Investigator Initiated Trials: Common Quality Oversights & Effective Corrective Actions

Many factors can influence the quality of a clinical trial. Those that follow good clinical practice (GCP) adhere to universal scientific and ethical quality standards. Successful trials develop a system of tracking quality issues through all stages of the study—design, conducting, recording and reporting. Trials that don’t may run into delays and compliance issues that call into question the study’s legitimacy.

Here are common quality oversights and how to avoid them:

Compromised or missing data.

The foundation of a successful trial is the accuracy and credibility of its data. Set up a process to ensure all team members are obtaining and tracking data in a consistent way. Integrity checks can identify impossible or internally inconsistent data entries. Keep a close eye on it with a clinical trial management system that brings the data together with enrollment, budget, regulatory and other buckets under one roof. Study data are integrated with the other elements of the database, reducing errors and improving overall quality.

Failure to ensure the safety of human subjects.

In trials involving human subjects, safety is the top quality issue. Patients expect their rights, integrity and confidentiality to be protected. It starts with informed consent documents that are written in easy to understand language and provide a thorough accounting of the trial process, its potential risks and benefits, and the role of the patient in the trial. Build a workflow of checks and balances to ensure the study is following regulatory requirements around patient safety. You can do this easily with a CTMS and eClinical solutions that automate administrative workflow processes, ensuring that all patient history paperwork is filed consistently and electronically for easy access and correct versioning

Incorrectly handling biospecimens.

Missing or mixed up samples, incomplete data and other quality missteps can lead to higher costs, patient drop-off and study quality concerns. You can ensure specimens are managed correctly during handling, transport and storage with a logistics strategy that includes a documented chain of custody. Take advantage of collection kits and other tailored clinical supplies that make the job easier.

Problem areas or bottlenecks at any point in the research process may pose a compliance risk. With CTMS reporting tools, you can more easily identify these concerns—and improve the quality of your trial.

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