All personnel performing study-related tasks need to be GCP-certified. This includes PI and fellow surgeons, study coordinators, study nurses, data nurses, secretary… For PT’s Hiruz made an exception, which is described in this Note:
This note to file documents that in the mobile app RCT, the study team is not required by the sponsor to train the physiotherapists on the latest approved version of the protocol, nor collect a signed CV and/or recent GCP certificate of each physiotherapist.
The physiotherapists are responsible for rehabilitating patients, included in the Mobile app RCT, according to the convention that is signed by the hospital. Training of the physiotherapists on the use of the mobile app is done by the manufacturer moveUP and is documented within their platform. The physiotherapists must know to which study specific randomization arm the patient has been assigned. This information is communicated by the study team to the physiotherapists and the manufacturer via the moveUP platform. The sponsor requests that a representative of the physiotherapists in the hospital is delegated by the PI on the delegation log.
Physical therapists don’t need to be GCP-certified, including the PT representative delegated by the PI.