The interview consisted of items on: spontaneous recall and knowledge of trial design; understanding of the trial design and the informed consent procedure; the amount and clarity of the information given; and reasons for participating. Finally patients and relatives were asked whether they would ...
In a traditional clinical trial, the design is fixed in advance, the study is carried out, and the data analysed after completion [1]. In contrast, adaptive designs pre-plan possible modifications on the basis of the data accumulating over the course of the trial as part of the trial proto...
Informed consent This research has involved human subjects who have freely given their informed consent to participate, by signing an information form provided by the researchers before the start of the interviews. The participants were informed about the object of the research and the identity of th...
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A growing number of clinical trials have shown that regulatory T (Treg) cell transfer may have a favorable effect on the maintenance of self-tolerance and immune homeostasis in different conditions such as graft-versus-host disease (GvHD), solid organ tr
relevant personnel. The GCP training has a strong focus on documentation in source data (usually theEHRsystem of the institution) and the entering of data based on the source data from theEHRinto the electronic Clinical Research Form (eCRF) for the clinical trial in question. This process is ...
Ethical approval and informed consent from study participants was gained in the original study and additional consent was therefore not required for the present study. Measures LBP-Specific Disability The primary outcome in the STarT Back trial was back pain disability at 12 months measured using the...
Ethical approval for this study was granted by University College Dublin Human Research Ethics Committee (LS-E-22-02-Mooney) on 6 January 2022. Written informed consent was obtained from all participants. 2.2. CDSS for the Prediction of GDM To evaluate the impact of explanations on participants...
Informed consent was obtained from all the participants. Data Availability Statement The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy restrictions. Acknowledgments ...
For a study to gain IRB’s approval, it must benefit the participants (human subjects) and have minimal risks to their health. The study’s design reduces risks to participants by seeking prior informed consent to decrease emotional/psychological risks. Moreover, during the 6-week period, the...