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

Types of Reports III: Telephone and Verbal Reports01:26

Types of Reports III: Telephone and Verbal Reports

871
Telephone and Verbal Reports in healthcare settings are two communication methods for conveying therapeutic instructions from healthcare providers to nurses or other healthcare staff.
Here's an overview of each type:
Telephone Orders
871
Pharmacovigilance01:19

Pharmacovigilance

1.4K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.4K
Types of Reports II: Incident or Occurrence Report01:21

Types of Reports II: Incident or Occurrence Report

1.0K
An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
1.0K
Methods of Documentation VI: Case Management Model01:15

Methods of Documentation VI: Case Management Model

695
The case management model is a multidisciplinary approach that involves healthcare professionals from diverse disciplines, such as physicians, nurses, therapists, social workers, and pharmacists, working collaboratively to address the various needs of patients. Each healthcare professional brings unique expertise and perspectives, contributing to a more comprehensive understanding of the patient's condition and tailoring treatment plans accordingly.
For example, a patient with a chronic...
695
Types of Reports I: Hands-off Report01:25

Types of Reports I: Hands-off Report

1.3K
A hand-off report, also known as a change-of-shift report, is a crucial nursing process that ensures the smooth transition of patient care responsibilities between nursing staff.
Following are the key components and categories of hand-off reports:
Purpose and Process:
1.3K
Data Validation01:15

Data Validation

383
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
383

You might also read

Related Articles

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

Sort by
Same author

Using Intervention Mapping to Codevelop Orchid, a Digital Tool for Reproductive Life Planning: Development and Feasibility Study.

JMIR human factors·2026
Same author

Gender norms and responsibility for preconception health improvement: challenges and recommendations for action from the 2024 UK preconception EMCR network conference.

Reproductive health·2026
Same author

Data Resource Profile: Maternity Services Dataset (MSDS).

International journal of population data science·2026
Same author

Evaluation of efficacy in prostate cancer contouring for MR-guided radiotherapy using structured contouring training modules.

Technical innovations & patient support in radiation oncology·2026
Same author

Reduction of crayfish activity and light avoidance in response to artificial light at night.

microPublication biology·2025
Same author

A pilot study investigating the acceptability and feasibility of a group intervention for parents of autistic young people with anorexia nervosa within a specialist eating disorders service.

Journal of eating disorders·2025
Same journal

Different Clinical Questions Need Different Estimands.

Therapeutic innovation & regulatory science·2026
Same journal

Medicinal Chemistry Perspectives on Drug Repurposing: Innovative Approaches and Therapeutic Breakthrough.

Therapeutic innovation & regulatory science·2026
Same journal

Understanding the Added Value of Action Limits for QTL Monitoring.

Therapeutic innovation & regulatory science·2026
Same journal

Implementing Project Optimus in Oncology Dosage Optimization: Where are We Now?

Therapeutic innovation & regulatory science·2026
Same journal

Validation of the Ontario Protocol Assessment Level (OPAL) Tool for Assessing Clinical Trial Complexity and Supporting Workforce Planning in the Italian Clinical Research Context.

Therapeutic innovation & regulatory science·2026
Same journal

The Effect of Covariate Adjustment for Cox Regression in Cardiovascular Outcome Trials.

Therapeutic innovation & regulatory science·2026
See all related articles

Related Experiment Video

Updated: Nov 11, 2025

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

Protocol Deviations: A Holistic Approach from Defining to Reporting.

Laura Galuchie1, Catherine Stewart2, Frank Meloni3

  • 1Global Clinical Trial Operations, Merck Research Laboratories, 126 East Lincoln Ave, Rahway, NJ, 07065, USA. laura.galuchie@merck.com.

Therapeutic Innovation & Regulatory Science
|March 30, 2021
PubMed
Summary
This summary is machine-generated.

Improving clinical trial efficiency involves better management of protocol deviations. TransCelerate developed a clear definition and a flexible, holistic approach to identify and manage these critical deviations effectively.

Keywords:
Issue managementProtocol deviation (PD)Quality Management System (QMS)Risk assessment categorization tool (RACT)Risk managementTransCelerate

More Related Videos

Improving IV Insulin Administration in a Community Hospital
12:08

Improving IV Insulin Administration in a Community Hospital

Published on: June 11, 2012

19.1K
Author Spotlight: Deciphering the Cognitive and Neural Mechanisms of Gesture in Communication
07:18

Author Spotlight: Deciphering the Cognitive and Neural Mechanisms of Gesture in Communication

Published on: January 26, 2024

1.1K

Related Experiment Videos

Last Updated: Nov 11, 2025

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
Improving IV Insulin Administration in a Community Hospital
12:08

Improving IV Insulin Administration in a Community Hospital

Published on: June 11, 2012

19.1K
Author Spotlight: Deciphering the Cognitive and Neural Mechanisms of Gesture in Communication
07:18

Author Spotlight: Deciphering the Cognitive and Neural Mechanisms of Gesture in Communication

Published on: January 26, 2024

1.1K

Area of Science:

  • Clinical trial management
  • Regulatory compliance
  • Pharmaceutical research

Background:

  • Inconsistent interpretation of guidelines complicates protocol deviation management.
  • Inefficient processes create noise, hindering the identification of critical deviations.

Purpose of the Study:

  • To enhance process efficiencies in clinical trials.
  • To reduce ambiguity in protocol deviation identification and management.
  • To establish consistent application of deviation management across studies.

Main Methods:

  • TransCelerate identified key principles for defining protocol deviations.
  • A holistic approach to protocol deviation management was developed.
  • The approach was designed for flexibility across various study types.

Main Results:

  • Clarified definition of a protocol deviation.
  • Developed a holistic and flexible management framework.
  • Supports consistent application within studies, programs, and organizations.

Conclusions:

  • Improved interpretation and management of protocol deviations increase efficiency.
  • The holistic approach aids in rapid identification of important deviations.
  • Flexible framework ensures broad applicability in clinical research.