Within the application, you will need to describe how your study will select its participants from a population, or group of people, how to define everyone who meets the eligibility criteria, and how you will recruit participants to your study.

  • Sample size is determined to minimize the risks associated with a possible breach of confidentiality.
  • Appropriate sample size calculations limit the amount of patient data being recorded to just the amount necessary to answer the study question.
  • This section should explain the sample size that the principal investigator will be able to get and whether or not the suggested sample size is sufficient for the study’s primary objective.
  •  If the principal investigator is not conducting hypothesis testing which lends to a formal sample size calculation, he or she will still need to identify and justify the study parameters.
  • This section, if applicable, chould also include the number of charts that the principal investigator is planning to review. Note that the number the principal investigator plans to review is the total number of charts reviewed, not just those that meet the inclusion criteria and are included in the final sample.
  • For multi-center studies, include the total number of sites expected and the total number of subjects to be included across all sites. Finally, provide the rationale for the sample size.
  • The principal investigator will need to describe the procedures for securing informed consent from subjects.
  • This includes, if applicable, the request for a Waiver of Informed Consent and HIPAA Authorization due to the retrospective nature of the study.
  • Screening procedures could include a survey that would go out to potential subjects with an informational sheet and a link to participate.
  • The principal investigator should describe the pre-screening procedures for potential subjects fully.  
  • Once general eligibility is determined, the protocol should explain where potential subjects will be approached will be approached by study staff.
  • Prior to drawing any blood or performing any other procedures related to the study, the permission/assent form or consent form will be reviewed carefully with the participant (and parent) in person or by telephone in extenuating circumstances (i.e. out-of-state non-custodial parent, divorce, or separation).
  • Some studies use telephone consenting, and the principal investigator would need to fully explain those situations when it would be used (i.e. in case the non-custodial parent cannot physically attend the visit).