Senior Clinical Research Associate Interview Questions and Answers

Protocol deviations are documented by thoroughly describing the deviation, its impact on the study, the reason for the deviation, and any corrective actions taken.

• Thoroughly describe the protocol deviation, including what happened and when it occurred

• Explain the impact of the deviation on the study, such as potential risks to subject safety or data integrity

• Provide the reason for the deviation, whether it was due to a mistake, unforeseen circumstances, or other factors

• Documen...read more

New changes in CT rules affect clinical research

• New CT rules require more transparency in clinical trial data

• Changes include mandatory registration of clinical trials and reporting of results

• CT rules also require informed consent from trial participants

• These changes aim to improve patient safety and ensure reliable data for drug approvals

Clinical research phases include preclinical, phase 1, phase 2, phase 3, and phase 4.

• Preclinical phase involves laboratory research and animal testing.

• Phase 1 involves testing the drug on a small group of healthy volunteers.

• Phase 2 involves testing the drug on a larger group of patients to determine efficacy and side effects.

• Phase 3 involves testing the drug on an even larger group of patients to confirm efficacy and monitor adverse reactions.

• Phase 4 involves post-marketing s...read more

Bispecific drugs are a type of medication designed to target two different molecules at the same time, often used in cancer treatment.

• Bispecific drugs can target two different antigens or receptors simultaneously, leading to enhanced efficacy and reduced side effects.

• Examples of bispecific drugs include blinatumomab, which targets CD19 and CD3 in the treatment of leukemia, and catumaxomab, which targets EpCAM and CD3 in the treatment of ovarian cancer.

• These drugs can redirect...read more