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

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

Different regulatory bodies oversee clinical research in various countries.

• FDA (Food and Drug Administration) in the United States

• EMA (European Medicines Agency) in Europe

• MHRA (Medicines and Healthcare products Regulatory Agency) in the UK

• Health Canada in Canada

• TGA (Therapeutic Goods Administration) in Australia

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