CRA Interview Questions and Answers

ICH GCP guidelines were updated in 2016 with an addendum in 2018.

• The updated guidelines emphasize risk-based approaches to clinical trial design and conduct.

• The addendum includes new sections on electronic records and essential documents, as well as clarification on sponsor responsibilities.

• The guidelines also address the use of electronic informed consent and the role of ethics committees.

• The updates aim to improve the quality and efficiency of clinical trials while ensuring...read more

SAE reporting involves timely and accurate submission of adverse event data to regulatory authorities.

• SAE reporting timelines vary depending on the severity of the event and the regulatory requirements

• In general, serious adverse events must be reported within 24-72 hours of becoming aware of the event

• SAE reporting process involves collecting and analyzing data, determining causality, and submitting reports to regulatory authorities

• SAE reports must include detailed information...read more

Phase refers to a distinct stage or step in a process or development.

• Phase is a specific period or step within a larger process or project.

• It helps to organize and structure the work.

• Examples include the phases of clinical trials, software development lifecycle, or project management phases.

New CT rules were implemented in 2019.

• The new rules aim to reduce radiation exposure during CT scans.

• They require facilities to record radiation doses and report any incidents.

• The rules also require facilities to have a quality control program in place.

• Patients should be informed about the risks and benefits of CT scans.

• The rules apply to all CT scans, including those for research purposes.

CRA plays a crucial role in ensuring compliance with protocols, regulations, and good clinical practices in clinical trials.

• Monitoring study sites to ensure protocol adherence

• Verifying data accuracy and integrity

• Ensuring patient safety and rights are protected

• Communicating with investigators and study staff

• Preparing and submitting regulatory documents

• Conducting site initiation, interim, and close-out visits