Effective_Trial_Management_Flashcards

What are the key learning outcomes of the Effective Clinical Trial Management course?

An overview of clinical trial conduct activities and the importance of patient adherence and retention.

What is participant accrual in clinical trials?

Accrual refers to the process of enrolling participants into a clinical trial.

Why is patient adherence important in clinical trials?

Adherence ensures that participants comply with the intervention and follow-up schedule, allowing researchers to collect reliable data.

What can be a consequence of poor retention in clinical trials?

Incomplete data sets, no study outcome, and inconclusive trial results.

What strategies can improve patient retention in trials?

Assessing potential risks pre-trial, involving PPI representatives, and ongoing communication and support for participants.

What is the purpose of trial monitoring?

To protect human subjects' rights, ensure trial data accuracy, and check compliance with the approved protocol and regulatory requirements.

What is an Independent Data Monitoring Committee (IDMC)?

A committee that assesses the progress of a clinical trial regarding safety and efficacy and makes recommendations to the sponsor.

What are some factors that affect participant retention?

Extra study visits, adverse events, toxicity, and burdens imposed on participants.

What does the Trial Steering Committee (TSC) do?

Provides independent oversight and safeguards the scientific integrity of a clinical trial.

When might an IDMC be necessary?

In trials involving life-threatening diseases, vulnerable populations, or when monitoring safety is crucial.