Trial activities and rights

The following table summarizes the rights and other authorizations that a user needs to perform typical trial activities. For information about the rights required to perform administrative and user management activities, including the rights to manage data validation checks, see the system administration overview.

To perform this activity	A user must have these rights
Miscellaneous user rights:
Print a CRF	Print
Create and edit Frequently Asked Questions (FAQs) on CRF items	Edit Study FAQ
Create Visit Reports	Monitor
Create records of regulatory document reviews	Monitor
Run reports with the InForm Reporting and Analysis module	Reports
Screen and enroll trial candidates	Enroll Patients Enter Data into a CRF View CRF
View Screening Log (read-only)	Enroll or Monitor, with no CRF rights
Display Required Signatures page and see CRF signing status for all signature groups (read-only)	View CRF Signature Information
Display Required Signatures page and see Case Book signing status for all signature groups (read-only)	View Case Book Signature Information
Export listings of CRF data to an external data source	Data Export Listings
Transfer patient records from one site to another	Change site for patient
CRF rights:
Enter CRF data	Enter Data into a CRF View CRF
Edit CRF data	Edit Data on a CRF View CRF
Enter comments on a CRF item or on a whole CRF	Enter Comments into a CRF View CRF
Freeze a CRF	Freeze a CRF View CRF
Unfreeze a CRF	Unfreeze a CRF View CRF
Lock a CRF	Lock a CRF View CRF
Unlock a CRF	Unlock a CRF View CRF
Indicate a CRF is ready for source verification, or indicate that a CRF that was ready for source verification is no longer ready	Mark a CRF as Ready for SV View CRF
Perform source verification on CRF data	Mark and Unmark a CRF as SV'd View CRF To view the Source Verification Listing, the Monitor right is also required.
Sign a CRF	Sign a CRF View CRF Additionally, the user must be in the same signature group as the CRF to sign.
Case Book rights:
Sign a Case Book	Sign a Case Book View CRF Additionally, the user must be in the same signature group as the CRF designated as the signing CRF for the Case Book.
Indicate a Case Book is ready for source verification, or indicate that a Case Book that was ready for source verification is no longer ready	Mark and Unmark a Case Book as Ready for SV View CRF
Freeze a Case Book	Freeze a Case Book View CRF
Unfreeze a Case Book	Unfreeze a Case Book View CRF
Lock a Case Book	Lock a Case Book View CRF
Unlock a Case Book	Unlock a Case Book View CRF
Query rights:
Open a Candidate query so that it becomes visible to the site	Change Query State from Candidate to Open View CRF Additionally, the user must be defined as a Sponsor user.
Delete a Candidate query	Change Query State from Candidate to Deleted View CRF Additionally, the user must be defined as a Sponsor user and must be a member of the same query group as the user who created the Candidate query.
Close an answered query	Change Query State from Answered to Closed View CRF Additionally, the user must be a member of a query group.
Close a query in the Opened state	Change Query State from Open to Closed View CRF Additionally, the user must be defined as a Sponsor user and be a member of the same query group as the user who opened the query
Close a query that has been reissued in the Candidate state	Change Query State from Reissued Candidate to Closed View CRF Additionally, the user must be defined as a Sponsor user and be a member of the same query group as the user who reissued the query
Answer a query	Answer Query View CRF
Enter a query in the Candidate state so that it is not visible to the site	Enter Query in Candidate State View CRF Additionally, the user must be defined as a Sponsor user
Enter a query in the Opened state so that it is visible to the site	Enter Query in Open State View CRF
Reissue an answered query in the Candidate state so that it is not visible to the site	Re-issue Query in Candidate State Enter Query in Candidate State View CRF Additionally, the user must be defined as a Sponsor user and must be a member of the same query group as the user who created the query.
Reissue an answered query in the Opened state so that it is visible to the site	Re-issue Query in Open State Enter Query in Open State View CRF Additionally, the user must be a member of the same query group as the user who originally created the query.
Resolve a query that is in a conflict state because multiple users using different copies of a trial acted on it before synchronizing	Resolve Query in Conflict View CRF Additionally, to resolve a Site Conflict, a user must be defined as a Site user. To resolve a Sponsor Conflict, a user must be defined as a Sponsor user.
Rule rights:
Cancel an active rule	Deactivate a rule
Run an existing rule	Run a rule
Edit an existing rule	Modify a rule Note: The Modify a rule right doesn't allow for deactivation or cancelation of a rule.
Navigation rights:
Move through a trial by visit across patients at the same site.	Navigate by Visit View CRF
Move through a trial by form across patients at the same site.	Navigate by Form View CRF
Place patients (at a site) in a particular order for more efficient data entry.	Reordering Of Patients View CRF
System Admin rights:
Set remote update options	Manage Software Patch
View status of patch installation and distribution; apply a stored patch to a remote server	View Software Patch Status
Portal rights:
Configure global settings for the InForm Portal application, and create and manage Portal Administrators (InForm Portal users with certain administrator rights).	InForm Portal Config Admin