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Planning a Clinical Trial Checklist

This checklist will provide assistance if you are planning a Clinical Trial. For more detailed guidance please visit Planning a Clinical Trial

 

1.Protocol developmentDevelop an outline protocol to describe the basic details of the trial.
2.Is it a Clinical Trial of an Investigational Medicinal Product (CTIMP)?To help you establish whether your proposed project is a Clinical Trial under the Regulations please see Is my study a Clinical Trial?
3.Trial Master File (TMF)To set up a TMF please refer to the and the
4.Sponsorship

Guidance on the procedures for obtaining Sponsorship from Cardiff University is provided in the SOP: Obtaining acceptance of Sponsorship from Cardiff University (CTIMPs) A Sponsor Registration form is available here

Start preliminary discussions with the Contracts Team in RACD.

5.Partner consultationDiscuss your trial with potential partners to ensure possible issues are identified at an early stage.
5.1.Trial teamCheck the trial team have previous experience of Clinical Trials and that they have up to date Good Clinical Practice (GCP) training. 
5.2.External fundingIdentify if there are external funding opportunities available.
5.3.Trial management

Consider how the trial will be managed. e.g.

  • Will a Clinical Trials Unit be involved?
  • Does the trial team include a medical statistician?
  • How will adverse event reporting responsibilities be met?
  • Will a trial manager be required to liaise with the research sites?
5.4.Host managementEnsure the intended host organisations will have the resources and facilities available to support the trial. Contact the relevant R&D Office or Hospital Department.
5.5.IMP managementConsider how the IMP will be managed. You should discuss with pharmacy and pharmaceutical companies.
Identify any anticipated problems with IMP supply (IMP availability, packaging and labelling, accountability, distribution and dispensing).
6.Risk assessmentComplete a Risk Assessment Form. This document should be used to help design the protocol and trial management requirements. It will also be used by the University to determine the areas and frequency of monitoring which will be required throughout the trial.

Complete Cardiff University's IT Survey to ensure planned IT systems are appropriate.
7.Apply for fundingFollow the normal University costing process by contacting the RACD Pre-awards team. Ensure you follow any school specific procedures.
Ensure you have considered costs associated with trial management including archiving, additional NHS costs, IMP management, Clinical Trial Insurance, MHRA Clinical Trial Authorisation (CTA).
8.Develop trial documents 
8.1.ProtocolEnsure the protocol complies with GCP standards. Refer to: SOP: Protocol Content and Format to meet ICH-GCP standards
8.2.Patient information and consent formEnsure the Patient information leaflet (PIL) and consent form complies with NRES Guidelines. The PIL and consent form will need to be approved by RACD prior to applying for MHRA, Ethics and R&D approval.
8.3.Investigator's brochurePlease refer to: International Conference on Harmonisation Guidance on Good Clinical Practice (Topic E6)(CPMP/ICH/135/95)
8.4.Trial documentationSOPs, CRFs, delegation log, etc
9.Finalise contractsLiaise with RACD Contracts Team to ensure all necessary contracts are in place. Contracts should only be signed by authorised individuals in RACD.

Delegation of Sponsorship Responsibilities Agreement will need to be signed between RACD and the CI. 
10.Approvals checklistUse the 'Am I ready to obtain approvals?' checklist.
Once RACD has received the necessary documents, CI will receive a new letter providing Sponsor authorisation to submit to REC and MHRA.
11.Clinical Trial AuthorisationApply for a EudraCT number and an application for a Clinical Trial Authorisation from the MHRA.
12.Ethics approvalComplete the NHS REC form using the Integrated Research Application System (IRAS)
13.R&D approval

Obtain Host Organisation approval using the Integrated Research Application System (IRAS)

In case of multi-centre trials, the CI informs local PIs they may proceed with local R&D approval. Each host organisation will need to sign a site agreement.

14.Sponsor initiation visitOnce all the necessary 'Essential Documents' are in place in your TMF, contact the Research Governance Team to set up an 'Initiation Visit' to inspect the TMF in order to verify that the trial management systems are satisfactory.
Following a satisfactory initiation visit you will be issued with a Sponsor 'approval to commence' letter.