The form ”Clinical Research Information” should be used by external party/company (Sponsor) /CRO, for notifying Inven2 about new trials. For partly funded investigator initiated studies the form should be filled in by hospital personnel.
Information about the form
Who should fill in and send the trial notification?
Sponsor or sponsor's representative is responsible for notifying Inven2 about the trial.
When to send the notification?
As soon as it is decided that a study will run at the hospital and a final protocol exists.
What should the notification contain?
The type of information we need is provided in the form. The more information provided in the form, and the more of the practical aspects that are resolved (who does what) at the time of notification, the faster Inven2 will be able to process the budget and contract.
What documents to include in the notification?
Study protocol (electronic version)
The study protocol is mandatory and Inven2 will not start processing the study before the protocol is present. If the protocol is amended during the process, we should receive the latest version.
Procedure Manuals (lab, radiology etc.):
Documents not present at time of notification needs to be forwarded. Several contributing departments at the hospital will not be able to confirm capacity and price before the manual(s) have been read.
Contract proposals can be forwarded later if it is not present at the time of notification.
Other (not mandatory):
Other documents or information that could be of assistance to Inven2 in the processing of the trial (i.e. feasibility questionnaire, operational manual and patient informed consent).
Management of notifications/trials at Inven2
The sender of the notification form will receive a receipt of notification per e-mail within 7 days. The receipt contains:
- Reference number: Each trial is allocated a unique trial number (M-no). Please refer to this number in all further correspondence with Inven2 for the trial with regards to the contract and invoicing.
- Contact details to the assigned contact manager responsible for the trial at Inven2.
Inven2 will send a study budget template, together with other relevant documents, to the PI within 7 days from the date sponsor is informed of our receipt of the study request. Inven2 will send Sponsor feedback on the legal text in the agreement within 14 days from the date we receive a contract template from Sponsor.