Sponsors face a challenge in ensuring that clinical trial training management is fit for purpose and that they can adequately keep track of site and staff training compliance. Current practice in training management solutions typically involves paper-based systems, which are both cumbersome to administer and make tracking training compliance difficult, particularly for pharma companies with a large study portfolio.

This complexity comes with risks and the inability to adequately track and report training compliance can result in a warning letter being issued by regulatory authorities.

As a result of a regulatory finding, a large pharma customer was looking for a solution that increased training compliance and provided comprehensive oversight of ongoing training.

A standard enterprise Learning Management System (LMS) used by companies to manage the training requirements for their internal staff seemed like a potential alternative to a paper-based system. However, this system was typically designed to support the business processes involved in internal training management only.

Clinical trial training has a unique set of requirements, such as training site staff who are not employees of the company, and are not usually supported by such a system.

The FIRECREST LMS was designed specifically for clinical trials. The single sign-on Site Portal that hosts the LMS makes it easier to deliver, track and report on site and staff training to ensure compliance and quality data.

Deploying FIRECREST provided the customer with oversight of protocol training compliance across all of its studies. This oversight resulted in an increase in training compliance from 73% to 94% in 6 months and helped the company close a warning letter with the FDA. FIRECREST continues to be used as a central location to report on all protocol training across the customer’s entire portfolio of studies.

Most recently, FIRECREST assisted a top 5 pharma company in launching and completing COVID-19 studies in record time.

Sponsors are required by regulatory guidance to demonstrate that they have selected investigators qualified by training and experience to conduct a trial. Site staff are also required to be familiar with the purpose of the study and the protocol, to be informed of any pertinent changes during the conduct of the trial and receive additional training as appropriate to remain compliant.

To support this requirement, a study team will typically provide site staff with training on the study protocol at the outset and provide additional training on any protocol amendments for the duration of the trial. The sponsor study team, or CRO on behalf of the sponsor, will also track completion of this training and maintain evidence of its completion.

Protocol training management is a significant burden for study teams. For example, a typical Phase 3 trial with multiple amendments requires tracking and maintaining records of training completion across hundreds of individual training sessions for thousands of site staff over several years and across multiple countries.

Prior to adopting FIRECREST to manage training across the company, the organisation’s typical training management process for clinical trials would have involved the following:

• The study team created the protocol training and any subsequent amendment training.
• The training was delivered by different individuals at multiple training sessions using a variety of different methods, including;
• Study team presentation at an Investigator meeting
• CRA presentation at Site Initiation Visit (SIV) or monitoring visits
• Principal Investigator’s presentation of study team material to site staff
• A member of the study team then collected a copy of the evidence of all training completions and recorded the completion in a central tracker such as a spreadsheet.
• The evidence of completion was then filed in the trial’s electronic Trial Master File (eTMF).

Challenges with this practice

Time consuming and resource heavy - At a study level, a study team may spend hundreds of hours ensuring that all training is adequately tracked and appropriate evidence is maintained.

Compliance - The manual method leaves it open to human error and is difficult to track training compliance.

Reporting - Using the current approach, it is almost impossible for a large organisation to report on protocol training data across an entire portfolio of studies.

Identifying the reasons for non-compliance, the first step in solving the problem.

The customer had received a warning letter from the US Food and Drug Administration (FDA) in relation to investigator non-compliance with the study protocol in the execution of its trials. As part of the root cause investigation, it was identified that protocol training compliance was only 73% across the customer’s portfolio of trials. It was also found that tracking training using paper training logs made it impossible to report on protocol training data across the portfolio of ongoing trials. Another key challenge identified was maintaining oversight of the quality of protocol training delivered to sites.

In response to the warning letter and to the Corrective and Preventive Actions (CAPA) that was issued as a result of these findings, the customer decided that they required a solution that would allow them to track and report on all protocol training activity across their entire portfolio of studies from one central location.

One potential solution explored by the customer was to use a standard enterprise LMS used by companies to manage the training requirements for internal staff. An LMS is typically deployed as follows:

• The LMS is linked to the customer’s people management system and obtains the employee’s role and job status, such as whether the employee is active or on leave.
• Training is centrally approved and uploaded to the LMS and marked with the roles that are required to take the training.
• An employee receives a notification that training is available.
• The employee can complete the training online and mark the training as complete if completed offline.

