Nadig Consulting 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

Hypothesis testing is a statistical method used to determine if there is enough evidence to support or reject a hypothesis.

• It involves formulating a null hypothesis and an alternative hypothesis

• Data is collected and analyzed to determine the probability of obtaining the observed results if the null hypothesis is true

• If the probability is low, the null hypothesis is rejected in favor of the alternative hypothesis

• Examples include testing a new drug's effectiveness, determining ...read more