Inside Terminal C

What this team does

Visits sites to check the study is done the way the protocol says.

Compares what is in the system with what is in the patient's records.

Is the person the site calls first when something goes wrong.

A day here

1. 5:40Airport. The 6:30 is delayed. The site visit is at 9.
2. 9:20Arrive late, apologise, start with consent forms for the two new patients.
3. 11:45One consent form is the old version. The patient must sign the current one at the next visit.
4. 14:00Check the drug fridge log and count returned bottles in the pharmacy.
5. 21:00Hotel room. Start the visit report. It is due in five working days, and you want it done on the plane.

Roles, junior to senior

• In-house CRA
• CRA
• Senior CRA
• Lead CRA
• CRA line manager

1. In-house CRARemote checks, site calls and tracking documents from the office.Clinical Research AssociateSource Documentation and Data IntegrityRegulatory and Essential RecordsCommunication
2. CRAMonitoring visits at a group of sites, from start-up to close-out.Clinical Research AssociateSource Documentation and Data IntegrityQualityStudy Conduct and Operational Execution
3. Senior CRAHarder sites, training new CRAs and the visits where something is wrong.Clinical Research AssociateQualitySource Documentation and Data IntegrityInvestigational Product
4. Lead CRAThe CRA team on one study: consistency, escalations and site issues.Clinical Research AssociateQualityCommunication
5. CRA line managerA group of CRAs: workload, coaching, travel and quality of their reports.CommunicationQuality

Who they talk to every day

• Site 204
• The Clinic
• Project Tower
• Data Works
• Central Lab

Words you will hear

SDV

Source data verification. Checking entries in the system against the patient's records.

SDR

Source data review. Reading the records for quality, not ticking each number.

RBM

Risk-based monitoring. Checking more where the risk is, less where it is not.

Visit report

The write-up after every monitoring visit, with findings and actions.

Follow-up letter

The letter to the site after a visit listing what they need to fix.

Close-out

The last visit, when the study ends at that site.

Escalation

Sending a problem up when the site cannot or will not fix it.

Common moves in and out

Most CRAs were coordinators, research nurses or lab scientists first.

CRAs move into project management, line management, quality and audit, or site start-up.

Some go back to sites as managers, because they now know what sponsors look for.