The PI is responsible for ensuring participant safety and well-being at the research site. The PI is responsible for ensuring participant safety and well-being at the research site.
Which two roles are central in conducting a clinical study under GCP? Which two roles are central in conducting a clinical study under GCP?
The sponsor is responsible for ensuring proper monitoring of the trial. The sponsor is responsible for ensuring proper monitoring of the trial.
A sponsor may transfer duties to a CRO but retains ultimate responsibility for data quality and integrity. A sponsor may transfer duties to a CRO but retains ultimate responsibility for data quality and integrity.
The PI retains ultimate oversight responsibility even when tasks are delegated. The PI retains ultimate oversight responsibility even when tasks are delegated.
Before a study begins, the PI must comply with IRB/IEC requirements and obtain approval. Before a study begins, the PI must comply with IRB/IEC requirements and obtain approval.
Research coordinator responsibilities may include: Research coordinator responsibilities may include:
QA staff may review protocols and monitoring reports to ensure issues are addressed. QA staff may review protocols and monitoring reports to ensure issues are addressed.
If a study is suspended or stopped early, who ensures participants receive appropriate follow-up? If a study is suspended or stopped early, who ensures participants receive appropriate follow-up?
