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RDCRN Alumni Rules of Engagement

RDCRN Alumni Rules of Engagement

The purpose of the RDCRN Alumni Site is to provide investigative teams funded under the Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional) (RFA-TR-18-020) of the opportunity for continued access to the RDCRN Operational Environment cloud platform once funding ends.

The RDCRN Alumni Site includes all databases related to the specific consortium that were active during the consortium’s tenure as an RDCRC and the ongoing use of network tools.

The RDCRN Data Management Coordinating Center (DMCC) (RFA-TR-24-021) will only handle security management, account management, and data storage. Any custom development, setup, additional data, or data management requirements will be the responsibility of the alumni.

Investigators who have been approved by the NCATS RDCRN Program Director and the Program Official (PO) of the original award to access and use consortia data within the Alumni Site in the RDCRN DMCC Operational environment agree to:

  1. Comply with all applicable local, state, and federal laws, regulations, and policies regarding data use, privacy, and security, and exercise responsible stewardship of data, software, or other tools contained within the RDCRN Alumni Site.

  2. Adhere to the guidelines, best practices, methodologies, procedures, and processes established under the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), as outlined by the HHS Secretary.

  3. Follow the regulatory policies related to data management and sharing as specified by the Rare Diseases Clinical Research Consortia (RDCRC) for the Rare Diseases Clinical Research Network (RDCRN) (U54 Clinical Trial Optional) (RFA-TR-18-020).

  4. Comply with the NIH policy for data and safety monitoring, which ensures the oversight and monitoring of all NIH-conducted or supported human biomedical and behavioral intervention studies (clinical trials) to safeguard participant safety and maintain data validity and integrity. Further details are available at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

  5. Ensure that all protocols are reviewed by the institution's IRB or IEC to protect the safety of participants in ongoing studies. The recipient must provide the NIH with copies of documents related to any major changes in the status of ongoing protocols.

  6. Abide by the rules of engagement and expectations for participating in the RDCRN Alumni Site.

  7. Report any data breaches within two (2) business days of discovery by the User or the Accessing Institution to DMCC and NCATS via email.

  8. WAIVE ALL LIABILITY AND FURTHER AKNOWLEDGE THAT NO WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT IS PROVIDED HEREWITH. IN NO EVENT SHALL THE NCATS OR ITS EMPLOYEES BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY OF ANY KIND. 

  9. Acknowledge that NCATS reserves the right to terminate the relationship in the event of a breach of these terms.

 

In addition to the above,

  • RDCRN alumni will be required to meet semi-annually with the DMCC to review the alumni’s activities within the RDCRN cloud environment.

  • RDCRN alumni should be responsive to requests from DMCC and NCATS staff. Failure to respond could result in access becoming limited.