|A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc.|
- Data-Availability statement and
- registration number from the https://register.clinicaltrials.gov during submission of the manuscript.
Conflict of Interest
We customized the format of ICMJE (International Committee of Medical Journal Editors) Conflict of Interest form. We provided that form to fill-up by each author to submit separately from each author's email after completion of the peer review of the manuscript.
- All authors of the submitted manuscript are requested to disclose any actual or potential conflict of interest including any financial, personal or other relationships with other people or organizations within two years of beginning the submitted work that could inappropriately influence, or be perceived to influence, their work.
Informed Consent Guidelines
- The research article related to a clinical trial must have a statement that an informed consent document was filled-up by the volunteer/patient.
- The subjects in the study must participate willingly, having been adequately informed about the research.
- In the case of children, the researcher must first obtain the permission of parents in addition to the consent of the children.
- Informed consent documents should be written at a level appropriate to the subject population, generally at an 8th grade reading level.
- A best practice is to have a colleague or friend read the informed consent document for comprehension before submission with the IRB application.
The Editor-in-Chief may request to upload the following files into www.osf.io :
- all raw data
- filled consent forms
- approved protocol
- approval letter of your clinical trial obtained from the IRB/Ethical Committee, and other images
> If you do not have the above-mentioned materials, then there is no need to submit the manuscript.