For accessing CPTR data:

Terms and Conditions

I request access to data collected by the Critical Path to TB Drug Regimens (CPTR) Regulatory Science Consortium for the purpose of scientific investigation, teaching or the planning of clinical research studies and agree 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 these data beyond the use(s) specifically outlined in this application.
3. I will require anyone with whom I share these data to comply with the terms and conditions of this data use agreement.
4. I will accurately provide any information requested regarding persons who will use these data and the analyses that are planned using these data.
5. I will comply with any rules and regulations imposed by my institution and its institutional review board in requesting and using these data.
6. I will not sell any of the data comprising the CPTR Database or any portion of the data comprising the CPTR Database unless pursuant to a separately negotiated licensing agreement with a Consortium Member.

If I publish abstracts using data from the CPTR Database, I agree to the following:

7. I will cite CPTR as the source of the data.
8. Group authorship of CPTR will not be cited in the authorship line of the abstract.

If I publish manuscripts using data from the CPTR Database, I agree to the following:

*Data used in the preparation of this article were obtained from the Critical Path to TB Drug Regimens (CPTR) Database. As such, the investigators within CPTR contributed to the design and implementation of the CPTR Database and/or provided data, but did not participate in the analysis of the data or the writing of this report.

9. On the author line of the manuscript, after the named authors, I will include the phrase "for the Critical Path to TB Drug Regimens*" with the asterisk referring to the following statement and list of names:

"Data used in the preparation of this article were obtained from the Critical Path to TB Drug Regimens (CPTR) Database. The Critical Path to TB Drug Regimens (CPTR) initiative is a public-private partnership launched in March 2010 by Critical Path Institute (C-Path), the Bill & Melinda Gates Foundation (BMGF) and the Global Alliance for TB Drug Development (TB Alliance)"

I will submit all manuscripts to C-Path on behalf of CPTR prior to submitting them to a journal. This review will not be a scientific review, but is intended to ensure that the items required above are correctly implemented. CPTR will maintain confidentiality of the manuscript and will complete its review within two weeks of receipt.

10. I will include language similar to the following in the methods section of my manuscripts to accurately acknowledge data gathering by CPTR. 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.

11. I will ensure that Investigators who utilize CPTR data use appropriate administrative, physical, and technical safeguards to prevent the use or disclosure of the data other than as provided for by this Agreement.
12. I will report any use or disclosure of the data not provided for by this Agreement of which I become aware within 5 days of becoming aware of such use or disclosure.
13. No consortium member makes any representation or warranty, express, implied, statutory or otherwise with respect to the CPTR Database or the data contained therein.
14. 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 CPTR Database or any of the data contained therein (whether as a result of direct, indirect, incidental, 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 possibility of such damage.
15. By accessing the CPTR 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 CPTR Database and/or your possession and use of any data you obtained from the CPTR 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: It is the policy of the Critical Path to TB Drug Regimens to add additional data as it becomes available. However, data analysis is expected to take years as methods for analysis of these data evolve. Therefore, I understand that any processed data that I download might be preliminary and that results may change as new data are added.

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

I understand that failure to abide by these guidelines will result in termination of my access to the CPTR Database.