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Table 6 Alex Pet Peeves

From: The SPIRIT Checklist—lessons from the experience of SPIRIT protocol editors

• Items that are missing from the checklist or marked N/A without explanation

• Identification of a location in the SPIRIT Checklist which does not provide information that answers the checklist question

• Failing to identify whether the trial has a sponsor separate from the funder

• Failing to provide a model consent form

• Failing to describe the framework of the trial

• Listing multiple primary outcomes without accounting for this in the statistical plan

• Failing to say who is responsible for generating the allocation sequence, who is responsible for enrolling the participants, and who is responsible for obtaining informed consent

• Failing to describe how important protocol modifications are communicated to interested parties

• Failing to state whether there are any provisions for ancillary and post-trial care for any participants harmed during the trial