• Scientific design and conduct of the study.
• Approval of appropriate scientific review boards.
• Examination of predictable risks/ harms.
• Examination of potential benefits.
• Procedure for selection of subjects in methodology including inclusion/ exclusion/ withdrawal criteria and other issues like advertisement details. Criteria for withdrawal of patients, suspending or terminating the study
• Management of research related injuries, adverse events and serious adverse events.
• Compensation provisions.
• Patient information sheet and informed consent form in local language.
• Protection of privacy and provision of confidentiality.
• Involvement of the community, when and where necessary.
• Plans for data analysis and reporting, along with safety and quality assurance report(s).
• Competence of investigators, research and supporting staff.
• Facilities and infrastructure of study sites.
In case of clinical trials:
• Justification for placebo in control arm, if any.
• Availability of products after the study, if applicable.
• Adherence to all regulatory requirements and applicable guidelines.
