Tag: GCP compliance

Using External and Real-World Data to Inform Sample Size Planning

Posted on By digi

Using External and Real-World Data to Inform Sample Size Planning Effective sample size planning is crucial for the success of clinical trials, particularly when aiming to meet regulatory expectations from entities such as the FDA, EMA, and MHRA. This guide provides a step-by-step tutorial on how to leverage external and real-world data to inform sample…

Read More “Using External and Real-World Data to Inform Sample Size Planning” »

Sample Size & Power Calculations

CtQ in Decentralized and Digital Trials: What Changes and What Doesn’t

Posted on By digi

CtQ in Decentralized and Digital Trials: What Changes and What Doesn’t CtQ in Decentralized and Digital Trials: What Changes and What Doesn’t The landscape of clinical trials is rapidly evolving with the advent of decentralized and digital methodologies. As the industry adapts to these changes, understanding the Critical-to-Quality (CtQ) factors becomes essential. This article serves…

Read More “CtQ in Decentralized and Digital Trials: What Changes and What Doesn’t” »

Critical-to-Quality (CtQ) Factors

Documenting CtQ Rationale for Inspectors and Senior Leadership

Posted on By digi

Documenting CtQ Rationale for Inspectors and Senior Leadership Documenting CtQ Rationale for Inspectors and Senior Leadership The increasing complexity of clinical trials necessitates a precise understanding of Critical-to-Quality (CtQ) factors. As professionals in clinical operations, regulatory affairs, and medical affairs, understanding these elements is essential not only for compliance with regulations but also for enhancing…

Read More “Documenting CtQ Rationale for Inspectors and Senior Leadership” »

Critical-to-Quality (CtQ) Factors

Dynamic Fields, Skip Logic and Calculated Variables in Modern EDC

Posted on By digi

Dynamic Fields, Skip Logic and Calculated Variables in Modern EDC Dynamic Fields, Skip Logic and Calculated Variables in Modern EDC The utilization of Electronic Data Capture (EDC) systems has become imperative in the execution of worldwide clinical trials inc, enabling efficient data management and regulatory compliance. This guide aims to provide a detailed approach to…

Read More “Dynamic Fields, Skip Logic and Calculated Variables in Modern EDC” »

CRF/eCRF Design & Edit Checks

Reducing Free Text and Unstructured Fields to Improve Data Consistency

Posted on By digi

Reducing Free Text and Unstructured Fields to Improve Data Consistency Reducing Free Text and Unstructured Fields to Improve Data Consistency Data consistency is crucial for the integrity of clinical trials, particularly in environments that involve multiple stakeholders and data management systems. When conducting crm clinical trials, it is imperative to standardize data entry methods to…

Read More “Reducing Free Text and Unstructured Fields to Improve Data Consistency” »

CRF/eCRF Design & Edit Checks

Sample Size Strategies for DCT, Hybrid and Pragmatic Clinical Trials

Posted on By digi

Sample Size Strategies for DCT, Hybrid and Pragmatic Clinical Trials Sample Size Strategies for DCT, Hybrid and Pragmatic Clinical Trials In the evolving landscape of clinical research, innovative methodologies such as decentralized trials (DCT), hybrid trials, and pragmatic trial designs require precise strategies for sample size calculation. These trials differ in their execution and objectives,…

Read More “Sample Size Strategies for DCT, Hybrid and Pragmatic Clinical Trials” »

Sample Size & Power Calculations

Aligning CtQ Factors With KRIs, QTLs and Risk Controls

Posted on By digi

Aligning CtQ Factors With KRIs, QTLs and Risk Controls Aligning CtQ Factors With KRIs, QTLs and Risk Controls In the evolving landscape of clinical trials, ensuring the quality of data is paramount. This article presents a comprehensive guide designed for clinical operations, regulatory affairs, and medical affairs professionals engaged in managing electronic data capture in…

Read More “Aligning CtQ Factors With KRIs, QTLs and Risk Controls” »

Critical-to-Quality (CtQ) Factors

Cross-Functional Workshops to Define CtQ Factors That Matter

Posted on By digi

Cross-Functional Workshops to Define CtQ Factors That Matter Cross-Functional Workshops to Define Critical-to-Quality Factors In the complex landscape of clinical trials, particularly in the context of electronic data capture in clinical trials, defining Critical-to-Quality (CtQ) factors is essential for ensuring that clinical studies produce reliable and actionable results. This article provides a comprehensive step-by-step guide…

Read More “Cross-Functional Workshops to Define CtQ Factors That Matter” »

Critical-to-Quality (CtQ) Factors

Aligning CRF Design With CDISC Standards and Downstream Analysis

Posted on By digi

Aligning CRF Design With CDISC Standards and Downstream Analysis Aligning CRF Design With CDISC Standards and Downstream Analysis Clinical trials are vital to developing new medical therapies, requiring a precise and systematic approach to data capture and management. Accurate and compliant data collection forms the foundation of credible clinical trial results. This guide outlines a…

Read More “Aligning CRF Design With CDISC Standards and Downstream Analysis” »

CRF/eCRF Design & Edit Checks

Stakeholder Reviews: Getting Biostats, Safety and Sites Aligned on eCRFs

Posted on By digi

Stakeholder Reviews: Getting Biostats, Safety and Sites Aligned on eCRFs In the realm of clinical research, effective data management is crucial, especially when utilizing electronic data capture in clinical trials. One essential component of this process is the design and review of electronic case report forms (eCRFs). This article aims to provide a comprehensive step-by-step…

Read More “Stakeholder Reviews: Getting Biostats, Safety and Sites Aligned on eCRFs” »

CRF/eCRF Design & Edit Checks