Study Lifecycle

Start Up Activities

Study

Lifecycle

Maintenance Activities

Lifecycle of a study

Click on an icon to begin.

Start Up

Close Out Activities

Maintenance

Closeout

Close Out

Study close-out involves a series of activities to officially close a study. These include validating/locking the database so no new data can be entered, closing out the DOA/DTL, and filing the applicable closures to regulatory agencies and the IRB of record. During the closing phase, Finance ensures all costs have been applied, charges invoiced, and payments received. Since there are multiple stakeholders involved in any given trial, tying up these loose ends are important so that resources can be used for other studies.

Close Out

• Final Financial Reconciliation
• Close-Out Monitoring Visit
• DOA/DTL Close-Out
• IRB Close-Out
• Report Results

Start Up Activities

• Budget Development
• Contract Execution
• Site Feasibility
• Site Initiation Visit
• Regulatory Submissions
• Assign DOA/DTL
• Protocol Development (IITs)
• Create Database (IITs)

Start Up

Study Start-Up encompasses the activities that must be complete before the study can officially begin enrolling patients. Activities such as developing a protocol, creating a budget and securing funding, ensuring appropriate contracts and agreements are in place, obtaining the required regulatory approvals, assigning DOA/DTL activities, creating a database and forms/manuals for the study are all required to have in place before the first patient is recruited and enrolled to the study. Many of these items will be overseen or provided by the sponsor for industry studies, and this list is not inclusive for getting a study up and running.

Maintenance

• Patients Recruited and Enrolled
• Billing, Invoicing and Payment Tracking
• Safety Reporting
• Amendments
• Routine Monitoring Visits
• Study Audits

Maintenance

The maintenance phase is where patients are recruited and enrolled in a study and study activities occur. Throughout the study, there are many checks and balances that assist with maintaining patient safety and data validity. These checks ensure that good clinical practice (GCP), policies and regulations are being followed. Additionally, the maintenance phase is where finances are tracked and accounts reconciled for costs incurred. Changes or corrections to the study documentation may also occur in the form of amendments.