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

Clinical Trials: Overview01:11

Clinical Trials: Overview

5.1K
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...
5.1K
Clinical Trials01:16

Clinical Trials

10.9K
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...
10.9K
Preclinical Development: Overview01:28

Preclinical Development: Overview

6.1K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
6.1K
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

246
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...
246
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

289
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
289
Drug Regulation01:25

Drug Regulation

3.2K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
3.2K

You might also read

Related Articles

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

Sort by
Same author

Longitudinal plasma neurofilament light chain and patient-reported outcomes as complementary markers of vincristine-associated peripheral neuropathy in adults with lymphoma: a cohort study.

medRxiv : the preprint server for health sciences·2026
Same authorSame journal

The Role of Oncology Nurses in National Breast and Cervical Cancer Screening Programs.

Clinical journal of oncology nursing·2026
Same author

Integrating a Nurse Practitioner Into an Interprofessional Team to Optimize Care for People With Cancer and Substance Use Disorder.

Clinical journal of oncology nursing·2026
Same author

Safety and efficacy of peptide receptor radionuclide therapy in neuroendocrine tumors: A single center experience.

PloS one·2024
Same author

A retrospective cohort study describing chemotherapy-induced peripheral neuropathy in Non-Hodgkin lymphoma patients treated with EPOCH ± R: does HIV status matter?

Leukemia & lymphoma·2024
Same author

Stigma in Clinical Oncology.

Clinical journal of oncology nursing·2024

Related Experiment Video

Updated: Feb 22, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.4K

Clinical Trial Amendments: Development of a Process for Consistent Implementation
.

Gretchen A McNally1, Amanda K Hrnicek1, Hallie Barr1

  • 1Ohio State University Comprehensive Cancer Center-Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

Clinical Journal of Oncology Nursing
|September 26, 2017
PubMed
Summary

Clinical trial amendments are crucial for advancing cancer care. A new process at a major hospital ensures consistent communication and implementation, improving patient safety and research quality.

Keywords:
amendmentclinical trialsimplementationprocessprogram development

More Related Videos

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
06:18

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

3.8K
A GMP-Compliant Procedure for the Generation of Gene-Modified T cells
06:47

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells

Published on: October 6, 2023

1.0K

Related Experiment Videos

Last Updated: Feb 22, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.4K
Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
06:18

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

3.8K
A GMP-Compliant Procedure for the Generation of Gene-Modified T cells
06:47

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells

Published on: October 6, 2023

1.0K

Area of Science:

  • Oncology
  • Clinical Research Management

Background:

  • Clinical trials are essential for progress in cancer treatment.
  • Effective management of clinical trial amendments is vital for maintaining research integrity and patient safety.

Purpose of the Study:

  • To develop and implement a standardized process for managing clinical trial amendments.
  • To enhance communication and consistency in amendment implementation within a major academic cancer hospital.

Main Methods:

  • Formation of an interdepartmental work group.
  • Development of a systematic protocol for amendment communication and execution.
  • Implementation of the new process across relevant departments.

Main Results:

  • Consistent communication and implementation of clinical trial amendments achieved.
  • Improved patient safety protocols during clinical trials.
  • Enhanced overall quality of cancer research.

Conclusions:

  • A structured process for clinical trial amendments significantly improves patient safety and research quality.
  • Interdepartmental collaboration is key to successful implementation of research management strategies.