Key Documents

Research study confirmation process - Guidance for Researchers

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

Key Service Support (KSS) Department Contact Details

Please use the OneForm app to request support / approval from the research support services.

Complete this form to request access to the OneForm app.

Training is available on how to use the OneForm from different user perspectives.

Guidance for Research Delivery Staff

Approval request form -via link to LTHT intranet site

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)  

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)

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).

• QCRES 01 A Researchers Guide to Pharmacovigilance v3.0
• QCRES 02 Researchers Guide to Protocol Deviations Violations and Potential GCP Breaches v3.0
• QCRES 03 Researchers guide to Notification of Amendments for UoL/LTHT Sponsored CTIMPs v4.0
• QCRES 04 Researchers Guide to appropriate Delegation of Duties for UoL/LTHT Sponsored CTIMPs v3.0
• QCRES 05 Version Control for Trial Documentation v3.0
• QCRES 06 Researchers Guide to Staff Training Records v3.0
• QCRES 07 Researchers Guide to Data Management v2.0
• QCRES 08 Researchers Guide to End of Trial Procedures v2.0
• QCRES 09 A Researchers guide to RSI V2.0 
• QCRES 10 A researchers guide to Trial Steering Committees and Data Monitoring Committees v2.0
• LTU QM22 LTHT/UoL Sample Management for CTIMPs v2.0
• LTU QM23 A Researchers Guide to Source Documentation v3.0 
  • LTU QM24 A Researchers Guide to Trial Documentation v4.0

CTIMP Checklists

• CTC01 Researchers Checklist for UoL/LTHT Sponsored CTIMPs v20.0

CTIMP Templates

• CTT04A QM07 LTHT/UoL Clinical Trial Risk Assessment (CTRA) Form A v14.0
• CTT04B QM07 LTHT/UoL Clinical Trial Risk Assessment (CTRA) Form B v10.0
• CTT05 LTHT/UoL Sponsor Notification of CTIMP Amendment v14.0
• CTT07 Urgent Safety Measure form v11.0
• CTT12 TMF Contents v7.0
• CTT20 LTHT/UoL CTIMP Protocol Deviations, Violations and Potential GCP Breaches v7.0
• CTT21 Serious Adverse Event (SAE) Form v8.0
• CTT21 A SAE Form Supplemental page v3.0
• CTT55 LTHT/UoL DSUR Template v2.0
• CTT58 Data Management Plan v2.0
• Template mNCA V12.0

 CTIMP News & Updates

- QA Bulletin 10 -Updates to the Amendment Submission and Approval Process

Please see below for the latest QA bulletin which provides guidance regarding recent changes to the Amendments Submissions process

- QA Bulletin #10 - Updates to the Amendment Submission and Approvals Process 

- EU Exit Transition 

Please see below for the latest QA bulletin which provides guidance regarding Submitting to the MHRA post EU exit 

- QA Bulletin #9 - EU Exit Transition- Changes to MHRA Clinical Trial Submission Systems

- How to get the most out of QA monitoring

Please see below for the latest QA bulletin which provides guidance regarding LTHT/UoL Monitoring

- QA Bulletin #8 - How to get the most out of QA monitoring

- CTIMP GCP Protocol Deviation Guidance

Please see below for the latest QA bulletin which provides guidance regarding Serious Breaches/Protocol Deviations in LTHT/UoL Sponsored CTIMP's 

- QA Bulletin #7 - Protocol deviations and serious breaches of GCP in a CTIMP

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

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 Intellectual Property Policy (206 KB)
LTHT Research Governance Policy (229 KB)
LTHT Policy on Industry Funded Research (11 KB)

Principal Investigator responsibilities in research delivery

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

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

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)

Template Protocol writing guidance (91 KB)

Peer Review Guidance for Researchers (305 KB)
Peer Review Proforma (74 KB)