During study start-up and throughout monitoring, regulatory documents must be kept current. There are essential documents that are regulated by the sponsor and the FDA that the monitoring team must always have available. Managing these documents is vital for the study to stay compliant with regulations. Some of these documents include:

• Investigator’s Brochure (IB)

• Protocol amendments

• Informed consents

• Monitoring Plan

• Study protocol

Once a study is completely over, the study must be officially closed. There are different reasons for why a study may close; enrollment has ended and all activities are completed, study was terminated, statistical measures were met, and/or treatment found was unsafe. Whatever the reason, all close-out activities must be completed. Study Close-Out activities include:

• Case Report Form (CRF) review

• Investigator’s Study File must be checked

• Complete drug accountability inventory

• Outstanding queries or open issues

All trials need a Clinical Trial Management System (CTMS) to manage the trial effectively. The CTMS tracks and manages the activities of the study such as start-up, planning, monitoring, regulatory, and close-out. This will give the investigator and the monitoring team access to vital information for the trial. Clinical Management Systems include:

• Document management

• Patient monitoring

• Electronic Data Capture

• Regulatory coordinating

The study monitoring plan is important throughout the duration of the study. Regardless of whether the visit takes place remotely or in person, every precaution must be taken to complete thorough monitoring visits. Depending on the type of visit, monitors will meet with study staff, review study documents, query resolutions, training and any other issues that may need attention. These visits include, but are not limited to:

• Pre-qualification visit

• Site Initiation Visit (SIV)

• Interim Monitoring Visit (IMV)

• Close-Out Visit (COV)

Our staff will provide consulting services for your business needs from assisting with internal auditing, training, and/or coordinating and monitoring clinical trials. We also provide mentoring for those that have an interest in clinical research or those who desire to have more knowledge of the different areas of clinical research.