The Source Document

Way to go!

noreply@blogger.com (Anupama) — Thu, 18 Nov 2010 07:43:00 +0000

Nimita Limaye, VP and global head, strategic data services and medical writing at Siro Clinpharm, has been chosen as the incoming chair of the Society for Clinical Data Management (SDCM).

I read this in Outsorcing-Pharma.com. My first thought -Wow, way to go!

Couldn't help but feeling extremely happy and inspired too.

Got my reasons. First, I have met Nimita a few times, heard her speak and it is no wonder that she reached where she has.

Second, a young woman, and non-North American to be nominated thus, and on her own merits, Wow, she just broke through more than a couple of clichéd (but as always true!) bastions. And at the current moment,she is part of an Indian company!

India has more often than not been projected as a back office for clinical research and outsourcing. And very rarely represented at positions internationally where it could standup and be counted. And back home there exists something of a clique culture (which thankfully too is being outclassed by the new kids on the block!), which does not necessarily foster excellence or innovation, that to thus shine through is phenomenal.

Why is this on my blog?

Coz I am celebrating the future that is here!!!!

Where are the PIs?

noreply@blogger.com (Anupama) — Fri, 18 Sep 2009 12:32:00 +0000

Once ever so often, in public forums/conferences etc of the CR industry in India or behind the scenes discussions, I hear someone or the other raise this concern-The Principal Investigator is THE key player in the clinical trials we do and we hardly ever have Investigators participating/present in CR workshops or conferences. Shouldn’t we ensure that they too attend?

The discussions go round and round and reach nowhere really yet again!!

I don’t know what or how you feel about this but I can’t help but roll my eyes and groan –oh no, not again!!

Drastic reaction, do you think?

My two bits on this is-

1. The PI is not THE key player in CTs! Important yes, THE key to recruitment yes!

But THE key player- is the patient!

How come we are not talking about patient help or support groups and communities to be a thriving part of such gatherings?

Happens in the USA for instance, but very rarely here.

2. The PI (and the ones everyone wants as PIs anyway) are important busy people. Why on earth would they want to attend a conference/workshop that caters nothing for them?

One lone lecture by a KOL does not an important conference make.

If you look at the agenda of any one of the now many conferences that are organised around the country, it solely caters for those in the CR industry and pharma companies.

Why should then a doctor attend????

A gynaec doesn’t attend a conference on arthritis and a dermatologist will not attend one on irritable bowel’s, so why would they attend a conference that talks mostly of things they don’t really need to know. Just curious, How many of the people in CR industry attend Doctor’s conference except if invited as a speaker?

So is it that the twain shall never meet?

Not really, until we as an industry raise awareness about clinical research, its requirements and methodologies where it matters most.

Amongst the medical college graduates and postgraduates, disease support groups and media.

We DO need investigators, and good investigators at that. And we need them today and ten years later too.

We need to build capacity AND capability.

Like it is said that the best time to plant a tree was twenty years back, but the second best time is now.

We should have thought of all our key players ten years back, but nevertheless it is not too late yet.

Before training comes building awareness and the places to start are medical colleges and no not the professors, but the medical student’s, (graduates and post graduates) they are the PIs of tomorrow and more eager to learn and more often than not work as CRCS at academic sites.

Once that happens there automatically would be pressure on the senior docs to know more and be a more active participant to the process.

Then comes focused training of potential sites and PIs.

The current level of well meaning but fragmented efforts at PI training on GCP etc is good but by itself wont achieve the rate and results expected.

I had one grand dad write to me on wanting to find some information about CTs running in India on Duchene’s muscular dystrophy. Garnering the support of and educating Support communities for illnesses such as these makes a lot of sense for bringing the right trial to the right person and helping someone maybe, who is living on little other than hope.

There is a lot waiting to be done, but the number one is to start asking the RIGHT questions!!!

Careers in Clinical Research

noreply@blogger.com (Anupama) — Sat, 14 Mar 2009 10:11:00 +0000

Careers in Clinical Research

CRO is the new BPO, or call it KPO if you like to.

Contract outsourcing by any name or rather many names! Clinical Research, the new career option for the medical, paramedical, life sciences graduates and postgraduates is less about research and more about development.
So les get a few facts straight, It is not about discovering new drugs, not about exciting Eureka moments in the lab for the next best thing in prolonging life, eliminating obesity, zapping cancers, producing designer babies or reading people’ minds!
It is about running trials or collecting, entering, analyzing, reporting data on a day to day basis ,that prove/disprove that the drugs under development are safe and effective for patients.

And you do it the way the regulatory (read govt agencies) ask you to and you do it in a way that your conscience lets you sleep a night of peace.

Which basically means you follow plenty of rules and regulations all the time, (not just when someone is watching) and you learn to deal effectively with data, documents, records, paper, non-paper, some useful, some just plain fanciful!

Oh, So does everyone do this? Allopathic Doctors, Pharamacists, Life sciences people, Physiotherapists, Ayurveds, homeopaths, other graduates?

Ah,Yes! Everyone, except in different shades of green and degrees of separation.

But why am I talking about this? Because every day , my mailbox is flooded with young, bright hopefuls looking for a suitable opportunity in my small company.

What is this suitable opportunity? And what happens after the opportunity comes by?

