E6(r2): Good Clinical Practice - Cancer Science

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Bayesian Methods for Quality Tolerance Limit (QTL) Monitoring.

Issue Release: 2024

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

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Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery (EFISS): a study protocol of two-arm, randomised trial.

Issue Release: 2023

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials.

Issue Release: 2023

The revamped Good Clinical Practice E6(R3) guideline: Profound changes in principles and practice!

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

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

Issue Release: 2021

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

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

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