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If the participant clearly understands the protocol, he/she will is invited to sign a full consent form.
The pilot study revealed that it was overly time-consuming to read the full consent form on a small screen; that there were erroneous skip patterns, wording, and terminology problems; that the operational instructions appeared only in English; and that entering Chinese characters using the handwriting recognizer was too time-consuming (Table 2).
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Full consent forms were signed by the subjects after the nature and motif of the study was clearly explained to them.
Full written consent forms were obtained from the parents of the newborns and all rules were respected.
Before each interview, any questions about the study were discussed in full and a consent form approved by the ethics committee signed.
The final trial report will link the full protocol, protocol amendments, consent form, final statistical analysis plan and laboratory methods.
Interested patients will be given the complete patient information sheet and the consent form (full study documents pack).
The research assistant responds to caregivers' questions until it is clear that the caregiver has full comprehension of the consent form and their involvement in the study.
Mailing 3. The principal investigator mails Group B subjects and Group A test-concordant subjects to confirm dates of the smoking cessation sessions and full patient information leaflet and consent form enclosed.
We added the following elements to our extraction sheets: date of participant enrolment, unblinding of the trial, protocol for which we had the full text, protocol amendments, statistical analysis plan for which we have the full text (and its amendments), patient consent form, randomisation list and certificate of analysis.
Six to eight weeks prior to surgery patients are sent a full participant information sheet and a consent form with a self-addressed envelope by the trial co-ordinator.
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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