The COVID-19 pandemic has increased the use of digital technology by as much as 40%. Private and public businesses have been scrambling this past year to pivot to remote work, communications, and service and product delivery in as many areas as possible.
How has this tectonic shift played out in clinical research? Lab work with live samples must be conducted in person, as must delivery of medical interventions and necessary patient-clinician visits — but just about every other aspect of clinical trials that wasn’t previously accomplished digitally has been moving online. This includes electronic informed consent (eIC) and online/offline ePRO, on top of data management and analytics.
One key piece of clinical trial management — site monitoring — is also in transition. Previously, clinical research or monitoring personnel travelled regularly to clinical sites to review documentation and processes in person; to evaluate the study data’s accuracy, completeness, and faithfulness to the study protocol; to verify ongoing patient safety, and to ensure process and documentation adherence to all applicable regulations.
Clinical trial monitoring encompasses these three areas:
- Treatment: Assessment of treatment effects.
- Patient Safety: Review of the incidence and severity of adverse events, and the safeguarding of subject confidentiality.
- Performance: Subject recruitment, retention, and follow-up; the flow and quality of data and supporting materials; and data and process compliance with the study protocol and all relevant local, regional, and international regulations.
To implement remote monitoring, you need:
- Secure online access to the study data and source information.
- Secure online document storage and management of all key study documents.
- Secure online trainings, meetings, and communications recording and documentation.
- A secure CDMS that enables the review, reports, and SDV (source data verification) that are essential to clinical trial monitoring.
One key piece of these requirements is to secure online access to all study data and related documents and to host trainings, meetings, and other needed communications. The other vital piece is your clinical data management system — whether you are licensing it, using it in house, or have hired a trusted data management services organization to manage it.
How secure and agile is the CDMS you’ve entrusted your trial data to? Can it store and yield the information required by auditors, sponsors, reviewers, and monitors? Can it adapt to the conditions required to enable remote monitoring?
Here’s how DFnet’s hybrid CDMS DFdiscover supports remote monitoring:
Nonrepudiation: DFdiscover CDMS captures and maintains a complete history of all data changes including:
- User ID, date, and time
- Complete record details each time data is committed to a study database.
This audit trail, and the study setup specifications, can either be viewed for individual records within the system or exported to Excel for review of multiple records.
Reproducibility: This is a key requirement of any trial master file (TMF). DFdiscover can display the complete history of each record and the source of images that support them (when applicable). Multiple records can be exported or viewed by authorized staff. DFdiscover can produce subject packages in pdf format —with data annotated on CRF images (aCRFs) — that include any data and audit trail information selected for specified subjects. These files can be password-protected and stored on any appropriate media for later review by authorized individuals. DFdiscover client servers are hosted in Microsoft Azure, which offers regional access wherever in the world you work, and full backup storage in a different region, tested daily.
Source Data Verification: Verification checkboxes can be built into the database next to relevant fields. DFdiscover can accept attachments to subject records, such as ECG strips, chart notes, and lab data and securely store them with the individual record.
Retention: In DFdiscover, a study database can be converted to read-only status, allowing records to be viewed by authorized users, but not added to or modified by anyone. Pending or other designated DFdiscover records may be withheld from a study database if needed but are never removed from the audit trail.
DFdiscover’s built-in access levels, review, storage, and exporting capabilities mean you don’t have to purchase or learn a new system interface in order to successfully perform monitoring assessments remotely.
Download | Remote Monitoring with DFdiscover CDMS
Download an informative slide deck on how to set up your clinical study for remote monitoring with DFdiscover.
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Learn more about DFdiscover, DFnet’s Hybrid CDMS.
Learn More | Clinical Data Management Services
Learn more about DFnet’s tailored clinical data management and analytics services.