Frequently Asked Questions
The NIHR CDA has been drafted, in conjunction with members of the industry road map group to ensure that the agreement covers all industry’s legal requirements. Once the generic agreement has been signed off, the company can then discuss any study feasibility with the seven topic specific networks
- Will there be a charge for any of these services?
The sponsor will be charged for completion of the full feasibility and capability review on a per site basis. In return DeNDRoN will identify study investigators, perform an in-depth patient database review to reliably commit patient numbers, provide all necessary information for completion of the COREC SSA and if adopted provide nurses or trial officers to support ethics and R&D submissions, to ensure recruitment is completed to target and timelines. No charge will be made for the initial feasibility review.
- What happens if the study isn’t adopted by DeNDRoN?
If the study is not adopted, for example if there are too many competing studies on the portfolio, the information collated during the feasibility and capability review will still be provided to the sponsor, to move forward without DeNDRoN support.
- Can we still work with investigators outside of DeNDRoN?
It should be noted that DeNDRoN is not the gatekeeper of research in the UK and approaches to any investigators can still be made. DeNDRoN LRNs only cover England and this is not full geographical coverage, so it will be necessary to work separately with investigators outside the network.
- Who are contracts made with?
All Clinical Trial Agreements, financial agreements and R&D applications will continue to be made directly with the investigator and their trust. The LRN manger will be able to work with the sponsor to facilitate approvals in a timely manner.
- Will the sponsor need to pay to use DeNDRoN staff?
For industry studies adopted by networks, there is the proviso that all research is supported by the network on a full cost recovery basis.
For example, if the investigator requires LRN staff to work on any procedure already incorporated in the per-patient fee, the LRN will invoice the investigator’s trust for any costs directly associated with using DeNDRoN resource.