Two of the biggest barriers to both clinical trial success and efficiency are slow study start-up times and issues with patient recruitment. That’s why getting your study teams off to the best possible start is crucial. A critical aspect of this is the relationship that is established with sites right at the beginning of the trial at the site initiation visit (SIV).
What is a site initiation visit?
The SIV is where the sponsor (often through Clinical Research Associates [CRAs]) ensures that the site team has everything it needs to commence the study. This includes making sure the site staff have been fully trained in – and understand – the trial protocol and their responsibilities in delivering it, as well as making sure the site is ready to start enrolling participants.
An SIV often covers the following aspects:
- Roles and responsibilities of the Principal Investigator (PI) and site team during the trial
- Training on the protocol, eligibility and withdrawal criteria, and endpoints
- Resourcing of the trial, including staffing levels and technology requirements
- Safety reporting and data management procedures
- A trial walkthrough from the participant’s perspective to ensure all study procedures are set up correctly
- Access to all systems that will be used for the trial
- Training on data handling and electronic systems
- Timings and requirements for monitoring visits
- Availability, storage, dispensing, destruction, and accountability for investigational drugs (or equivalent for other interventions)
Although a face-to-face SIV is the most common method for initiating participating sites, they may also be run jointly with investigator meetings, which provides an opportunity for study teams to come together with the sponsor or CRO to discuss the protocol. This is especially valuable for a complex study.
How can a site prepare for the SIV?
One of the most important aspects of preparing for an SIV is to ensure that the right people are in the room. It is mandatory for the PI to attend, but the SIV should involve all clinical research staff, plus those from supporting functions such as pharmacy, local labs, radiology, and so on.
Ideally, the SIV will be planned collaboratively between the PI and the sponsor, so that joint responsibility can be taken for ensuring that the site team is fully briefed and the SIV can be tailored to the site, taking into account their experience of running trials and unique expertise.
How can a site get more out of a SIV?
In our focus groups with site teams, they were firmly of the opinion that face-to-face investigator meetings are important for discussion and interactivity with peers. They told us that investigator meetings should be more focused and interactive, with key procedures and eligibility criteria covered in detail, and less time given to general training. Sites expressed a preference for being able to take some training online in advance, so that the face-to-face discussion time during the Investigator Meeting could be maximized.
The same can be said of SIVs, which are an opportunity for sites to discuss questions they have after reviewing all the study documents and completing essential training. To this end, it is critical that the CRA prepares and knows the SIV materials, as well as implementing time saving approaches where possible, to make most efficient use of investigator and site staff’s time.
One easy way to do this is to make use of online training modules that can be completed by site teams beforehand, as well as being a central resource for all study-related documentation, thus allowing more time for an interactive SIV session, or indeed reducing the time needed to complete the SIV altogether. This also frees up additional time which can be devoted to many other essential items on the SIV checklist, such as lab kit checks, completion of logs, and ensuring site staff have everything they need to run the trial.
Using engaging online training tools that can aid understanding of the protocol will not only be more effective at engaging site teams with a study, but will lead to fewer protocol deviations, cleaner data faster recruitment, and less time spent on resolving issues. Ultimately, this will result in faster study start-up and greater efficiencies throughout the study.