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Documenting patient protection in device studies

The roles that documentation serves in clinical research are to communicate to other health care professionals and to demonstrate the competence with which we do our jobs, and for clinical research, that means being able to prove that subjects were protected throughout the entire clinical research process. As inferred in the terms “clinical research” there are documentation requirements pertinent to a subject’s “clinical” status and there are documentation requirements pertinent to the “research” itself, thus increasing the documentation efforts required exponentially.

While many look at informed consent as the main way to document patient protection in clinical research, this is only the beginning of the story.

This post is sponsored by IMARC Research Inc.

By Brandy Smith, Chief Clinical Officer for IMARC
The roles that documentation serves in clinical research are to communicate to other health care professionals and to demonstrate the competence with which we do our jobs, and for clinical research, that means being able to prove that subjects were protected throughout the entire clinical research process. As inferred in the terms “clinical research” there are documentation requirements pertinent to a subject’s “clinical” status and there are documentation requirements pertinent to the “research” itself, thus increasing the documentation efforts required exponentially.

While many look at informed consent as the main way to document patient protection in clinical research, this is only the beginning of the story. As clinical researchers, whether we work for the sponsor, the contract research organization (CRO), or the investigative site, we are responsible for ensuring patient protection throughout the clinical research process, and we could be called on to prove that we did just that.

How do we prove it? Through documentation. It’s all about doing it right, and taking credit for it. This white paper will examine a small sample of the requirements in clinical research, which at times, can be confusing, and will provide recommendations for how to think through situations to ensure that your documentation adequately proves that you protected subjects throughout the study.

In summary, regulations that govern clinical research were put in place to protect clinical research subjects, and during FDA inspection, the extent to which a clinical researcher complied with those regulations — or protected patients — will come under scrutiny. If in doubt about the appropriate documentation practices, read though the regulations in question and think to yourself, “How can I document my compliance with the regulation?” Oftentimes we make decisions in order to meet the regulations, but neglect to take that extra step to document our actions. If someone was to review your work, would it be clear that the regulations were followed? The patients protected?
After all, “if it’s not documented, it’s not done!”

Please take time to review IMARC’s most recent white paper.

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