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.