Protocol

The preparation of a protocol is an important step in the research process in order to adequately consider the research aim, planning before you begin, and collaborators can give feedback and agree to their responsibilities. The protocol provides the basis for funding and ethics considerations.  

A protocol also guards against scope creep. You need to state deviations from this protocol in a manuscript, for example, when the the analysis plan needed to be changed due to unexpected data properties.

Note: Some of the aspects below will not be relevant for some study types.

Key aspects of the protocol: 

• Title
• Principal investigator and co-investigators
• Background. Introduction to the research topic. Prior studies. Rationale.
• Study objectives 
  • Statement of the problem
  • Primary objectives and, if needed, secondary objectives.
  • Aims – Each aim should address a single hypothesis.
• Study Design
  • Administrative details: participating units/sites, conflicts of interest
  • Study population
  • Inclusion/Exclusion Criteria
  • Study procedures
• Study methodology
  • Interventions
  • Procedures and schedule of procedures
  • Measurements
• Metadata
  • Data dictionary
  • Data collection tools 
  • Plans for data management
• Statistical Considerations
  • Sample size and power
  • Statistical methods to address the research question
  • Analysis plan
• Safety considerations and safety monitoring plan, if needed
• Strengths and Limitations. Potential sources of bias.
• Project management
  • Timeline
  • Roles and responsibilities of team members
• References
• Budget, if requesting funding
• Note: If this will be your first protocol, ask colleagues for copies of previous protocols they’ve written as examples/templates.  The CSTAT Team will help with the statistical methods section and power analysis statement.

Resources for protocols: 

• ClinicalTrials.gov. Some studies are required to submit their protocol prior to starting the collection of data (by law or by journal requirement). For others it is a good idea to do so. As of 2019 there are over 300,000 protocols in the database. Observational studies for human beings can also be registered.
• There are journals that publish protocols. Check them out.
• Some journals ask that study protocols are published in the supplementary materials. 
• The Equator Network has reporting guidelines for various types of studies. Journals may require some of these: http://www.equator-network.org/

Scientific review:

• It is a good idea to have others review your protocol. There may be a Scientific Review Committee (SRC) in your unit. Ask your PI/advisor/mentor or colleagues for feedback.
• You may request a scientific review from the CSTAT SRC.
• Plan ahead, this process takes time, but the better you prepare your protocol the higher the likelihood you will get approval and funding.