Successful studies rely on good preparation.

Consider trial design before developing your protocol. Identify all the practical requirements.

  • Is your proposal relevant to the patient population?
  • Can you get Patient and Public Involvement (PPI)? - Many funders now require genuine involvement as a condition of funding as growing evidence suggests that PPI has a positive impact on both recruitment and retention in clinical trials
  • Have you chosen the appropriate outcome(s)
  • What is the intervention?
  • When and for how long?
  • If you are using a drug, how will you obtain this?
  • Realistically consider if you will be able to recruit your recruitment target

Contact Pharmacy for:

  • Budgeting for IMP costs
  • Help to ensure you comply with the regulations required for IMP management
  • Storage of drug

Contact Statistician for:

  • Justification of sample size
  • Randomisation requirements
  • Statistical analysis plan

Contact Data Management for:

  • Help with the design of Case Report Form (to collect data for your outcomes)
  • Design of database
  • Help with a website

Contact Clinical Trials Unit for:

  • Randomisation
  • Trial management advice

Identifying all practical requirements early will assist in preparing a research grant application.

Go to the SOPs and Templates page for all SOPs relevant to setting up and managing a clinical study sponsored by NHS Grampian and/or the University of Aberdeen.


Planning Research

 

Study Design Facilities Scientific Peer Review Secure Funding Prepare study documentation Sponsorship Protocol Contracts Registration on public database Finalise study documents Statutory Approvals Ethics Review