Central data monitoring of clinical trials: a survey of the UK clinical research collaboration (UKCRC) registered clinical trial units
Central data monitoring of clinical trials: a survey of the UK clinical research collaboration (UKCRC) registered clinical trial units
Background: central data monitoring involves activities performed by trial staff to improve the quality, integrity, and reliability of trial processes and data collection whilst a trial is open. The aim of this research was to determine the variation in activities conducted and the factors, roles and documentation involved across UKCRC registered clinical trials units (CTUs).
Methods: a survey asking about the central data monitoring activities conducted by trials units was sent to all UKCRC registered CTUs on 25th April 2025. We listed 16 central monitoring activities and asked about whether or not they were conducted on any, some or all trials and which staff role was responsible.
Results: responses were received from 63.5% (33/52) of CTUs) between until 5th June 2025. 8 of the 16 activities: protocol non-compliance, patient flow (e.g., CONSORT chart), recruitment versus predicted recruitment, eligibility issues, consent issues, data completeness for primary analysis, missing case report forms (CRFs), and data outliers, are conducted for all trials by at least 27/33 (81.8%) of the units and for some trials by all the trials units. 10/16 (62.5%) of the activities were done by a mixture of staff roles at the majority of units.
Conclusions: our survey shows the variety in the central data monitoring activities conducted by UKCRC CTUs and the variation as to who is conducting these activities. We recommend actions to improve the consistency and quality of monitoring in trials run by UKCRC-registered CTUs. When setting up new trials, CTUs should consider implementing the central data monitoring activities described, with particular emphasis on the eight activities undertaken by all units surveyed.
Central data monitoring, Clinical trials
Hurt, Chris
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Casbard, Angela
32e86c77-826c-44ae-b7c3-44680889a0aa
Kilburn, Lucy
df00b0c7-a52d-4241-97af-2ee1c20c08a5
Lazaroo, Michelle Jasmine
a3a9e757-5eb2-477f-b066-f0cd95ee328f
Masters, Lindsey
4429cea6-adc6-4581-bf84-6e9430ff7831
Haviland, Joanne
2cf81bd6-e1e3-49ed-a309-7867dfd7a899
Love, Sharon B.
310dcdee-7f96-404b-a50d-fefd5e82ba82
13 March 2026
Hurt, Chris
bf8b37a0-8f08-4b47-b3f3-6fc65f7ab87f
Casbard, Angela
32e86c77-826c-44ae-b7c3-44680889a0aa
Kilburn, Lucy
df00b0c7-a52d-4241-97af-2ee1c20c08a5
Lazaroo, Michelle Jasmine
a3a9e757-5eb2-477f-b066-f0cd95ee328f
Masters, Lindsey
4429cea6-adc6-4581-bf84-6e9430ff7831
Haviland, Joanne
2cf81bd6-e1e3-49ed-a309-7867dfd7a899
Love, Sharon B.
310dcdee-7f96-404b-a50d-fefd5e82ba82
Hurt, Chris, Casbard, Angela, Kilburn, Lucy, Lazaroo, Michelle Jasmine, Masters, Lindsey, Haviland, Joanne and Love, Sharon B.
(2026)
Central data monitoring of clinical trials: a survey of the UK clinical research collaboration (UKCRC) registered clinical trial units.
Contemporary Clinical Trials, 164, [108282].
(doi:10.1016/j.cct.2026.108282).
Abstract
Background: central data monitoring involves activities performed by trial staff to improve the quality, integrity, and reliability of trial processes and data collection whilst a trial is open. The aim of this research was to determine the variation in activities conducted and the factors, roles and documentation involved across UKCRC registered clinical trials units (CTUs).
Methods: a survey asking about the central data monitoring activities conducted by trials units was sent to all UKCRC registered CTUs on 25th April 2025. We listed 16 central monitoring activities and asked about whether or not they were conducted on any, some or all trials and which staff role was responsible.
Results: responses were received from 63.5% (33/52) of CTUs) between until 5th June 2025. 8 of the 16 activities: protocol non-compliance, patient flow (e.g., CONSORT chart), recruitment versus predicted recruitment, eligibility issues, consent issues, data completeness for primary analysis, missing case report forms (CRFs), and data outliers, are conducted for all trials by at least 27/33 (81.8%) of the units and for some trials by all the trials units. 10/16 (62.5%) of the activities were done by a mixture of staff roles at the majority of units.
Conclusions: our survey shows the variety in the central data monitoring activities conducted by UKCRC CTUs and the variation as to who is conducting these activities. We recommend actions to improve the consistency and quality of monitoring in trials run by UKCRC-registered CTUs. When setting up new trials, CTUs should consider implementing the central data monitoring activities described, with particular emphasis on the eight activities undertaken by all units surveyed.
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Accepted/In Press date: 8 March 2026
e-pub ahead of print date: 9 March 2026
Published date: 13 March 2026
Keywords:
Central data monitoring, Clinical trials
Identifiers
Local EPrints ID: 511344
URI: http://eprints.soton.ac.uk/id/eprint/511344
ISSN: 1551-7144
PURE UUID: fbac57de-ee5f-4934-b518-de91ab527e8e
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Date deposited: 12 May 2026 16:45
Last modified: 13 May 2026 02:09
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Contributors
Author:
Chris Hurt
Author:
Angela Casbard
Author:
Lucy Kilburn
Author:
Michelle Jasmine Lazaroo
Author:
Lindsey Masters
Author:
Joanne Haviland
Author:
Sharon B. Love
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