Senior Research Manager Interview Questions and Answers

Clinical study protocols of medical conducted in India follow the guidelines set by the Indian Council of Medical Research (ICMR).

• ICMR provides ethical guidelines for clinical research in India

• All clinical studies must be approved by the Institutional Ethics Committee (IEC)

• Informed consent from participants is mandatory

• Data confidentiality and privacy are strictly maintained

• Adverse events must be reported to the IEC and Drug Controller General of India (DCGI)

Sample size of clinical studies is calculated based on various factors.

• Sample size is determined based on the study design, research question, statistical power, effect size, and alpha level.

• The larger the sample size, the more reliable the results.

• Sample size calculation is important to ensure that the study has enough statistical power to detect a significant difference between groups.

• Various statistical software and online calculators are available to calculate sample size...read more

The insurance amount of a clinical trial is calculated based on various factors such as the number of participants, the type of trial, and the potential risks involved.

• The insurance amount is typically calculated by the sponsor or CRO of the trial

• Factors such as the number of participants, the type of trial, and the potential risks involved are taken into consideration

• The insurance amount may also depend on the location of the trial and the insurance requirements of the count...read more

PMCF of a medical device is conducted to evaluate its safety and performance in real-world use.

• PMCF stands for Post-Market Clinical Follow-up.

• It involves collecting data on the device's safety and performance in real-world use.

• The data is collected from patients, healthcare professionals, and other sources.

• PMCF is required by regulatory authorities to ensure the ongoing safety and effectiveness of the device.

• Examples of PMCF activities include patient surveys, clinical studie...read more

MDR came into effect on May 26, 2021.

• MDR stands for Medical Device Regulation.

• It replaced the previous Medical Device Directive (MDD).

• MDR aims to improve the safety and performance of medical devices.

• It applies to all medical devices sold in the European Union.

• The transition period for MDR implementation ended on May 26, 2021.