Why You Need a Centralized Source of Documents for Your Clinical Trial

Posted by Paddy Wall on Mar 6, 2018 2:59:00 PM

 

With 59% of Phase III trials now running at more than 11 sites, how can you keep each clinical site well informed and up-to-speed?

Clinical research sites tell us that, in the absence of official source documents, they will often create their own cheat sheets. This means each of your sites could be using different, non-controlled documents as their go-to guides, which can be an inspection finding.

Sites report that they often feel out of the loop and ill-prepared, and that’s a sure-fire way to guarantee poor site performance. So, as the study manager, how can you support your sites with the information they need, while ensuring that you have oversight of key documentation at the same time?

1. Provide One Single, Centralized, and Accurate Source of Information

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Holding all your key trial documentation in a single, centralized, and easily accessible repository could really transform your day-to-day study management. This repository provides a secure place where you, your sites, and ideally patients, can access information that is specifically relevant to them – ranging from training materials for patients and site staff through to the latest protocol amendment.

Providing a single, centralized, and accurate repository puts you back in the driving seat because it means that you control exactly who has access to each document; when it’s deployed; and when it’s revoked. It also means that you provide all the documentation once-off for all sites, and can easily update and replace files as needed, giving you peace of mind that every site has the latest version.

Not only does this offer you greater certainty of the accuracy and authenticity of information about your trial, it also saves you time. Rather than site staff having to root around to find that latest regulatory document, they can recall it at any time from a single source – this leads to fewer repeat requests for information and more time to focus on the bigger picture of how your trial is progressing.

2. Assure your Site’s Compliance 

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Have you ever sent out that email memo into the ether and wondered if anyone has actually read it? The second invaluable function of a centralized repository is the ability to track documents and information. Busy site staff who are constantly bombarded with reminders and new information are likely to miss things. With a centralized repository, you can see instantly whether your site staff have received and reviewed the essential documents you need them to read.

This reassures you that your message has been received loud and clear, and means you have a full audit trail of items distributed and read by site staff for your clinical trial management system (CTMS). Rather than sending complex information via email alone, our technology enables you to automatically let people know by SMS or email when an update is available. They can read it at a convenient time, and you can also give them a gentle nudge, if they aren’t complying, to read and acknowledge receipt of the item.

3. Boost Site Engagement - Make Document Management Easy

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Most site staff tell us that communication to and from their study team occurs via email. These emails must be printed and filed in the study file, which is both time-consuming and unreliable. Simplifying this paper trail using a centralized repository won’t just make your study management easier, it will also provide your sites with better information and audit processes too. In turn, this will improve their day-to-day experience of running the trial, enabling them to deliver top-notch site performance and a better patient experience – both of which are essential to the success of your clinical trial.

Signup for a Demonstration of Longboat's Clinical Trial Platform

Many clinical trial technology platforms will also allow you to tailor the format of certain types of information to match both site staff and patient preferences. For example, Longboat’s site and patient portal includes 24/7 mobile access to the latest study news and updates. This presents patients with the ability to opt-in for regular communications or visit reminders direct to their mobile device, which helps to boost patient compliance and retention.

Take Back Control of your Trial Information

In summary, a single centralized repository for all your trial documents could revolutionize your study management, by:

  • Allowing you to upload documents once, in the knowledge that all sites have the latest version
  • Providing everything from training resources, protocols, regulatory documents, and trial memos in real-time
  • Giving you easy control over who sees what, how they see it, and when they see it
  • Enabling site staff and patients to recall and request information, as and when they need it
  • Providing one-click confirmation that memos have been received and read, as well as a full audit trail of your trial communications for audit trail purposes
  • Simplifying information management to boost site and patient engagement
  • Providing information in a way that best fits with site staff and patient behavior (i.e. straight to their mobile device when they are on the move)

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Topics: Clinical Research Conduct, clinical trial technologies, monitoring, rbm, ICH GCP E6 R2