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The project team will ensure that an audit trail of decisions made at each stage in the study is documented so that the decision-making process can be scrutinised.
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All information needed for the study was documented in study-specific registers at CTRL.
Adverse events experienced by subjects during the study were documented by the investigator at each visit.
All data collected during the study were documented anonymously and were not available for the GP.
Any adverse events occurring during the study were documented and proper measures were taken.
The source of information about the study was documented for each participant.
Also no relevant changes of nutrition or activity status during the study were documented.
At least one dose reduction during the study was documented for 25 (4.8%) patients.
This study was prospective, infants were recruited consecutively, and criteria for inclusion in the study are documented.
Study characteristics including age range, gender ratio and total number of participants in the study were documented.
The last routine manual office blood pressure recorded on the visit immediately before entry into the study was documented.
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