Agreements, negotiation and responsibility
Inven2 is responsible for the negotiation of clinical study agreements of clinical studies on behalf of hospitals and investigators. This process takes place in parallel to the budget process, and includes both quality assurance of the legal content and negotiation of price and other terms and conditions with the industry.
Inven2 has lawyers who provide legal advice in the agreement negotiations, and we have our own agreement templates, which can be used if the sponsor is not obliged to use their own company templates.
- Inven2 coordinates the agreement signing with the hospital and archives the signed agreement
- Electronic signing of the agreement is preferable as it facilitates faster start up times. The hospital accepts scanned documents.
The agreement is a three-party agreement to be signed by:
- The sponsor or CRO on behalf of the sponsor
- The health trust represented by the head of the department where the primary investigator is employed.
The investigator signs the agreement as ‘read and acknowledged’, but is not a party to the agreement.
The responsibility between the parties to the agreement is as follows:
- Industry: Responsibility as sponsor according to Good Clinical Practice (GCP)
- The health trust: Responible for the conduct oft the study in accordance with GCP. This includes scientific responsibility, responsibility for the recruitment of patients and the medical follow up of the patients. The Principal Investigator carries out the study as an employee of the health trust
- Inven2: Responsible for contract negotiation and invoicing on behalf of the health trust