New Streamlined CDA Contracting Process for CHCOMar 6, 2020
University of Colorado and Children’s Hospital Colorado are continuing to collaborate as one team to identify areas where the existing contracting processes for child health research can be streamlined. We’re excited to announce that effective March 10, 2020, University of Colorado will be the contracting party and signatory of industry confidential disclosure agreements (CDAs).
Industry CDAs are agreements with for-profit entities that result in confidential information about industry funded/sponsored projects being provided to University of Colorado for purposes of exploring clinical research to be conducted at Children’s Hospital Colorado by University of Colorado employees.
Why? A joint work session on February 6, 2020 highlighted two distinct workstreams for CDA processing by the two organizations that could be successfully merged. This change simplifies the initial presentation to third parties of our organizational structure, as University-employed Principal Investigators (PIs) are the primary recipients of confidential information at this stage in the child health research contracting process.
By moving CDA submission for industry research at Children’s Hospital Colorado into the existing CU Anschutz Agreements Portal and contracting workflow, we anticipate greater efficiency in the industry CDA contracting process. Use of one intake portal and a central repository for these CDAs will allow for the tracking of timelines from initial CDA submission to the date of CDA full execution.
The new intake process is simple. CDAs are initiated at the CU Anschutz Agreements Portal* and will be reviewed and negotiated by University’s Clinical Research Administration Office (CRAO) contracting staff.
- The submitter will (i) answer basic questions (what information is being disclosed, which entities are disclosing and/or receiving information, whether the University of Colorado will share information with the other party, etc.), (ii) upload an editable (Word) version of the contract, and (iii) provide contact information for the external entity.
- The CRAO intake coordinator will provide email confirmation of receipt of the CDA submission form, identify the CRAO contracting specialist handling the CDA and the unique identifying record numbers for tracking purposes.
- The submitter and PI will be copied on negotiation correspondence, and when final, the CDA will be sent to the PI for acknowledgment signature, per the current practice.
- Fully executed CDAs will be stored in a contract repository accessible by both organizations.
Join us at the Research Operations Forum on Tuesday, March 10, to better understand the new process. Hosted in Mt. Oxford, in the second floor Conference Center at Children’s Hospital Colorado, this is your opportunity to ask questions of Operations leaders and ensure all who touch study start up understand this new streamlined process.
Attached, you will find a Q&A document, so that all of us can share consistent information as questions arise. Or your can direct questions to firstname.lastname@example.org and email@example.com. *https://ucdenverdata.formstack.com/forms/rss_ra_ogc_ra