The importance of pre-screening
As we all know in Clinical Research providing qualified subjects, clean/good data and the safety of our subjects is of the utmost important. Therefore it is vitally important to complete a thorough pre-screening of each potential subject. In order to do this the following should be done;
Request 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 …show more content…
If the potential subject is new to you (referred by the marketing firm or by another physician), you can email or fax a Medical Release Form to the potential subject to complete and send back to your site or they can take it to their physician themselves and have the records sent to you. Either way, get the potential subject involved in helping collect their own Medical Records. If the subject knows that you must receive the Medical Records first to review, they will be very helpful in making sure they get to you in a timely manner. If your institution does not allow you to send out a Medical Record request in advance of the subject signing the ICF, then you could have the potential subject sign a Medical Records release form that is provided by their PCP or ENT/Otolaryngologist office and have the records sent to you. If the records are not received in a few days, either call the office they were ordered from or better yet, call the potential subject and let them be the “squeaky wheel” that keeps calling the physician’s office to have them sent as soon as
As we all know in Clinical Research providing qualified subjects, clean/good data and the safety of our subjects is of the utmost important. Therefore it is vitally important to complete a thorough pre-screening of each potential subject. In order to do this the following should be done;
Request 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 …show more content…
If the potential subject is new to you (referred by the marketing firm or by another physician), you can email or fax a Medical Release Form to the potential subject to complete and send back to your site or they can take it to their physician themselves and have the records sent to you. Either way, get the potential subject involved in helping collect their own Medical Records. If the subject knows that you must receive the Medical Records first to review, they will be very helpful in making sure they get to you in a timely manner. If your institution does not allow you to send out a Medical Record request in advance of the subject signing the ICF, then you could have the potential subject sign a Medical Records release form that is provided by their PCP or ENT/Otolaryngologist office and have the records sent to you. If the records are not received in a few days, either call the office they were ordered from or better yet, call the potential subject and let them be the “squeaky wheel” that keeps calling the physician’s office to have them sent as soon as