Feb 12, 2020
Clinical monitoring provides a key method for ensuring that reliable clinical data, or clinical evidence, is collected during clinical trials for medical devices in order to support claims of safety and effectiveness.
The clinical trial sponsor, who bears primary responsibility for the study, must ensure that all study-related activities are conducted in accordance with relevant regulations as well as clinical trial protocols. This is achieved through clinical monitoring.
During clinical monitoring the sponsor’s representative, the Clinical Research Associate (CRA), visits the investigational site, which can be a hospital or a private practice. During this visit the CRA ensures that the clinical study is conducted according to the Clinical Investigation Plan, and that data provided to the sponsor is comprehensive and accurate. In addition, the CRA reports observations made during these visits to the sponsor, who has to intervene correctively, if needed.
The investigational site is the place where any clinical monitoring requested by legislators and the sponsor must be carried out. However, a CRA visit may pose a significant extra burden for the investigational site.
Investigational site managers must take steps to prepare for CRA visits, including ensuring availability of necessary personnel during these visits; setting up CRA access to relevant records and study documentation; and ensuring that all study documentation is up to date.
The site’s day-to-day business such as patient care and emergency management, however, must not be allowed to suffer due to the CRA visit. In addition, many investigational sites conduct more than one study, leading to increased time pressure on site personnel.
To perform successful clinical monitoring at the investigational site, the CRA has to overcome several challenges.
Even at well-prepared sites, frequently the CRA faces limited functionality of tools and equipment used in a clinical trial. Other challenges specific to individual clinical trials may also need to be addressed by the CRA.
Open and respectful communication is fundamental to achieve a good relationship between the investigational site and the CRA, and ultimately to facilitate adequate clinical monitoring.
For example, the sponsor might request additional activities to support proper trial conduct and documentation, but which are often not done at the investigational site in question. Some of these trial activities might even be seen as superfluous or off-point by investigators and site personnel. Especially for these cases it is essential that the CRA discusses these concerns with the investigational site and explains the purpose of the planned activities. If the site’s concerns are well-founded or cannot be clarified, the CRA has to communicate the site’s concerns to trial management, which then has to determine the next course of action.
Furthermore, the CRA should always encourage the site to request additional information on processes not fully understood.
The better that all parties involved in the clinical trial process understand the activities and challenges involved, the more effective their collaboration will be.
Dietmar Falke is Head of Clinical Research at Emergo by UL.
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