This type of LMS would enable the customer to centralise all training assignments in one location, track training completion, provide real time oversight of training compliance and report on training completion from one central location.

However, there were some significant challenges that this standard solution would not overcome. The primary challenge  management of user access. Clinical research site staff who require training are typically not employees of the sponsor and it is not practical to try and manage user access to an internal LMS for non- employees across a large portfolio of ongoing trials. In addition, an enterprise LMS is typically designed to support the business processes involved in internal training management, while clinical trial training has its own unique requirements that are not usually supported by a standard non-clinical system.

The next challenge the customer faced was how to implement the solution quickly across its portfolio of trials.

The customer decided that the FIRECREST LMS had all the features that were needed to improve compliance and enable improved oversight of training. Since the LMS is hosted on the single sign-on FIRECREST site portal, specially designed for clinical trials, it was a more suitable solution for the customer. The FIRECREST team capability to create high-quality, interactive, engaging and impactful protocol training could also be used to improve comprehension of the study protocol.

Step 1: Establishing governance
A governance structure was established which included key stakeholders from the customer, partner Clinical Research Organisations (CROs) and FIRECREST team to manage the implementation of the solution.

Step 2: Solution definition
The most appropriate solution for a trial, depending on the trial size, was identified. For Phase 1 trials performed at one research site it was agreed that the most suitable solution would be to facilitate tracking of protocol training performed at the site with no need for online training. For larger trials, the need for delivery of online training was identified as a key element of the solution. Trials most suitable to use FIRECREST-developed protocol training were also identified.

Step 3: Management of retrospective studies
Once a suitable solution was identified, the team needed to determine how to implement the solution retrospectively for trials that were ongoing for a number of years. This presented a challenge in cost terms because these trials had not budgeted for the FIRECREST solution. There were some initial difficulties working with the study teams because this was a new cost that would have to be absorbed. To address the challenge, the customer agreed to assign an umbrella budget to cover all ongoing studies. This worked well because it meant that the study teams did not have to bear the cost for FIRECREST from their existing budget and at the same time would experience the benefits of FIRECREST.

Step 4: Integration with the Clinical Trial Management System (CTMS)
A key element for success was to integrate the solution with the customer’s CTMS. This ensured that site staff would automatically be granted access to FIRECREST with the correct role and study. The integration also facilitated the daily feedback of training completion metrics on each study, which individual study teams could use to track protocol training compliance and ensure that their studies were hitting compliance targets.

Step 5: Training approval step
Another key challenge for the customer was to ensure that protocol training delivered to site staff was of the appropriate level and quality. A step was introduced into the solution to enable the study clinician to review and approve the training content for quality and relevance for delivery to the site. Study teams were also required to approve FIRECREST-developed protocol training when deployed.

Probably the biggest operational challenge at the beginning of the implementation process was overcoming the resistance of site staff to change current practices and the substantial effort involved in educating the study teams on the benefits of the solution and how to use it for their studies. In several studies, where existing systems were in place, site staff initially had to duplicate work and input the same training records into FIRECREST so there was substantial resistance to this in some centres. The team developed communications to outline the benefits of deploying FIRECREST and the necessity to ensure that all data was inputted with the ultimate goal of centralising training management.

Interactive and educational online sessions were conducted with key personnel identified as champions to encourage and motivate study staff to adopt FIRECREST. These were typically held twice a week during the first year after implementation to bring everyone up to speed with the system and to share the ultimate goals.

• A software development project team was deployed to work closely with the customer to implement new features and functionality that would further simplify and improve the solution to meet the customer’s goals and objectives.
• A tailored communications plan was put in place to maintain momentum, with regular governance meetings to review and address any challenges.
• Weekly data quality meetings were held to review any potential user issues and to discuss how these could be resolved as quickly as possible.

FIRECREST has empowered the customer to seamlessly manage all protocol training for site staff across more than 500 ongoing studies. At any point in time, the customer can review any individual’s training history and at the same time is ableto report fully on protocol training across all ongoing studies.