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For medical device manufacturers, clinical data is more than a collection of numbers and statistics—it’s a snapshot of the lives of patients you’re trying to help. And while there are undoubtedly pressing business needs to consider, it’s even more important to protect human subjects during clinical investigations.
In order to protect these individuals, the medical device industry relies on the guidance of Good Clinical Practices (GCP). Not only are these principles virtuous, they also are required in regulated markets around the world.
With that in mind, let’s take a deep dive into the basics of Good Clinical Practices, how they apply to clinical data collection in medical device studies, and how MedTech companies can comply with them.
Good clinical practice (GCP) is a set of ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects. GCP is an internationally recognized standard, and ensures that the rights, safety, and well-being of subjects are protected and that all clinical data is credible.
Though GCP has roots leading back to the late 1940s, the version we know today is from the 1996 International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) publication of the ICH Guidelines: Topic E6 Guideline for GCP.
Overall, there are 14 guiding principles of Good Clinical Practice, including:
All clinical trials should be conducted in accordance with ethical principles, sound scientific evidence and clear detailed protocols.
The benefits of conducting trials should outweigh the risks.
The rights, safety and well-being of trial participants are of paramount importance and these should be preserved by obtaining informed consent and maintaining confidentiality.
The care must be given by appropriately qualified personnel with adequate experience.
Records should be easily accessible and retrievable for accurate reporting, verification and interpretation.
Investigational products should be manufactured according to Good Manufacturing Practice
Though GCP was initially designed for pharmaceutical trials, the general principles are industry-agnostic, meaning they can be applied to clinical data management in any life science industry.
However, we know that medical device clinical trials are built differently. From a functional standpoint, devices can only be studied by observing them in use. As a result, device studies are often small and require unique methodologies for clinical data collection from a variety of different individuals, such as healthcare providers, physicians, investigators, and patients.
Additionally, clinical data collection in device studies and clinical operations for devices is conducted around the whole life cycle of a device, from early-stage to later-stage for market approval, and post-market.
ISO 14155- Clinical investigation of medical devices for human subjects — Good clinical practice , most recently updated in 2020, is intended to:
Protect the rights, safety, and well-being of human subjects
Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
Define the responsibilities of the sponsor and principal investigator
Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved
In the EU, complying with good clinical practices means following the requirements laid out in ISO 14155. This includes clauses covering:
Closing out clinical investigations
Responsibilities of the sponsor and investigator
The ethical considerations of a clinical investigation are paramount. For starters, all study participants must provide informed consent, meaning they must be fully informed about the nature and purpose of the study, the risks and benefits involved, and their rights as participants.
ISO 14155 also prohibits the use of members of vulnerable populations in clinical investigations, except where the investigation could not otherwise be conducted. This is to protect the most vulnerable members of society, such as children or individuals with cognitive impairments.
To ensure clinical investigations are carried out with these ethics in mind, GCP compliance also requires that an independent oversight committee be established to protect the rights, safety, and well-being of the investigation subjects.
Before a clinical investigation begins, ISO 14155 requires the development of a clinical investigation plan (CIP) that outlines the objectives, design, methodology, statistical considerations, and organization of the clinical investigation. Any changes to the CIP must be documented and approved by the ethics committee and regulatory authority.
ISO 14155 also requires the application of another well-known standard—ISO 14971. This means weighing the, “foreseeable risks and inconveniences against the anticipated benefit for the individual subject and and society.”
In terms of conduct, the good clinical practices outlined here are intended to ensure that the investigation maintains strict accountability and tight controls over documentation and recording.
Privacy and confidentiality of test subjects is another key part of clinical investigation conduct, and requires that data be protected against unauthorized access.
The good clinical practices for closing out a clinical investigation are found under Clause 7 of ISO 14155. These guidelines explain what to do if an investigation is to be prematurely terminated or suspended, versus a routine close-out of a clinical investigation.
Clause 7 also contains requirements for the clinical investigation report that manufacturers must prepare as well as expectations for document retention after the investigation comes to a close. Document retention must be in line with the appropriate regulatory body requirements.
