The clinical trial should be carried out in accordance with a written protocol agreed upon and signed by the investigator and the sponsor. Any change(s) subsequently required must be similarly agreed on and signed by the investigator and sponsor and appended to the protocol as amendments.

The protocol, appendices and any other relevant documentation should state the aim of the trial and the procedures to be used; the reasons for proposing that it should be undertaken on humans; the nature and degree of any known risks; the groups from which it is proposed that trial subjects be selected and the means for ensuring that they are adequately informed before they give their consent. Other important items to be included in a clinical trial protocol are listed in Appendix 2.

The protocol, appendices and other relevant documentation should be reviewed from a scientific and ethical standpoint by one or more (if required by local laws and regulations), review bodies (e.g. institutional review board, peer review committee, ethics committee, drug regulatory authority), constituted appropriately for this purpose and independent of the investigator(s) and sponsor.