Enabling FAIR data stewardship in complex international multi-site studies: Data Operations for the Accelerating Medicines Partnership® Schizophrenia Program

Tashrif Billah^#¹, Kang Ik K Cho^#¹, Owen Borders², Yoonho Chung^{3

4}, Michaela Ennis⁵, Grace R Jacobs¹, Einat Liebenthal^{3

4}, Daniel H Mathalon^{6

7}, Dheshan Mohandass², Spero C Nicholas^{6

7}, Ofer Pasternak^{1

2}, Nora Penzel², Habiballah Rahimi Eichi^{3

4}, Phillip Wolff⁸, Alan Anticevic^{9

10}, Kristen Laulette¹¹, Angela R Nunez^{9

10}, Zailyn Tamayo⁹, Kate Buccilli^{12

13}, Beau-Luke Colton^{12

13}, Dominic B Dwyer^{12

13}, Larry Hendricks^{12

13}, Hok Pan Yuen^{12

13}, Jessica Spark^{12

13}, Sophie Tod^{12

13}, Holly Carrington¹, Justine T Chen², Michael J Coleman¹, Cheryl M Corcoran¹⁴, Anastasia Haidar¹, Omar John², Sinead Kelly¹, Patricia J Marcy¹⁵, Priya Matneja¹⁵, Alessia McGowan¹⁴, Susan E Ray¹⁵, Simone Veale¹, Inge Winter-Van Rossum¹⁴, Jean Addington¹⁶, Kelly A Allott^{12

13}, Monica E Calkins¹⁷, Scott R Clark^{18

19}, Ruben C Gur¹⁷, Michael P Harms²⁰, Diana O Perkins²¹, Kosha Ruparel¹⁷, William S Stone²², John Torous²², Alison R Yung^{23

24}, Eirini Zoupou¹⁷, Paolo Fusar-Poli^{25

26}, Vijay A Mittal²⁷, Jai L Shah^{28

29}, Daniel H Wolf¹⁷, Guillermo Cecchi³⁰, Tina Kapur¹, Marek Kubicki^{1

2}, Kathryn Eve Lewandowski^{4

31}, Carrie E Bearden¹¹, Patrick D McGorry^{12

13}, René S Kahn¹⁴, John M Kane^{32

33}, Barnaby Nelson^{12

13}, Scott W Woods^{9

10}, Martha E Shenton^{1

2

34}; Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ); Justin T Baker^{3

4}, Sylvain Bouix^{35

36}

Affiliations

¹ Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
² Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
³ Institute for Technology in Psychiatry, McLean Hospital, Belmont, MA, USA.
⁴ Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
⁵ Harvard Medical School, Boston, MA, USA.
⁶ Department of Psychiatry and Behavioral Sciences and Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.
⁷ Mental Health Service 116D, Veterans Affairs San Francisco Health Care System, San Francisco, CA, USA.
⁸ Department of Psychology, Emory University, Atlanta, GA, USA.
⁹ Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
¹⁰ Connecticut Mental Health Center, New Haven, CT, USA.
¹¹ Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.
¹² Orygen, Parkville, VIC, Australia.
¹³ Centre for Youth Mental Health, The University of Melbourne, Parkville, VIC, Australia.
¹⁴ Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹⁵ Northwell Health, Glen Oaks, NY, USA.
¹⁶ Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
¹⁷ Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
¹⁸ The Discipline of Psychiatry, University of Adelaide, Adelaide, SA, Australia.
¹⁹ Basil Hetzel Institute, Woodville, SA, Australia.
²⁰ Washington University School of Medicine, St. Louis, MO, USA.
²¹ Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
²² Department of Psychiatry, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.
²³ Institute of Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, Geelong, VIC, Australia.
²⁴ School of Health Sciences, University of Manchester, Manchester, UK.
²⁵ Department of Psychosis Studies, King's College, London, UK.
²⁶ Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
²⁷ Department of Psychology, Northwestern University, Evanston, IL, USA.
²⁸ Douglas Research Centre, Montreal, QC, Canada.
²⁹ Department of Psychiatry, McGill University, Montreal, QC, Canada.
³⁰ IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.
³¹ Psychotic Disorders Division, McLean Hospital, Belmont, MA, USA.
³² Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
³³ Institute of Behavioral Science, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, USA.
³⁴ Department of Radiology, Brigham and Women's Hospital, Boston, MA, USA.
³⁵ Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. sylvain.bouix@etsmtl.ca.
³⁶ Department of Software Engineering and Information Technology, École de technologie supérieure, Montreal, QC, Canada. sylvain.bouix@etsmtl.ca.

