Announcing VISION™ eConsent!

Announcing eConsent!

Prelude’s unique eConsent functionality is the latest in a long line of enhancements aimed at eliminating paper from clinical trials. Up until now, most clinicians have obtained owner and subject consent on paper forms that are then uploaded into the system. Now sites can obtain owner and subject consent electronically the same as for any other user signature for the study.Animal Studies

For animal studies, the process for obtaining owner signatures begins with an owner profile added by the site.  The owner then logs on and immediately signs an electronic signature agreement. After the generic agreement is signed the owner is able to electronically sign any study-specific consent forms. Once the subject is enrolled the owner is free to fill in their own demographic information as well as any forms that are required for the study such as a dosing schedule or owner diary.

Human Studies

For human studies, brand-new technology has been implemented to attach the signed consent form directly to the appropriate PDF document. No personal data will be collected about the subject until the informed consent is signed electronically by the subject.

Notifications

The eConsent feature of VISION includes the ability to send (and re-send) notifications to the subject to remind them to sign relevant forms. A notification can also be sent to site personnel to alert them when a form has been signed. The forms can also be provided with multiple language options for studies enrolling non-English-speaking subjects.

Electronic Signature

An electronic signature is a distinctive mark appended to a document for verification. It offers the same validity as an ink signature yet with an even higher degree of contemporaneousness as it also includes the time/date stamp and logged-on user information. It is a safer, faster, and more cost-effective approach for capturing signatures.

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Performing a Remote Audit of your EDC Vendor

There has been a great deal of discussion lately on remote trials, remote monitoring, e-consent, etc., in the context of COVID-19. Another great topic worth discussing is remote auditing. Sponsors and CROs typically conduct on-site audits of their EDC vendors on a bi-annual or tri-annual basis, but what if that can’t be done on schedule? Add in the fact that experienced auditors are amongst the most vulnerable population, and the need for an alternative becomes painfully obvious. 

Recently, Prelude Dynamics has experienced an increase in Requests for Information and Vendor Qualification Questionnaires. Instead of becoming overwhelmed by filling in the same information multiple times, we have come up with a solution to streamline the process. We created a proprietary Remote Audit Response document for distribution to our Sponsor and CRO clients. It is a comprehensive document which will provide a suitable baseline for remote audits going forward. If you’re interested in receiving a copy, Contact Us. 

Remote Audit Checklist

We recently attended a webinar on the topic of remote audits so that we could provide helpful information to our Sponsor and CRO clients. Here are the most important tips we learned:  

Use a risk-based approach to identify providers to audit 

  • The FDA uses a risk formula to determine inspection priorities. 
  • It may be appropriate to assess less risky organizations and sites using a questionnaire. Software-as-a-Service (SaaS) providers are very good candidates for remote audit. 
  • Consider auditing 10% of the riskiest providers. The complexity of the service provided and proximity to market (GMP) factor into risk. 

Establish protections for Intellectual Property and methods of communication and data transfer. 

  • Non-Disclosure agreements protect both Sponsors/CROs and vendors and promote the flow of information. 
  • Test web-based video teleconferencing platforms and data transfer mechanisms in advance. 

Conduct the remote audit in phases. 

  • Ask the provider for an initial set of documentation and use that as a basis for a second request for information. Establish a deadline for submittal. 
  • The initial set should include indices (such as an SOP list), Organization Charts and Quality Manuals. 
  • Plan subsequent phases to address issues and questions that remain after the initial set has been reviewed. 

Formulate and communicate the agendas for additional phases in advance. Both parties should confirm receipt of all audit related communications. 

  • Requests for information should not be all inclusive. Request subsets such as specific training records, validation results and backup and restore evidence. 

Conduct opening and closing meetings to review status and remaining agenda items. 

  • If interviews with specific personnel are required, collaborate on scheduling. 

Conduct a closeout meeting to discuss observations. Only assign severities in the final report. 

  • Set realistic timeline for audit response. Define how results of any CAPAs will be reviewed (e.g., video telecon, copies of documentation). 

We are ready to collaborate with you on your next remote audit of Prelude Dynamics! 

Prelude Dynamics offers process improvements to help you cope with this new normal. Prelude Dynamics

 

 

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Announcing Source Data Verification in VISION EDC

Source Data Verification 

Prelude Dynamics continues to enhance our VISION™ platform with crucial features requested by our clinical trial user community. The ability to perform Source Data Verification (SDV) in the context of EDC has become more and more important as we’re migrating away from paper. VISION’s SDV functionality operates at the field level and complements the existing form review capability. How does it work? 

Users who have permission to review forms can activate the SDV feature simply by clicking an icon on the form. When this is done, check boxes appear next to the fields on the form.

 

Check boxes give clinical trial monitors an easy way to see which fields still need to be verified.

