The accessibility of the user to the eCRF depends on the access right matrix determined and validated by the sponsor.
All the users of the eCRF belong to a specific user group. The different user groups are determined by the sponsor depending on the user function in the study protocol.
For example, the usual user groups in a clinical study are investigator, nurse, TEC, monitor, sponsor, data manager,….
For each user group, the access right matrix defines the rights of the user on each eCRF feature activated.
For the eCRF completion, the access rights are defined for each section of the eCRF. The user can either only read, create, update or suppress the pages of a section. The user rights also define the population of patients that the user can specifically follow.
If the user does not have the access right for an eCRF section or feature, the system blocks the user and informs him that he does not have the correct access rights.
The accessibility to the eCRF platform can be denied for all the users during the maintenance period. In that case the maintenance day and time duration are communicated to the users in the study information in advance.