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A study protocol in accord with the criteria of the Declaration of Helsinki was reviewed and approved by the local institutional review board and verbal and written consent was obtained from parents and children.
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The protocol is in accord with the SPIRIT 2013 statement [ 37, 38], and the intervention is described according to the CONSORT-EHEALTH checklist [ 39].
The study protocol was in accord with the ethical guidelines of the 1975 Declaration of Helsinki and was approved by the Ethics Committees of the Shandong Eye Institute and the National Research Institute for Family Planning.
The study was performed in strict adherence to the protocol and in accord with the Declaration of Helsinki, the applicable guidelines for good clinical practices, ISO 14155, Clinical Investigation of Medical Devices for Human Subjects, mandates of the Ethics Committees, and all applicable national and local laws and regulations.
This protocol is reported in accord with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidance for protocols of clinical trials.
The animal use protocol, approved by the University of Nebraska Medical Center Animal Care and Use Committee, is in accord with the National Institutes of Health guidelines for the use of rodents.
Experimental animals were maintained in an AAALAC International-approved and specific pathogen-free facility, and used in accord with the protocol approved by the IACUC at Case Western Reserve University.
17 male right-handed volunteers (mean age = 28 years; SD = 5) participated in the study after having given their written informed consent in accord with the protocol of the local Ethics Committee of the Medical Faculty of the RWTH Aachen University.
Twenty four right-handed native German-speaking healthy volunteers (12 female; mean age: 28.2 years, SD = 7.0 years) participated in this study after having given their written informed consent in accord with the protocol of the local Ethics Committee of the RWTH Aachen Medical Faculty.
The study protocol received approval from, and followed procedures in accord with, the standards of the University of Wisconsin Health Sciences Institutional Review Board.
An endotoxin test was performed using a commercial kit, and the subsequent procedure was in accord with the manufacturer's protocol.
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