PMID- 35156002
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220501
IS  - 2574-2531 (Electronic)
IS  - 2574-2531 (Linking)
VI  - 5
IP  - 1
DP  - 2022 Apr
TI  - ATRI EDC: a novel cloud-native remote data capture system for large multicenter 
      Alzheimer's disease and Alzheimer's disease-related dementias clinical trails.
PG  - ooab119
LID - 10.1093/jamiaopen/ooab119 [doi]
LID - ooab119
AB  - OBJECTIVE: The Alzheimer's Therapeutic Research Institute (ATRI) developed a 
      novel clinical data management system, the ATRI electronic data capture system 
      (ATRI EDC), to address the complex regulatory, operational, and data requirements 
      that arise in the conduct of multicenter Alzheimer's disease and Alzheimer's 
      disease-related dementias (AD/ADRDs) clinical trials. We describe the system, its 
      utility, and the broader implications for the field of clinical trials and 
      clinical research informatics. MATERIALS AND METHODS: The ATRI EDC system was 
      developed, tested, and validated using community-based agile software development 
      methods and cloud-native single-page application design principles. It offers an 
      increasing number of application modules, supports a high degree of 
      study-specific configuration, and empowers study teams to effectively communicate 
      and collaborate on the accurate and timely completion of study activities. 
      RESULTS: To date, the ATRI EDC system supports 10 clinical studies, collecting 
      study data for 4596 participants. Three case descriptions further illustrate how 
      the system's capabilities support diverse study-specific requirements. 
      DISCUSSION: The ATRI EDC system has several advantages: its modular capabilities 
      can accommodate rapidly evolving research designs and technologies; its 
      community-based agile development approach and community-friendly licensing model 
      encourage collaboration per the principles of open science; finally, with 
      continued development and community building efforts, the system has the 
      potential to facilitate the effective conduct of clinical studies beyond the 
      field of AD/ADRD. CONCLUSION: By effectively addressing the requirements of 
      multicenter AD/ADRD studies, the ATRI EDC system supports ATRI's scientific 
      mission of rigorously testing new AD/ADRD therapies and facilitating the 
      effective conduct of multicenter clinical studies.
CI  - (c) The Author(s) 2022. Published by Oxford University Press on behalf of the 
      American Medical Informatics Association.
FAU - Jimenez-Maggiora, Gustavo A
AU  - Jimenez-Maggiora GA
AUID- ORCID: 0000-0001-9745-5121
AD  - Alzheimer's Therapeutic Research Institute, Department of Neurology, Keck School 
      of Medicine of USC, Los Angeles, California, USA.
FAU - Bruschi, Stefania
AU  - Bruschi S
AD  - Alzheimer's Therapeutic Research Institute, Department of Neurology, Keck School 
      of Medicine of USC, Los Angeles, California, USA.
FAU - Qiu, Hongmei
AU  - Qiu H
AD  - Alzheimer's Therapeutic Research Institute, Department of Neurology, Keck School 
      of Medicine of USC, Los Angeles, California, USA.
FAU - So, Jia-Shing
AU  - So JS
AD  - Alzheimer's Therapeutic Research Institute, Department of Neurology, Keck School 
      of Medicine of USC, Los Angeles, California, USA.
FAU - Aisen, Paul S
AU  - Aisen PS
AD  - Alzheimer's Therapeutic Research Institute, Department of Neurology, Keck School 
      of Medicine of USC, Los Angeles, California, USA.
LA  - eng
GR  - U24 AG057437/AG/NIA NIH HHS/United States
PT  - Journal Article
DEP - 20220117
PL  - United States
TA  - JAMIA Open
JT  - JAMIA open
JID - 101730643
EIN - JAMIA Open. 2022 Feb 24;5(1):ooac008. PMID: 35224459
PMC - PMC8826990
OTO - NOTNLM
OT  - Alzheimer disease
OT  - clinical research informatics
OT  - clinical trials
OT  - data management
OT  - remote electronic data capture
EDAT- 2022/02/15 06:00
MHDA- 2022/02/15 06:01
PMCR- 2022/01/17
CRDT- 2022/02/14 05:37
PHST- 2021/08/17 00:00 [received]
PHST- 2021/11/05 00:00 [revised]
PHST- 2021/12/31 00:00 [accepted]
PHST- 2022/02/14 05:37 [entrez]
PHST- 2022/02/15 06:00 [pubmed]
PHST- 2022/02/15 06:01 [medline]
PHST- 2022/01/17 00:00 [pmc-release]
AID - ooab119 [pii]
AID - 10.1093/jamiaopen/ooab119 [doi]
PST - epublish
SO  - JAMIA Open. 2022 Jan 17;5(1):ooab119. doi: 10.1093/jamiaopen/ooab119. eCollection 
      2022 Apr.