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HTA standard operating procedures

SOP reference number  SOP and appendix title
N/A HTA Policy on Compliance (PDF, 191KB)
 HTA-A1000

Document control (PDF, 173KB)

Appendix 1 Read Log (Word, 35KB)

 HTA-A1001

Transferring to the HTA research licence 12384 (PDF, 587kb)

Appendix 1 Flow Chart - Relevant and non relevant material approvals (PDF, 171KB)

Appendix 2 End of study samples application form (Word, 450KB)

Appendix 3 Flow Chart - Sample Retention (PDF, 82KB)

 HTA-A1002

Applying for a HTA NHS REC-Approved Tissue Banks (PDF, 221KB)

Appendix 1 Research tissue bank application (Word, 42KB)

Appendix 2 Guidance for Business Cases for CBG approval (Word, 26KB)

 HTA-A1003 Storage of HTA material beyond NHS REC approval (PDF, 201KB)
 HTA-A1004

Disposal of HTA Material (PDF, 419KB)

Appendix 1 Flow diagram of disposal process (Word, 158KB)

Appendix 2 Disposal request form (Word, 38KB)

Appendix 3 Awaiting disposal record form (Word, 37KB)

Appendix 4 OBSOLETE

 HTA-A1005

Import and export of HTA material (PDF, 218KB)

Appendix 1 Sample application form for imported samples (Word, 49KB)

 HTA-A1006

University of Leicester Ethics Projects (UEIC) HTA Samples (PDF, 213KB)

Appendix 1 OBSOLETE

 HTA-A1007

Procurement of relevant material (PDF, 206KB)

Appendix 1 Sample application form for procured material (Word, 47KB)

 HTA-A1008 Contracts Transfer of HTA Relevant Material (PDF, 188KB)
 HTA-A1009

Management of Fridges, Freezers and Liquid Nitrogen (PDF, 202KB)

Appendix 1 Template notice (Word, 38KB)

Appendix 2 Cleaning log (Word, 38KB)

Appendix 3 Defrosting log (Word, 37KB)

Appendix 4 Temperature trend (Word, 40KB)

Appendix 5 Freezer alarm challenging report (Word, 37KB)

 HTA-A1010

Room Temperature Monitoring HTA Rooms (PDF, 190KB)

Appendix 1 Room temperature monitoring form (Word, 36KB)

 HTA-A1011 Equipment Management and Maintenance (PDF, 204KB)
 HTA-A1012

Transfer of Human Biological Samples (PDF, 198KB)

Appendix 1 Transfer of archival tissue (Word, 40KB)

Appendix 2 Transfer of internal samples (Word, 40KB)

 HTA-A1013

Coding and Tracking of HTA Specimens (PDF, 195KB)

Appendix 1 Sample Tracking Log (Word, 38KB)

 HTA-A1015 HTA Existing Tissue Holdings (Pre-2006) (PDF, 204KB)
 HTA-A1016A Responses to Alerts on Haier Monitoring System (PDF, 192KB)
 HTA-A1016b Haier Temperature Monitoring Testing (PDF, 156KB)
 HTA-A1017 DNA analysis (PDF, 205KB)
 HTA-A1018

PD Master files (PDF, 155KB)

Please email HTAenquiries@le.ac.uk for a copy of the latest PD Masterfile documents

 HTA-A1019

Auditing HTA Licenced Areas (PDF, 242KB)

Appendix 1 AUDIT REPORT - Type A (Word, 37KB)

Appendix 2 AUDIT REPORT - TYPE B (Word, 41KB)

Appendix 3 AUDIT REPORT - TYPE C (Word, 40KB)

Appendix 4 AUDIT REPORT - TYPE D (Word, 40KB)

Appendix 5 AUDIT REPORT - TYPE E (Word, 40KB)

Appendix 6 AUDIT REPORT - TYPE F (Word, 36KB)

Appendix 7 AUDIT REPORT - TYPE G (Word, 40KB)

Appendix 8 OBSOLETE

Appendix 9 OBSOLETE

Appendix 10 Internal Audit checklist response document (Word, 59KB)

Appendix 11 PD Mini Audit Pairings (PDF, 75KB)

Appendix 12 PD Mini Audit Template (Word, 69KB)

 HTA-A1020

Management of HTA Records (PDF, 43KB)

Appendix 1 OBSOLETE

Appendix 2 OBSOLETE

Appendix 3 Human Tissue training checklist (Word, 43KB)

Appendix 4 OBSOLETE

 HTA-A1021

HTA Risk Identification Analysis (PDF, 184KB)

Appendix 1 Risk Assessment Form (Word, 164KB)

Appendix 2 Risk Register log (Word, 35KB)

Appendix 3 Risk Assessment Flow Chart (PDF,124KB)

 HTA-A1022

HTA Adverse Events (PDF, 175KB)

Appendix 1 Incidents &  AE Report Form (Word, 39KB)

Appendix 2 Matrix for Grading Incidents (Word, 40KB)

Appendix 3 Adverse Events Flow Chart (PDF, 81KB)

 HTA-A1023

Emergency Planning (PDF, 145KB)

Appendix 1OBSOLETE

 HTA-A1024 HTA Procedure in event of non-compliance(PDF, 275KB)
 HTA-A1025 Retaining Samples and Data (PDF, 176KB)
 HTA-A1026 Pending
 HTA-A1027

Persons Designated Roles and Responsibilities (PDF, 171KB)

Appendix 1 HTA PD Role Description UoL (Word, 32KB)

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