Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit
Background Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these ai...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Published: |
BioMed Central
2014
|
| Subjects: | |
| Online Access: | https://eprints.nottingham.ac.uk/31675/ |
| _version_ | 1848794250318184448 |
|---|---|
| author | Smith, Catrin Tudur Williamson, Paula Jones, Ashley Smyth, Alan R. Hewer, Simon Langton Gamble, Carrol |
| author_facet | Smith, Catrin Tudur Williamson, Paula Jones, Ashley Smyth, Alan R. Hewer, Simon Langton Gamble, Carrol |
| author_sort | Smith, Catrin Tudur |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Background
Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these aims, the variety of methods and lack of an empirical evidence base can present challenges for clinical trial practitioners.
Methods
This paper describes the monitoring methods and procedures that are utilised by a noncommercial clinical trials unit which coordinates a range of clinical trials across a variety of clinical areas with different associated risks.
Results
Monitoring activities and approaches should be selected to be proportionate to the risks identified within a trial. A risk-proportionate approach to monitoring is described giving details of methods that may be considered by clinical trial practitioners during the development of a trial monitoring plan. An example risk assessment and corresponding monitoring plan for a low risk (type A in the Medicines and Healthcare Products Regulatory Agency (MHRA) classification system) pediatric trial is provided for illustration.
Conclusion
We present ideas for developing a monitoring plan for a clinical trial of an investigational medicinal product based on our experience. Alternative approaches may be relevant or preferable in other settings based on inherent risk. |
| first_indexed | 2025-11-14T19:13:12Z |
| format | Article |
| id | nottingham-31675 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:13:12Z |
| publishDate | 2014 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-316752020-05-04T16:46:35Z https://eprints.nottingham.ac.uk/31675/ Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit Smith, Catrin Tudur Williamson, Paula Jones, Ashley Smyth, Alan R. Hewer, Simon Langton Gamble, Carrol Background Some level of monitoring is usually required during a clinical trial to protect the rights and safety of trial participants and to safeguard the quality and reliability of trial results. Although there is increasing support for the use of risk-proportionate approaches to achieve these aims, the variety of methods and lack of an empirical evidence base can present challenges for clinical trial practitioners. Methods This paper describes the monitoring methods and procedures that are utilised by a noncommercial clinical trials unit which coordinates a range of clinical trials across a variety of clinical areas with different associated risks. Results Monitoring activities and approaches should be selected to be proportionate to the risks identified within a trial. A risk-proportionate approach to monitoring is described giving details of methods that may be considered by clinical trial practitioners during the development of a trial monitoring plan. An example risk assessment and corresponding monitoring plan for a low risk (type A in the Medicines and Healthcare Products Regulatory Agency (MHRA) classification system) pediatric trial is provided for illustration. Conclusion We present ideas for developing a monitoring plan for a clinical trial of an investigational medicinal product based on our experience. Alternative approaches may be relevant or preferable in other settings based on inherent risk. BioMed Central 2014-04-16 Article PeerReviewed Smith, Catrin Tudur, Williamson, Paula, Jones, Ashley, Smyth, Alan R., Hewer, Simon Langton and Gamble, Carrol (2014) Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit. Trials, 15 (127). ISSN 1745-6215 Monitoring Central monitoring On-site monitoring Risk proportionate Quality assurance http://www.trialsjournal.com/content/15/1/127 doi:10.1186/1745-6215-15-127 doi:10.1186/1745-6215-15-127 |
| spellingShingle | Monitoring Central monitoring On-site monitoring Risk proportionate Quality assurance Smith, Catrin Tudur Williamson, Paula Jones, Ashley Smyth, Alan R. Hewer, Simon Langton Gamble, Carrol Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit |
| title | Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit |
| title_full | Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit |
| title_fullStr | Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit |
| title_full_unstemmed | Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit |
| title_short | Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit |
| title_sort | risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit |
| topic | Monitoring Central monitoring On-site monitoring Risk proportionate Quality assurance |
| url | https://eprints.nottingham.ac.uk/31675/ https://eprints.nottingham.ac.uk/31675/ https://eprints.nottingham.ac.uk/31675/ |