Clinical Trial Contracting Updates

Dear Research Colleagues,

As we indicated last week, we have seen a significant turnover of staff specifically in the clinical trial contracting team. Unfortunately, this will impact the turnaround time for CTAs, CDAs and MTAs in the near term. We are working hard to minimize the disruption to research activity and wanted to update you with the following information:

New Approach to Clinical Trial Agreements (CTAs)

• Presently, we have developed a working relationship nationally with WCG and an external legal firm to negotiate CTAs using the university’s established contracting guidance documents.
• We have identified several qualified applicants and are expeditiously working through the HR process of onboarding these individuals.
• We have also developed an assessment tool to help evaluate an individual study. We will be using this information in the short term, to help us prioritize studies.
• We are in the process of re-structuring the workflow process to be more efficient and reevaluating the support model to optimize this process long term in a sustainable way.

New Process for Confidential Disclosure Agreements (CDAs)
We encourage all research teams to use the new partially executed CDA template that is now available on our Research Agreements page.
The research team must complete the CDA template to include details of the sponsor and project and then send it to the sponsor.

• Once the sponsor has signed, it is fully executed, and the research team should maintain a copy for their records. It does not need to be submitted to central administration.
• The Clinical Research Administration team will continue to process more complex CDAs but there will be some delays due to volume and current staffing.

Temporary Support for Material Transfer Agreements (MTAs)

• Currently, MTAs are being reviewed with the support of OGC staff and CU Innovation staff, but as there is a large volume, there are likely to be some delays for the next 1-2 months as we train new staff.

Overall, we are currently slower than normal but thanks to everyone pulling together, we have been able to keep the workflow moving. Staffing shortages are currently affecting research institutions nationwide, and we are committed to doing everything we can to keep your important work moving forward with minimal disruptions.

Thank you for your patience as we work through this temporary slowdown,

Alison Lakin, PhD

Clinical Trial Contracting Updates

Dear Research Colleagues,

As we indicated last week, we have seen a significant turnover of staff specifically in the clinical trial contracting team. Unfortunately, this will impact the turnaround time for CTAs, CDAs and MTAs in the near term. We are working hard to minimize the disruption to research activity and wanted to update you with the following information:

New Approach to Clinical Trial Agreements (CTAs)

• Presently, we have developed a working relationship nationally with WCG and an external legal firm to negotiate CTAs using the university’s established contracting guidance documents.
• We have identified several qualified applicants and are expeditiously working through the HR process of onboarding these individuals.
• We have also developed an assessment tool to help evaluate an individual study. We will be using this information in the short term, to help us prioritize studies.
• We are in the process of re-structuring the workflow process to be more efficient and reevaluating the support model to optimize this process long term in a sustainable way.

New Process for Confidential Disclosure Agreements (CDAs)
We encourage all research teams to use the new partially executed CDA template that is now available on our Research Agreements page.
The research team must complete the CDA template to include details of the sponsor and project and then send it to the sponsor.

• Once the sponsor has signed, it is fully executed, and the research team should maintain a copy for their records. It does not need to be submitted to central administration.
• The Clinical Research Administration team will continue to process more complex CDAs but there will be some delays due to volume and current staffing.

Temporary Support for Material Transfer Agreements (MTAs)

• Currently, MTAs are being reviewed with the support of OGC staff and CU Innovation staff, but as there is a large volume, there are likely to be some delays for the next 1-2 months as we train new staff.

Overall, we are currently slower than normal but thanks to everyone pulling together, we have been able to keep the workflow moving. Staffing shortages are currently affecting research institutions nationwide, and we are committed to doing everything we can to keep your important work moving forward with minimal disruptions.

Thank you for your patience as we work through this temporary slowdown,

Alison Lakin, PhD