Study Design

Study Design

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.

Diagram illustrating order of stages in planning research: 1: Study design; 2: Facilities; 3: Scientific Peer Review; 4: Secure Funding; 5: Prepare study documentation; 6: Sponsorship; 7: Protocol; 8: Contracts; 9: Registration on public database; 10: Finalise study documents; 11: Statutory approvals; 12: Ethics review; 13: Initiation of study