When Choosing Clinical Trial Institutions For An In-vitro Diagnostic (IVD) Reagent, What Else Should Be Considered In Addition To The Qualifications Required By Regulations?

To conduct clinical trials of IVD reagents, the clinical trial institutions should have registered in the Filling Management Information system for medical device clinical trial institutions in accordance with the Provisions for Medical Device Clinical Trial Institution Conditions and Filing Administration. In addition to meeting the above requirements, it is also necessary to consider whether the clinical trial institutions have possessed the professional and technical level, management capabilities, and conditions suitable for the clinical trials to be conducted, including:

First, the clinical trial institutions must routinely carry out related tests. If the test is for a new marker, the clinical trial institutions should also be familiar with related trial methods and carry out routine diagnosis and treatment of related diseases. Clinical trial institutions should have the ability to interpret diagnostic results, give proper treatment, and have emergency mechanisms to prevent and deal with emergencies and serious adverse events in clinical trials.

Secondly, the staffing and laboratory testing conditions of clinical trial institutions should meet the qualification requirements for testing laboratories. Participants of the clinical trials should be familiar with the professional knowledge and regulatory provisions related to the clinical trials. Participants must have good trial technologies and be able to correctly interpret test results.

In addition, clinical trial institutions should have enough subjects that can meet the needs of the clinical trial, and have professional background and discipline advantages in the relevant professional field about the investigational products.

Finally, clinical trial institutions should be able to manage clinical trials scientifically, ensure that clinical trials are carried out in accordance with the protocol strictly, and be able to cooperate during the product registration application process including conducting necessary supplementary trials and cooperating with the authenticity check of clinical trials.