Author: digi

Causality Re-Assessment After Unblinding in Clinical Trials

September 19, 2025

Causality Re-Assessment After Unblinding in Clinical Trials Re-Assessing Causality of Adverse Events After Trial Unblinding Introduction: Why Causality Must Be Revisited After Unblinding In blinded clinical trials, investigators and sponsors assess adverse event (AE) causality without knowing whether a participant received the investigational product (IP), placebo, or comparator. While this preserves study integrity, it also…

Adverse Event Reporting and Management, Causality and Severity Assessments

Case Studies on Developing eLearning Modules for Site Staff and CAPA Solutions

September 19, 2025

digi

Case Studies on Developing eLearning Modules for Site Staff and CAPA Solutions Building Effective eLearning Modules for Site Staff: Global Case Studies and CAPA Insights Introduction As clinical trials grow in complexity, the need for consistent, scalable, and regulatorily compliant training has led to the rise of eLearning modules for investigator site staff. Unlike traditional…

Remote Monitoring and Virtual Visits, Remote Site Training

The Role of NIH in Funding Clinical Trials in the United States

September 19, 2025

digi

The Role of NIH in Funding Clinical Trials in the United States Understanding the NIH’s Role in Supporting Clinical Trial Funding in the U.S. Introduction The National Institutes of Health (NIH) is the largest public funder of biomedical research in the world, playing a central role in advancing clinical trials across the United States. Through…

Clinical Trials in USA, Country-Specific Clinical Trials

SOP for Sample Retention and Destruction

September 19, 2025

digi

SOP for Sample Retention and Destruction { “@context”: “https://schema.org”, “@type”: “Article”, “mainEntityOfPage”: { “@type”: “WebPage”, “@id”: “https://www.clinicalstudies.in/sop-for-sample-retention-and-destruction” }, “headline”: “SOP for Sample Retention and Destruction”, “description”: “This SOP defines procedures for the retention and destruction of biological samples collected in clinical trials, in compliance with FDA, EMA, CDSCO, WHO, and ICH GCP requirements. It includes…

Global SOPs (Applicable to all Agencies), SOP for GCP

Role of PI in Site Success and Trial Quality

September 19, 2025

digi

Role of PI in Site Success and Trial Quality Principal Investigator’s Role in Driving Site Success and Trial Quality Introduction: The Central Role of the PI in Clinical Research Success The Principal Investigator (PI) is more than a figurehead in clinical trials—they are the operational anchor for site success, trial integrity, and patient safety. Regulatory…

PI (Principal Investigator) Experience Evaluation, Study Feasibility and Site Selection

Compliance Playbook – Virtual Onboarding Programs for Sites

September 19, 2025

digi

Compliance Playbook – Virtual Onboarding Programs for Sites Implementing Compliant Virtual Onboarding Programs for Clinical Trial Sites Why Virtual Onboarding Programs Are Now Critical in Remote Trials As clinical trials increasingly shift toward hybrid and decentralized models, site onboarding has also evolved. Traditional in-person site initiation visits (SIVs) are being replaced or supplemented with virtual…

Remote Monitoring and Virtual Visits, Remote Site Training

Predicting Regulatory Audit Findings Using Risk Assessment Models

September 19, 2025

digi

Predicting Regulatory Audit Findings Using Risk Assessment Models Using Risk Assessment Models to Predict Regulatory Audit Findings Introduction: The Role of Risk Prediction in Regulatory Audits Regulatory inspections are traditionally reactive, highlighting compliance deficiencies after they occur. However, with increasing complexity in clinical trials, sponsors and CROs are turning to risk assessment models to proactively…

Case Studies & Trends in Audit Findings, Regulatory Audit Findings

Training Investigators on Causality Judgments in Clinical Trials

September 19, 2025

digi

Training Investigators on Causality Judgments in Clinical Trials How to Train Investigators on Causality Judgments in Clinical Trials Introduction: Why Training on Causality Is Essential In clinical trials, the causality judgment—deciding whether an adverse event (AE) is related to an investigational product (IP)—is one of the most critical responsibilities of investigators. Regulators including the FDA,…

Adverse Event Reporting and Management, Causality and Severity Assessments

Scoring and Evaluating Readiness Drill Outcomes for Clinical Trial Inspections

September 19, 2025

digi

Scoring and Evaluating Readiness Drill Outcomes for Clinical Trial Inspections How to Score and Evaluate Readiness Drill Outcomes for GCP Inspections Introduction: Why Scoring Matters in Mock Inspection Drills Mock inspections are not just practice sessions—they are performance assessments that help teams identify gaps in regulatory compliance. Without a defined scoring or evaluation system, it…

Audit Trails and Inspection Readiness, Mock Inspections and Readiness Drills

Pediatric Clinical Trials and FDA PREA Requirements in the United States

September 19, 2025

digi

Pediatric Clinical Trials and FDA PREA Requirements in the United States Conducting Pediatric Clinical Trials in the U.S.: Navigating FDA PREA Requirements Introduction Pediatric clinical trials present unique ethical, scientific, and regulatory challenges. To address historical gaps in pediatric drug development, the U.S. Congress enacted the Pediatric Research Equity Act (PREA) in 2003, requiring sponsors…

Clinical Trials in USA, Country-Specific Clinical Trials