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This information should be checked during QC against the clinical dossier to ensure verifiability.
Patients weight (0010,1030) (kg) This tag has to be verified against the patient's clinical dossier.
Patient height/patient size (0010,1020) (cm) This tag has to be verified against the patient's clinical dossier and across the longitudinal scans record.
If patient's position is changed at a follow-up scan compared to the baseline, there should be a reasonable explanation about this in the clinical dossier and provided to the sponsor.
It is important that the IG mandate the use of a calibrated scale at the PET department and that each patient is weighed prior to each PET scan, and this information is correctly recorded in the PET scanner, as well as the clinical dossier.
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While some clinical data could be extracted from surveillance records, clinical dossiers of individual patients were not available for analysis.
Depending on the number of research questions investigated and clinical studies included, a dossier assessment may contain more than one individual assessment.
Clinical data in the dossier were based on a MenA conjugate vaccine that used group A polysaccharide made at SynCo Bio Partners in Amsterdam.
Because biosimilars are the copies of molecules that have already been approved through a rigorous clinical trial program, the dossiers for their approval are reduced compared to those of the originators.
All clinical protocols and the regulatory dossier were reviewed by WHO.
However, one cannot fully exclude that this additional filter may introduce bias, thus emphasising the need for the publication of full clinical study reports from the dossiers.
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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