Why is it important to strictly follow the protocol of clinical trials?

The violation of the requirements of the test plan during the test will cause many problems: the management authority will measure the current situation of the quality of the test and the research base according to the violation of the test plan during the inspection; A trial protocol that violates the approval of the ethics committee is a violation of the approval of the Ethics Committee (sometimes the regulatory authority); Subjects who are not enrolled according to the enrollment / exclusion criteria may not be compensated by the sponsor in case of damage; Subjects not enrolled according to the test plan may increase the deviation of the test results and make the test unable to achieve the purpose of the peak period; The test cannot provide valid data or results; Sometimes, the sponsor will impose financial penalties on researchers who violate the trial plan, such as refusing to pay the trial funds for the number of subjects who fail to enroll as required. In the past, researchers could destroy the old version of the trial protocol. But now the new regulation stresses that the old version of the test documents should be kept and indicated with expiration date. Or use different color covers to distinguish the old version from the new version, and place the expired documents elsewhere to prevent confusion.