Method of implementing the allocation sequence Aim: to describe how the allocation sequence will be run in the study. Successful randomisation in practice depends on two interrelated aspects: 1) generation of an unpredictable allocation sequence and 2) concealment of that sequence until assignment irreversibly occurs. Protocols should describe: the system to use be used e.g. a web based randomisation/treatment allocation system who will access this at each site how the allocation will be documented e.g. will the system provide an immediate allocation with a confirmatory email who else will be provided with a copy of the treatment allocation or randomisation number etc. how will randomisation codes be accessed out-of-hours or in an emergency Blinding Aim: to describe the blinding process to avoid bias in detail. If blinding is not to be used then justification should be provided. The protocol should explicitly describe: who will be blinded to intervention groups including: study participants care providers outcome assessors A full description is essential and ambiguous terminology such as or “single blind” “double should not be used. blind” the comparability of blinded interventions e.g. similarities in appearance, use of specific flavours to mask a distinctive taste the timing of final unblinding of all study participants (e.g., after the creation of a locked analysis data set) any strategies to reduce the potential for unblinding such as prestudy testing of blinding procedures. when blinding of study participants and care providers is not possible because of obvious differences between the interventions, blinding of the outcome assessors can often still be implemented. It may also be possible to blind participants or study personnel to the study hypothesis in terms of which intervention is considered active. Unblinding Aim: to provide a clear description of the conditions and procedures for unblinding. The study code should only be broken for valid medical or safety reasons e.g. in the case of a severe adverse event where it is necessary for the investigator or treating health care professional to know which treatment the patient is receiving before the participant can be treated. Subject always to clinical need, where possible, members of the research team should remain blinded. The following information should be inserted into the protocol:
Method of implementing the allocation sequence Aim: to describe how the allocation sequence will be run in the study. Successful randomisation in practice depends on two interrelated aspects: 1) generation of an unpredictable allocation sequence and 2) concealment of that sequence until assignment irreversibly occurs. Protocols should describe: the system to use be used e.g. a web based randomisation/treatment allocation system who will access this at each site how the allocation will be documented e.g. will the system provide an immediate allocation with a confirmatory email who else will be provided with a copy of the treatment allocation or randomisation number etc. how will randomisation codes be accessed out-of-hours or in an emergency Blinding Aim: to describe the blinding process to avoid bias in detail. If blinding is not to be used then justification should be provided. The protocol should explicitly describe: who will be blinded to intervention groups including: study participants care providers outcome assessors A full description is essential and ambiguous terminology such as “single blind” or “double blind” should not be used. the comparability of blinded interventions e.g. similarities in appearance, use of specific flavours to mask a distinctive taste the timing of final unblinding of all study participants (e.g., after the creation of a locked analysis data set) any strategies to reduce the potential for unblinding such as prestudy testing of blinding procedures. when blinding of study participants and care providers is not possible because of obvious differences between the interventions, blinding of the outcome assessors can often still be implemented. It may also be possible to blind participants or study personnel to the study hypothesis in terms of which intervention is considered active. Unblinding Aim: to provide a clear description of the conditions and procedures for unblinding. The study code should only be broken for valid medical or safety reasons e.g. in the case of a severe adverse event where it is necessary for the investigator or treating health care professional to know which treatment the patient is receiving before the participant can be treated. Subject always to clinical need, where possible, members of the research team should remain blinded. The following information should be inserted into the protocol:
Protocol-Template.docx