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Pooled Resource Open-Access ALS Clinical Trials Database

Database Access Request Application.


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Terms and Conditions
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I request access to the common database created and maintained by the members of the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) Consortium (the “PRO-ACT Database”), a collection of institutions that have agreed to contribute data relating to ALS to the PRO-ACT Database for the purpose of scientific investigation, teaching, or the planning of clinical research studies.
I acknowledge and agree that each of the following institutions have either contributed data to the PRO-ACT Database and/or are members of the PRO-ACT Consortium: Neurological Clinical Research Institute at MGH, Northeast ALS Consortium, Novartis, Prize4Life Israel, Regeneron Pharmaceuticals, Inc., Sanofi, and Teva Pharmaceutical Industries, Ltd. (each a “Consortium Member” and collectively, the “Consortium Members”) and that Prize4Life Israel and its representatives will bear primary responsibility for overseeing access to and the usage of the PRO-ACT Database.
I also acknowledge that in the future additional institutions may contribute data to the PRO-ACT Database and that from and after such contribution, each of these institutions will be considered a Consortium Member for all purposes hereunder and that from and after such contribution the term “Consortium Members” will be read to include any institution that has contributed data to the PRO-ACT Database.
I do hereby agree with each of the Consortium Members to the following terms and conditions:
  1. I will not attempt to establish the identity of, or make contact with, any of the subjects.
  2. I will not disclose any of the data comprising the PRO-ACT Database unless such disclosure is made in accordance with these Terms and Conditions.
  3. I will not sell any of the data comprising the PRO-ACT Database or any portion of the data comprising the PRO-ACT Database unless pursuant to a separately negotiated licensing agreement with a Consortium Member.
  4. I will not share access to the PRO-ACT Database with anyone who has not signed this agreement and acknowledged the terms and conditions set forth herein.
  5. I will accurately provide any information requested by Prize4Life Israel regarding identification of persons who will use the data contained in the PRO-ACT Database and the purpose-of-use for this data.
  6. I will use appropriate safeguards to prevent use or disclosure of the data comprising the PRO-ACT Database and I will report any use or disclosure of the data comprising the PRO-ACT Database not provided for herein of which I become aware immediately upon becoming aware of such use or disclosure.
  7. I will comply with any relevant rules and regulations imposed by my institution and, if applicable, its institutional review board in requesting and using these data.
If I publish an abstract using data from the PRO-ACT Database, I agree to the following:
  1. I will cite the PRO-ACT Database as the source of the data.
  2. The PRO-ACT Consortium will not be cited in the authorship line of the abstract unless first agreed to in writing by a representative of the PRO-ACT Consortium.
If I publish a manuscript using data from the PRO-ACT Database, I agree to the following:
  1. On the author line of the manuscript, after the named authors, I will include the phrase "the Pooled Resource Open-Access ALS Clinical Trials Consortium*" with the asterisk referring to the following statement and list of names:

    *Data used in the preparation of this article were obtained from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) Database. As such, the following organizations and individuals within the PRO-ACT Consortium contributed to the design and implementation of the PRO-ACT Database and/or provided data, but did not participate in the analysis of the data or the writing of this report:

    • Neurological Clinical Research Institute, MGH
    • Northeast ALS Consortium
    • Novartis
    • Prize4Life Israel
    • Regeneron Pharmaceuticals, Inc.
    • Sanofi
    • Teva Pharmaceutical Industries, Ltd.

  2. I will include language similar to the following in the methods section of my manuscripts to accurately acknowledge data collection by the PRO-ACT Consortium. Depending upon the length and focus of the article, it may be appropriate to include more or less than the example below; however, inclusion of some variation of the language shown below is mandatory.

    "Data used in the preparation of this article were obtained from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) Database. In 2011, Prize4Life, in collaboration with the Northeast ALS Consortium, and with funding from the ALS Therapy Alliance, formed the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) Consortium. The data available in the PRO-ACT Database has been volunteered by PRO-ACT Consortium members."

