Clinical Research Software

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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trial master file

What is the difference between paper TMF and eTMF?

A Traditional Paper Master File (TMF) is a physical collection of documents that are used to store and manage important information related to a clinical trial. These documents are typically stored in binders or folders and are usually kept in a secure location, such as a study site or sponsor’s office. An Electronic Master File …

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Clinical Data Management: Basics for Freshers

This article is posted from https://www.linkedin.com/pulse/clinical-data-management-basics-freshers-pharmatech-life/ Clinical data management (CDM) is one of the most popular fields in clinical research. Many of the freshers and even experienced want to pursue clinical data management jobs. In the article on how to start a career in clinical data management, we discussed the groundwork and planning needed to start a …

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Behavioral Interview Questions and Sample Answers

Behavioral interview questions are a type of interview question that asks the candidate to provide specific examples of how they have handled certain situations in the past. These types of questions are designed to help the interviewer understand how the candidate thinks, reacts, and behaves in different situations, and how they would handle similar situations …

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Role-of-a-Clinical-Research-Associate

Clinical Research Associate: Roles & Responsibilities

Introduction Clinical research plays a pivotal role in advancing medical knowledge and patient care. At the heart of this process are Clinical Research Associates (CRAs), professionals who ensure the efficacy and safety of clinical trials. As the pharmaceutical and biotechnology industries expand, so does the demand for skilled CRAs. This blog aims to demystify the …

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Clinical Research Coordinator: Role and Responsibilities

Introduction The role of a Clinical Research Coordinator (CRC) is pivotal in the landscape of clinical trials and research. These professionals are primarily responsible for managing the daily operations of clinical studies, ensuring compliance with regulatory requirements, and maintaining high standards of care and accuracy. Key Responsibilities of a Clinical Research Coordinator A Day in …

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Top Guidance Tips for CLINICAL RESEARCH Freshers

Amaan Ansari COMPLETED B PHARM FROM NORTH MAHARASHTRA UNIVERSITY, HAVING 3.5+ YEARS OF EXPERIENCE IN CLINICAL DATA MANAGEMENTON A PERSONAL FRONT, I AM KEEN TO HELP AND GUIDE INDIVIDUALS IN CLINICAL DATA MANAGEMENT AND PHARMACOVIGILANCE.ALSO ON GENERAL ASPECTS SUCH AS COMMUNICATION SKILLS, INTERPERSONAL SKILLS, INTERVIEW TIPS, RESUME WRITING, EMAIL WRITING. This content is copied from Amaan …

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