Thorough preparation for inspection of the EDC system used in a clinical trial is of great importance. The regulatory authorities see the EDC system used for a clinical trial as an important computerized system with regards to both patient safety and data integrity.

To assist in this process, Viedoc has developed the Viedoc Inspection Readiness Packet (VIRP) which provides you with the information you need to prepare for a regulatory inspection and to fulfil regulatory expectations and requirements. The VIRP introduction describes the contents of VIRP in more detail, and also talks about additional documentation you should provide. The VIRP introduction is included in VIRP.

If you decide to use VIRP we provide an eLearning lesson which describes the information needed step-by-step in order to fulfil inspector expectations: Inspection Readiness When Working in Viedoc

You can read about how to download the Viedoc Inspection Readiness Packet here: VIRP

You will need to give full read-only access and invite the inspector to the Regulatory Inspector role in the Viedoc system as described below.

Configure the role

This step is performed by the Designer.

To allow the Regulatory Inspector viewing access to study data, their role must be configured with read-only and view anonymized and blinded data permissions on the Roles page.

Note!

• The role of Regulatory Inspector must be turned on in Designer.
• By default, a set of predefined roles is set up by the system, and can be modified for your study. Permissions for the role of Regulatory Inspector should be set to READ-ONLY access to all parts of the system, including the eTMF (if it is used) and the eLearning.

Configure Logistics permissions if used

If the study uses Viedoc Logistics, the following role permissions in Logistics Rights for the Regulatory Inspector role must be configured on the Roles page:

• View IP (Investigational Product) on study level,
• View IP on site level
• View subject ID when allocated
• View blinded info (e.g. Active/Placebo).

See Configuring roles.

Note! Should the inspector also require access to Viedoc Admin or Viedoc Designer, you are always welcome to contact your Viedoc representative if you need assistance.

Invite a Regulatory Inspector

This step is performed by the Study Manager.

Note! For randomized studies, the inspector should also be invited to the study with the role of Unblinded Statistician, in order to have access to the randomization lists and be able to download them in Viedoc Admin.

See Managing users.

Map eTMF permissions if used

If the study is using the eTMF, map the Regulatory Inspector study role to an eTMF role with the permissions read-only TMF Admin, read-only Trial Master File and Download audit trail.

This step is performed by the Study Manager/eTMF Manager.

Launch Viedoc

Launch Viedoc Clinic and Viedoc eTMF and Viedoc Logistics (if used in the study) from the landing page.

This step is performed by the Regulatory Inspector.

• Previous
• Next