 

Check boxes are automatically cleared if the reviewed field is later changed – letting monitors easily see which fields need to be re-reviewed, while preserving the reviewed state of other data entry elements on the formThis is a time-saver for monitors, and saving time saves money! 

These field-level SDV reviews are fully attributed and preserved in the audit trail in a 21 CFR compliant manner. 

 

The audit trail shows information about the user who performed the Source Data Verification.

 

Even though most of our clients use VISION to directly enter data as the source (eSOURCE), in some cases there might be a need for SDV. Let’s consider a few scenarios. 

Transcription of data from paper forms 

First consider the transcription of data from paper forms (or pictures of paper forms) such as subject/owner logs or paper patient reported outcome forms to EDC. In the past, Double Data Entry (DDE) was typically used for situations such as these. SDV is an improved replacement for DDE, especially when used along with a file upload that allows a copy of the original paper form to be uploaded directly to the EDC.  

Review of Adverse Events 

Monitors typically want to review Adverse Events as soon as they are entered into the EDC as part of their safety assurance responsibilitiesOccasionally, investigators haven’t completed all the information in the Adverse Event eCRF because they are still conducting analysis on the possible cause. In cases such as this, Monitors can review the data that has been already entered. When they revisit the form later, they will know which information has already been reviewed. This also works well for Concomitant Medications. 

Want to learn more? Contact us to schedule a demo and stay tuned for news of other new features such as Site Level Batch Data Entry and quick report filters! 

 

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Best Practices for Remote Clinical Monitoring 

What does it mean to conduct effective remote clinical monitoring? It’s critical to be using an EDC in order to accomplish this, but what else is necessary? Keeping the primary goals of the monitor in mind, we will outline several techniques for streamlining this process.   

What are the primary goals of the study monitor? First, and most critical, is to ensure the safety of all study participants – including clinical personnel. Second, is ensuring data quality and integrity.  

Letdiscuss the EDC features that can help in each of these areas. 

Ensuring Safety 

Monitors are relied upon to use their knowledge and expertise to recognize potential safety risks, and to report them when discovered.  The EDC can’t replace monitors, but it can assist them greatly in their daily workflow. 

Use of Notifications. The EDC can be configured to automatically notify monitors when certain events occur. Examples of this include the entry of adverse eventsthe reporting of out-ofrange lab results and new subject enrollmentWhen automatic notifications are used, monitors are informed in real time and the need to continually review eCRFs for potential issues is eliminated – saving valuable time. Think about the potential risk factors for a study and consider how notifications can be configured to assist the monitor.  

Use of Reports and Graphs. Some EDCs support flexible, configurable reporting tools that facilitate the aggregation of data for review. Graphs can be used to more intuitively spot outliers and aid in understanding trends. If such tools are not available, consider asking your EDC provider for custom summary reports that can be used to review study endpoints, exam results and adverse events in a comprehensive way. 

Use of Study Dashboards. Dashboards that aggregate reports from multiple sources can provide a convenient starting point for a monitor’s daily workflow. Monitors can log in to the EDC and navigate to a central page to review notifications, study metrics and risk-aware reports. 

By proactively thinking about the types of information monitors need, each study can be configured to provide tools such as these before the first subject is enrolled. With the VISION EDC systemmid-study updates can easily be made to support data monitoring needs that weren’t anticipated at study build time. 

Ensuring Data Quality and Integrity 

Sophisticated EDC systems support automated data cleaning in a variety of wayswhich naturally improves data qualityMonitors and data managers can contribute their expertise at study build time to make sure that this automation is included as comprehensively as possible.  

Use of “Completeness” Checks. Completeness checks answer the question “is all required data on the eCRF?”. This is especially important when some data can be entered conditionally (e.g., only if another data entry element has a certain value). related question is “why wasn’t this form been filled out?”. It’s a good practice to implement a “Not Done” checkbox on forms such as Adverse Events and Necropsy that are (hopefully) not often used. This practice lets monitors know in a proactive way that the form is intentionally blank, which effectively reduces the amount of questions from the monitor. 

Use of “Correctness” Checks. Correctness checks help answer the question “is the data correct and in the right format?”. While study protocols usually provide information about the resolution (e.g., number of decimal places) of data to be collected, they don’t always specify things such as the expected range for data points. Enlisting the support of data managers at study build time will help ensure these checks are in place and are as complete as possible. 

Use of Visual Error Indicators. When visual error clues are present and easily viewable, monitors don’t have to spend time manually reviewing each form for errors. They can focus their efforts on strategic reviews instead. Such indicators also provide immediate feedback when data is entered, which prompts clinical personnel to correct entries in real time. 

