1, national policy and institutional qualification
While the "Code for the Quality Management of Clinical Trials of Medical Devices" requires that the clinical trials of medical devices need to be accredited by the medical device clinical trial organization, but as of now, the directory of the medical device clinical trial organization has not yet been published. And the choice of medical device clinical trial department, from past experience, medical device clinical trial department can not be recognized by the drug clinical trial organization professional department range of restrictions.
The catalog of drug clinical trial organizations is dynamically updated in real time, in addition to understanding whether the qualifications of the organization meet the requirements when choosing a hospital. It is also necessary to pay close attention to the relevant provisions of the National Bureau and provincial bureaus to keep abreast of the updates of the relevant regulations.
2. Investigators
When screening the principal investigator (PI), a suitable chief physician should be screened as the principal investigator from the departmental directory of the clinical site, usually the department head (or a physician of the director level or above);
The principal investigator should be a clinical expert familiar with the clinical pharmacology, with experience in the clinical trials of medical devices, and with a certain degree of authority and professional Influence, can coordinate and organize other units *** with the implementation of clinical trials.
The selection of the principal investigator can usually be referred to by the following factors:
(1) investigators who have worked on research projects with the sponsor and the CRO company;
(2) suggestions from the drug regulatory authorities;
(3) reference to a list of clinical research units;
(4) reference to abstracts of academic conferences;
(5) reference to a pool of experts;
(6) to have sufficient time to ensure that the trial is carried out and to be interested in the trial research work;
It should also be confirmed that the PI has an ongoing study of a relevant project, which may affect the investigator's time and effort, may lead to confusing the project information in the process of carrying out as well as possibly affecting the speed of enrollment of the cases.
3, sponsors
Sponsors in the process of research with the clinical site selection, in addition to the basic telephone communication, but also based on the actual, make an appointment to study the researcher, to determine a good time to meet. And bring samples, detailed product technical information (such as: researcher's manual (instructions for use), the first draft of the program and other preclinical research information) to visit. After a preliminary conversation with the investigator, the confirmation of the investigator should be followed up regularly;
For the clinical trial funding budget, the sponsor should try to choose a clinical site that can afford the cost, as for the specific cost of how much is appropriate, there is no absolute standard, by the sponsor to assess their own.
4, other considerations
In accordance with the latest "Quality Management Standards for Clinical Trials of Medical Devices", and in conjunction with specific projects, when conducting clinical trials, the first thing to consider is whether it is necessary to carry out a multi-center clinical trials; at the same time, should also be considered in the clinical laboratory to meet the requirements of the test conditions, such as: whether there are sufficient personnel, whether equipped with the test of the professional facilities and conditions and other factors should be taken into account. The clinical department should also consider whether the conditions of the trial can meet the requirements, such as whether it has sufficient personnel and whether it is equipped with the specialized facilities and conditions required for the trial.
In the process of clinical trial management, in addition to the CFDA has the basic clinical trial regulations, the provincial drug regulatory departments and some hospitals will have some of their own regulations on this basis, which need to fully understand the selected hospital's clinical trial management process and operational requirements, in the actual operation of the process will be twice the result with half the effort.
Screening as close as possible to the clinical institutions, which relates to: (1) communication and labor travel costs; (2) the convenience of monitoring; (3) the ease of case collection, trial costs, and so on.
Finally, it is important to consider the degree of cooperation of the department. If it is through the hospital leadership or clinical trial organization authorities to let the department to take over this project, it is necessary to ask the director of the specific department to carry out. Since the department is the executing department of the trial, a lack of willingness on the part of the department is likely to lead to delays in the project. Therefore, it is crucial to get good communication and cooperation with the specific conducting department!
Two, medical device clinical trial organization selection method tool
1, the list of drug clinical trial organization, you can in the official website of the State Food and Drug Administration (www.sda.gov.cn) home page - enterprise query - drugs - drug The list of clinical trial organizations can be found on the home page of the official website of the State Food and Drug Administration (). Special attention should be paid to the validity period of the organization's qualification.
2. The academic status of the researcher, you can log on the official website of the hospital to check the main research areas and directions of the PI. It is best to contact the director of the relevant department directly to inquire about the intention to cooperate, relevant operational experience, the speed of case enrollment, as well as the cost of the situation.
3, the contact information of the clinical organization office, etc., you can log on to the official website of the hospital to check the contact information of the organization office of the hospital.
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