ADG International Interview Questions and Answers

Protocol, informed consent form, phases of clinical trials, phase 1 objective, and participants in clinical trials.

• Protocol is a detailed plan outlining the objectives, design, methodology, and conduct of a clinical trial.

• Informed consent form is a document that provides information about the trial to participants and ensures their voluntary participation.

• Clinical trials have different phases: Phase 1, Phase 2, Phase 3, and Phase 4.

• Phase 1 trials aim to evaluate the safety, d...read more

A data management plan is a document that outlines how data will be collected, organized, stored, and shared.

• A data management plan (DMP) is a formal document that describes the processes and procedures for managing data throughout its lifecycle.

• It includes details on data collection, storage, organization, documentation, sharing, and preservation.

• A DMP ensures that data is managed effectively, securely, and in compliance with relevant regulations and policies.

• Discrepancy man...read more

CDM starts in the data collection phase of clinical trials. Blinding is a method to reduce bias. There are different types of blinding.

• CDM starts in the data collection phase of clinical trials.

• Blinding is a method used to reduce bias in clinical trials.

• Blinding involves withholding information from participants, investigators, or both.

• Types of blinding include single-blind, double-blind, and triple-blind.

• In single-blind trials, participants are unaware of the treatment they ...read more

The phases in clinical data management are study setup, data collection, data cleaning, data analysis, and study closeout.

• Study setup involves designing the data collection forms, creating the database, and defining data validation rules.

• Data collection involves collecting the required data from various sources, such as electronic health records or patient surveys.

• Data cleaning involves reviewing the collected data for errors, inconsistencies, and missing values, and resolvin...read more

Adverse events are unexpected or harmful reactions that occur after exposure to a drug or medical intervention.

• Adverse events refer to any undesirable or unintended signs, symptoms, or diseases that occur after using a drug or medical intervention.

• These events can range from mild side effects to severe reactions.

• Serious Adverse Events (SAEs) are events that result in death, life-threatening situations, hospitalization, disability, or birth defects.

• SAEs can be related or unrel...read more

Clinical data management involves the collection, organization, and analysis of data from clinical trials and studies.

• It includes data collection, data entry, data cleaning, and data validation.

• Clinical data management ensures the accuracy, integrity, and quality of clinical data.

• It involves the use of electronic data capture (EDC) systems and standardized data management processes.

• Examples of clinical data include patient demographics, medical history, laboratory results, ad...read more

Preclinical trials are conducted to evaluate the safety and effectiveness of a drug or medical treatment before testing on humans.

• Preclinical trials are conducted on animals or in vitro to gather data on the potential effects of a drug or treatment.

• These trials help researchers understand the pharmacokinetics, pharmacodynamics, and toxicology of the drug.

• Data from preclinical trials is used to determine if a drug should proceed to clinical trials.

• Preclinical trials involve te...read more