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Anonymity and informed consent will be ensured.
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Informed consent will be obtained from all participants and confidentiality will be ensured.
Allocation concealment will be ensured, as the website will not release the randomisation code until participants have returned their consent forms/baseline surveys and their consent and information is entered into the secure website.
Allocation concealment will be ensured.
As consent will be undertaken during labour, to ensure similar information is provided to all women during the consent process, a guideline script will be provided to staff for use when discussing the trial.
The controls will be invited to voluntarily participate and informed consent will be obtained for performing ultrasonography and analytical tests to ensure the absence of manifest hepatic disease.
Informed written consent will be obtained from the participants and codes will replace names to ensure privacy.
Pre-randomisation eligibility checks will be carried out to ensure that participants are not randomised in error, and informed written consent will be obtained prior to randomisation.
Pre-enrolment eligibility checks will be carried out to ensure that participants are not enrolled in error, and informed written consent will be obtained prior to enrolment.
Informed consent will be obtained during the screening interview where both a psychiatrist and research professional will be present to ensure that the patient fully understands the nature of the trial and answer any questions.
Informed consent will be solicited.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com