The Importance Of Pre-Screening In Clinical Research
the Medical Records of the potential subject and make sure they are RECEIVED and reviewed PRIOR to Visit 1. Why is this so important? Having the Medical Records in advance is proactive and could prevent Protocol Deviations. The Inclusion/Exclusion of any protocol is not only there for collecting the data we need for the study, but more importantly is there for the safety of the subject. We do not want to enroll a subject into a study that does not met the Inclusion/Exclusion criteria. These criteria’s have been set in advance for the safety of the subject and it is vital that each potential subject met these criteria’s. There are two ways to find out Medical History of a subject, one is with Medical Records and the other is by the subject self-reporting. Therefore to be vigilant we need to do both, receive and review the potential subject’s Medical Records and have a good througral conversation with the potential subject prior to having them come in and enroll into the study.
Prior to Visit 1, all the Inclusion/Exclusion criteria’s can be met with the exception of Inclusion #10 and #11. As mentioned above this is done by receiving and reviewing the Medical Records and talking with the potential subject prior to Visit 1.
Sometimes collecting the Medical Records can seem as a daunting task, but we have some great tips to streamline the process. If the potential subject is new to you (referred by the marketing firm or by another physician), you can email or fax a Medical…