^# Contributed equally.

PMID: 40180978
PMCID: PMC11968805
DOI: 10.1038/s41537-025-00560-x

Enabling FAIR data stewardship in complex international multi-site studies: Data Operations for the Accelerating Medicines Partnership® Schizophrenia Program

Tashrif Billah et al. Schizophrenia (Heidelb). 2025.

. 2025 Apr 3;11(1):55.

doi: 10.1038/s41537-025-00560-x.

Authors

Affiliations

¹ Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
² Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
³ Institute for Technology in Psychiatry, McLean Hospital, Belmont, MA, USA.
⁴ Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
⁵ Harvard Medical School, Boston, MA, USA.
⁶ Department of Psychiatry and Behavioral Sciences and Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA.
⁷ Mental Health Service 116D, Veterans Affairs San Francisco Health Care System, San Francisco, CA, USA.
⁸ Department of Psychology, Emory University, Atlanta, GA, USA.
⁹ Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
¹⁰ Connecticut Mental Health Center, New Haven, CT, USA.
¹¹ Department of Psychology, University of California Los Angeles, Los Angeles, CA, USA.
¹² Orygen, Parkville, VIC, Australia.
¹³ Centre for Youth Mental Health, The University of Melbourne, Parkville, VIC, Australia.
¹⁴ Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹⁵ Northwell Health, Glen Oaks, NY, USA.
¹⁶ Department of Psychiatry, Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.
¹⁷ Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
¹⁸ The Discipline of Psychiatry, University of Adelaide, Adelaide, SA, Australia.
¹⁹ Basil Hetzel Institute, Woodville, SA, Australia.
²⁰ Washington University School of Medicine, St. Louis, MO, USA.
²¹ Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
²² Department of Psychiatry, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.
²³ Institute of Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, Geelong, VIC, Australia.
²⁴ School of Health Sciences, University of Manchester, Manchester, UK.
²⁵ Department of Psychosis Studies, King's College, London, UK.
²⁶ Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
²⁷ Department of Psychology, Northwestern University, Evanston, IL, USA.
²⁸ Douglas Research Centre, Montreal, QC, Canada.
²⁹ Department of Psychiatry, McGill University, Montreal, QC, Canada.
³⁰ IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.
³¹ Psychotic Disorders Division, McLean Hospital, Belmont, MA, USA.
³² Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.
³³ Institute of Behavioral Science, Feinstein Institutes for Medical Research, Northwell Health, Manhasset, NY, USA.
³⁴ Department of Radiology, Brigham and Women's Hospital, Boston, MA, USA.
³⁵ Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. sylvain.bouix@etsmtl.ca.
³⁶ Department of Software Engineering and Information Technology, École de technologie supérieure, Montreal, QC, Canada. sylvain.bouix@etsmtl.ca.

^# Contributed equally.

PMID: 40180978
PMCID: PMC11968805
DOI: 10.1038/s41537-025-00560-x

Abstract

Modern research management, particularly for publicly funded studies, assumes a data governance model in which grantees are considered stewards rather than owners of important data sets. Thus, there is an expectation that collected data are shared as widely as possible with the general research community. This presents problems in complex studies that involve sensitive health information. The latter requires balancing participant privacy with the needs of the research community. Here, we report on the data operation ecosystem crafted for the Accelerating Medicines Partnership® Schizophrenia project, an international observational study of young individuals at clinical high risk for developing a psychotic disorder. We review data capture systems, data dictionaries, organization principles, data flow, security, quality control protocols, data visualization, monitoring, and dissemination through the NIMH Data Archive platform. We focus on the interconnectedness of these steps, where our goal is to design a seamless data flow and an alignment with the FAIR (Findability, Accessibility, Interoperability, and Reusability) principles while balancing local regulatory and ethical considerations. This process-oriented approach leverages automated pipelines for data flow to enhance data quality, speed, and collaboration, underscoring the project's contribution to advancing research practices involving multisite studies of sensitive mental health conditions. An important feature is the data's close-to-real-time quality assessment (QA) and quality control (QC). The focus on close-to-real-time QA/QC makes it possible for a subject to redo a testing session, as well as facilitate course corrections to prevent repeating errors in future data acquisition. Watch Dr. Sylvain Bouix discuss his work and this article: https://vimeo.com/1025555648 .

