Thank you for your interest in using NCI's PRO-CTCAE™ (version 1.0) in your clinical research.
PRO-CTCAE is freely available for all to use in their clinical research, including pragmatic trials, implementation trials, and other clinical research conducted in real-world settings using electronic data collection platforms, including the electronic health record (EHR). We encourage and facilitate this use in clinical research, and no permission is required.
To protect the integrity of PRO-CTCAE, the US National Cancer Institute holds all rights and title to PRO-CTCAE, all translations, and related documents.
- 'Provider': the National Cancer Institute
- 'Recipient': the party who receives PRO-CTCAE™ from the Provider under this agreement
- 'PRO-CTCAE™': questions selected by the Recipient from the items in the PRO-CTCAE item library version 1.0 created by Provider
- Recipient agrees that use of PRO-CTCAE is limited to describing in aggregate the safety and tolerability of a therapeutic compound or device, and does not include the use of PRO-CTCAE for diagnostic, prognostic or therapeutic purposes in human subjects, or the use of PRO-CTCAE to assess the efficacy of medical drugs or devices.
- Recipient agrees not to adapt, alter, amend, abridge, modify, condense, make derivative works, or translate PRO-CTCAE without prior written consent from the Provider.
- Recipient shall not reproduce PRO-CTCAE except as is necessary to conduct their research study. Recipient shall not distribute, publish, sell, license, or provide by any means whatsoever to third parties not involved with the study copies of PRO-CTCAE without the prior written agreement of the Provider.
- Recipient agrees and undertakes not to sell or incorporate PRO-CTCAE into materials for sale, with the exception of educational materials, such as printed books and journals.
- In case of any kind of presentation or publication reporting PRO-CTCAE results, Recipient shall include a reference to the PRO-CTCAE website (https://healthcaredelivery.cancer.gov/pro-ctcae/).
- Recipient will include Provider's trademark ownership statement on all copies of the PRO-CTCAE in the same form as it appears on the document that Recipient is downloading from this website.
- Recipient agrees and undertakes to indemnify and hold Provider harmless against any and all claims, loss or damage, including fees, penalties or fines and third party claims, and attorneys' fees arising from Recipient's use of PRO-CTCAE.
- Should Recipient desire to use PRO-CTCAE in a manner not permitted under these Terms and Conditions, please e-mail NCIPROCTCAEInquiries@mail.nih.gov.