What role does a PI and coordinator play in a protocol?
Should they data entry privilege or only query?
~Sri
What a PI does in OS can vary from PI to PI and on the protocol. If the protocol states that the PI cannot see and PHI then the PI will only be querying for data (the coordinator would have access to the PHI). Then there are PIs that are allowed to see PHI and that will monitor their trial and query for data with PHI on a regular basis. Finally there are PIs that can see PHI but will rely on the coordinator to provide study updates (query for data)
The Coordinator should be able to register participants, see the specimen data (in the cards) but not edit it. The coordinator will also need to query for the data.
Thanks @Amy_Brink
Unlike in OS v1.x and before, in OS v2.0, every access is defined by what “role” one has. For “PI” and “Coordinator”, we will only give “read” access to all data. At specific protocol level you can grant them extra roles as per the protocol’s need. This will be the most flexible approach.
~Sri