Agatha Remote ISF – Monitor your sites with an eISF for clinical trials

Choose an eISF for remote site monitoring

Eliminate the need for on-site monitoring with an electronic investigator site file. Remote monitoring and quality management for clinical sites is made simple by Agatha’s eISF solution for clinical trials.

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Customer Story

Remote site monitoring during clinical trials improves quality and reduces costs

If you’re spending a lot of time and money monitoring your clinical sites and you’re looking for a better way to do it – one that doesn’t require you to be there in person, we’ve got you covered.

Standardize your various clinical research sites by removing paper binders

Simplify your clinical trial process and keep your clinical study documentation audit ready with Agatha’s eISF solution for clinical trials. Make all your essential study documents available remotely and identify missing documents much more easily than by reviewing individual, paper regulatory binders at each testing site.

Connect monitors and  sites with remote monitoring

It enables monitors and inspectors to review the source files, make notes, and complete their monitoring tasks. The application also allows for the creation and assignment of tasks for site administrators, including notifications and tracking.

Eliminate regular monitoring visits to clinical trial sites with Agatha
“Monitors would go out to sites and physically browse the documentation they needed access to and provide feedback to sites. Study coordinators and other site members were often there, and there was this feedback and interaction that you don’t get in a remote framework. We wanted to make sure that monitors felt like they could do their job properly even though it was remote and that we were mirroring monitoring procedures.”

Guilia Bignami
Clinical Research Associate, Optos

Improve Your Site Setup and Documentation  Processes with Agatha

RM General View

Easy Site & Study Set Up

Create separate, secure areas for each Site to manage its documentation. Each site and study comes with a complete set of placeholders for expected documents. Use configurable auto naming to enable naming conventions aligned to study standards.

Access Workspaces and Tasks in the Dashboard

View all your workspaces for each clinical trial site in the dashboard and quickly see and access tasks assigned to you. Use the configurable views to inspect, verify, and identify gaps in the expected eTMF contract at any time.
Agatha Dashboard Workspace
RemoteNotes2

Share Binder Contents in real time

Share binder (investigator site files, or ISF) contents between monitors, sites, and sponsors to enable remote document review and quality check. Use forms to share monitor notes and assign tasks to site personnel.

Manage Quality Checks & automate regulatory compliance

Designate documents for the quality check process and track the quality review using custom views. Leverage workflows with electronic signatures to meet all compliance requirements and set up automated workflows to move final clinical study documents to the Master TMF.

Remote ISF

The best way to know if an Agatha Application meets your needs is to try it out. And good news – we offer a free trial of our eISF for your clinical trials.

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There’s More to Agatha Remote eISF

Custom Forms and Rendering

Leverage forms to drive processes based on metadata and use metadata to generate renditions.

Basic Preview and Annotations of essential site documents

Preview and annotate PDF and Office documents, and image.

Cross Workspace Reporting

Create views and reports across workspaces and export results to Excel for dashboard reporting.

Extended Template Sets

Collect feedback from sites with Post Market Surveys and collect consent documents with Informed Consent.

Advanced Policy and Access Management

Manage policies, associated roles, and access control easily.

Advanced Integration Toolkit

Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation and sample code).

Learn more about remote site monitoring and Agatha’s electronic investigator site file solution

What is an electronic investigator site file (eISF)?

An electronic investigator file (eIF) is used to organize, collect, and maintain study documentation for a specific clinical trial site. The eISF is an electronic version of a traditional investigator site file, which was traditionally stored in paper format. A clinical trial is also responsible for maintaining and archiving their own investigator files.

Why use  an eISF?

Clinical trial sites often operate without a standardized protocol when it comes to the ISF, and it is often still papr documentation. This can cause difficulties, particularly considering that sponsors might enforce differing binder structures. As a consequence, the investigation website file (ISF), likewise called the website’s regulatory binders, is unique to every study location and collaboration is made difficult because of the paper medium. Agatha Remote ISF offers a solution and a reference model for improved ISF during clinical trials  
Offer standardized filing structures for your trial sites ISF

What documents are kept in the Investigator Site File (ISF)?

An ISF contains essential documentation that shows that the clinical trials sites and investigators are adhering to the regulatory standards outlined by the ICH GPCP. According to the ICH GCP 4th edition, essential documentation includes “docu­ments which individually and collectively permit evalua­tion of the conduction of the study and the quality of the evidence produced.” All important documents must be submitted to the ISF within five working days of receiving them. These include any correspondence, reports, invoices, and contracts. They must be made readily available for inspection by the sponsor, its auditors, and regulators.

Examples of documents kept in an eISF

The investigator site file should include all relevant study documents, training documents, funding information, safety documentation, monitoring documents and more. Documents expected to be available for audit in the eISF are:
  • Trial Protocol;
  • Participant Information Sheet and Consent Forms;
  • Investigator Brochure;
  • Regulatory documents, applications and approvals;
  • Delegation Logs;
  • Safety Reports;
  • Correspondence between delegated site staff and Sponsor;
  • Pharmacy File;

How long are eISF documents conserved after a clinical study?

Following the end of clinical trials and the closing of a clinical study, essential documents must be conserved following regulatory requirements. The industry standard is to keep eISF documents for 30 years to be accessed by monitors or regulators if needed.

What is the difference between an eTMF and an eISF?

The electronic Investigator Site File (ISF) is a subset of documents stored in the electronic Trial Master File (eTMF). The difference between the eTMF and the eISF is that the investigator site file is compiled individually by each trial site. The research sponsor can then gather ISF files from each trial site and compile them in the eTMF.

ETMF systems and the TMF reference model have been adopted industry wide, but there is no specific ISF model for sites: they still do not have precise, standardized filing structures. Removing paper ISF files and managing a site’s essential ISF documents electronically ensures a standard structure across all study sites.

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