The Mentality Of Pre-Study Visit By George Bernard Shaw
Pre-Study Visit
“Progress is impossible without change, and those who cannot change their minds cannot change anything”. Words of one of the world’s greatest playwrights, George Bernard Shaw. Indeed, one might think that after hearing such negative comments about the site, no one would even dare to attempt having the site participate in the study. But who is to say that within this seemingly short period of a year that the site has not learnt from its mistakes and picked itself up from there? We must first strive to understand the mentality of the Principal Investigator (PI), Professor Chan, before jumping to any conclusions.
Upon meeting the PI, first strive to understand more about his background and ideals. Take a peek into his mind and see what are his goals for conducting clinical studies. Lofty aspirations aside, see and decide if the PI has the heart for his patients and would place them as the focus of what he does. This is a crucial step in making the site a good one to work with. Find out if the PI has attended any Good Clinical Practice (GCP) training and ask for a copy of his Curriculum Vitae and GCP certificate. This would help in determining if it was negligence which caused those inspection findings or simply a lack of training. Simple questions such as who would he ask to conduct …show more content…
As such, find out if the site has a system to monitor the temperature of drugs and if qualified pharmacists at the site are able to help with the dispensation and drug accountability. Assuming that the PI has managed to arrange for a Pharmacy Visit, grab this chance to see the Pharmacy’s facilities and find out if they have any Standard Operating Procedures (SOPs) for drug receipt, storage, maintenance and destruction. Check out the areas for drug storage and see if the drugs are stored separately from each other and clearly labelled to prevent any mixup or wrong
“Progress is impossible without change, and those who cannot change their minds cannot change anything”. Words of one of the world’s greatest playwrights, George Bernard Shaw. Indeed, one might think that after hearing such negative comments about the site, no one would even dare to attempt having the site participate in the study. But who is to say that within this seemingly short period of a year that the site has not learnt from its mistakes and picked itself up from there? We must first strive to understand the mentality of the Principal Investigator (PI), Professor Chan, before jumping to any conclusions.
Upon meeting the PI, first strive to understand more about his background and ideals. Take a peek into his mind and see what are his goals for conducting clinical studies. Lofty aspirations aside, see and decide if the PI has the heart for his patients and would place them as the focus of what he does. This is a crucial step in making the site a good one to work with. Find out if the PI has attended any Good Clinical Practice (GCP) training and ask for a copy of his Curriculum Vitae and GCP certificate. This would help in determining if it was negligence which caused those inspection findings or simply a lack of training. Simple questions such as who would he ask to conduct …show more content…
As such, find out if the site has a system to monitor the temperature of drugs and if qualified pharmacists at the site are able to help with the dispensation and drug accountability. Assuming that the PI has managed to arrange for a Pharmacy Visit, grab this chance to see the Pharmacy’s facilities and find out if they have any Standard Operating Procedures (SOPs) for drug receipt, storage, maintenance and destruction. Check out the areas for drug storage and see if the drugs are stored separately from each other and clearly labelled to prevent any mixup or wrong