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In case of elevated iron parameters or severe anaemia, the unblinded physician amends the study treatment as described above.
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All the authors discussed and amended the study protocol.
During the original study, it was decided to amend the study protocol to include the follow-up during Years 2 5 of the second consecutive LNG-IUS.
Anecdotal feedback from potential participants during the recruitment process has led us to consider amending the study brochure to use less clinical, more inclusive language.
Figure 1 shows the anticipated timing to gain approvals, run the focus group and amend the study based on focus group feedback.
In 2006 we amended the study protocol by asking the children to write each measurement from the Piko meter in the symptom diary and encouraged the community workers to check these carefully to ensure compliance and technique.
After receiving approval from the JHU Institutional Review Board in July 2009 to amend the study protocol, the HFS team began training CHWs to distribute combined hormonal contraceptive pills and condoms, in accordance with Bangladeshi government protocols for in-home provision of contraceptives by community-based workers.
They can contribute, for instance, to amending the study protocol and design, a more substantial scientific contribution that later impacts the field procedures, although any amendment should be done according to the rules defined by or with collaborators: " Most of time, the sponsor comes with the study protocol already done.
Owing to the unexpected early occurrence of DLT at dose level II and the rather big gap in Caelyx dosage between levels I and II, we decided to amend the study protocol and include a dose level Ia (Caelyx 20 mg m−2).
Although the protocol was amended during the study to restrict the scheduled CPRS-R assessments to baseline, visit 4 and visit 7, CPRS-R data were available for most of the patients in each group for all visits (Fig. 1a).
As the result of identifying an unfavorable benefit/risk ratio with semagacestat in an interim safety analysis, the IDENTITY studies were amended to discontinue the study drug and follow study subjects for an additional 7 months.
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