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Remote Source Data Verification (rSDV)

The Clinical Trial Industry at large is adjusting its operational procedures in response to the physical site access disruptions associated with the COVID pandemic. This emergent situation has compelled the industry to move away from its traditional onsite monitoring regimen and adopt an alternative remote monitoring approach.

Most of the clinical research sites maintain source documents and essential site master file (SMF) documents either on paper or on hard to access digital storage tools. This process hinders the work of CRAs who are now barred from visiting the clinical site and forced to work remotely. Because of the stringent regulations that bound the sharing of source documents and clinical trial regulatory files, utilization of generic non purpose- built file share systems, cloud- based folders, fax, or email platforms can introduce significant compliance risks. A well designed and secure remote source data verification (rSDV) application supports the immediate need for clinical sites and clinical research associates (CRAs) to continue working together while onsite visits have mostly become remote.

Why choose Octalsoft rSDV application?

To mitigate this risk of regulatory non-compliance while enabling remote collaboration, Octalsoft has introduced a 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA compliant remote source data verification (rSDV) application. The Octalsoft rSDV module allows sponsors and CROs to maintain regulatory oversight of clinical sites by enabling remote access to study documents over a secure portal. It allows the users to remotely manage and track the workflow and downstream processes for source and study document review and verification.

Octalsoft has always been on the forefront to identify and implement the best solution for our customers’ projects to meet the regulatory, quality, and efficiency expectations. In current times when Risk Based Monitoring (RBM) and remote SDV are evolving into a standard model, our rSDV module is one such attempt at revolutionizing site monitoring by reducing the need for on-site SDV through secure file sharing and virtual collaboration.

Product Features

Integrated and Standalone rSDV module

Octalsoft rSDV is available as both, a standalone application, as well as an integrated single sign-on module with Octalsoft EDC software. The module also has a provision in place to upload site master file documents, which serves as the central repository and work area for the CRA performing remote review and verification.

Standardized Study Document Folders

The system automatically creates a subject-specific folder in the application as and when a new subject is enrolled in the EDC. Alternatively, the site user can create folders and sub-folders in a standalone application according to a sponsor specified nomenclature. The folders thus created store the uploaded source/study documents and streamline document management while giving your monitors easy access to the uploaded documents.

Upload Documents Securely

The sites can easily upload the scanned source documents or images into the subject/study folders. The investigative clinical site would retain originals and control of the source documents. The nature of storage of the uploaded documents is temporary and the application has a provision to delete the documents whose remote review has concluded. The system also maintains a complete audit trail for the full document status history.

Reports and Dashboard

The Octalsoft rSDV application provides real-time dashboards and interactive reports in order to track activities, check statuses and manage workflows pertaining to study documents verification.

Controlled Document Access

The Octalsoft rSDV module has extensive permission-based controls to limit document visibility and functional capabilities as defined by the client.

Automated Alerts

The application is able to send email alerts/ notifications as required for specific tasks such as when the source is uploaded or when the comments are appended and require attention from the CRA or CRC; as well as sharing the listing of which documents are reviewed or verified.

Document Review Workflow

The Octalsoft rSDV module has a collaborative feedback mechanism in place which allows the CRA/CRC to append comments to the uploaded source/study file in order to complete data review and verification. In an EDC integrated system, the application further allows dual display of the uploaded source document file and the relevant eCRF page, in a single screen. Because of this inbuilt feature, the CRA does not have to toggle from one screen to another during the review process. This electronic document workflows automates a significant portion of your manual tasks with a significant reduction in document review cycle time.

Product Benefits

Increased Productivity

Octalsoft rSDV application is a fully web based solution. The module increases clinical trial monitoring productivity, by reducing the need for on-site source document verification (SDV). It provides the users with a collaborative environment, which CRC/CRA can easily access, while also ensuring the privacy and confidentiality of subject/study data.

Cost Reduction

The rSDV process saves significant cost in monitoring visits due to reduction in associated travel and logistics, and also makes monitoring visits less disruptive and more valuable to the clinical site and the CRO or Sponsor.

Prompt Action

The rSDV application further allows the CRA to assess clinical site issues identified through remote verification and establish a prompt course of action prior to the scheduled onsite visit.

Enhanced Visibility

The Octalsoft rSDV module allows sponsors/CROs to gain visibility into study site performance and strengthen the site master file completeness with faster site document workflows. In addition, it comes with a process in place for necessary follow-up activities to be performed remotely, which saved time and money and a reduction in onsite rework.

Interested in learning more about Octalsoft Remote Source Data Verification (rSDV) Solution?