1-Role/tasks in the research/project:
Wrongly stated the aim of the work instead of the role of the investigator in the study.
2- Study type: missing
3- Fund amount: missing
4- Co-investigator: name is incomplete (inji)
5- Procedure in Details
An observational, randomized, case control study…
The procedures do not give any details about the cases or controls, why and how will the randomization be done, and what are the procedures that will be done to the patients, e.g. is there blood drawing? How much blood will be drawn and how many times? How long will be the holter testing? Will the participant pay anything? etc.
6- Inclusion criteria: What gender will the participants be?
7- Risks: “There have been adverse effects observed during the use of Holter ECG and laboratory investigations” What are these risks? Please mention them
8- Benefits: Will there be a benefit for the children participating in the study or the benefits will be for the future patients with obesity?
9- Will the information be disclosed to third parties, the answer is written as yes. Please explain to whom and why?
The status is marked as deferred for incomplete documents, but still I put some comments that may help the investigator.