Contracting

Having a formal contract agreement in place for any research study is a vital step in the process. It is mandatory to have an agreement in place before a study can go ahead at Mid Yorks.

There are 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.

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 two 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.

It is the RM&S team’s role to agree contractual terms with external parties and obtain the authorised signatures.

Confidentilaity agreements

The RM&S team will also coordinate and agree contractual terms for all confidentiality disclosure agreements (CDAs) related to clinical trials. More information can be found by emailing MY.research@midyorks.nhs.uk