Remote monitoring…the evolution of the Clinical Research Associate profession (CRA)
In recent years, with the expansion of electronic notebook, pharmaceutical companies increasingly prefer the remote monitoring and are developing tools to help the CRA to put it into practice. Some see a new way to create a relationship of trust with the investigation center through greater empowerment on collecting data for which he is in charge; when others are only seeing a new way to reduce the costs of monitoring for the pharmaceutical company.
We would like to thank Séverine Lopez, ARC senior, for sharing her knowledge and experiences with us by writing this article.
The remote monitoring … what does it include?
The remote monitoring is a review of some data remotely, this of course implies the use of an electronic CRF (E-CRF). Once the center’s staff entered the data in the e-CRF, the CRA checks their consistency and valid them as “data reviewed.” Check the consistency of data is simply checking, for example, that a patient defined as “masculine” does not have, a hysterectomy, as medical history …
This review is done every week or as soon as the data is entered during screening in order to identify possible failures of selection and especially avoid wrongly included.
All data entered into the e-CRF are reviewed in this sense, and some can be checked by comparison with other electronic systems used in the study:
- Review system of lab results (date of birth, date of visit, patient weight, sex of the patient …
- Study treatment dispensation System (date of dispensation, arms attributed to the patient if applicable, number of batches delivered to the patient, patient weight if applicable)
When data does not seem consistent or is different from that found on another system, a query can then be issued and allow the Clinical Study Technician (Site Study Coordinator) to check and correct (or not) the data.
And the “real” monitoring … what does it become?
Monitoring is reviewing the data collected by the investigator center where the study takes place, by comparing the data carryover book (Clinical Report Form) and “data sources” (patient record, clinical report, medical notes …). The remote monitoring does not replace this part of monitoring but simplifies it by eliminating entry errors before the coming of the CRA to the center.
During his monitoring, the CRA can therefore focus on checking the accuracy of data, and pursue other related activities as the study personal staff training, review and collection of essential documents or the review of the follow-up letters of serious adverse events.
Some protocols establish a review focused only on some study data (endpoint, safety, efficiency criteria). The review is no longer on 100% of the data, but only on data called “targets”, in this case it is about the “target data source verification.” The review of other data is then done essentially remotely.
Balance Benefits / Risks of this type of monitoring:
- The relationship promoter-center (CRA-Site Study Coordinator) is deepened by a more regular outreach.
- The center becomes more responsible in entering data knowing that they will be checked quickly.
- The rapidly identified errors are quickly corrected and even avoided during the next entries.
- The center understands better the promoter expectations regarding this entry, and the collaboration mode is more improved.
- The CRA knows what kind of cooperation will be established with the center, in view of the pace of data entries, their accuracy, it can orient its cooperation by being more insistent in monitoring or conversely much less.
- The costs are reduced by the reduction in number of visits to the center: indeed the equation is simple, more time to the center so more data reviewed so fewer extra visits to complete the review of all data.
The remote monitoring is an effective new way to review data remotely. Comparative studies have shown that the level of risk of error remains unchanged between conventional monitoring with a review of 100% of the data and remote monitoring with targeted data verification.
At a time when all our actions are related to electronics and computer networks (remote shopping, remote sport, telemedicine soon …!) The cyber monitoring finds its place and still a lot of way to grow!
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