While you can use your proposal as a template for your protocol, a proposal is written to only obtain support for your study. A study protocol contains detailed instructions on how the study will be conducted and includes information to meet regulatory requirements (if applicable). Advancing Health provides protocol templates for use in interventional and non-interventional clinical studies.
- The National Institutes of Health (NIH) in the US, recently released a protocol template for Phase 2 and 3 clinical trials funded by the NIH that are being conducted under a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application. View the NIH document here.
- Statistics and Statistical Analysis Plan: What is the purpose of the analysis and how will the results be used? (See CHÉOS consultation document in the introductory section.)
- Note that UBC requires that any protocol that is more than minimal risk*, must undergo a peer review. See UBC Research Ethics, General Guidance Notes, Article 8.2 for more information. Peer review should come from a colleague not involved in the research, or a supervisor or mentor for trainees. In rare circumstances, it may come from the funding agency or sponsor.
*The BC Ethics Harmonization Initiative (2013) defines minimal risk research as “research in which the probability and magnitude of possible harms implied by participation is not greater than those encountered in the aspects of everyday life that relate to the research”. Read the minimal risk common criteria guidelines here.