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 

 

Gaining Clinical Service Unit (CSU) confirmation/ Applying to the Leeds Clinical Research Facility (LCRF)  

CSU Capacity and Capability (C&C) Assessment Form (includes LCRF request form) Completion of this form is MANDATORY1st February 2018
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 

New Interventional Procedures  

Approval request form -via link to LTHT intranet site

 

R&I Finance - Obtaining confirmation of study costings 

Human Tissue Act (HTA) 

To comply with the HT Act and related legislation, the Leeds Teaching Hospitals Trust (LTHT) and the University of Leeds (UoL) work collaboratively and share policies and standard operating procedures (SOPs). 

The joint Trust and UoL SOPs are available on the University website via the link below:

http://ris.leeds.ac.uk/hta

Standard Template Tissue Transfer Agreements for HTA

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

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

 

Sponsor CTIMP Standard Operating Procedures 

LTHT/UoL Sponsored CTIMP Documents

SOPs for CTIMPs which are NOT sponsored by either LTHT or UoL can be found via this link (Internal link only).

CTIMP Checklists

CTIMP Templates

 CTIMP News & Updates

- CTIMP GCP MHRA inspection Guidance

Please see below for the latest QA bulletin which provides guidance regarding preparing for a LTHT & UoL CTIMP GCP MHRA inspection.

- QA Bulletin #6 - Preparing for a LTHT & UoL CTIMP GCP MHRA inspection - February 2018

- CTIMP Laboratory Guidance

Please see below for the QA bulletin which provides Laboratory Guidance for CTIMPs Sponsored by LTHT or UoL.

- QA Bulletin #5 - Laboratory Guidance for Clinical Trials of Investigational Medicinal Products (CTIMPs) - December 2017

- CTIMP Source Data Management

Please see below for the 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/ 

 

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)

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)

Tips on writing a protocol