Study training is a high-stakes process. Missing study training documentation can lead to critical
inspection findings, resulting in commercialization delays and lost revenue. The potential cost of
receiving an FDA Form 483 can easily top $250,000.
Recent FDA warning letters reveal various study training-related challenges at sites, including:
- Role training
The investigator and sub-investigators needed
more training on study roles and compliance
with the delegated tasks. - SOP training
The investigator and other clinical research
personnel needed training on applicable SOPs. - Process training
The investigator failed to ensure that study
participants met protocol-required inclusion
criteria and needed to facilitate training on
additional SOPs and internal processes. - Documentation training
Site staff needed training on proper
documentation according to Attributable,
Legible, Contemporaneous, Original, Accurate,
and Complete (ALCOAC) guidelines.
However, sponsors and CROs can implement processes to mitigate these risks and improve the
study training they deliver to sites. This guide will assess the regulatory landscape and share tips
to streamline and improve site training.
Reduce SIV training time and increase efficiency
In addition to its regulatory implications, study training represents a large hidden cost during
clinical trials.
For the average Phase 2 study with 40 sites, site initiation visits (SIVs) cost upward of $140,000 —
assuming $3,500 per SIV. It costs an additional $900 on average to train each internal study
team member. This means that study training costs more than $200,000 per study, assuming
that everyone completes training once and correctly. With retraining, study training costs
$350,000 per Phase 2 study.1
In particular, improving SIVs can help sponsors and CROs start on the right foot with sites.
Companies can reduce study training costs by administering study training, including protocol
training, ahead of the SIV via a purpose-built learning management system (LMS). Picture a scenario
in which site staff are gathered in a room, reviewing a PowerPoint presentation with screenshots
of each section of the protocol. Then imagine replacing that with an interactive package of online
materials, including a video overview of the compound and a quiz on the protocol.
The latter is more effective and efficient, enabling
clinical research associates (CRAs) to spend less
time on-site administering training. Instead, they
can focus on higher-value activities such as:
- Answering PI questions on the protocol
or dosing - Reviewing enrollment criteria
- Building relationships with site staff
Within the purpose-built LMS, CRAs can also
easily record proof of completion in a compliant
manner. This saves time during the SIV that would
otherwise be spent gathering paper signatures.
An LMS also makes it easier to account for
training of site staff who miss the SIV.
These incremental changes add up. If the sponsor
or CRO can shorten the SIV from two days to one
with this approach, they can cut the costs of site
training in half.
Support sites throughout the study
Sponsors and CROs can similarly improve site study training throughout the course
of a trial, better engaging sites in conduct and closeout.
One large biopharma currently uses non-purpose-built systems to deliver training
to sponsor and site users. The biopharma’s clinical systems implementation
director notes that the systems frustrate users: “The systems weren’t originally
built to support protocol training, and users find the systems to be cumbersome
and time-consuming.”
They are looking to replace these systems with a purpose-built solution to improve
study training, curriculum structure, and user satisfaction.
Increase study training effectiveness
with microlearning
Sponsors and CROs can also increase the effectiveness of study training by implementing
microlearning methods.
Microlearning improves learner interaction and knowledge retention with shorter, focused, more
compelling content delivered through channels like video. It compliments macrolearning, which
typically deals with larger, more complex skill areas.
Two key characteristics of microlearning are brevity and specificity. A microlearning experience:
- Has a single, well-defined learning objective
- Focuses on a discrete task, skill, or topic
- Typically takes less than 15 minutes for a learner to complete
For example, this could include a two-minute video overview of a study’s compound. The benefits
are clear: Studies show that microlearning results in 85% higher sustained knowledge, especially
when used after long-form training.
Here are some practical ways to apply microlearning techniques to more effectively train
site staff:
Before and after the SIV, sponsors and CROs can supplement on-site time with microlearning
opportunities. This ultimately improves compliance and reduces the risk of protocol deviations,
which leads to better patient safety and less retraining.
More effective training will also improve working relationships with sites and enable sponsors
to become a site’s sponsor-of-choice.
Learn how you can increase your organization’s study training efficiency and effectiveness with Vault Study Training.
1Internal analysis, Veeva Systems, June 2024.