Baseline assessments

Baseline assessments are the pieces of data collected at the very start of the study before any intervention takes place. It should be clear when baseline assessments are going to take place, for example ‘following consent but prior to randomization’. Bullet points of the types of assessment should be given in this section of the protocol, such as:

  • 1. ‘Complete an anonymous questionnaire assessing demographic data’
  • 2. ‘Take part in a 30-minute focus group with other participants’
  • 3. ‘Provide a 1mL saliva sample through a straw into a 2mL tube’

Often, data collection measures such as questionnaires are provided as appendices to the protocol.

Subsequent assessments

Subsequent assessments are the pieces of data collected at any other timepoint of the study. If there are multiple different timepoints, this section should state exactly which data are being collected at each timepoint, when timepoints occur, and when the study will finish. If assessment plans are relatively complex in design, tables or Gantt charts (a type of chart used for mapping workplans discussed in Chapter 5) may help to clarify when and how data will be collected.

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