Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Ethical Dilemmas II01:30

Ethical Dilemmas II

1.7K
Resolving an ethical dilemma in healthcare involves a systematic approach that considers every aspect of the issue, respecting both the patient's needs and values and the healthcare professional's ethical obligations. Here are potential steps to resolve an ethical dilemma:
1.7K
Standards of Care II01:19

Standards of Care II

855
Nurses bear specific legal responsibilities under several federal statutes, including:
855
Standards of Care I01:22

Standards of Care I

881
Federal statutes profoundly impact nursing practice, providing critical guidelines to ensure patient care is equitable, accessible, and of the highest quality. The following laws address distinct aspects of healthcare provision and patient rights:
881
Clinical Trials: Overview01:11

Clinical Trials: Overview

4.0K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.0K
Clinical Trials01:16

Clinical Trials

9.9K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
9.9K
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

55
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
55

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

The theoretical understanding of risk perception and dual-method contraceptive decision-making among Texas adolescent and young adult cisgender females.

PloS one·2026
Same author

Beyond the Injury - Exploring the Foundations of Health-Related Quality of Life in Older Adults and Their Caregivers.

The Journal of surgical research·2026
Same author

"I Had No Idea about This:" A Mixed-Methods Exploration of Sexual Health and HIV Prevention Needs among Black Youth in a Southern City.

Adolescents (Basel, Switzerland)·2025
Same author

Enhancing Cardiovascular Health in Southeastern United States for Underrepresented Racial and Ethnic Minorities With HIV: A Qualitative Inquiry Using the Health Belief Model.

The Journal of the Association of Nurses in AIDS Care : JANAC·2025
Same author

Community-engaged adaptation and pilot testing of a mental health and substance use screening and referral process in HIV pre-exposure prophylaxis (PrEP) care in the Southern USA.

PLOS mental health·2025
Same author

Experiences of Resilience Among Newly Graduated Nurses Transitioning to Practice: A Nationwide Longitudinal Qualitative Study.

Nurse educator·2025
Same journal

Brief transdiagnostic cognitive behavioral therapy and expressive writing for hazardous drinking and posttraumatic stress symptoms among sexual and gender minority adults: Pilot trial protocol.

Contemporary clinical trials communications·2026
Same journal

Prehabilitation in lung cancer patients undergoing lung resection surgery (Fit4LungNeo): study protocol.

Contemporary clinical trials communications·2026
Same journal

Orforglipron for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity or overweight: Study design and baseline characteristics of ATTAIN-OSA, a phase 3 trial.

Contemporary clinical trials communications·2026
Same journal

Implementation science and the clinical trial workforce: A national needs assessment of training and practice.

Contemporary clinical trials communications·2026
Same journal

Understanding recruitment challenges in Swiss oncology trials: Patient voices from focus groups.

Contemporary clinical trials communications·2026
Same journal

Effectiveness of couple-based maternity education on husbands' involvement in maternity continuum of care service utilization in rural communities of Central Ethiopia: Protocol of cluster randomized controlled trial.

Contemporary clinical trials communications·2026
See all related articles

Related Experiment Video

Updated: Nov 5, 2025

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
14:43

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Published on: January 12, 2018

12.3K

Stakeholders' recommendations for revising Good Clinical Practice.

Amy Corneli1,2,3, Annemarie Forrest1, Teresa Swezey1,2

  • 1Clinical Trials Transformation Initiative, Duke University, Durham, NC, USA.

Contemporary Clinical Trials Communications
|May 17, 2021
PubMed
Summary
This summary is machine-generated.

Stakeholders identified key areas for revising International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. The Investigator and Sponsor sections, along with quality assurance and monitoring, need the most updates for better clinical trial conduct.

Keywords:
Clinical trialsEthicsGood clinical practiceICH E6 GCPRegulatoryStakeholders

More Related Videos

Author Spotlight: Evaluating Clinicians' Adoption of Ultrasound-Guided Vascular Cannulation Through Simulation Training
05:04

Author Spotlight: Evaluating Clinicians' Adoption of Ultrasound-Guided Vascular Cannulation Through Simulation Training

Published on: August 9, 2024

1.2K
Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting
06:16

Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting

Published on: June 6, 2020

4.0K

Related Experiment Videos

Last Updated: Nov 5, 2025

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
14:43

A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting

Published on: January 12, 2018

12.3K
Author Spotlight: Evaluating Clinicians' Adoption of Ultrasound-Guided Vascular Cannulation Through Simulation Training
05:04

Author Spotlight: Evaluating Clinicians' Adoption of Ultrasound-Guided Vascular Cannulation Through Simulation Training

Published on: August 9, 2024

1.2K
Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting
06:16

Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting

Published on: June 6, 2020

4.0K

Area of Science:

  • Clinical research regulation
  • Pharmaceutical development
  • Regulatory science

Background:

  • The International Council for Harmonisation (ICH) is updating its ICH E6 Good Clinical Practice (GCP) guidelines.
  • The Clinical Trials Transformation Initiative (CTTI) sought stakeholder input to inform these revisions.
  • Understanding stakeholder priorities is crucial for effective guideline updates.

Purpose of the Study:

  • To identify stakeholder priority areas and suggestions for revising ICH E6 GCP.
  • To determine which principles and sections of ICH E6 GCP stakeholders believe need revision.
  • To provide ICH with data-driven insights for their revision efforts.

Main Methods:

  • A global online survey was conducted to gather stakeholder opinions.
  • 327 stakeholders from diverse research roles and organizations participated.
  • Survey data analyzed to identify frequently mentioned areas for revision in ICH E6 GCP.

Main Results:

  • The Investigator (75%) and Sponsor (74%) sections were identified as needing the most revision.
  • Key principles needing revision include quality assurance, medical care provision, and data privacy.
  • Monitoring within the Sponsor section was the most frequently cited topic for revision (45%).

Conclusions:

  • While no single area was universally identified for revision, significant stakeholder consensus exists on specific areas.
  • Findings offer valuable insights for ICH to focus revision efforts on high-priority sections and topics.
  • The study highlights the importance of stakeholder engagement in regulatory guideline development for clinical trials.