The 4th Annual Embracing Change Conference for Clinical Research was a well-produced event from Arizona State University’s Clinical Research Management program. If you did not make it and would like a copy of the Status of Paperless Trials Presentation, send Florence a short email by clicking here.
A substantial portion of the conference revolved around the benefits, and potential pitfalls, of paperless trials. Here are some highlights that comport with what we’ve heard from leading sites who have gone paperless.
- Technically, a paperless trial is possible.
After analyzing all the the rules, regulatory expert Dr. Michael Hamrell, says it’s official: as long as a trial site has strong SOPs, they do not have to ever, EVER, have a piece of paper on site. Why don’t we see more paperless studies? Sites face inconsistent monitor demands where the letter of the law differs from reality. The pulse of the event suggested a balance may lie in a 90% digital study, where a few critical documents like 1572s and delegation of authority (DOA) logs were available in hard copy with wet signatures—with other documents managed digitally.
- HIPAA has matured
Evelyn Zeller of the HHS OCR Seattle Office walked through the details of the privacy rule versus the security rule. The nice thing is that the are no significant, recent changes. Take comfort: The stability of HIPAA is the one thing that trial teams can count on in the next 5 years.
- Storage is a real issue
Trial teams are dealing with storage issues on all fronts. Teams at the symposium reported full record rooms, documents stored in their own offices, and digital storage limitations imposed by IT in their inboxes. Learn more about how eBinders can save your office and data space as well as keep your trials 21 CFR 11 compliant.
- Electronic specifics matter
The event dedicated time to the specifics of how certain processes should be managed in a paperless world. A great discussion was had on how exactly to document “clinical significance” when there is no paper to put in front of a PI. The described answer lies in a powerful SOP and dynamic documentation using technology built with coordinator workflows in mind.
Send Florence a short email to receive a copy of the Status of Paperless Trials Presentation from the 4th Annual Embracing Change Conference.