Building a Better Clinical and Safety Portal

Having been actively deployed by TransCelerate members for several years now, InnovoCommerce has been able to learn many lessons not only from our success, but also where we've come up short.

Our approach is to keep abreast of developments in the industry, guidance from the FDA and industry bodies, and -- perhaps most importantly -- listen to our customers and collaborate on finding better solutions to day-to-day, real-world challenges.

Lessons From Industry

The Clinical Trials Transformation Initiative (CTTI) is an organization comprised of more than 80 members drawn from across clinical trial enterprise, government agencies, industry representatives, patient advocacy groups, professional societies, investigator groups, academic institutions, and other parties.

Their mission, as stated is:

To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials

This influential group has published many recommendations and findings with regards to improving clinical trials, including:

Meanwhile, the FDA, as part of their recommendations from the Final Rule, provided key guidance to industry as well:

Let's look at some key points in this guidance and see how investigatorFIRST helps you improve your clinical and safety document processes.

Notification and Acknowledgement

Ability to batch safety report notifications (per day/week) as per investigative site user’s preference
Intuitive, easy-to-navigate interface (e.g., few “clicks” required to access safety reports directly; safety report can be accessed directly via hyperlink contained in an email notification)

Per the CTTI investigator survey, they found that "respondents noted that generic email notifications are not particularly helpful and many choose to block these emails" and additionally that respondents reported "receiving too many generic email notifications".

investigatorFIRST addresses this issue by sending batched, digest emails like those sent by Twitter, Quora, and LinkedIn. The digest interval is configurable by the customer; send it once a day or every other day to balance the need for timely notification against generating too much noise.

Each item in the digest email has a configurable priority value, configurable action prompt, and a direct link to the task

Notifications are only sent up to three times per task: when the task is created, when the task is "due soon" and when the task is overdue. This reduces the noise so that users can decide when to complete the task.

Ability for PI to delegate the task of accessing safety reports via portal to another person at the site

investigatorFIRST supports delegation by default; tasks can be assigned by role, to a specific user, or to the site. When the task is assigned to the site, any user at the site can complete the task and the task history tracks who completed the task as well as the role of the user:

Easy acknowledgement of safety reports by investigative site staff (e.g., click on a link to the report, check a box or check-all option)

investigatorFIRST allows investigators to use the batch acknowledgment feature to acknowledge reports in a batch:

We'll also look at some other features that help sponsors reduce the safety distributions in the first place based on FDA guidance.

Ability to send and record acknowledgement of a safety report only once across multiple trials for the same investigational product, yet still showing the report under each trial

investigatorFIRST supports targeting of the safety reports by program/compound level so that the user only has to acknowledge once in the scope of the program/compound, regardless of how many trials and sites the investigator is participating in:

The documents are listed by programs so the user can quickly identify their relevant safety reports.

Consistent with US FDA guidance, an electronic sign off requirement by the Principal Investigator or other investigative site staff is not a desired attribute.

In recent years, the FDA has issued explicit guidance that electronic signatures on individual SUSARs are not required and, in fact, "not desired". investigatorFIRST supports multiple modes of safety report distribution including:

  • Safety with Acknowledgement Use this mode when distributing line listings and periodic safety reports or when regional regulations require acknowledgements.
  • Safety with Acknowledgement and Role Targeting Use this mode when a specific role at the site must complete the task.
  • Safety No Acknowledgement Use this mode when distributing individual SUSARs or ICSRs so the sites have the information on file, but do not need to take action.

This flexibility ensures that you're able to meet internal and agency regulations on acknowledgement of safety reports. Use different rules for different document types and map those document types to different geographic scopes to comply to regional variations in regulatory requirements.

Report Management

Ability to print reports or download multiple reports with one click to a compact disc, computer or electronic investigator site file
Reports remain visible for the life of the trial

innovoPOINT provides an electronic investigator site file (eISF) functionality which allows sponsors or sites to download all of the site's contents with just two clicks:

The ISF package includes a single PDF report which contains the full inventory of the site's documents.

The reports are always available in the users' Site Document Checklist as well as in a convenient eISF package which can be downloaded and archived at any time.

Improving Signal to Noise Ratio

Per the FDA guidance on safety reporting requirements:

During the course of the clinical trial, the sponsor must update the investigator brochure on an ongoing basis with new important safety information (21 CFR 312.55)...An update to reflect a minor change in a suspected adverse reaction rate could be done on an annual basis. There is more than one acceptable approach for updating the investigator brochure with new safety information. For example, adding a new serious and unexpected suspected adverse reaction to the investigator brochure as an addendum, rather than reissuing the entire brochure

investigatorFIRST has been designed with process support for FDA guidance on best practices for managing safety reports to investigator sites. The system supports suspending individual SUSARs once they have been incorporated into an updated investigator brochure or addendum. Using this mechanism, new sites will only need to acknowledge the IB and not any suspended SUSARs (which remain available for existing sites to view individually).

This ensures that critical, serious adverse events are made more accessible to the investigators and reduces the noise generated by individual case safety reports.

Configure multiple document types -- Investigator Brochure and Investigator Brochure Addendum -- to distribute non-critical updates quarterly or annually for the Investigator Brochure and as necessary for critical items which can be distributed to the investigator as an addendum to the Investigator Brochure.