Clinical Research Trends

Regulatory Affairs-Interview Questions & Answers

Regulatory Affairs-Interview Questions & Answers

Regulatory Affairs in the Pharmaceutical industry is a profession that acts as the interface between the pharmaceutical industry and Drug Regulatory authorities across the world. It is mainly involved in the registration of the drug products in respective countries prior to their marketing. What are the goals of Regulatory Affairs Professionals? What are the Roles […]

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Risk-Based Monitoring

Centralized Monitoring/Risk-Based Monitoring

Centralized monitoring is a remote evaluation of the study data, carried out by a team including central monitors, and medical reviewers at a location other than the sites at which the clinical investigation is being conducted. The major difference between CRA monitor and centralized monitor is onsite monitoring and centralized monitoring respectively. Before you appear for

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Mastering the Art of Job Application Emails: 12 Templates and Tips

Mastering the Art of Job Application Emails: 12 Templates and Tips

In today’s competitive job market, standing out to potential employers is more crucial than ever. One of the first hurdles in the job application process is crafting an email that not only captures the attention of hiring managers but also convincingly conveys your suitability for the role. Whether you’re a recent graduate, a seasoned professional, or transitioning careers, mastering the art of the job application email is an essential skill. Below, we offer 12 customizable templates and invaluable tips to help you make a memorable first impression.

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Source documentation in clinical trials

We all have heard this saying “If it’s not documented, it didn’t happen” concerning clinical trials. But the question is for clinical trials what is to be documented and how? Today we will walk through insights about source documents in clinical research. Source means originality. Source documents are original documents, data, or records that are created during a clinical

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What is an Investigator Site File (ISF

What is an Investigator Site File (ISF)

In the context of clinical trials, ISF stands for “Investigator Site File,” which is a collection of documents and records that are maintained by the clinical trial site or investigator. The ISF contains all essential documents that demonstrate compliance with Good Clinical Practice (GCP) guidelines, applicable regulations, and study-specific protocols. The ISF binder is a

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What is a Trial Master File?

Electronic Trial Master File

Electronic trial master file (eTMF) is an electronic mode of collection of essential documents that allow the conduct of a clinical trial to be reconstructed and evaluated. It is the story of how the trial was conducted and managed. Management of essential trial documentation is undoubtedly one of the most time-consuming and costly activities associated with conducting a clinical trial. A

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Investigator Site File

What is an Investigator Site File (ISF)?

ISF plays a critical role in a study’s success. The investigator site file consists of trial documents from the initiation to closeout. Maintaining the site file is the responsibility of principal investigators. Principal investigators are doctors or any medical practitioner for a particular disease or indication. Principal Investigators have many responsibilities. They conduct clinical trials under

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