Having a formal contract agreement in place for any research study is a vital step in the Governance Approval process. It is mandatory to have a signed agreement in place before a study is approved by the Research and Innovation department for all clinical trials conducted at Leicester’s Hospitals.
There are rare occasions when a formal agreement is not required; for instance, some of the non-commercial studies where the sponsor may issue a ‘Statement of Activity’ instead of a formal agreement.
Contracts are also drawn up for any support services, consultancy, confidentiality, datasets, intellectual property and any other services either provided by Leicester’s Hospitals or bought in from external source for Research and Innovation activities.
All of Leicester’s Hospitals’ investigators will have a Sponsorship Agreement with the Research and Innovation department to conduct a study.
The most common types of contracts generally drawn-up and agreed are:
- Model Agreements for Clinical Trial studies – mCTA
Used in a clinical trial sponsored by a private company (e.g. pharmaceuticals)
- Model Agreement for Non Commercial Research – mNCA
Used for clinical trials either sponsored by, or conducted in, public organisations – such as the Trust, universities or charities.
- Model Agreement for Clinical investigation with Medical technology – mCIA
Used for medical devices trial in clinical setting
- Material transfer Agreement – MTA
This is used when 2 or more organisations are using/exchanging human tissue samples for clinical research
- Collaboration Agreements mainly with Universities
- Site Services Agreement
- Service Level Agreement
- Miscellaneous agreements such as non- disclosure confidentiality agreement, consultancy, sample testing, interviews etc.
It is the Research and Innovation team’s role to agree contractual terms with external parties and obtain the authorised signatures.