Ich E6 (r2) - Gynecology

Relevant Publications

Determining the extent and frequency of on-site monitoring: a bayesian risk-based approach.

Issue Release: 2024

Bayesian Methods for Quality Tolerance Limit (QTL) Monitoring.

Issue Release: 2024

Developing generic templates to shape the future for conducting integrated research platform trials.

Issue Release: 2024

A low molecular weight dextran sulphate, ILB®, for the treatment of amyotrophic lateral sclerosis (ALS): An open-label, single-arm, single-centre, phase II trial.

Issue Release: 2024

A quality management system aiming to ensure regulatory-grade data quality in a glaucoma registry.

Issue Release: 2023

Quality Tolerance Limits\' Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters.

Issue Release: 2023

Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications.

Issue Release: 2023

ProFertil study protocol for the investigation of gonadotropin-releasing hormone agonists (GnRHa) during chemotherapy aiming at fertility protection of young women and teenagers with cancer in Sweden-a phase III randomised double-blinded placebo-controlled study.

Issue Release: 2023

Stakeholders\' views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2).

Issue Release: 2022

Impact of Monitoring Approaches on Data Quality in Clinical Trials.

Issue Release: 2022

The BRAVO Clinical Study Protocol: Oral Varespladib for Inhibition of Secretory Phospholipase A2 in the Treatment of Snakebite Envenoming.

Issue Release: 2022

Protocol for a prospective, international cohort study on the Management and Outcomes of Perioperative Care among European Diabetic Patients (MOPED).

Issue Release: 2021

Toolkit for ICH E6 (R2) Quality Risk Management for Small to Medium Size Companies.

Issue Release: 2020

Quality Tolerance Limits: Framework for Successful Implementation in Clinical Development.

Issue Release: 2020

Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development.

Issue Release: 2019

Risk based monitoring (RBM) tools for clinical trials: A systematic review.

Issue Release: 2016

International Council for Harmonisation E6(R2) addendum: Challenges of implementation.

Issue Release: 0000

What Causes Varicose Veins in the Pelvis?

Can the Due Date Change?

How Can I Reduce My Risk of Getting a Positive Result?

Why Are Fragrance-Free Detergents Important in Gynecology?

Why is Confidence Important for Patients?

How to Search for Gynecology Literature?

How is the Pelvic Type Diagnosed?

What is Epithelial Ovarian Cancer?

What Should You Expect During a Midwife Appointment?

How Does the FTA-ABS Test Compare to Other Syphilis Tests?

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