Tag: clinical trials

Case Studies: Deviation Hotspots in Oncology, Rare Disease and Vaccine Trials

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Case Studies: Deviation Hotspots in Oncology, Rare Disease and Vaccine Trials Case Studies: Deviation Hotspots in Oncology, Rare Disease and Vaccine Trials Introduction to Protocol Deviations in Clinical Trials Clinical trials are essential for the development of new therapies and interventions. However, the occurrence of protocol deviations can impact the integrity and validity of trial…

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Common Deviation Patterns & Fixes

Mapping Deviation Patterns to CAPA and Process Redesign

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Mapping Deviation Patterns to CAPA and Process Redesign Mapping Deviation Patterns to CAPA and Process Redesign In the realm of clinical research, adherence to the protocol and regulatory requirements is paramount. Deviation from these established guidelines can lead to significant challenges, necessitating a Comprehensive Corrective and Preventive Action (CAPA) plan to address these issues. This…

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Common Deviation Patterns & Fixes

Integrating Publication Policies & Authorship Criteria With Data Privacy, GDPR and HIPAA Requirements

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Integrating Publication Policies & Authorship Criteria With Data Privacy, GDPR and HIPAA Requirements Integrating Publication Policies & Authorship Criteria With Data Privacy, GDPR and HIPAA Requirements Introduction In the realm of clinical trials, adherence to rigorous standards for publication policies and authorship criteria is paramount. This article serves as a comprehensive guide aimed at clinical…

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Publication Policies & Authorship Criteria

Vendor and Partner Oversight Considerations for Publication Policies & Authorship Criteria

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Vendor and Partner Oversight Considerations for Publication Policies & Authorship Criteria Vendor and Partner Oversight Considerations for Publication Policies & Authorship Criteria The landscape of clinical trials and their accompanying publication activities is essential for ensuring scientific integrity and regulatory compliance. For clinical operations, regulatory affairs, and medical affairs professionals, understanding the nuanced dynamics involved…

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Publication Policies & Authorship Criteria

Digital-First ICFs, Assent & Short Forms Strategies for Complex and Decentralized Trials

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Digital-First ICFs, Assent & Short Forms Strategies for Complex and Decentralized Trials Digital-First ICFs, Assent & Short Forms Strategies for Complex and Decentralized Trials The landscape of clinical trials is rapidly evolving, with an increasing emphasis on decentralized and complex trial designs. The incorporation of digital solutions is not merely complementary; it has become essential…

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ICFs, Assent & Short Forms

Using Trending Data to Identify Systemic Deviation Drivers

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Using Trending Data to Identify Systemic Deviation Drivers Using Trending Data to Identify Systemic Deviation Drivers Introduction to Systemic Deviation Drivers in Clinical Trials In the context of clinical trials, understanding and addressing protocol deviations is crucial for ensuring compliance with regulatory standards and maintaining the integrity of trial data. A protocol deviation refers to…

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Common Deviation Patterns & Fixes

Cross-Functional Workshops to Design Fixes for Recurrent Deviations

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Cross-Functional Workshops to Design Fixes for Recurrent Deviations Protocol deviations represent a significant challenge in clinical trials, impacting trial integrity and regulatory compliance. As clinical operations, regulatory affairs, and medical affairs professionals, it is essential to establish effective cross-functional workshops to address the recurrent deviations and enhance compliance with good clinical practice (GCP). This tutorial…

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Common Deviation Patterns & Fixes

KRIs, KPIs and Dashboards to Monitor Publication Policies & Authorship Criteria Across Portfolios

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KRIs, KPIs and Dashboards to Monitor Publication Policies & Authorship Criteria Across Portfolios KRIs, KPIs and Dashboards to Monitor Publication Policies & Authorship Criteria Across Portfolios Introduction to KPIs, KRIs, and Dashboards in Clinical Research Management In clinical research, especially in the realms governed by rigorous regulatory standards such as those from the FDA, EMA,…

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Publication Policies & Authorship Criteria

Case Studies: Publication Policies & Authorship Criteria That Strengthened Public and Regulator Trust

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Case Studies: Publication Policies & Authorship Criteria That Strengthened Public and Regulator Trust The increasing emphasis on clinical trial transparency is essential for enhancing public trust and regulatory confidence. The presence of robust publication policies and well-defined authorship criteria is instrumental in ensuring that both scientific integrity and ethical standards are maintained. This article will…

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Publication Policies & Authorship Criteria

Aligning ICFs, Assent & Short Forms With Protocol, SAP and Risk Management Frameworks

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Aligning ICFs, Assent & Short Forms With Protocol, SAP and Risk Management Frameworks Aligning ICFs, Assent & Short Forms With Protocol, SAP and Risk Management Frameworks In the sphere of clinical trials, ensuring compliance with regulatory standards while effectively communicating study information to participants is pivotal. This guide offers a structured approach for clinical research…

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ICFs, Assent & Short Forms