Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial.
Independent Data Monitoring Committee
Monitoring
Non-regulated trial
Journal
HRB open research
ISSN: 2515-4826
Titre abrégé: HRB Open Res
Pays: Ireland
ID NLM: 101754913
Informations de publication
Date de publication:
2023
2023
Historique:
accepted:
04
12
2023
medline:
17
9
2024
pubmed:
17
9
2024
entrez:
16
9
2024
Statut:
epublish
Résumé
Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ' This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James's Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit. The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date. This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial. ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019.
Sections du résumé
Background
UNASSIGNED
Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the '
Methods
UNASSIGNED
This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James's Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit.
Results
UNASSIGNED
The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date.
Conclusion
UNASSIGNED
This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial.
Registration
UNASSIGNED
ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019.
Identifiants
pubmed: 39280895
doi: 10.12688/hrbopenres.13763.2
pmc: PMC11401978
doi:
Banques de données
ClinicalTrials.gov
['NCT03958019']
Types de publication
Journal Article
Langues
eng
Pagination
46Informations de copyright
Copyright: © 2023 O'Neill L et al.
Déclaration de conflit d'intérêts
No competing interests were disclosed.