Best practice, but technically not required. University policy prohibits PIs from being a party to the agreement or signing on behalf of the University. Instead, PI will sign "read and acknowledged" to ensure awareness of obligations.
What is the difference between an MTA and a Purchase/Service Agreement?
MTA: 1) no money tied to the agreement, with the exception of shipping/prepping costs; and 2) the Recipient needs to have designed, or contributed to the design of, the
research project.
Service Agreement: Provider designs the project with the Recipient performing tasks (often for a fee).
Purchase Agreement: Money is exchanged for materials.
Does CRAO have University templates to use?
Yes! Please indicate in the Formstack if a template/draft was not provided and CRAO will start negotiations with a University template.
Will I be copied on contract negotiation correspondences?
CRAO staff will reach out when input is needed from study teams related to contract negotiations. Prior experience showed large email threads with many CC's led to confusion and delayed contract completion.
What Amendments does CRAO handle?
CDA, MTA, and CTA Amendments. Rule of thumb when routing an Amendment: If an office helps with the contract, the same office helps with the Amendment.
Prior to signatures of a CTA Amendment, any new budget is submitted by CRAO to UCH for final approval. Revisions to budget language may be necessary to comply with rules and regs.
1
Complete the web-based intake form.
Answer all questions.
Include as much information as possible to help us review your agreement in the comment boxes.
Upload all pertinent documents. We can't begin our review until this step is complete.
2
Based on your intake form answers, the MTA or CDA/NDA will be routed and processed accordingly.
Negotiations will be handled by the CRAO Contacts Team
3
Email amendments to CRAO.
If you wish to use the UCD/CU Anschutz partially executed CDA follow these steps
1
Research team must complete ALL the highlighted sections of this form.
The University will not accept any redlines/edits to this CDA. It has been designed to allow for immediate acceptance.
4
If the sponsor insists on using its own CDA then it will need to be submitted in accordance with the current process.
It is likely to take a minimum of 3-5 weeks to execute.
5
Do not route to CU Anschutz central administration as the document is already executed by the University.
6
Once the sponsor signs the agreement it is fully executed, and the sponsor can share documents.
7
It is the responsibility of the PI and research team to maintain a copy of the executed agreement and provide it to university administration on request.
8
If the PI decides to move forward with the clinical trial, provide a copy of the executed CDA with the HSR portal submission
9
If the sponsor refuses to use this new system, please submit the CDA through the portal.
Children's Hospital of Colorado CHCO
Researchers & Research Teams
This portal is only used to submit CDA/NDA’s for research projects performed at CHCO.
CTA’s, MTA’s, DUA and BAA’s for projects performed at CHCO have a different routing process.
