Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE Project.
REDCap
Regulatory compliance
SAE collection
SAE processing
SAE reporting
SUSAR
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
24 Jul 2024
24 Jul 2024
Historique:
received:
28
02
2024
accepted:
03
07
2024
medline:
24
7
2024
pubmed:
24
7
2024
entrez:
23
7
2024
Statut:
epublish
Résumé
It is essential that electronic data collection (EDC) systems are both compliant with regulations and the principles of Good Clinical Practice (GCP) to allow for the timely and accurate reporting of data including safety data. For clinical trials of investigational medicinal products (CTIMPs), investigators must immediately report to the sponsor any serious adverse event (SAE) that occurs in a site for which they are responsible. It is therefore expected that sponsors provide systems for timely review and reporting should a SAE be classified as a suspected unexpected serious adverse reaction (SUSAR). Challenges arise when data related to adverse events (AEs) needs to be re-entered for SAEs; this can be prone to error and may delay reporting. Additionally, recognising what has changed from an initial SAE report when an investigator responds to queries raised can cause errors. A multi-disciplinary working group came together from a UK academic clinical trials unit (CTU) to establish if an electronic system could be created in the unit's open-source EDC system-REDCap, to manage SAEs in an efficient way. A module has been created in REDCap to facilitate electronic SAE reporting: enabling an AE form to automatically trigger an SAE form for any AE which is also a SAE, prepopulating relevant fields of the SAE form, reducing the risk of delay and error when entering data into the SAE form. The system has also been developed with an embedded code to allow for instant visual recognition of any data updated following reporting to allow the sponsor to immediately review and resolve SAEs in a timely manner, complying with UK regulatory reporting. This functionality 'The eSAE Project' is now an active project for all of our new trials where data collection is undertaken using the REDCap system. The eSAE Project coded into REDCap offers a unique way of populating SAE forms with information already entered in the initial AE forms as applicable, coupled with highlighting any updates during the lifetime of the SAE for sponsors to identify any new information that needs to be reassessed to process and report the SAE.
Sections du résumé
BACKGROUND
BACKGROUND
It is essential that electronic data collection (EDC) systems are both compliant with regulations and the principles of Good Clinical Practice (GCP) to allow for the timely and accurate reporting of data including safety data. For clinical trials of investigational medicinal products (CTIMPs), investigators must immediately report to the sponsor any serious adverse event (SAE) that occurs in a site for which they are responsible. It is therefore expected that sponsors provide systems for timely review and reporting should a SAE be classified as a suspected unexpected serious adverse reaction (SUSAR). Challenges arise when data related to adverse events (AEs) needs to be re-entered for SAEs; this can be prone to error and may delay reporting. Additionally, recognising what has changed from an initial SAE report when an investigator responds to queries raised can cause errors.
METHOD
METHODS
A multi-disciplinary working group came together from a UK academic clinical trials unit (CTU) to establish if an electronic system could be created in the unit's open-source EDC system-REDCap, to manage SAEs in an efficient way.
RESULTS
RESULTS
A module has been created in REDCap to facilitate electronic SAE reporting: enabling an AE form to automatically trigger an SAE form for any AE which is also a SAE, prepopulating relevant fields of the SAE form, reducing the risk of delay and error when entering data into the SAE form. The system has also been developed with an embedded code to allow for instant visual recognition of any data updated following reporting to allow the sponsor to immediately review and resolve SAEs in a timely manner, complying with UK regulatory reporting. This functionality 'The eSAE Project' is now an active project for all of our new trials where data collection is undertaken using the REDCap system.
CONCLUSION
CONCLUSIONS
The eSAE Project coded into REDCap offers a unique way of populating SAE forms with information already entered in the initial AE forms as applicable, coupled with highlighting any updates during the lifetime of the SAE for sponsors to identify any new information that needs to be reassessed to process and report the SAE.
Identifiants
pubmed: 39044237
doi: 10.1186/s13063-024-08317-0
pii: 10.1186/s13063-024-08317-0
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
503Informations de copyright
© 2024. The Author(s).
Références
Sahoo U, Bhatt A. Electronic Data Capture (EDC) - a new mantra for clinical trials. Qual Assur. 2004;10(3–4):117–21.
doi: 10.1080/10529410390892052
Franklin JD, Guidry A, Brinkley JF. A partnership approach for electronic data capture in small-scale clinical trials. J Biomed Inform. 2011;44 Suppl 1(Suppl 1):S103–8.
doi: 10.1016/j.jbi.2011.05.008
pubmed: 21651992
Kuchinke W, et al. Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres. Trials. 2010;11:79.
doi: 10.1186/1745-6215-11-79
pubmed: 20663165
pmcid: 2918594
Harris PA, et al. Research Electronic Data Capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.
doi: 10.1016/j.jbi.2008.08.010
pubmed: 18929686
Harris PA, et al. The REDCap consortium: building an international community of software platform partners. J Biomed Inform. 2019;95:103208.
doi: 10.1016/j.jbi.2019.103208
pubmed: 31078660
pmcid: 7254481
Lobe M, Meineke F, Winter A. Scenarios for using OpenClinica in academic clinical trials. Stud Health Technol Inform. 2019;258:211–5.
pubmed: 30942748
Research Electronic Data Capture REDCap. Available from: https://www.project-redcap.org/ .
Shah J, et al. Electronic data capture for registries and clinical trials in orthopaedic surgery: open source versus commercial systems. Clin Orthop Relat Res. 2010;468(10):2664–71.
doi: 10.1007/s11999-010-1469-3
pubmed: 20635174
pmcid: 3049639
Inan OT, et al. Digitizing clinical trials NPJ Digit Med. 2020;3:101.
doi: 10.1038/s41746-020-0302-y
pubmed: 32821856
ICH harmonised guideline - Good Clinical Practice (GCP) E6(R3). 2023; Available from: https://database.ich.org/ .
Guideline on computerised systems and electronic data in clinical trials 2023; Available from: https://www.ema.europa.eu/en .
Lawrence CE, et al. A REDCap-based model for electronic consent (eConsent): moving toward a more personalized consent. J Clin Transl Sci. 2020;4(4):345–53.
doi: 10.1017/cts.2020.30
pubmed: 33244416
pmcid: 7681162
Cheng AC, et al. REDCap on FHIR: clinical data interoperability services. J Biomed Inform. 2021;121:103871.
doi: 10.1016/j.jbi.2021.103871
pubmed: 34298155
pmcid: 9217161
Harris PA, et al. The REDCap mobile application: a data collection platform for research in regions or situations with internet scarcity. JAMIA Open. 2021;4(3):ooab078.
doi: 10.1093/jamiaopen/ooab078
pubmed: 34527889
pmcid: 8435658
Harris PA, et al. MyCap: a flexible and configurable platform for mobilizing the participant voice. JAMIA Open. 2022;5(2):ooac047.
doi: 10.1093/jamiaopen/ooac047
pubmed: 35673353
pmcid: 9165428
London JW, et al. The automation of clinical trial serious adverse event reporting workflow. Clin Trials. 2009;6(5):446–54.
doi: 10.1177/1740774509344778
pubmed: 19737847
pmcid: 3088507