Information for Researchers

# Contact the QSCTC to meet early to discuss the flow and approach to clinical trials. 

# Early contact with JRO is adviced. 

# The first contact questionnaire can be completed even before the grant  is attained if sponsorship is needed. 

# Cost completely and comprehensively. This is particularly important. Costing early is important to assist with negotiations.

Don’t forget to cost for:

• Randomisation
• Patient travel reimbursement (also an important ethical issue – not to exclude subgroups of patients)
• Statistician
• MHRA costs

Resources for PIS: 

• Brief overview of the process (for a site PI)
• NIHR roadmap for clinical trials 

# Recommend contact with QSCTC to get an overview of the process. 

# Early contact with JRO

• UCL first contact questionnaire even before grant attained for UCL sponsorship (for UCL)

# Confidential disclosure agreement (CDA) for UCL studies is done via worktribe, and for UCLH via JRO. 

# pre-award - worktribe tips (UCL):

• start working on application no less that 4-6 weeks prior to due date
• support for costs need to uploaded
• application needs to be uploaded 
• need to submit full completed worktribe to pre-award at least 5 days prior to grand deadline for their checks
• Further information on costing via worktribe: 

   Resources

• How to make a worktribe project

# Cost completely and comprehensively.

• Don’t forget:
  • Randomisation
  • Patient travel reimbursement (also an important ethical issue – not to exclude subgroups of patients)
  • Statistician
  • MHRA cost

# IRAS form and documents

• Don’t forget patient 24hr contact card
• Invitation letters
• ALL patient facing forms/documents should be submitted
• It is a major amendment to change patient facing documents so worth doing right the first time

# Trial Steering Committee (TSC) tips

• Key Roles:
  • assessing progress according to protocol and Sponsor timeline/milestones
  • considering recommendations from the Data Monitoring Committee; assessing patient safety and Good Clinical Practice
  • assessing and advising on any major decisions e.g. continuation of trial, amendments  
  • assessing any new or external information to decide if any action needs to be taken 
  • manage any data access requests 
  • oversee any complaints 
  • feedback to sponsor/funder and Trial Management Group 
• frequency of meeting and number of members is proportionate to risk of the clinical trial
• generally 50% independent members 

Resources for PIs: 

• Brief overview of the process
• NIHR trials roadmap

# Please contact QSCTC to get an understanding of process. 

# Consider Space early.

# Costing should be complete. 

• don't forget to cost for space
• cost for travel reimbursement. 

# Approvals/agreements for different components such MRI, pathology, different lab components can take time and chasing. 

# Do not start the study until capacity and capability green light is received. 

# pre-award - worktribe tips (UCL):

• start working on application no less that 4-6 weeks prior to due date
• support for costs need to uploaded
• application needs to be uploaded 
• need to submit full completed worktribe to pre-award at least 5 days prior to grand deadline for their checks
• Further information on costing via worktribe

Resources

• Brief overview of the process
• How to make a worktribe project:  

A collaboration to bring together research practitioners, clinical research nurses, trials co-ordinators and research assistants across Queen Square to share knowledge, support and ideas. Queen Square is home to a wealth of research active staff with a wealth of knowledge and enthusiasm to share. 

If you are interested in joining please email the QSCTC head Dr. Vino Vivekanandam on v.vivekanandam@ucl.ac.uk