Clinical data manager (CDM)

A person who is responsible for preparing and maintaining a trial database and for reviewing data.

Clinical project manager

A person who is responsible for all aspects of one or more clinical trials 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 trial.

Also called monitor, site monitor.

Clinical research coordinator (CRC)

An assistant to the investigator at a site.

Also called site coordinator, trial coordinator.

Principal investigator (PI)

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

Also called clinical investigator, investigator, primary investigator.

Medical monitor

A person who designs the trial 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 patients into a trial.
• 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 patients from one site to another.
• Runs standard reports.
• Creates ad hoc (custom) reports.

Support user

An InForm user, typically responsible for support or troubleshooting tasks. Support users behave like all other InForm sponsor users, except they cannot edit their user name or user type.