Investigator led trials processes

# Recommend contact with QSCTC to get an overveiw 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 subit full completed worktribe to pre-award atleast 5 days prior to grand deadline for their checks
link for further information on costing via worktribe: https://www.ucl.ac.uk/clinical-trials-and-methodology/intranet/finance/research-costing

standard process:

Link

# 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 accoring to protocol and Sponsor timeline/milestones
- considering recommendations from the Data Monitoring Commitee; 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 fo the clinical trial
generally 50% independent members

BRIEF OVERVIEW OF PROCESS:

Resources of PIs:

NIHR trials roadmap: