Users with the role ‘research specialist’ are often seen as the head researcher of the study within EDC. The rights they have are virtually identical to those of the researcher, except that they are allowed to sign a subchapter – whereafter a monitor can pick up the process. Furthermore, a research specialist is always allowed to add patients, and always has the right to the entire CRF instead of only a part of the chapters.
A research specialist can:
- Look at, change and remove patient details.
- Look at, change, print and remove CRF information.
- Save the CRF as Missing, Incomplete or Complete.
- Look at patient self-service and send invitations to patients.
- Log into the CRF as a patient e.g. when the patient is present in the hospital.
- Read and respond to commentary and queries.
- Look at the audit trail.
- Sign a subchapter.
A research specialist cannot:
- Change the settings of the application or study.
- Export data.