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“Why should I do it” I complained. “I already know GCP” I insisted! After months of negotiations, my line manager was growing weary of trying to persuade me to sign up to the ACRP CRA accreditation. I’ll be honest, it wasn’t exactly my life’s ambition to be able to quote section 6 word for word. However one fateful day in June, following yet another discussion about the benefits of a professional qualification (and having thrown a hint of a potential promotion into the equation) I decided to take the plunge.
Now, all of us who have worked in the industry for a while might consider ourselves to be experts in GCP and as a monitor, I generally expect my site staff to have a reasonable understanding as well. However, haven’t we all been flabbergasted at one point or another when, during a pre-study visit, a would-be investigator asks “what is a sponsor?” Or during a monitoring visit when we discover an entire SAE form covered in Tippex!
And so I accepted that there may be some gaps in my knowledge too and set out to read the guidelines cover to cover… but let’s face it, GCP isn’t exactly a page turner and instead I ended up spending countless evenings playing the Pharmaschool GCP game which although incredibly frustrating, turned out to be also oddly addictive… in fact I’m quite sure it will be the next big thing in the world of online gaming.
Anyway September 16th, 5.36 am (being a CRA I thrive on an early morning start), I boarded the train to Manchester riddled with excitement and just a smidgen of trepidation about what lay ahead. The exam room was suitably depressing and having navigated the prison-like security procedures without too much of a hullaballoo, I cheerfully settled into 3 hours’ worth of multiple choice questions. To this day I still don’t understand the marking system so I’m just going to assume I passed with flying colours.
I proudly returned to the office the following day with my head held high and hailed a hero amongst my peers as fellow CRAs clamoured to ask questions of how I’d survived my ordeal and what they should expect as they took similar steps into the unknown.
But what about the original question I hear you ask…? Have I actually benefitted from becoming accredited…? Well despite my initial reservations and (somewhat obvious) scepticism noted above, I have in fact found this to be an overall positive experience. One week on, I’m certainly far more confident in my knowledge and was surprised by how many things that I do on a daily basis in my work are actually specified in the regulations – perhaps I owe my project manager an apology for all the times I’ve moaned about having to complete a review of the investigator site files… or perhaps I’ll just continue to moan but with a fuller understanding of the reasoning behind it!
It is too early to say just yet, how much of a long term impact this accreditation is likely to have on my career but what I hope it will bring is confidence. Not only in the way of self-assurance but also that those I work with will have greater belief in me too.
And so to the ACRP I must say thank you. As I move forward in my role I will be able support my site staff with an enhanced dimension to my monitoring and never again will a PI be able to say to me “duh, don’t you know that ALL investigators must be medically qualified!” Perhaps going forward I will be able to tell him with added conviction that that is not entirely accurate!
Now, all of us who have worked in the industry for a while might consider ourselves to be experts in GCP and as a monitor, I generally expect my site staff to have a reasonable understanding as well. However, haven’t we all been flabbergasted at one point or another when, during a pre-study visit, a would-be investigator asks “what is a sponsor?” Or during a monitoring visit when we discover an entire SAE form covered in Tippex!
And so I accepted that there may be some gaps in my knowledge too and set out to read the guidelines cover to cover… but let’s face it, GCP isn’t exactly a page turner and instead I ended up spending countless evenings playing the Pharmaschool GCP game which although incredibly frustrating, turned out to be also oddly addictive… in fact I’m quite sure it will be the next big thing in the world of online gaming.
Anyway September 16th, 5.36 am (being a CRA I thrive on an early morning start), I boarded the train to Manchester riddled with excitement and just a smidgen of trepidation about what lay ahead. The exam room was suitably depressing and having navigated the prison-like security procedures without too much of a hullaballoo, I cheerfully settled into 3 hours’ worth of multiple choice questions. To this day I still don’t understand the marking system so I’m just going to assume I passed with flying colours.
I proudly returned to the office the following day with my head held high and hailed a hero amongst my peers as fellow CRAs clamoured to ask questions of how I’d survived my ordeal and what they should expect as they took similar steps into the unknown.
But what about the original question I hear you ask…? Have I actually benefitted from becoming accredited…? Well despite my initial reservations and (somewhat obvious) scepticism noted above, I have in fact found this to be an overall positive experience. One week on, I’m certainly far more confident in my knowledge and was surprised by how many things that I do on a daily basis in my work are actually specified in the regulations – perhaps I owe my project manager an apology for all the times I’ve moaned about having to complete a review of the investigator site files… or perhaps I’ll just continue to moan but with a fuller understanding of the reasoning behind it!
It is too early to say just yet, how much of a long term impact this accreditation is likely to have on my career but what I hope it will bring is confidence. Not only in the way of self-assurance but also that those I work with will have greater belief in me too.
And so to the ACRP I must say thank you. As I move forward in my role I will be able support my site staff with an enhanced dimension to my monitoring and never again will a PI be able to say to me “duh, don’t you know that ALL investigators must be medically qualified!” Perhaps going forward I will be able to tell him with added conviction that that is not entirely accurate!
