A4 Data Use Agreement
LONI | A4 Data Use Agreement
A4/LEARN Studies
PRE-RANDOMIZATION DATA USE AGREEMENT
I request access to pre-randomization study data collected by the Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4)/Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) Study for the purpose of scientific investigation, teaching or the planning of clinical research studies and agree to the following terms.
  1. I understand I am being granted a one-time, non-exclusive, non-transferable license for use of anonymized, participant-level data from the A4/LEARN study for the sole purpose of the request specified in the data use application form and for no other purpose.
  2. I will comply with all applicable federal, state and local laws and regulations relating to data protection and the privacy of participant health information. I will only receive access to de-identified data and will not attempt to establish the identity of, or attempt to contact any of the A4/LEARN participants. I will not combine study data with other sources of data that would lead to the identification of any participant. I will not attempt to make direct contact with A4/LEARN investigators or staff at sites concerning the specific results of individual participants.
  3. I will not further disclose these data beyond the uses outlined in this agreement and my data use application and understand that redistribution of data, beyond the permitted uses, in any manner is prohibited.
  4. I will require anyone on my team who utilizes these data to comply with this data use agreement and data use application.
  5. I will respond promptly and accurately to any requests to update this information.
  6. I will comply with any rules and regulations imposed by my institution and its institutional review board in requesting these data.
  7. I understand that this data use agreement applies only to A4/LEARN pre-randomization data.
  8. The data will not be used as part of a filing with a regulatory authority, whether for a marketing application or supplement or investigational drug application.

If I publish abstracts using pre-randomization data from A4/LEARN, I agree to the following:

  1. I will cite A4/LEARN as the source of data and the A4/LEARN funding sources in the abstract as space allows.

If I publish manuscripts using data from A4/LEARN pre-randomization data, I agree to the following:

  1. I will include the following acknowledgment statement:

    The A4 Study is a secondary prevention trial in preclinical Alzheimer's disease, aiming to slow cognitive decline associated with brain amyloid accumulation in clinically normal older individuals. The A4 Study is funded by a public-private-philanthropic partnership, including funding from the National Institutes of Health-National Institute on Aging, Eli Lilly and Company, Alzheimer's Association, Accelerating Medicines Partnership, GHR Foundation, an anonymous foundation and additional private donors, with in-kind support from Avid and Cogstate. The companion observational Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) Study is funded by the Alzheimer's Association and GHR Foundation. The A4 and LEARN Studies are led by Dr. Reisa Sperling at Brigham and Women's Hospital, Harvard Medical School and Dr. Paul Aisen at the Alzheimer's Therapeutic Research Institute (ATRI), University of Southern California. The A4 and LEARN Studies are coordinated by ATRI at the University of Southern California, and the data are made available through the Laboratory for Neuro Imaging at the University of Southern California. The participants screening for the A4 Study provided permission to share their de-identified data in order to advance the quest to find a successful treatment for Alzheimer's disease. We would like to acknowledge the dedication of all the participants, the site personnel, and all of the partnership team members who continue to make the A4 and LEARN Studies possible. The complete A4 Study Team list is available on: www.actcinfo.org/a4-study-team-lists.

  1. If I become aware of any use or disclosure of the data not provided for by this Agreement, I will report it within 48 hours of becoming aware of such use or disclosure.

In the event that I download data from the A4/LEARN database for the purposes of analysis and future publication in the form of abstracts and/or publications,

  1. I will note the version of the data I download, and I will check the database to determine if updated data has been provided prior to submission of any material for publication.
  2. I understand that the data may be updated over time due to ongoing quality assurance processes.

I understand that failure to abide by these guidelines will result in termination of my privileges to access the A4/LEARN pre-randomization data.

I Agree
I Disagree