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Conflict of interest statement

Competing interests: A.A. is a cofounder, serves as a member of the Board of Directors, as a scientific adviser, and holds equity in Manifest Technologies, Inc.; and is a coinventor on the following patent: Anticevic A, Murray JD, Ji JL: Systems and Methods for NeuroBehavioral Relationships in Dimensional Geometric Embedding, PCT International Application No. PCT/US2119/022110, filed Mar 13, 2019. D.D. has received honorary funds for one educational seminar for CSL Sequiris. J.K. is consultant to, or receives honoraria and/or travel support and/or speakers bureau: Alkermes, Allergan, Boehringer-Ingelheim, Cerevel, Dainippon Sumitomo, H. Lundbeck, HealthRhythms, HLS Therapeutics, Indivior, Intracellular Therapies, Janssen Pharmaceutical, Johnson & Johnson, Karuna Therapeutics/Bristol Meyer-Squibb, L.B. Pharmaceuticals, Mapi, Maplight, Merck, Minerva, Neurocrine, Newron, Novartis, NW PharmaTech, Otsuka, Roche, Saladax, Sunovion, Teva. He is on the advisory boards of Alkermes, Boehringer-Ingelheim, Cerevel, Click Therapeutics, Karuna/BMS, Lundbeck, Merck, Newron, Novartis, Otsuka, Sumitomo, Teva, Terran. He receives grant support from Lundbeck, Janssen, Otsuka, Sunovion. He is a shareholder of Cerevel (public/stock), HealthRhythms (private/stock options), Karuna/BMS (public), L.B. Pharmaceuticals, Inc. (private/stock options), North Shore Therapeutics (private/stock), Vanguard Research Group (private/40% owner). P.F.P. has received research funds or personal fees from Lundbeck, Angelini, Menarini, Sunovion, Boehringer Ingelheim, Proxymm Science, Otsuka, outside the current study. P.J.M. has been a consultant for Otsuka and TEVA. R.S.K. has been consulting for Alkermes, Boehringer-Ingelheim. S.W.W. has received speaking fees from the American Psychiatric Association and from Medscape Features. He has been granted US patent no. 8492418 B2 for a method of treating prodromal schizophrenia with glycine agonizts. He owns stock in N.W. PharmaTech. J.T. is advisor to Precision Mental Wellness. Research support from Otsuka. K.A. is on the CIAS Advisory Board for Boehringer Ingelheim. Z.T. is a consultant for Manifest Technologies. All other authors declare no Competing Financial or Non-Financial Interests.

Figures

**Fig. 1. Diagram of the AMP SCZ data management system and flow.**
Data are captured, aggregated and de-identified within each research network before being transferred for processing and curation to the DPACC.

**Fig. 2**
The PHOENIX directory structure categorizing multimodal data depending on whether they contain sensitive information.

**Fig. 3. EEG quality checking tool.**
Raters are presented with a set of charts (e.g., line noise and response measures), which inform the QC rating captured in the application.

**Fig. 4**
Total number of form data variables received over time.

See this image and copyright information in PMC

References

1. Fusar-Poli, P. et al. Heterogeneity of psychosis risk within individuals at clinical high risk: a meta-analytical stratification. JAMA Psychiatry73, 113–120 (2016). - DOI - PubMed
1. Salazar de Pablo, G. et al. Longitudinal outcome of attenuated positive symptoms, negative symptoms, functioning and remission in people at clinical high risk for psychosis: a meta-analysis. EClinicalMedicine36, 100909 (2021). - DOI - PMC - PubMed
1. Salazar de Pablo, G. et al. Probability of transition to psychosis in individuals at clinical high risk: an updated meta-analysis. JAMA Psychiatry78, 970–978 (2021). - DOI - PMC - PubMed
1. Addington, J. et al. Sample Ascertainment and Clinical Outcome Measures in the Accelerating Medicines Partnership® Schizophrenia Program. Schizophrenia10.1038/s41537-025-00556-7 (2025). - PMC - PubMed
1. Mathalon, D. et al. The Electroencephalography Protocol for the Accelerating Medicines Partnership® Schizophrenia Program: Reliability and Stability of Measures. Schizophrenia10.1038/s41537-025-00607-z (2025).

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Enabling FAIR data stewardship in complex international multi-site studies: Data Operations for the Accelerating Medicines Partnership® Schizophrenia Program

Affiliations

Enabling FAIR data stewardship in complex international multi-site studies: Data Operations for the Accelerating Medicines Partnership® Schizophrenia Program

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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