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Compliance In Focus
Posted by Matt Carandang on Wed, Apr 1, 2020

Is Remote Clinical Trial Monitoring the New Norm?

The new coronavirus might be the tipping point for remote clinical trial monitoring, but technology has been taking us in this direction for a while.

Remote-monitoring

This post will discuss trends in remote monitoring, how to support your research team from a distance and the benefits of using a contract research organization (CRO) to conduct remote monitoring.

Trends in Remote Clinical Trial Monitoring

Despite the long-held standard of the clinical research industry to conduct on-site monitoring visits, national regulations and international authorities have been encouraging the use of remote monitoring over the past decade.

In 2011, the FDA released a guidance document that prompts sponsors to tailor their monitoring plans to the specific needs of their trials, including the use of remote monitoring. Two international organizations that regulate clinical trials, ICH and ISO, have also accepted and encouraged the use of remote monitoring within their guidelines. This shift was in response to the growing number of clinical trials and their increasing complexity. The industry has taken note and many sponsors are beginning to at least explore remote monitoring options. It becomes easier for them to do so every year with the emergence of new technology. Adobe-Sign and ShareFile are two examples that demonstrate compliance with 21 CFR 11 and help with remote clinical trial monitoring.

There are also many more applications that assist with remote monitoring and that list will only continue to grow, while traditional paper binders remain intimidating and cumbersome to review.

Granting Access To Medical Records For Remote Monitoring

Additional technologies developed specifically for the purpose of clinical research include commercially available electronic Trial Master Files (eTMFs) and IRB portals, which not only help keep study documents organized, but also make remote review available in a safe and secure manner. The electronic medical record (EMR) is also an underutilized tool in the realm of remote monitoring, as many sites are apprehensive about allowing monitors into their medical records and accessing protected health information. Regulations do allow for remote access to a site’s EMR, but there are some hurdles associated with data privacy and security. This case study from the Association of Clinical Research Professionals explores a possible solution to these hurdles at the Medical University of South Carolina. The university granted monitors read-only access to the medical records of clinical study patients while limiting them only to the charts of patients who had consented to monitoring of the trial.

Safe, secure remote access to EMR offers great benefits to remote monitoring and should be further explored in this increasingly technological world.

3 Benefits of Using a CRO for Remote Clinical Trial Monitoring

 

1. Remote Regulatory Review

The ability to see essential study documents as they are obtained gives monitors ample time to assess that documentation meets ALCOA guidelines—meaning it is attributable, legible, contemporaneous, original, and accurate in accordance with FDA standards. This will help sites maintain compliance so that they are audit ready.

2. Periodic Review of Clinical Trial Data

With increasing trial complexity, more and more data needs to be reviewed. Remote monitoring allows for the regular review of data so sponsors can be frequently updated on the latest trends in their trial. More frequent reviews also obligate more focused reviews from monitors, decreasing the chances that something is missed.

3. Early Identification of Site Deficiencies

It is common for a monitor to hold off on site visits until a few patients have already been enrolled in the study. By this time, some errors or protocol deviations may have already occurred repeatedly. Remote monitoring, especially in the beginning of the trial, can help identify site deficiencies before they become bigger problems. You can also use remote training capabilities to improve site compliance.

How IMARC Can Help

IMARC can assist with remote monitoring and data entry using secure, encrypted file-sharing technology

Our experienced monitors have a strong working knowledge of clinical research regulations and best practices.

We can also collaborate with your team via video conferencing to help you navigate your next steps in this uncharted territory. 

Contact us to learn more about our remote monitoring services. 

Have you been performing remote monitoring visits? Please let us know how your experience went by sharing in the comments below.

Hiring A Contract Research Organization - 20 Questions

Sources:

1 U.S. Department of Health and Human Services, Food and Drug Administration. (2011). Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring. (On-line). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring

2. Bell, Leslie, et al. “Providing Restricted Access to an Electronic Medical Record for Research Monitoring.” ACRP, ACRP, 22 Mar. 2018, acrpnet.org/2018/03/13/providing-restricted-access-electronic-medical-record-research-monitoring/.

 

Topics: COVID-19

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