Clinical trial protocol is a vital component in IVD clinical design and, in China, the details of the protocol never fail to be questioned by NMPA (CFDA) reviewers. ChinaMed Device, LLC summarizes the key issues in writing IVD clinical protocols:
- The intended use shall be identical to the description of the intended use from the IFU.
- The sample collection requirements for the control product should follow its IFU.
- Manufacturers need to determine or justify if samples from different age groups need to be tested.
- The protocol shall contain the inclusion criteria for samples.
- Pay attention to the expiration date of the control product certificate.
- A clinical trial flow chart should be added to the study method.
- Some reviewers now require that evaluation criteria should be defined in the protocol, specifically the minimum requirements to be met by the statistical analysis methods.
- Determine if the detailed criteria of the specified test need to be specified.
- Summary of Test does not need to be included in the protocol.
- Change Opinion of Ethics Committee to Opinion of PI. (PI’s opinion is required and mandatory; EC’s opinion is not necessary).
- The protocol does not need to be signed by all investigators. Normally, a list of all investigators can be included in “Section 1.2 Investigators Involved in Clinical Trials”.
In addition, all materials need to be well organized. Some NMPA reviewers, if not all, are very strict about the format and content order. ChinaMed Device, LLC has processed 1,000+ NMPA (CFDA) certificates. We can provide the clinical trial protocol of similar products for your reference. info@ChinaMedDevice.com.
ChinaMed Device recommends manufacturers to refer to the following NMPA requirements to revise IVD protocol.
NMPA Requirements for IVD Clinical Trial Protocol Design
- General information
including product information, time and personnel of clinical trials, relevant information of the sponsor, relevant information of the sponsor, etc.
- Background information on clinical trials
- Study objectives
- Study design
Including clinical trial methods, determination of clinical reference standards or selection of comparative reagents, selection of validation methods (if any), selection of clinical trial institutions, subject selection criteria, sample size estimation, sample size distribution, clinical evaluation Indicators, statistical analysis methods, etc.);
- Study management
Including clinical trial procedures, bias control, clinical pre-test training, clinical trial quality control, data management, sample management, analysis of the likelihood of adverse events, and provisions for adverse events and product defect reporting;
- Provisions for the amendments of clinical trial protocol;
- Ethical issues and descriptions of clinical trials and the text of informed consent (if any);
- Other content that needs to be explained.
NMPA published a draft of IVD Clinical Trial Guidelines for feedback on November 22nd, 2018. For specified requirements for clinical protocol design, please email us at info@ChinaMedDevice.com.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.