hey guys ECR G here back with another episode
today we're gonna be talking about what is source document review or SDR now
this is different from SDV I'm gonna do a completely different video on STV and
source data verification but source document review is something that see
arrays do on-site or good CRA should do on-site a lot of times it does not get
done a lot of times CRA is just do s DV source static document verification so a
lot of people have heard about that you know 100% s DV or 70% s DV you may have
heard about that risk based monitoring but lesser known is SD our source
document review and I'm gonna give you guys a definition of what that is right
here so SDR is defined as the review of source documentation to check on quality
compliance staff involvement in other areas that aren't associated with a CRF
data field so this is when you go on site when a CRA goes on site and this
has to be conducted when you have the source documentation so it's and this
source documentation is only held on site and a site is going to use that
source document source documents to upload information key information from
that source documents into the CRF field that's an EDC system like metadata rave
so they're gonna use information from those source documents to input data
that the data management and the study team wants in metadata rave or other EDC
platforms so what is source tech document review what does the CRA have
to do with this well there are a bunch of documents in
source documents that are they're gonna be like fields maybe summary pages that
the study coordinator is gonna fill out that are gonna document some of the
testing that's been done maybe put in some of the key lab values and things
like that but the thing is though there's the trend transcription errors
errors can happen so when you've got a point you
get a printout from an EKG machine and they want you to input that information
on to another source document like like a you know a paper that has like key
fields on it there can be some transcription errors or let's say let's
say you know there's a patient has a diary log and they list some headaches
constipation they list some of those things which could be considered a ease
adverse events lately list those on there and those aren't transcribed to
the AE low the AE log or they're not transcribed to the physician didn't talk
about them in their physician notes so it's up to the CRA to reconcile all
these things to cross-check you need to connect the con meds log they need to
check the AE log they need to see if the doc has mentioned it in their progress
notes or the study coordinator has mentioned in their progress notes they
need to check the patient's diary to see if they talked about it there so all of
this has to be cross-checked with each other and that's what's called source
document review it is the cross-checking and reconciling of source documents to
make sure the information lines up and that a story can be you know made
available that a story and that everything makes sense in the series
mind and in the study teams mind so that is source document review and that is
something that not a lot of see arrays do all the time and they really should
because you catch a lot of mistakes that are made you catch a lot of things that
happen in the study when you do good source document review and really it
should be done before source data verification that's why I'm doing this
video beforehand the sort the SDV video source document review should be done
before SDV because by the time it goes into the CRF then you've got to issue
queries and all that stuff so you really want to catch these mistakes and
reconcile these differences before it even makes it into the EDC if possible
although a lot of times that's not possible because study coordinators are
inputting data you know right before you come on site and things of that nature
but you definitely want to make sure that you know these errors are checked
and proper things happen whether it's protocol deviations whether it's action
items or queries later on down the line so that is source document verification
hope that was I hope that explained that well hope you got get an idea this is
something that you really if you haven't had any interaction with source
documents whether you're not a study coordinator or maybe your study doesn't
have any electronic source documents review available available or you know
if your CRA you would know about this but this is this may be a little bit
hard to understand if you haven't been on site before and that's just the
nature of it so try and try and go on site before if you haven't then this
will make a lot more sense so hope this video was great guys as always email me
Ali clinical group at gmail.com for any increases you may have resume review
program any kind of interview prep maybe you guys are interested in that email me
there take care
you