For HRA-authorized studies, HRA`s initial evaluation letter (and HRA authorization letter) specifies the corresponding agreement for each type of site in a study. The document may refer to the declaration of activity and the timing of events, to a model of agreement (for example. B mCTA) or another sponsor document. The inclusion of a third party (CRO) in the conduct of studies leads to another set of interactions that need to be addressed in the model agreement. The MCIA CRO is structured and drafted to clarify the commitments of each of the parties. In general, the differences between the CIA in two parts and the mCIA CRO reflect how the sponsor`s obligations are met by the sponsor or delegate to the CRO, and the text identifies the part (sponsor or CRO) with which the NHS-Panel must interact on each issue. Certain investigative tasks may be carried out, at the discretion of the promoter, either by the sponsor or by the CRO. If the agreement refers to either „either the sponsor or the CRO,“ it is not necessary for the responsible party to be specified. This wording can be found, for example, in the definitions (paragraph 1.1) of the listener and the audience and in paragraphs 3.2 (last sentence) and 4.10 (first sentence). In these cases, the use of the term „sponsor or CRO“ means that the NHS organization can be informed either by the sponsor or by the CRO. In other places, z.B clause 4.10 (last sentence) or 4.15, this means that either the sponsor or THE CRO can act as indicated. Other examples are in the agreement as a whole.
Clause 4.2 refers to Schedule 4. In the CIA model, which is a blank model in which the sponsor and CRO expose the tasks and functions of the sponsor in connection with the investigation, in accordance with EN ISO 14155 or ICH GCP, performed by the CRO. The degree of detail indicated in this appendix is left to the discretion of the parties to the agreement. It is NOT intended to replicate ISO 14155 or JE GCP, but it will bring together, for the benefit of the employees of all parties who manage the investigative body, issues on which the NHS service will come into contact with the CRO.