  3. I will submit all manuscripts to Prize4Life Israel (to proact@Prize4Life.org) prior to submitting them to a journal. Prize4life Israel will review the author list and materials and methods to ensure compliance with articles 10 and 11 of these terms and conditions. Prize4Life Israel will maintain confidentiality of the manuscript and will complete its review within 3 business days of receipt.
  4. NO CONSORTIUM MEMBER MAKES ANY REPRESENTATION OR WARRANTY, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE WITH RESPECT TO THE PRO-ACTDATABASE OR THE DATA CONTAINED THEREIN.
  5. NO CONSORTIUM MEMBER, NOR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES SHALL HAVE ANY LIABILITY TO YOU AS A RESULT OF YOUR USE OF THE PRO-ACT DATABASE OR ANY OF THE DATA CONTAINED THEREIN (WHETHER AS A RESULT OF DIRECT, INDIRECT, INCIDENTIAL, SPECIAL, EXEMPLARY, PUNITIVE, CONSEQUENTIAL OR OTHER DAMAGES) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION WILL APPLY EVEN IF A CONSORTIUM MEMBER HAS BEEN ADVISED OF THE POSSIBLITY OF SUCH DAMAGE.
  6. BY ACCESSING THE PRO-ACT DATABASE YOU AGREE TO INDEMNIFY, DEFEND AND HOLD HARMLESS EACH CONSORTIUM MEMBER AND EACH OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, AGENTS AND AFFILIATES (EACH AN “INDEMNIFIED PARTY” AND COLLECTIVELY, THE “INDEMNIFIED PARTIES”), FROM AND AGAINST ANY AND ALL LIABILITIES, LOSSES, DAMAGES, COSTS AND EXPENSES (AND ALL LEGAL COSTS INCLUDING REASONABLE ATTORNEYS’ FEES, COURT COSTS, EXPENSES AND SETTLEMENTS RESULTING FROM ANY ACTION OR CLAIM) INCURRED BY, OR ASSERTED AGAINST ANY INDEMNIFIED PARTY ARISING FROM OR RELATING TO ANY CLAIM OR ACTION BROUGHT BY A THIRD PARTY THAT ARISES FROM OR RESULTS FROM YOUR USE OF THE PRO-ACT DATABASE AND/OR YOUR POSSESSION AND USE OF ANY DATA YOU OBTAINED FROM THE PRO-ACT DATABASE, WHETHER BY DOWNLOAD OR OTHERWISE. IF ANY SUCH CLAIM OR PROCEEDING ARISES, THE APPLICABLE INDEMNIFIED PARTY SHALL GIVE WRITTEN NOTICE OF THE CLAIM TO YOU PROMPTLY AFTER THE INDEMNIFIED PARTY RECEIVES NOTICE OF ITS EXISTENCE. YOU SHALL HAVE THE RIGHT, AT YOUR EXPENSE, TO EMPLOY COUNSEL TO DEFEND AGAINST THE CLAIM, AND TO COMPROMISE, SETTLE OR OTHERWISE DISPOSE OF THE CLAIM, ALL AT YOUR EXPENSE, PROVIDED THAT NO COMPROMISE OR SETTLEMENT OF ANY CLAIM ADMITTING LIABILITY OF OR IMPOSING DUTIES OR PERFORMANCE UPON ANY INDEMNIFIED PARTY MAY BE EFFECTED WITHOUT THE PRIOR WRITTEN CONSENT OF SUCH INDEMNIFIED PARTY. IF YOU DO NOT INITIATE EFFORTS TO DEFEND AGAINST OR RESIST THE CLAIM WITHIN THIRTY (30) DAYS AFTER RECEIVING NOTICE FROM ANY INDEMNIFIED PARTY, THE INDEMNIFIED PARTY SHALL BE FREE TO INVESTIGATE, DEFEND, COMPROMISE, SETTLE OR OTHERWISE DISPOSE OF THE CLAIM AND INCUR OTHER COSTS IN CONNECTION THEREWITH, FOR THE ACCOUNT AND AT THE EXPENSE OF YOU IN SUCH MANNER AS THE INDEMNIFIED PARTY DEEMS IN ITS BEST INTEREST.

IMPORTANT NOTE: The PRO-ACT Consortium will update and add additional data as it becomes available. I understand that any data that I downloaded in the past may not reflect the most current data in the database.

Finally, in the event that I download data from the PRO-ACT Database for the purposes of analysis and future publication in the form of abstracts and/or publications, I will note the date of data download, and I will check the database to determine if updated data have been provided prior to submission of any material for publication.

I understand that failure to abide by these terms and conditions may result in termination of my access to the PRO-ACT Database and constitute breach of contract and that I will be required to destroy any data previously downloaded and if requested by Prize4Life Israel or any other Consortium Member to provide reasonably satisfactory evidence of the same.

On June 23th 2014, Prize4Life has assigned all its rights and obligations under this Terms of Use to Prize4Life Israel. For those who accepted these terms prior to June 23th 2014, every reference to "Prize4Life" should be understood as Prize4Life Israel. Every reference to "Prize4Life" in this website should be understood as Prize4Life Israel.

I Agree:
I. Basic Login Information (for Access)
II. Applicant Information

III. Confirmation of validity of request
IV. Confirmation of Identity/Credibility/Affiliation
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