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Format

In addition to specific sections, the formatting of protocols is fairly standardized. Protocols often have headers reiterating the version number and date, and footers giving the short title of the protocol and providing a confidentiality statement.

Table of contents

Following the covering page, protocols often have a table of contents outlining the main sections. These often include the following, each of which will be discussed individually:

  • ? Summary information
  • ? Background and rationale
  • ? Objectives and outcomes
  • ? Study design
  • ? Participant identification
  • ? Study procedures
  • ? Intervention
  • ? Analysis
  • ? Data management
  • ? Ethical and regulatory considerations
  • ? Finance and insurance
  • ? Publication policy
  • ? References

Summary information

Synopsis

Following the table of contents, it is common to see study synopses. These set out the basic information about the study, partly as an aide-memoire, and partly so that the reader can instantly get an idea of the aim and design of the study. Synopses are normally directly copied from text later in the protocol, so are often the last thing to be completed to ensure they most accurately reflect the rest of the document. Synopses typically include the study title, study design, study participants, planned sample size, planned study period, and primary objectives and endpoints, all of which are discussed in more detail below.

 
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