Use of Document Uploads. When it is necessary to transcribe data from paper forms, it’s good practice to provide an upload mechanism for those forms so the transcription can be reviewed more easily. This mechanism, along with Source Data Verification (SDV) functionality, is also useful in converting a paper study to EDC. VISION’s SDV functionality allows the monitor to sign off on each data entry field individually or at the form level. 

Use of Integrated Query Functionality. Having the ability to enter queries directly into the EDC system, and to easily see whether queries have been resolved, is an enormous aid to monitors. It eliminates the need for them to revisit queries that have been resolved and move on to more important work. 

Qualify the EDC Vendor’s Infrastructure. We’ve defined mechanisms for ensuring the completeness and correctness of data, but how secure is it? EDC vendors should be asked about their backup strategy.  How often is data backed up? How much data could I potentially lose? How long does it take to restore data? How long is data retained? These are some good questions to ask your EDC provider before your study commences.  Prelude recommends (and performs) hourly backups. Questions about barriers to system access are also importantAsk your vendor what their average up-time is. If clinical personnel can’t enter data in real time, data integrity could be impacted. 

Monitor Workflow – Continuous Monitoring 

 Here are some recommendations for conducting remote clinical monitoring using VISION™. 

  • Identify a monitoring schedule and stick to it. For slow-enrolling studies, this might be once or twice a week. Larger, more active, studies may require full time monitoring efforts. 
  • Create focused reports that highlight potential risk areas and promote identification of outliers or undesired patternsConfigure the Dashboard to include these reports and share them with other clinical personnel to promote awareness. 
  • Consult the Dashboard to make sure notifications have been handled and to get an idea of emerging trends that require analysis. 
  • Review forms that have been submitted by clinical personnel and use the Query function to call attention to questionable data. 
  • Review recent lab results for out-of-range results and determine if those relate to Adverse Events. 
  • Review fields with changes to see if there are any patterns and clarify their use with clinical personnel. 

It’s important to perform these activities continuously. Contemporaneous identification of issues is critical when safety is concerned and helps clinical personnel recall specifics they are likely to forget after time passes. Also, when monitoring is done continuously, study close-out activities can be completed much earlier since most of the work has already been done! 

Conclusion 

Monitors who understand the capabilities of their EDC provider and the automation that has been included in their study have an advantage. They can rely on the EDC system to handle the “grunt work” and concentrate instead on critical outcomes and analyses that can’t be automated.  

New Reality of Remote Audits

This morning, Prelude attended a meeting on the new reality of remote audits and inspections. In the past, remote auditing of sites was viewed as a nice capability. As many in the industry are now learning, remote capabilities are now a necessity. Sites that collect data on paper will need to scan all their documents into digital formats as fast as possible. This process can present many issues including legibility, legality, and availability of documents (documents located in locked down facilities will be unavailable for the foreseeable future).

Auditors understand the struggles for documentation at this time, and they will be giving sites more lead time as well as more time for the actual inspections. However, a simple increase in time permitted for an audit is not a sustainable solution. This method is merely a Band-Aid. Recording studies on paper is no longer sustainable. The time to switch to a digital platform is now. Let Prelude’s team of certified data managers help you transition to a more efficient and more effective eCRF database. We are working with companies around the world to meet industry standards and deadlines to ensure a brighter future for all.

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How to Make the Most of Remote Trials During COVID-19

For years, technology’s detractors have bemoaned the loss of in-person interaction. While we admit this has been an issue on occasion, it’s now an asset to moving important clinical research forward. 

Many human and animal health studies are either still done on paper or require labor-intensive source document verification (SDV). If sites are not using technology for direct data entry, in-person site visits are required to track the data throughout the life of the study.  

Another prevalent challenge under current “social distancing” norms is to obtain signatures remotely that are CFR 21 Part 11 compliant. Many data managers are considering eliminating DocuSign as insecure. Adobe Sign has likewise been found by some to be untrustworthy as PDFs can be changed after the original signing. The print/sign/scan method is outdated and cost prohibitive. Many team members do not have printer/scanner combinations in their home office.  

Finally, many GCP studies are struggling right now due to a lack of study participants coming into their clinics or bringing their pets back for follow-ups. Enrollment and compliance with a visit schedule are not feasible in these uncertain times where many patients aren’t even allowed in the door.  

Given the challenges above, a robust electronic data capture system (EDC) can be more valuable to clinical trials than ever before. Prelude’s EDC, VISION, has been officially CFR 21 Part 11 compliant for close to two decades.  The system has been purposefully designed to make direct data entry as seamless as using paper, with eCRFs capable of mirroring the same look and feel as a paper form.  

Prelude’s new ePro application gives patients and pet owners unprecedented access to their own forms so that they can follow up on their enrollment schedule from their own home, in many cases eliminating the need to visit clinical sites.

 

 

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