eTMF Automation – FAQ

Frequently Asked Questions about eTMF Automation

How can we truly go paperless if trial sites prefer wet signatures?

The short answer is that you don’t have to force sites to go paperless. We have found that tens of thousands of users at sites using our Study Collaboration Portal software were thrilled to go paperless, including eSignature, once they logged in to the portal and saw that it supported both wet signature and eSignature.

There is always a bit of cultural change required when technology advances. But in this case, our customers learned sites become the biggest advocates once they experience how much time can be saved by moving away from wet signatures. However, when sites do execute wet signatures, our software sends that document with its wet signature into a special QC check. Once the wet signature is approved, that document and its wet signature continue to move along as a paperless document.

Do you have any stats on how long it takes for a document in your system to go from site collaboration and collection to eTMF?

During paper-based trials, essential documents can take 40 to 60 days from scan until final QC check, prior to adding them to your eTMF system. Our Study Collaboration Portal solution eliminates all the paper-based steps, including printing, signing, scanning, and scan inspections. That means when a document is distributed by our system, depending on whether or not it needs a signature, the document is ready for a final QC immediately or upon eSignature a few days later. This process includes the documents collected from the Sites. The eTMF can receive documents immediately after a single QC review. Timeliness and contemporaneousness become the default status of your eTMF.

How much time does a CRA need to spend in your system to review the site binder during a monitoring visit?

Because Study Collaboration Portal is automated and paperless, completeness is decoupled from site monitoring visits. There is never a reason to check the binder at a site because the binder can no longer be out of order, it wont be missing an artifact, and it can’t contain an outdated document. Site Binders are always in a state of completeness.

If a site needs to sign or acknowledge anything, the sponsor is already aware of the missing signature or acknowledgment without a site visit. And the site is aware of their incomplete task because it is the first thing they see when they log in. For these reasons, CRAs can spend time at the sites doing more productive things than reviewing paper binders.

Does your system send out a lot of emails to sites? Don’t paperless systems send out way too many reminders upon reminders?

Our customers usually set up Study Collaboration Portal to send once per week digest emails that contain clickable links to any actions that need to be taken care of. This strategy not only solves the issue of getting too much email, but it also gives sites a chance to get their work done without getting reminders from a system that doesn’t know whether the site already took care of a task. When we launched “Digest” messaging in version 6 of the Study Collaboration Portal, our site user productivity increased, and task cycle time dropped. It is a good balance between harping on users and helping users complete their work.

Study Startup has a lot of sub-processes. How does your software deal deal with the complexity of distributing and collecting the variety of startup documents?

A recent ACRP article on study startup said it best, “a large chunk of start-up effort is spent on coordinating the essential document compilation, review and reconciliation steps required for various submission packages”. Automating startup essential document workflow is complicated because there are 8 different essential workflows in every study and a study startup package contains at least 4 of them.

This is exactly where Study Collaboration Portal provides maximum benefit and efficiency. Our purpose built workflows are automated and they require no configuration as they route correctly, right out of the box. From trial start to trial finish, Study Collaboration Portal eliminates the study startup paper ISF, and manages a paperless compilation and automated distribution of the package as it tracks the package status in real-time until completed.

How can we effectively track and approve the Informed Consent that is being edited by the site prior to site startup?

The collaboration workflow built into the Study Collaboration Portal enables the site to edit the Informed Consent provided by the sponsor and send it back to the sponsor for approval. The sponsor can provide feedback or approve the document. Once the document is approved, it is locked and cannot be edited. The site can then submit the document for IRB/EC approval, provide IRB/EC feedback to sponsor and finally upload the IRB/EC approval letter back to Study Collaboration Portal. All versions of the Informed Consent along with changes made at every stage are maintained in an audit trail.

How do you handle the Closeout document collection process?

During the closeout process, all study files are reconciled with the Trial Master File. This used to be a painstaking and time-consuming process. However, Study Collaboration Portal has completely automated this process by designing a system that keeps essential documents validated at all times and transferred to the eTMF for QC in real-time. However, any missing document, such as study team licenses, CV’s, laboratory documentation, etc. will be available as an open task for the site to complete.

The CRA can simply monitor everything remotely during the trial to ensure the site completes all required documentation in a timely manner, long before closeout. Once a site’s role in the trial is complete, the sponsor has the ability, in one click, to archive all documents and communication provided to the site during the conduct of the study and provide that archive to the site. All documents and correspondence are automatically converted to PDF for long term retention by the site.

Why should I consider InnovoCommerce over [fill-in-the-blank]?

We don’t mess around when it comes to designing and building great software. We have been delivering enterprise scale software for drug safety, device complaint handling and clinical trials since 1995. Our team envisioned the Argus Safety product in 1996 and launched it to the world in 1998. (At a time when there were many other companies already offering software for adverse event handling.)

Today, Study Collaboration Portal is the only commercial software to deliver end-to-end automation of regulatory document distribution and exchange from study startup to study close out. Our customers are years ahead of their competition by using our product.

You can count on us to deliver a scalable enterprise solution to your trial document challenge, You don’t have to build your own. Contact us for a demonstration today.

Can you validate our installation?

Sure can! We can provide a spectrum of go-live support from supplying baseline validation templates to designing and executing your validation scripts for you. Every deployment starts with a set of project templates and other standard artifacts like administration guides, validation guides, and a functional design specification. Then we work with customers through pilots to identify gaps and find what they need to get the system up and running. Contact us for more information on deploying SCP at your organization..