You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
No matter your role in clinical research, you may encounter issues that require further investigation.
For instance, imagine you realize two medical devices are missing. You eventually find them, but in the meantime you're concerned they could have been accidentally implanted into patients who were not study participants.
Anytime you encounter a serious process-level issue, you should investigate the cause and create a corrective and preventive action plan, known as a CAPA.
Topics: CAPA
I love the straightforward definition this website provides on CAPA. “Simply put, Corrective Action is based on a nonconformance event that has happened in the past. Preventive Action is based on preventing a nonconformance event in the future. Both are similar procedurally, but with the focus as described. Together, Corrective and Preventive Actions are integral parts of a continuous improvement program.”
Topics: CAPA, Corrective and Preventive Actions, FDA