The Leeds Teaching Hospitals NHS Trust


Key Documents


 

 

This page contacts guidance, forms and advice to help you with gaining confirmations you require here at LTHT. 

R&I Guidance Notes on how to gain confirmation

Research study confirmation process - Guidance for Researchers

Tips on writing a protocol - 
Template Protocol writing guidance (91 KB)

Peer review - 
Peer Review Guidance for Researchers (20 KB
Peer Review Proforma (74 KB)

Gaining Clinical Service Unit (CSU) confirmation and applying to the Leeds Clinical Research Facility (LCRF) -

CSU Capacity and Capability (C&C) Assessment Form (includes LCRF request form)
List of Research Leads who can authorise CSU approval and C&C form.

 

Contacting Support Departments

Key Service Support (KSS) Department Contact Details

Radiology

Guidance for Researchers (318 KB)
Form 1 (330 KB)
Form 2 (354 KB)

IRMER

 IRMER Form  - Ionising Radiation (Medical Exposure) Regulations 

Pharmacy

Guidance for Researchers (99 KB)
Pharmacy Request Form

Essential Documents (52 KB)

Pathology

Pathology Form

Histopathology

Research Histopathology Assessment Form (317 KB)

Echocardiography

Approval request form (18 KB)

 Medical Physics - Off Label Devices

Approval request form 

R&I Finance - Obtaining confirmation of study costings

Guidance for the completion of costing templates

Guidance for the completion of the Commercial costing checklist including FAQs

Guidance for the completion of the Non-commercial costing checklist including FAQs

NIHR Industry Costing Template - please use the latest NIHR template

Trust Standing Financial Instructions (33 KB) 

 

LTHT/UoL Sponsored CTIMP Documents

CTIMP Standard Operating Procedures

CTIMP Checklists

CTIMP Templates

 CTIMP News & Updates

-  CTIMP Source Data Management

Please see below for the latest QA bulletin which provides guidance on Source Data Management for CTIMPs Sponsored by LTHT or UoL:

- QA Bulletin #4 - Source Data Management in a CTIMP - October 2017

- Update to the ICH Guidance for Good Clinical Practice document

The ICH Guideline for Good Clinical Practice E6 (R1) has been updated to incorporate numerous additions - the updated document is entitled ‘Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice E6 (R2)’ and came into effect on 14 June 2017.

The addendum impacts directly on Sponsors, Investigators, and Institutions. The ICH have provided the below summary presentation of the addendums made on their website for reference. However, please see the E6 (R2) document itself for full context and detail:

- E6 R2 Step 4 Presentation - 06 Feb 2017

- E6 R2 Step 5

Please note: As per the addendum, in the event of any conflict between the E6(R1) and E6(R2) addendum text, the E6(R2) should take priority.

- End of Trial Procedures for CTIMPs Sponsored by LTHT or UoL

Please see below for the QA bulletin which provides guidance on End of Trial Procedures for CTIMPs Sponsored by LTHT or UoL:

- QA Bulletin #3 End of Trial Procedures for CTIMPs Sponsored by LTHT or UoL - August 2017 

- Consent and Eligibility

Correct documentation of consent and eligibility is a MHRA hot topic - please see below for our QA bulletin which provides information regarding Consent and Eligibility:

- QA Bulletin #2 Consent and Eligibility - June 2017

- Reference Safety Information

Reference Safety Information (RSI) defines which reactions are expected for the Investigational Medicinal Product (IMP) being administered to subjects participating in a clinical trial.

Please see below for our QA Bulletin which provides information regarding the purpose and application of Reference Safety Information.

- QA Bulletin #1 - Reference Safety Information - April 2017

For additional information regarding the application of Reference Safety Information, please see below for a blog post from the MHRA.

- https://mhrainspectorate.blog.gov.uk/2016/03/02/reference-safety-information-for-clinical-trials/ 

- https://mhrainspectorate.blog.gov.uk/2017/01/18/reference-safety-information-ii/ 

Leeds Dental Institute

Research Leaflet (2.5 MB)
DenTCRU (Dental Translational and Clinical Research Unit) (335 KB)

Human Tissue Act (HTA)

Tissue Transfer Agreements for Non HTATissue Transfer Agreement (non HTA) (54 KB)

Tissue Transfer Agreements for HTA

Guidance Notes (34 KB)
Tissue Transfer Agreement (HTA) (60 KB)

National Institute for Health Research (NIHR)

NIHR: What can we do for you?

Yorkshire and the Humber local Clinical Research Network 

 Guidance for Chief and Principal investigators-
Lead/Chief Investigator Guidance (308 KB)
PI-responsibilities.docx 

Good research practice for Doctors - Guidance

 

Research and Innovation Strategy

The Research and Innovation Strategy, Engagement Document and Information for Patients leaflet are now available, outlining our aims and visions for the next five years as well as how you can get involved in research.

Research & Innovation Strategy 2015-20 (15.6 MB)
Research & Innovation Engagement Document (789 KB)
Clinical Research - Information for patients (1.7 MB)
NIHR Leeds Clinical Research Facility - Patient and Public Involvement Strategy 2015-17 (933 KB)
The Leeds Children's Hospital - Research & Innovation Strategy (1.7 MB)

LTHT R&I Policies

LTHT Intellectual Property Policy (206 KB)
LTHT Research Governance Policy (239 KB)
LTHT Research Misconduct & Fraud Policy (211 KB)
LTHT Policy on Industry Funded Research (11 KB)

Clinical Research Delivery Staff

Induction Resource for Clinical Research Delivery Staff **NEW PDF**

Printable forms from Clinical Research Delivery staff Induction Resource **NEW**

New guidance: Managing Trust research doctors & clinical research fellows

Guidance is now available on recruiting, training and supporting Trust research doctors and clinical research fellows. We wish to ensure that these non-training grade medical staff are fully supported and supervised in conducting the research element of their role and this guidance sets out key requirements.

Clinical research fellows - guidance for managers and clinical supervisors (41 KB)
Clinical research fellow template job description (48 KB)
Clinical research fellow template person specification - medicine (50 KB)
Clinical research fellow template person specification - surgery (46 KB)