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 ..................
Subscribe to:
Post Comments (Atom)
Posts
7 comments:
Vishal started a good debate. In this topic we feel that:
Investigators can’t capture the complete details of the patient in CRF easily, as they are making notes in patient files. If they try to capture the data in CRF as per Good Documentation Practice, that will consume more time. From the source data we can transcribe only the relevant information to the CRF. This process will consume more time and paper works, even though the quality of data generated can be maintained. The bottom copy of NCR CRFs are not that much legible and usually these copies are keeping in sites. In this case for any future reference the source documents will be helpful for auditors/monitors/inspectors etc..
We feel these practical problems may arise while capturing data directly in CRF.
Jayesh & Dilip
This is really interesting topic to discuss here.
As all of us are aware of the ICH GCP requirements related to capturing the study related data. CRF is the document in which we need to capture all relevant trial related details. GCP doesn't talk about the way of capturing information into the CRF directly or indirectly (i.e. transcribed from source data). It's totally depends on us based on what we need? How we can do it?
Hovewer, practically, it might be difficult, sometimes nearly impossible, to capture all the information related to conduct of the study in the CRF directly. Hence, it's always better to have source document other than CRF and later on, transcribe the relevant & the required information in the CRF from source documents. Obviously, this will add burden on the total no. of hours spent for the work done and some other demerits as mentioned by our other colleagues.
However, it has its own merits. Firstly, by trancribing the information from source documents to CRF, we can reduce the risk of reporting erroneous data to regulatory body as during this activity, OC activity is also being done simultaneously. Secondly, We can submit only relevant data and clean data to the regulatory body which will be more reviewer friendly. And hence, it will leads to better understanding and reconstuction of trial related events/activities and as a result,it increases the confidence of regulatory inspectors, which will further accelerate the regulatory approval process....finally, this activity generate the new JOBs for peoples.....seperate data menagement team required to handle the CRF transcription related activities.. this will benefit the society at a glance..as in today's world, it's difficult to generate new jobs....
based on above information, I personally feel to have seperate source documents and CRFs needs to be filled up later on.
Dear friends, I have a question here for you.
Is it necessosary for the investigator to address in the study protocol about what should be considered as "source data" to be used during the conduct of the study ?
Dear All,
It is a great platform to learn more about the subject. I was going through the comments of Rakesh and i really wanted to put my views and get all of your interpretations. Thanks to Vishal for the excellent topic
From my perspective the purpose of source document is to document the existence of the subject and substantiate the integrity of the study. My definition of source documents would also include "original documents related to the trial,history of the subject, previous medical diagonosis etc. Thus it might not be possible to enter all the data directly into the CRF considering the confidentiality aspects.
But i do think that certain details like vital, physical examination can go in directly in the CRF and can be maintained as source data.
I absolutely agree with Rakesh about his views on this.
Please do let me know if I have misinterpreated anything.
Regards
Rahul Mitra
Vishal started really very interesting debate.
If we think practically that is correct that is is very easy for the investigator that directly feel the CRF.
And lots of the investigator is complaining abt that to filling the sourcedata first.
But the major Problem is that if the investigator is filling CRF directly then What about the source data verification.
Actually i m working as a CRA and i m also facing the same problem coz investigator is filling the data in CRF and then study nurse is trascribe in patient's note.
and if there is a problem in the SDV the site is change the data in to the patient's note.
Is is acceptable?
Pls leave yr inputs.
Good post.
Interesting discussion...
As it is already being dicussed, entries can be made directly onto the CRFs however there are certain things to be kept in mind while doing the same. One is that the CRF has to be correctly designed so that the initial data entered is as per requirements of the study and no data is missed out.
Secondly the above mentioned procedure has to be supported with a written procedure either in the protocol or in SOPs
wherein it is instructed that that data can be directly entered in to the CRFs.However there are certain disadvantages too.
Post a Comment