies but may require alteration.  Text in red or within square brackets indicates wording that should be included if appropriate for the study).

Research Files Contents Checklist

Disposal Form Template

Guidelines

Guidelines for Research Files

 

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