The general specifications and requirements for clinical research of medical devices are outlined in ISO 14155:2020. The most recent edition of the standard, which was released in 2020, was created to act as a manual for clinical research specialists when planning, carrying out, documenting, and reporting clinical trials about the security and efficiency of medical devices.
The protection of human subjects’ rights, safety, and welfare is the goal of ISO 14155. Ensure the clinical investigation was conducted scientifically and that the findings were reliable. What are the sponsor’s and the lead investigator’s duties? assist sponsors, researchers, ethics councils, regulatory agencies, and other organizations involved in the compliance assessment of medical devices. The most recent version of the standard is ISO 14155:2020. It contains several improvements over the previous edition.
This standard has been revised to align with other worldwide GCP guidelines and best practices. Furthermore, the improvements indicate a modernization of research procedures, such as adopting flexibility for new technologies (such as electronic permission and signatures), embracing new methodologies such as quality by design and risk-based monitoring, and taking data privacy into account.
It’s crucial to realize that an ISO 14155 standard doesn’t provide you with specific instructions when you prepare your clinical investigation. As you organize your clinical inquiry, it outlines the components you must take into account. In addition to creating the required documents, it is crucial to go through the ISO 14155 audit checklist and check off all the boxes. The job you’ve done so far has not, however, come to an end.
Regulatory authorities will want to see the reasoning behind your judgments. They’ll want to know why you structured your study the way you did, why you chose that sample size, or how you came up with a specific statistic. More information on providing that rationale can be found in Section 6.3 (Rationale for the design of the clinical investigation). Keep this in mind when you develop the various planning documents. These ISO 14155 documents are as follows:
- The Clinical Investigation Plan (CIP): The CIP is the primary reference document for everyone involved in the clinical trial. It will comprise the clinical study’s objectives and design, as well as a justification for the study’s design and a benefit-risk analysis. Annex A of the standard has a complete list of what should be included in your CIP.
- The Investigator’s Brochure (IB): The IB’s goal is to offer enough data to the primary investigator to substantiate the clinical trial requested in the CIP. The IB will contain a synopsis of all preclinical work on the investigational device, as well as any existing clinical data. Annex B of ISO 14155:2020 contains the whole list of what should be included in the IB.
- Case Report Forms (CRFs): CRFs serve two functions. To begin, they offer information on the health of each individual who enters the study. Second, they collect data for each subject as specified by the CIP.
The full list of what should be included in a CRF may be found in Annex C of the standard. That basic definition of CRFs is deceptively easy. Case report forms are one of the strategies used to collect clinical data during a study. Using paper or general-purpose software for your CRFs puts you at risk of missing data or data input errors. These can greatly impede your studies.
