TransCelerate Site Qualification/Training Update

TransCelerate announced the launch of 11 optimized informational programs through its Site Qualification and Training (SQT) intitiative. These topic overviews were created in an effort to enhance clinical operational understanding for clinical study investigators, and site personnel who are new to clinical research. TransCelerate conducted a survey with investigative sites in order to identify pain points that new investigators undergo when conducting clinical trials, and these topic overviews speak to the needs identified by those investigators. Katarina Hugeneck, SQT Initiative Leader and Manager of Global Study Training at Eli Lilly and Company, and Theresa Stewart, SQT Informational Programs Leader, Director of Global Site Management Operations, and Regional Operations Manager at Allergan will elaborate on the SQT initiative in this interview.   Moe Alsumidaie: Why was the SQT initiative started, and what is the overall mission of this initiative?  

Katarina Hugeneck

Katarina Hugeneck: The TransCelerate Site Qualification and Training Initiative began in 2012 as one of the first areas of interest and need identified by TransCelerate. The goal was simple, reduce redundant GCP training and collection of non-study specific information, as these are major pain points for investigators and sites, as well as for biopharmaceutical companies. The Initiative aimed to streamline and enhance the clinical trial site qualification and training process through creation of common tools, processes and materials. This includes a framework for the mutual recognition of GCP training and EDC system training, basic clinical research informational programs for site staff, as well as forms, guidance and templates to facilitate the collection and dissemination of clinical trial related information.     Moe Alsumidaie: How has the SQT initiative enhance training efficiencies at study sites, and what type of sites would benefit most from this initiative? How do sponsors benefit from the SQT initiative?   Katarina Hugeneck: Through the Initiative’s efforts, TransCelerate Member Companies now have the opportunity to accept a number of external GCP training certificates. There are over 250 GCP training courses listed on the TransCelerate website, that training providers have self-certified meet with minimum criteria. This means that TransCelerate members can spend less time and resources on delivering training to site staff, and site staff. The same is true for the collection of generic site information. This is a big benefit for sites that continue to conduct several studies with sponsors using those forms. Because of these efforts, investigators and site personnel circumvent time spent on redundant on training and other administrative burdens such as the submission of the same information for multiple trial sponsors and studies, and instead, spend more time with the patients and managing the clinical trial protocol. The development of the SQT solutions are not rocket science, but have contributed to easier collaboration between sites and sponsors. All of the solutions are publicly available on the TransCelerate website, the more stakeholders that use them the greater the benefit will be for all.   Moe Alsumidaie: How did the SQT initiative evaluate the initiation of the informational programs for less experienced investigators?   Theresa Stewart: It started off with TransCelerate Member Companies talking about some of the larger challenges that we face during clinical trial execution, and one of the challenges can be the sponsor requirement to select investigators who are qualified based on training and experience for large studies or when conducting research in new indications. We decided to provide basic GCP information and educational materials that would be beneficial to less experienced investigators and study site personnel and make it easily accessible.

Theresa Stewart

  One of the challenges that we have with less experienced investigators is that they don't always have the basic knowledge base for informed decision making. Our hope is that distributing this information to clinical trial investigators, especially those less experienced, will increase successful operations in a clinical research environment. If we can get better clinical trial results and outcomes through educating our investigators, then we can improve clinical trial quality, and get medications to patients faster.   MA: Please elaborate on the informational programs in the SQT initiative.   TS: There are 11 topics of information in the form of interactive topic overviews (accessible by clicking here), and they take about 20-40 minutes each to complete. Once completed, investigators can print a certificate of completion. The topic overviews include:

• Clinical Research Overview

• Clinical Practice Versus Clinical Research

• Adverse Events and Safety

• Conducting a Study

• IRB/IEC Responsibilities & Informed Consent

• Delegation and Training

• Source Documentation

• Essential Documents for a Clinical Study

• Investigational Product

• Facilities and Equipment

• Monitoring and Auditing

We designed the topic overviews into bite-size learnings, so that site personnel could see the topic name, description and select the topic that would be of most interest to them without the process being an overwhelming six-hour commitment.     I must emphasize that these informational programs do not replace GCP training. They are meant to supplement the basic understanding of ICH/GCP for investigators and their staff who are less experienced in clinical research. This product focuses on providing information on key operational areas of clinical research.  

MA: How were the topics of the informational programs identified?

TS:

We surveyed our current investigators and their staff and we asked them:

• When they started clinical research what they wished they had known?

• What were the best practices investigators felt would benefit from knowing?

• What was the biggest challenge in their roles? 

We managed to take the information from the surveys and we bucketed them into 11 key topics. This is not just for principal investigators, but also for less experienced study coordinators and research nurses around the world.   

MA: Will this initiative promote efficiency in teaching investigators on how to better operate in clinical research settings?

TS:

Yes, absolutely. Investigators can select informational programs they believed to be most meaningful to them, as they were optimized and tailored for less experienced investigators. The featured topics were developed with experienced investigators, which provides for refresher courses in important areas in a clinical research setting.