For any new study, a site selection visit is organized with the principal investigator, a member of the CIC steering committee, and the relevant project manager. This visit serves to assess the feasibility of conducting the study at the CIC.

Prior to the visit, a setup procedure is sent to the ARC monitor for review. This procedure, which details the steps involved in the visit and the rules for using the service, is signed by the sponsor on the day of the visit.

Monitoring dates are set at least one month in advance in consultation with the coordinating IDE or ARC, the sponsoring ARC, and the principal investigator.

Each monitoring visit must be confirmed via email to the IDE or the coordinating ARC, with the principal investigator and the data entry coordinator copied in.

The list of documents to be monitored must be provided when requesting a storage unit reservation.

The ARC promoter must confirm their attendance at least 48 hours in advance by email.

Telephone monitoring is permitted only in exceptional public health situations.

Monitoring boxes are available from 8 a.m. to 5 p.m.

The documents made available to the project sponsor during monitoring visits include:

• Printouts from the ORBIS medical record
• External documents in paper format
• CIC Paper Medical Record

The referring physician may request access to the ORBIS electronic medical record under the APHP’s procedures. “Over-the-shoulder” viewing is not permitted. No source documents may leave the CIC. Anonymized photocopies may be made, and a computer is available in the monitoring stations.

During the study: The documents are stored in a live archive room, which is electronically locked and accessible only to authorized personnel.

After the study is completed: The documents are archived at an off-site facility in accordance with applicable regulations.

The CIC's computer equipment is connected to the secure APHP or ICM network. Maintenance is provided by service providers in collaboration with the IT Department. Each workstation is protected by a username and password, and files are stored in a locked room.

A backup of the file server is stored on encrypted media, with a weekly copy retained in the CIC Neurosciences archives.

For any new study, a site selection visit is organized with the principal investigator, a member of the CIC steering committee, and the relevant project manager. This visit serves to assess the feasibility of conducting the study at the CIC.

Prior to the visit, a setup procedure is sent to the ARC monitor for review. This procedure, which details the steps involved in the visit and the rules for using the service, is signed by the sponsor on the day of the visit.

Monitoring dates are set at least one month in advance in consultation with the coordinating IDE or ARC, the sponsoring ARC, and the principal investigator.

Each monitoring visit must be confirmed via email to the IDE or the coordinating ARC, with the principal investigator and the data entry coordinator copied in.

The list of documents to be monitored must be provided when requesting a storage unit reservation.

The ARC promoter must confirm their attendance at least 48 hours in advance by email.

Telephone monitoring is permitted only in exceptional public health situations.

Monitoring boxes are available from 8 a.m. to 5 p.m.

The documents made available to the project sponsor during monitoring visits include:

• Printouts from the ORBIS medical record
• External documents in paper format
• CIC Paper Medical Record

The referring physician may request access to the ORBIS electronic medical record under the APHP’s procedures. “Over-the-shoulder” viewing is not permitted. No source documents may leave the CIC. Anonymized photocopies may be made, and a computer is available in the monitoring stations.

During the study: The documents are stored in a live archive room, which is electronically locked and accessible only to authorized personnel.

After the study is completed: The documents are archived at an off-site facility in accordance with applicable regulations.

The CIC's computer equipment is connected to the secure APHP or ICM network. Maintenance is provided by service providers in collaboration with the IT Department. Each workstation is protected by a username and password, and files are stored in a locked room.

A backup of the file server is stored on encrypted media, with a weekly copy retained in the CIC Neurosciences archives.