What Is The Minimum Information Needed For Clinical Trial Registration?
Clinical trials are sensitive procedures, primarily due to the fact that they involve human beings. To protect the participants in a clinical trial and to ensure that the trial is legitimate and effective, there are criteria that need to be fulfilled before the trail can be registered. These criteria vary depending on the locality in which the study is being carried out, but there are general requirements that are found in nearly all cases.
A description of the study is an important element that needs to be defined before registering the clinical trial. Typically, this is a brief summary of the nature of the clinical trial and why it is being conducted. Most registering authorities require that the description be brief, about 5,000 words in length.
Proof that the clinical trial meets ethical standards is also necessary in many cases. Examination of the ethics involved in a trial is usually done by committees that oversee the trial. In the setting of a university, for instance, the particular faculty will have an ethics committee comprising senior members of the faculty. They go through the details of the clinical trial and how it will be conducted, and then determine if it violates human rights or other ethical precedents. If so, the trial will not be registered.
In some cases, all the stakeholders in the clinical trial need to be identified. These include the sponsors and any oversight committee steering the clinical trial. Of course, there is a lot more information you will need to provide before registering the trial, but the above are the minimum basics.