InForm users

Clinical data manager (CDM)

A person responsible for preparing and maintaining a study database and reviewing data.

Clinical project manager

A person responsible for all aspects of one or more clinical studies or for the entire clinical plan for a drug, device, or procedure.

Clinical research associate (CRA)

A person who is hired by a sponsor to supervise and monitor the progress of sites that are participating in a study.

Also called monitor, site monitor.

Clinical research coordinator (CRC)

An assistant to the investigator at a site.

Also called site coordinator, study coordinator.

Principal investigator (PI)

The clinician who is responsible for treating subjects, executing the protocol of a study at a specific site, and filling out CRFs for subjects.

Also called clinical investigator, investigator, primary investigator.

Medical monitor

A person who designs the study protocol and reviews data.

Site user

An InForm user, typically a CRC or PI, who performs the following tasks:

• Obtains an InForm site user name and password.
• Screens and enrolls subjects into a study.
• Enters and changes clinical data in electronic case report forms.
• Answers queries on clinical data.
• Prepares for monitoring visits.

Sponsor user

An InForm user, typically a CRA, CDM, or medical monitor, who performs the following tasks:

• Obtains an InForm sponsor user name and password.
• Reviews clinical data queries.
• Performs source verification.
• Transfers subjects from one site to another.
• Runs standard reports.
• Creates ad hoc (custom) reports.