Collaborative team. The collaborative team of the INVESTIGATOR shall be approved and shall be able to successfully accomplish with the intended clinical trial, satisfying the requirements of the suitability certificate of Exhibit IV. The Principal Investigator shall notify the CEIC and the Management of the Centre all the modifications and updates of the tasks of the team involved in the agreement. 3.1.4.- Other staff: If for the conduction of the present clinical trial staff unrelated to the CENTRE is required to be hired, it shall be notified to the CENTRE for inspection and access authorization and participation in the protocol by means of the appropriate accreditation. None of the requirements of this agreement constitutes an employment relationship between the CENTRE and the hired staff unrelated to the CENTRE participating in the trial. 3.1.5. - Monitor: The Sponsor, in compliance with Articles 35 and 36 of the Spanish Royal Decree 223/2004 of 6 February, appoints as monitor of the Trial Mr. of the company (if appropriate) . In the event the monitor is replaced, the Sponsor shall notify the identity of the new appointed monitor. 3.2. -
Collaborative team. The INVESTIGATOR’S research team, which shall be composed of staff who assist him in conducting the trial, must be approved by the DREC and be qualified to successfully carry out the planned clinical trial, complying with the requirements of the suitability certificate in appendix III. The Principal Investigator shall notify the DREC and the Management of the Site all the modifications and updates of the tasks of the team involved in the agreement.