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Welcome to the UKTMN Useful resources.

We hope that this compilation of documents and useful resources will be helpful in your daily work.

We welcome any new suggestions for useful additions to the UKTMN Useful resources, please do get in touch.

Please note presentations from UKTMN annual meetings and UKTMN local hub events have been moved to the following pages (click the link. UKTMN Full member's sign-in required)

UKTMN Annual Meeting Slides

UKTMN Oxford Local Hub events

Last Reviewed: December 2016


Archive of important reports

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Archive of relevant reports
Item Name Posted By Date Posted
A new pathway for the regulation and governance of PDF (1.83 MB)  more ] Administration 01/11/2011
Summary of major points in the AMS Review PDF (130.65 KB)  more ] Administration 01/11/2011

Checklists

Item Name Posted By Date Posted
PHARMACY GCP COMPLIANCE CHECKLIST PDF (798.79 KB)  more ] Administration 09/09/2011

Clinical Trials Insurance

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Clinical Trials Insurance
Item Name Posted By Date Posted
ABPI Clinical Trial Compensation Guidelines PDF (162.75 KB)  more ] Administration 01/11/2011
Research in the NHS Indemnity Link  more ] Administration 25/05/2016
Presentation PPT (493.5 KB) Administration 25/05/2016

Creation and Maintenance of Trial Master File

Item Name Posted By Date Posted
The Trial Master File Content DOC (43 KB)  more ] Administration 05/10/2011

Data Protection

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The Data Protection Act 1998 provides a legal framework for protecting personal rights and, in the case of clinical trials, protecting the participant and the researcher.The framework balances the legitimate needs of organisations to collect and use personal data for business and other purposes against the right of individuals to respect the privacy of their personal details. The legislation is underpinned by a set of eight principles. Detailed Guidance can be found on the Information Commissioner’s website
Item Name Posted By Date Posted
The Guide to Data Protection PDF (1.06 MB)  more ] Administration 22/11/2011
A Brief Guide to Notification PDF (266.64 KB)  more ] Administration 22/11/2011
Research involving the NHS - Retention of Records PDF (113.2 KB)  more ] Administration 22/11/2011
Caldicott Guardian Manual (Scottish version) Link  more ] Administration 25/05/2016
Caldicott Guardian Manual 2010 Link  more ] Administration 25/05/2016
Caldicott - Principles into Practice,Welsh Version Link  more ] Administration 25/05/2016
Information Governance Training Tool Link  more ] Administration 25/05/2016
Health and Social Care Act 2008 Link Administration 25/05/2016
Patient confidentiality and Access to Health Recor Link  more ] Administration 25/05/2016
ICO Guidance on the Data Protection Act Link  more ] Administration 25/05/2016
Data Protection Act 1998 Link  more ] Administration 25/05/2016

Education and Training

Item Name Posted By Date Posted
GCP Refresher Training PDF (1.91 MB)  more ] Administration 09/09/2011
GCP Training online Link  more ] Administration 25/05/2016
MSc in Clinical Trials at LSHTM Link  more ] Administration 25/05/2016
MSc in Clinical Trials at UCL Link  more ] Administration 25/05/2016
PharmaSchool Link  more ] Administration 25/05/2016
The Institute of Clinical Research Learning page Link  more ] Administration 25/05/2016
NIHR CRN GCP courses Link  more ] Administration 25/05/2016
IRAS e-learning module Link  more ] Administration 25/05/2016
The Information Governance Training Tool Link  more ] Administration 25/05/2016
Research and human tissue legislation e-learning Link  more ] Administration 25/05/2016
Task, Knowledge and Competency Framework for TM PDF (265.83 KB)  more ] Administration 01/06/2016

GCP Guidance Documents

Item Name Posted By Date Posted
GCP Considerations: Informed Consent PDF (1.06 MB)  more ] Administration 09/09/2011
GCP Considerations: Contraception PDF (486.98 KB)  more ] Administration 09/09/2011
GCP Considerations: The Investigator’s Brochure (I PDF (577.62 KB)  more ] Administration 09/09/2011
1998 MRC Guidelines for GCP in Clinical Trials PDF (109.92 KB) Administration 07/12/2011

Grant Costings

Item Name Posted By Date Posted
ARCO PDF (177.64 KB)  more ] Administration 14/03/2012
NIHR CRN CC Industry costing templates Link Administration 14/03/2012
NHS Research, Support and Treatment Costs Link  more ] Administration 14/03/2012
Southamton CRI Guidance (Examples of costs) PDF (109.58 KB)  more ] Administration 14/03/2012
Annex B FAQ April 2013 PDF (41.11 KB) Administration 26/06/2013
AcoRD Annex A PDF (14.62 KB)  more ] Administration 26/06/2013
AcoRD PDF (168.05 KB)  more ] Administration 26/06/2013
AcoRD Link  more ] Administration 25/05/2016
ARCO Link  more ] Administration 25/05/2016
ReSeT Guidance Link  more ] Administration 25/05/2016

Health Research in the Criminal Justice System

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Health research in the criminal justice system
Item Name Posted By Date Posted
Offender Health Research Network Toolkit Link  more ] Administration 08/12/2011

Help with Legislaton

Item Name Posted By Date Posted
DH Summary of Mental Capacity Act 2005 PDF (119.52 KB)  more ] Administration 04/10/2011

International and European Trials

Item Name Posted By Date Posted
International Compilation of Human Research Protec PDF (938.06 KB)  more ] Administration 03/10/2011
The Procedure for the Ethical Review of Protocols  Link  more ] Administration 25/05/2016

