Site Infrastructure & Performance
This term refers to the physical facilities and human resources a site must have to run clinical trials.
What is site infrastructure?
Recruiting patients for a trial depends on this local statistical data about disease prevalence.
What is epidemiological data?
Sponsors often face these types of delays when waiting for site approvals.
What are regulatory delays?
Before selecting a site, sponsors should first clarify these foundational trial elements.
What are clinical trial objectives?
This policy-related factor can shift during a trial and disrupt access to care.
What is evolving healthcare policy?
Experienced personnel such as these two roles are essential for efficient trial operations.
Who are clinical trial coordinators and data managers?
This type of campaign, often using social media, can enhance recruitment success.
What is digital outreach?
This review board ensures ethical oversight of trials.
What is an Institutional Review Board or IRB?
Sites that also run many other trials simultaneously may suffer from this resource issue.
What is trial competition or resource overload?
Sponsors must watch for this problem when site staff don’t fully understand protocols.
What is inadequate site training?
A well-performing site should adhere to this global standard for ethics and data quality.
What is Good Clinical Practice or GCP?
Providing transportation and using mobile health apps are examples of this kind of strategy.
What is a participant engagement strategy?
In global trials, this barrier can lead to miscommunication between sites.
What is language barriers?
Budget overruns and delayed payments may be caused by weak systems in this site-related area.
What is financial management?
A poorly chosen site might produce this kind of unreliable data.
What is incomplete or low-quality data?
This system allows sites to digitally collect and manage clinical trial data.
What is Electronic Data Capture or EDC?
This three-part factor involves gaining, enrolling, and keeping patients in a study.
What is recruitment, retention, and adherence?
Sites must comply with these country-specific trial rules and procedures.
What are national regulatory guidelines?
This term describes how well a site can operate under budget constraints while maintaining trial quality.
What is financial stability or cost efficiency?
This logistical issue can make it difficult to get trial supplies to remote sites.
What is poor site location or limited transport access?
Sites must have this quality to manage multi-arm or multi-phase studies and adapt to changing protocols.
What is capacity and flexibility?
Name one challenge that may reduce patient adherence over time.
What is lack of communication, logistical issues, or complex treatment regimens?
Ethical site behavior is often assessed through this type of ongoing compliance monitoring.
What is auditing or regulatory monitoring?
Sponsors evaluate this to ensure a site can handle budgets, reimbursements, and contract agreements.
What is financial oversight infrastructure?
A site’s past success in similar trials is referred to by this term.
What is site experience or site reputation?