ISO 14155 separates the good clinical practices for ‘Responsibilities’ into two clauses, Responsibilities of the Sponsor (Clause 8) and Responsibilities of the Principal Investigator (Clause 9).
The sponsor is responsible for planning and conducting the clinical investigation within prescribed quality assurance and quality control principles. It’s important to note that even if the clinical investigation is contracted out by the sponsor to a qualified third party, the sponsor still retains overall responsibility.
The responsibilities of the Principal Investigator include: the implementation and management of the day-to-day activities of the investigation in accordance with the CIP, ensuring the integrity of investigation data, and safeguarding the rights, safety and well-being of the human subjects involved in the study.
Though they are similar, medical device studies in the United States still have their own unique requirements. For example, data from clinical investigations that are used to support an FDA premarket application (PMA) need to fulfill the requirements under CFR 812.28 - a part of the GCP rules laid out by the FDA.
Additionally, for medical device clinical investigations conducted In the United States, the FDA’s additional requirements for GCP compliance are spread throughout 21 CFR, and can be grouped into five relevant sections.
In 21 CFR 812, there are multiple mentions of GCP requirements spread throughout the regulation. First, if any such investigation was not conducted in accordance with GCP, you must include either a waiver request or a brief statement of the reason for not conducting the investigation in accordance with GCP.
Furthermore, there must be a description of steps taken to ensure that the data and results are credible and accurate and that the rights, safety, and well-being of subjects have been adequately protected. 21 CFR 812 also requires documentation on how investigators have been trained in how to comply with good clinical practices.
Though it’s not explicitly mentioned in the text, there are applications for GCP all over 21 CFR 50. The legislation is primarily concerned with the wellbeing of human subjects in clinical trials, and the specified roles played by sponsors, investigators, and institutional review boards. It also has lengthy, separate guidelines for the protection of children as human subjects.
Additionally, you'll find detailed requirements and definitions for informed consent. This includes the processes of obtaining, documenting, disseminating, and verifying consent from participants, as well as any exceptions to consent requirements in the event of emergency research.
Similar to ISO 14155’s independent oversight committee, the FDA requires the inclusion of an institutional review board (IRB). 21 CFR 56 defines IRBs as
. . .any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.
The legislation goes on to outline the functionality, review process, and general In addition to the roles and responsibilities of IRBs in clinical trials. 21 CFR 56 also includes detailed descriptions for its registration and membership with the FDA.
In order to ensure the validity of the clinical data being collected, the FDA requires that appropriate steps be taken to minimize potential sources of bias. One major contributor to bias in clinical studies is the financial interest of the clinical investigator in the outcome of the study—something that generally takes the form of compensation for participants.
21 CFR 54 requires the disclosure of any applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsors and investigators. It also includes instructions for the documentation of financial records for FDA review.
Compliance with 21 CFR Part 11 is essential in the conduct of clinical trials as it establishes the criteria for the creation, modification, and maintenance of electronic records and electronic signatures. This regulation ensures that the data generated during clinical trials is accurate, reliable, and secure.
That’s a good thing, because in clinical data collection, you will undoubtedly wind up producing tons of documentation. Whether it’s eCRFs, CIPs, or e-consent signatures, these records must be stored and validated in a protected system that prevents any loss or damage to the relevant records.
Greenlight Guru Clinical is a software electronic data capture (EDC) system, purpose-built to help clinical trial sponsors and principal investigators comply with documentation, classification, and reporting requirements of Good Clinical Practices, ISO 14155:2020, and FDA’s 21 CFR regulations.
Greenlight Guru Clinical offers straightforward GCP-compliant reporting and customizable forms to fit the needs of any study, with flexible access and permissions, safeguarded data management for informed consent and electronic records, real-time event progress tracking, data export, and more.
Ready to learn more about how Greenlight Guru Clinical can help you stay GCP-compliant? Contact us today for your free personalized demo.
Jón Ingi Bergsteinsson, M.Sc. in Biomedical Engineering, is the co-founder of Greenlight Guru Clinical (formerly SMART-TRIAL). He was also the technical founder of Greenlight Guru Clinical where he paved the way for the platform’s quality standards, data security, and compliance.