Involving Patients and Carers in Clinical Trials

Item Name Posted By Date Posted
Payment for Involvement PDF (451.54 KB)  more ] Administration 25/10/2011
MHRN Model Payment Policy PDF (247.29 KB)  more ] Administration 25/10/2011
Exploring Impact PDF (450.65 KB)  more ] Administration 25/10/2011
PPI - INVOLVE Link  more ] Administration 04/04/2012
Public involvement in clinical trials supplement Link  more ] Administration 19/04/2012
Briefing notes for researchers Link  more ] Administration 19/04/2012

Mental Capacity Act Guidence

Item Name Posted By Date Posted
A simple guide to the Mental Capacity Act 2005 DOC (80.5 KB)  more ] Administration 07/12/2011

NCRN Staff Induction Handbook

Item Name Posted By Date Posted
NCRN Induction Manual PDF (1.85 MB)  more ] Administration 25/10/2011

NIHR CRN GCP Resources Document

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A compilation of links to useful on-line GCP quality tools and resources
Item Name Posted By Date Posted
NIHR CRN GCP Resources Document PDF (1.12 MB)  more ] Administration 11/10/2011

Research in the NHS-HR Good Practice Resource Pack

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Information for Researchers, R&D and Human Resources (HR) staff in
Higher Education Institutions (HEIs) and the NHS
Item Name Posted By Date Posted
Research in the NHS–HR Good Practice Resource Pack PDF (168.11 KB)  more ] Administration 04/10/2011

TMN Newsletter Archive

Item Name Posted By Date Posted
NIHR TMN Newsletter-February 2011 PDF (288.7 KB) Administration 09/09/2011
NIHR TMN Newsletter-April 2011 PDF (734.38 KB) Administration 09/09/2011
NIHR TMN Newsletter-June 2011 PDF (759.01 KB) Administration 09/09/2011
NIHR TMN Newsletter-August2011 PDF (1.42 MB) Administration 09/09/2011
NIHR TMN Newsletter - October 2011 PDF (2.14 MB) Administration 02/11/2011
NIHR TMN Newsletter - December 2011 PDF (803.79 KB) Administration 07/03/2012
NIHR TMN Newsletter - February 2012 PDF (795.09 KB) Administration 07/03/2012
NIHR TMN Newsletter February 2013 PDF (603.36 KB) Administration 19/02/2013
NIHR TMN Newsletter- April 2013 PDF (766.44 KB) Administration 27/06/2013
NIHR TMN Newsletter- June 2013 PDF (766.55 KB) Administration 10/09/2013
NIHR TMN Newsletter - August 2013 PDF (665.98 KB) Administration 10/09/2013
NIHR TMN Newsletter - October 2013 PDF (1022.74 KB) Administration 30/10/2013
NIHR TMN Newsletter - December 2013 PDF (962.64 KB)  more ] Administration 17/12/2013
UKTMN Newsletter - Summer 2014 PDF (201.71 KB) Administration 06/08/2014
UKTMN Newsletter - Summer 2015 PDF (339.36 KB) Administration 21/12/2015
UKTMN Newsletter - Christmas 2015 PDF (922.91 KB) Administration 21/12/2015
UKTMN Newsletter - Autumn 2016 PDF (592.55 KB) Administration 21/10/2016
UKTMN Newsletter - January 2017 PDF (642.46 KB) Administration 20/01/2017
UKTMN Newsletter - May 2017 PDF (415.42 KB) Administration 05/05/2017

UKCRC Registered CTUs Core SOPs task and finish gr

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UKCRC Registered CTUs Core SOPs task and finish group SOPs templates
Item Name Posted By Date Posted
Data Transfer Form DOC (48.5 KB) Administration 12/08/2011
Urgent Safety Measure Decision DOC (70.5 KB) Administration 12/08/2011
Document Control DOC (151.5 KB)  more ] Administration 12/08/2011
Sponsorship Contracts Agreements and Indemnity DOC (206 KB)  more ] Administration 12/08/2011
Confidentiality and Protectection of Personal Data DOC (173.5 KB)  more ] Administration 12/08/2011
Urgent Safety Measures DOC (200.5 KB)  more ] Administration 12/08/2011
CORE SOPs FOR UKCRC REGISTERED CTUs PDF (22.49 KB)  more ] Administration 12/08/2011

UKTMN Guide to Efficient Trial Management

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The Guide is intended as a reference tool, providing pragmatic advice and guidance to all those involved in the management of trials. It contains useful information, guidance and references, and tools and resources. It describes the process of managing trials and gives an overview of the trial management framework, both legal and operational, providing practical hints, tips and references to external resources. It documents information, practical experience, research, analysis and reflection for the effective and efficient management of trials.

It is aimed at both novice and experienced Trial Managers, and can be used as an induction tool with newly appointed staff. It may also be useful to students aspiring to pursue a career in trial management. The main focus is predominantly late-phase, interventional, academic trials.
Item Name Posted By Date Posted
A Guide To Efficient Trial Management [July 2014] PDF (1.15 MB)  more ] Administration 12/08/2014

Useful Articles

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Useful articles on managing clinical trials
Item Name Posted By Date Posted
Trial By Twitter PDF (109.56 KB)  more ] Administration 04/10/2011
Managing Clinical Trials PDF (223.22 KB)  more ] Administration 06/10/2011
Risk evaluation in clinical research PDF (301.66 KB)  more ] Administration 06/10/2011