Hi,
Vishal's comment on CRF and source notes appears at the end of Wednesday'S log on 'What is ICH'.
Sunday, August 19, 2007
Source Notes and CRF
Vishal has posted a very relevant and interesting question today.
He wants to know whether data generated in clinical trials can directly be recorded onto the CRF,or is it always necessary to generate Source note for everything and then transcribe data into the CRF.
I would invite you to read his very interesting and well written comment and post in your views on the topic.
I have also added a poll on this very pertinent poser in this blog and lets see what surprises it brings.
Do invite your friends in the industry to participate and make it cross sectionally relevant.
Help me create the buzz!!!
Will post about this once the poll gets over. Till then, I too am curious ..................
He wants to know whether data generated in clinical trials can directly be recorded onto the CRF,or is it always necessary to generate Source note for everything and then transcribe data into the CRF.
I would invite you to read his very interesting and well written comment and post in your views on the topic.
I have also added a poll on this very pertinent poser in this blog and lets see what surprises it brings.
Do invite your friends in the industry to participate and make it cross sectionally relevant.
Help me create the buzz!!!
Will post about this once the poll gets over. Till then, I too am curious ..................
Thursday, August 16, 2007
What Is ICH?
It started about 8 years ago when I walked into my then boss's office and asked him what is this GCP ?
Here I was a practicing physician (since 5 years then) and now a consultant physician for this Upcoming CRO. I remember the aghast look on his face (probably reflecting on the uphill task he faced in setting up his dream if all he had were people like me!) and said -"you don't know?"
"Obvious isn't it,"said I,a little taken aback with this violent display of emotion.
"Good Clinical Practice ."-said he through clenched teeth.
"Aha,"said a very relieved me,"I know about that,I have a clinical practice and its doing very Good,but what I don't understand is why do you have to send people to workshops to do that?
How does it help?"
By now his face was changing colours and am sure his B.P up a notch or two and I decided to beat a hasty retreat and try finding out for myself.
So ,I did find out that it is a set of Guidelines (in fact many sets of guidelines-Internationally harmonised and yet ironically country specific sets too,) which clinical investigators and their teams promise to comply to when conducting research, to ensure patient safety and data credibility.
That was then ,and this is now.
Much water has flown under the bridge and almost everyone in this industry knows about ICH GCP.
About GCP that is , but knowing or understanding GCP, well, that is another question!
Now I conduct several training workshops around the country,including ones on ICH GCP.
One of the questions that I almost always ask while in there is -What does ICH in ICH GCP stand for?
More often than not ,the looks that I receive are quite akin to the one my ex-boss gave me that morning 8 years ago.
Is this a question or what?
And the answer I get almost in unison is-International Conference for Harmonisation!
Satisfied faces all around!
'Great'' say I ,"and what are we harmonising ?The arts,the science,mp3 formats or the blueness of blue jeans worldwide? What is it that this International Conference of Harmonisation seeking to harmonise?"
It is rare that I have somebody instantly answer-It is the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for human use.
No,I am not suggesting that one needs to be memorising all abbreviations to be knowledgeable ,all I am driving at is the need for some native curiosity ,to wanting to know more than the information that is supplied ,to seek,to question ,to analyse......basically to research!
Isn't that what Clinical Research is supposed to be about?
But how much of the clinical research industry in India is research and how much of it is just an industry......is another blog away.
Meanwhile do write to me and if you would have an any GCP issues that you would like to discuss,feel free to ask.
I would love to be able to help you.
Anupama
Here I was a practicing physician (since 5 years then) and now a consultant physician for this Upcoming CRO. I remember the aghast look on his face (probably reflecting on the uphill task he faced in setting up his dream if all he had were people like me!) and said -"you don't know?"
"Obvious isn't it,"said I,a little taken aback with this violent display of emotion.
"Good Clinical Practice ."-said he through clenched teeth.
"Aha,"said a very relieved me,"I know about that,I have a clinical practice and its doing very Good,but what I don't understand is why do you have to send people to workshops to do that?
How does it help?"
By now his face was changing colours and am sure his B.P up a notch or two and I decided to beat a hasty retreat and try finding out for myself.
So ,I did find out that it is a set of Guidelines (in fact many sets of guidelines-Internationally harmonised and yet ironically country specific sets too,) which clinical investigators and their teams promise to comply to when conducting research, to ensure patient safety and data credibility.
That was then ,and this is now.
Much water has flown under the bridge and almost everyone in this industry knows about ICH GCP.
About GCP that is , but knowing or understanding GCP, well, that is another question!
Now I conduct several training workshops around the country,including ones on ICH GCP.
One of the questions that I almost always ask while in there is -What does ICH in ICH GCP stand for?
More often than not ,the looks that I receive are quite akin to the one my ex-boss gave me that morning 8 years ago.
Is this a question or what?
And the answer I get almost in unison is-International Conference for Harmonisation!
Satisfied faces all around!
'Great'' say I ,"and what are we harmonising ?The arts,the science,mp3 formats or the blueness of blue jeans worldwide? What is it that this International Conference of Harmonisation seeking to harmonise?"
It is rare that I have somebody instantly answer-It is the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for human use.
No,I am not suggesting that one needs to be memorising all abbreviations to be knowledgeable ,all I am driving at is the need for some native curiosity ,to wanting to know more than the information that is supplied ,to seek,to question ,to analyse......basically to research!
Isn't that what Clinical Research is supposed to be about?
But how much of the clinical research industry in India is research and how much of it is just an industry......is another blog away.
Meanwhile do write to me and if you would have an any GCP issues that you would like to discuss,feel free to ask.
I would love to be able to help you.
Anupama
Tuesday, August 14, 2007
About the Source Document
One of the oft used words in any clinical trial.The Source Document!
Helps track the conduct of any trial,leaves an audit trail to help reconstruct,evalute and hopefully also learn from all that happened during the trial.
This is what I'll try to do with this blog.
Pick up pieces from what is now the blazing trail of the clinical research industry in India.Where we shine,shimmer,or sometimes just gloss over.
The buzz about what the industry is,what it is great at and the paths it could explore. The story of the Research Industry ,so far and then go further!
Come walk with me and share your experiences,views,angsts ,hopes and I will share with you ,mine.
Be seeing you often!
Anupama
Helps track the conduct of any trial,leaves an audit trail to help reconstruct,evalute and hopefully also learn from all that happened during the trial.
This is what I'll try to do with this blog.
Pick up pieces from what is now the blazing trail of the clinical research industry in India.Where we shine,shimmer,or sometimes just gloss over.
The buzz about what the industry is,what it is great at and the paths it could explore. The story of the Research Industry ,so far and then go further!
Come walk with me and share your experiences,views,angsts ,hopes and I will share with you ,mine.
Be seeing you often!
Anupama
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