Quality assurance procedures
For studies taking place within healthcare institutions, there will often be standard quality assurance procedures to follow. In this case, these regulations can be briefly explained followed by a statement confirming accordance with them, such as:
The study may be monitored, or audited in accordance with the current approved protocol, relevant regulations, and standard operating procedures
For studies outside specific institutions, details of how the study team will monitor quality assurance should be set out, such as through audits or following the procedure of the university or host organization. It may be necessary to provide some of these documents as appendices.
Ethical and regulatory considerations
Declaration of Helsinki
© The Declaration of Helsinki is a set of ethical principles set out for health research studies by the World Medical Association for studies involving human subjects. It consists of a set of general principles, including acknowledging that the health and safety of participants comes above the research, recognizing the particular need for protection of vulnerable groups, and upholding the value of research protocols If this is being observed, the sample sentence below is often included here. If any aspect of the declaration is not being followed, strong justifications for this will be required.
The investigator will ensure that this study is conducted in accordance with the principles of the Declaration of Helsinki
In addition, some protocols may require descriptions of other regulations that will be followed, such as the ICH Guidelines for Good Clinical Practice (CPMP/ ICH/135/95) July 1996; an international set of standards for clinical trials.