Clinical Data: SQA Annual Meeting and Quality College Highlights
What a great week in Tampa! I thoroughly enjoyed my time at the recent Society for Quality Assurance (SQA) Annual Meeting and Quality College. I started my week as the invited speaker for the First Time Attendee breakfast. I enjoyed meeting so many new Quality Assurance professionals that were attending the Annual Meeting and Quality College.
A highlight of the week was the opening session featuring Commander Kirk Lippold, USN (Ret). Commander Lippold was the Commanding Officer of the USS Cole when it came under attack by al Qaeda in the port of Aden, Yemen. During his command, he and his crew saved the American war ship from sinking.
Key take-aways from the opening session were:
- How leadership translates into thinking in the now and in the future
- The importance of training because well-qualified and trained people know what to do in a crisis
- The power of confidence in your team, which inspires them to greatness and allows leaders to focus on the big picture
Clinical data management and quality assurance
There was an afternoon panel on e-archiving that had more than 200 people representing many areas involved in ensuring the quality of clinical data. This interactive session featured many questions as attendees are concerned about managing the process, controls, and access for e-archiving clinical data.
A key takeaway: as an industry, there are still many open questions. We now need to work together to come up with clinical data solutions and recommended best practices for e-archiving clinical trial data.
Clinical data management tools
On Wednesday I moderated a session on RACI (ie, responsible, accountable, consulted, and informed) tools, which are flexible and effective organizational management tools to communicate each person’s function across an organization.
This was another interactive session and the attendees identified numerous ways to implement these tools in their day-to-day workflow regardless of company size or how simple or complex the tasks. There is so much interest in this topic that an article is in development for an upcoming edition of the Quality Matters publication, and this topic will be expanded into a future workshop with other quality tools.
Good clinical practice and clinical trial quality assurance
At the end of the week I participated in an SQA panel of experts focused on good clinical practice (GCP) and clinical trials. This session featured GCP experts, and there were many questions regarding computer systems and validation.
A few key take-aways from this session include:
- There are many questions surrounding validation activities regarding equipment, the cloud, and archiving procedures.
- The complexity of global trials is challenging QA professionals to help meet the requirements of a;; the different regulations.
- There is a need for Regulators to clarify expectations.
I always enjoy attending the SQA Annual Meeting and Quality College – I learn so much at the sessions and I love the opportunity to collaborate with my SQA peers. I’m looking forward to the next SQA Quality College and Cloud Computing Symposium in Cleveland, Ohio, in late-September.
Guest blog contributor: Cheryl McCarthy
- Clinical Data Repository for a Business Critical Platform
- elluminate Helps in Clinical Data Management Around the World