The COVID-19 pandemic has created obstacles for site monitoring in both ongoing and upcoming studies. This brave new world has inspired new recommendations by the FDA, EMA, and MHRA and led to an urgent push to explore and implement remote monitoring and oversight solutions. Sponsors need to know that activities are tracking toward successful trial conduct in accordance with the study protocol and other relevant regulations. They also need to ensure patient safety, with visibility into product/dosing administration and endpoint activities.
It is important to be able to catch and address any deviations from SOPs and protocols to remain compliant and mitigate any risks to patient safety, patient retention, data integrity, and regulatory inspection findings.
Below are some key considerations for implementing remote monitoring:
Creating and Approving Study Documents
Remote, controlled document management is a great place to start. The opportunity to replace paper documentation for a more environmentally friendly, secure, and compliant approach is well established, and study teams can readily make this transition. Web-based, secure document collaboration allows for authoring, reviewing, and 21 CFR Part 11 compliant approvals via eSignature for study-related documents. The finalized document can be easily referenced and pushed to its final destination in the eTMF or other locations. This process needs to be enabled in a way that minimizes the burden on site and monitoring personnel—quick, easy, and convenient. Moreover, this also ensures that the full story of your study documents is captured from author-to-archive, along with information about any collaborative decisions that were made along the way in the event of regulatory inspection.
Remote Access to Investigative Site Source Documents
Processes must be put in place so that monitors can review source documentation, even in this time of travel restrictions and social distancing. If the site uses a web-based eSource system, direct access can be provided to the monitor. If the site uses paper source documents or regulatory document binders, documents can be scanned and uploaded to web portals so that the monitors are able to remotely review, verify, and provide queries and feedback, as required. These documents should also be added to and reconciled against the documents in the trial master file (TMF). In circumstances such as the current pandemic, mobile solutions are an important consideration for flexibility in the ability to scan and process documentation. Site portals and eISF solutions (across any device) can enable the ongoing processes and oversight required for site documentation.
Keep an eye on all activities that impact the protocol and patient safety. Make sure that you are actively reviewing your protocols, processes, agreements, and plans to ensure that they are synchronized with on-site requirements and remote monitoring plans. This observation becomes even more critical in the face of sudden procedural changes required to adapt to challenges related to COVID-19. These changes must be documented, and a close eye needs to be maintained on activities to shed light on any isolate or systemic errors. Short term, deviations can be agreed upon and approved, and longer term, plans and templates should be updated with provisions that accommodate remote options. Informed consent documents should already account for monitors reviewing source documents—these documents should also be reviewed, modified, and re-executed if additional language is found to be required and subsequently approved as applicable by the relevant IRBs/IECs.
Remote site visits are also low-hanging fruit with modern web conferencing and audio-video technology. Whenever possible, monitors should utilize secure video web conferencing to speak directly with site personnel during remote monitoring visits. Accomplishing site monitoring visits does not have to be an obstacle. It also helps to foster a personal connection and relationship building while providing a way for the monitor and site personnel to remotely share screens and have productive discussions in real time. Even site qualification visits, for example, can be performed remotely by giving a virtual tour of the relevant investigative site facilities to keep the clinical trial start-up process progressing.
Site Training and Tracking
Investigator meetings, site initiation visits, and additional training can be performed remotely and should be recorded and tracked in a compliant fashion. Capturing this activity can be accomplished by using web conferencing for live training, which should then be stored and tracked in a 21 CFR Part 11 compliant learning management system (LMS). This proof of training should also be added to the TMF to provide evidence of training certification for all study and site personnel. These certifications provide proof of collective knowledge of protocol, SOPs, regulations, and other important study-specific information required for compliance and study conduct.
Going Remote Is in Your Grasp!
At a high level, some of the main goals for ongoing studies continue to be:
Successfully executing the study protocol
Capturing and reviewing study data in near real time
Monitoring, managing, and reporting on patient safety
Remaining compliant with processes, plans, and global regulations
Remote monitoring needs to not only facilitate achieving study goals, but also provide immediate and ongoing value to the personnel who are managing the studies and processes. The good news? All the technology required to enable remote document and oversight processes exists, and there are entry points to remote monitoring and remote trial management, like document collaboration, secure investigative site source documentation, and remote site visits, that are all available to adopt and implement and allow you the flexibility your teams need to adapt to a constantly changing world.
If you would like information on the recent regulatory guidance, please access the FDA, EMA, and MHRA guidance documents on their websites.
For help with remote trial management and central monitoring, contact us at firstname.lastname@example.org.