The main purpose of a contract/agreement in the context of sponsored research is to make it clear to any contracted parties what is to be expected to be done, by whom, and to what standard and if that expectation/standard is not met how it will be identified and addressed. In signing (executing) a contract the party agrees to comply with all the relevant laws, regulations and codes of practice applicable to the responsibilities that they have been delegated.
Where a Noclor partner is sponsor they will be the contract giver (and recipient in regards to the prime contract with the funder). Noclor will propose, initiate (negotiate any changes as required) and execute the appropriate contracts/agreements with third parties as required for a study prior to any commencement of work.
- Model Contracts & Agreements
Nationally agreed model contracts are utilised where possible, including the DoH approved Model Non-Commercial Agreements (mNCA), to speed up what can otherwise be a lengthy contracting process. In-house templates are used only where no model agreements exists.
All contracts are drafted and negotiated by the Noclor Contracts Manager, who is trained in applying the model agreements as well as in evaluating departures from the model. Deviations from models/templates and any complex contractual negotiations or matters involving intellectual property are escalated to the Noclor Head of R&D.
Other Noclor personnel may also be involved in the drafting/review of contracts for their specialist knowledge (for example; for CTIMPs the Technical Agreement with IMP supplier/manufacture would be reviewed by the Pharmacy Clinical Trial Manager and financial details would be confirmed by Noclor Finance team (Senior Management Accountant)).
External specialist legal services (via the Trust membership of the NHS Litigation Authority) are procured on specific request from Noclor (Head of R&D) as appropriate.
- Authorised Signatories
Only authorised signatories are permitted to sign contracts and agreements on behalf of the Trust, where a Noclor partner is sponsor, these authorised signatories are the Noclor Service Director and Head of R&D.
Noclor operates a ‘wet ink signature’ regime, original signed contracts/agreements are filed in the Study/Trial Master file (S/TMF) (and a copy is scanned and attached to the electronic study file (on the Noclor Information Management System).
- Amendments to Contracts
It is the Chief Investigator’s responsibility to ensure that all contracts and agreement reflect current practice and are amended, renewed and terminated as appropriate.
In order to maintain effective oversight of contractors, Noclor will consider these requirements in study-specific monitoring plans as required.