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
Tips on writing a protocol -
Template Protocol writing guidance (91 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
IRMER Form - Ionising Radiation (Medical Exposure) Regulations
Essential Documents (52 KB)
Approval request form (18 KB)
Medical Physics - Off Label Devices
R&I Finance - Obtaining confirmation of study costings
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
LTHT/UoL Sponsored CTIMP Documents
CTIMP Standard Operating Procedures
- QCRES 01 Pharmacovigilance for Researchers For UoL/LTHT Sponsored CTIMPs v1.1
- QCRES 02 Researchers Guide to Protocol Deviations Violations and Potential GCP Breaches v1.0
- QCRES 03 Researchers guide to Notification of Amendments for UoL/LTHT Sponsored CTIMPs v1.0
- QCRES 04 Researchers Guide to appropriate Delegation of Duties for UoL/LTHT Sponsored CTIMPs v1.0
- QCRES 05 Version Control for Trial Documentation v2.0
- QCRES 06 Researchers Guide to Staff Training Records v1.0
- QCRES 07 Researchers Guide to Data Management v1.0
- LTU QM23 A Researchers Guide to Source Documentation v1.0
- CTT04A QM07 LTHT/UoL Clinical Trial Risk Assessment (CTRA) Form A v12.0
- CTT04B QM07 LTHT/UoL Clinical Trial Risk Assessment (CTRA) Form B v9.0
- CTT05 LTHT/UoL Sponsor Notification of CTIMP Amendment v12.1
- CTT06 Notification of CTIMP Amendment Supplemental Page v6.0
- CTT11 EMEA Declaration Of The End Of Trial Form
- CTT20 LTHT/UoL CTIMP Protocol Deviations, Violations and Potential GCP Breaches v6.1
- CTT21 Serious Adverse Event (SAE) Form v6.0
- CTT21 A SAE Form Supplemental page v2.0
- CTT55 LTHT/UoL DSUR Template v2.0
- CTT58 Data Management Plan v1.0
- Template mNCA V12.0
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:
- 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:
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:
- 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:
- 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.
For additional information regarding the application of Reference Safety Information, please see below for a blog post from the MHRA.
Leeds Dental Institute
Human Tissue Act (HTA)
Tissue Transfer Agreements for HTA
National Institute for Health Research (NIHR)
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
Clinical Research Delivery Staff
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)