Here lies the catch. The PGDCR diploma givers tell you that the industry is awash with opportunity, and fat salaries, and charge you a bomb for telling you that.
Being a CRA is what you dream of or its Data management companies you seek.
What they don’t tell you is that the fat salaries happen by and by, not on the first day of your first job and it does not help to jump jobs at the next 5% raise offer that comes along.. What they don’t tell you is that if you have a rock solid degree, which is in demand, you would have still got the great job without the diploma for which you took a loan. What they don’t tell you is that though you all might have done the same course and learnt the same things, the Industry will look at what professional degree you hold prior and offer you opportunities accordingly.
Which essentially means your PGDCR helps but is not the golden key that fits all doors.

But the industry excites you and you still want to be part of it. And it’s a great career you dream of. What do you do and how??
Is there more to this industry than being a CRA and what are the challenges it offers, in my next post.

Till then……

Been a while....too long

noreply@blogger.com (Anupama) — Sat, 21 Feb 2009 08:24:00 +0000

Been a while since I was here last.

Been on my mind though, that I need to get back, more for my own self than anything else. But like all things in life, it is the getting started, the first step which takes the longest, even if it is to some place you have been before.

Much water has flown under the bridge meanwhile.
The clinical Research industry in India has moved forward, backward, and also sideways. Some good, some not so good and some plain difficult to understand!

The industry is growing and has thrown open a lot of opportunities in the last decade, which many of us might not have thought possible. But sometimes we tend to forget that most of this work comes from outside, and was somewhere else yesterday and might go somewhere else tomorrow….. unless!
Unless we strengthen our strengths (What are they?) and work on our weaknesses (why? Do we have any???)

So how about sharing with me, what you think are our strengths and what you think our weaknesses? Would love to hear from you.
Meanwhile, I promise to be here more often, and ask you to drop by too.

Source notes and CRF

noreply@blogger.com (Anupama) — Sun, 02 Sep 2007 13:08:00 +0000

It was good to see the activity happening on this site while I was away.
Vishal’s query generated a lot of interesting threads of conversation with notable contributions from Rakesh, Rahul, Jayesh and Dilip.

I also had a lot of sms queries about the poll and its trends.
Dr Manjunath shared his concerns about the limited choices of imparting GCP training and understanding. He wonders whether apart from learning while working is there anything we can do apart from the workshops that offer GCP training.

Do write with ideas on this. And we will take this up in another blog.

For today, the focus is the source notes vs. CRF debate.
The poll reflected that it is possible and all right to directly record in the CRF, but there were a significant number of poll participants (30%) that felt that source notes are IT! (And by know you would have learnt you can’t ignore stats in Clinical Research!)

So where are we?
Whenever I have asked this question of people, I first get a little lost look, kinda wondering whether this is a trick question or what. It isn’t the same like the one my boss gave me 8 years back, coz by now I have managed to gain a little bit of credibility on my capabilities. Some relief!
But it is a look nevertheless!

The sample responses one gets usually go like this-
1.Sudden onset of selective deafness.
2.Ahem, huh! I guess it depends!
3.Of course one needs source notes for everything on the CRF, how else are we to do Source data verification and then what else will we do during the monitoring visits????

And so the debate goes on and so does the documentation.
If you were to take a spot survey of what is difficult about Clinical trials, the answers one would most likely get are documentation and the unending regulations.

Increasing and excessive documentation seems to have become the norm of CR life.
Document what you do and do what you document has become Do what you document and Document what you do, but remember to transcribe all!!

Lets examine what GCP and the regulations demand.

Section 6.4.9 of ICH GCP asks for -The identification of any data to be recorded directly on the CRFs (i.e., no prior or written or electronic data), and to be considered source data.

This section is part of 6.4 that details the trial design in the Clinical Trial Protocol.

In Chapter 8 which lists the Essential Documents for the conduct of clinical trials,the purpose of source documents is described as "to document the existence of the subject and substantiate integrity of trial data collected.To include original documents related to the trial,to medical treatment,and history of subject" and these source documents are to be located at the investigator site.

Further,the purpose of signed,dated and completed CRF s is described as" To document that the investigator authorized member of the staff confirms the observations recorded.The CRF itself is described as a document to record all of protocol-required information to be reported to the sponsor on each trial site.But protocol specific information does not necessarily create a complete audit trail.

You will agree with me that a good document follows ALCOA, i.e it is Attributable, Legible, Contemporary, Original, and Accurate and the whole purpose of documentation is to have a complete audit trail in order to reconstruct the trial to ensure that the data is credible and verifiable and that the trial was conducted as per norms(GCP,Protocol etc.)

So far, so good!

And now come our individual interpretations, FDA Folklore, sponsor/CRO specific SOPs and sometimes believe it or not individual wish lists!

Like Vishal puts it, we complicate our trials, increase documentation, add to time lines(more QC checks, QA time, DCF query resolution and all), add to costs(manpower,archival space).

The way out?

We need source notes for all critical endpoints. this would be Medical records and case histories, drug dispensing, informed consent procedures, lab results, IRB approval letters etc, which are not part of CRFs usually, but yes protocol related observations can definitely be directly entered on to the CRFs. The condition that would need to be fulfilled is that this would need to be stated prior in the protocol as per section 6.4.9 of GCP as part of trial design.

Apart from this, the CRF would need to be simple to understand and fill and designed to capture only the essential information related to the trial so as to minimise the need for transcription.

The investigator and site staff would need to understand the importance of ALCOA and be trained on good documentation and record maintainence and retention practices.

There is no FDA regulation or guideline that states that all data in the CRF must be duplicated in another location, or source document.
With the advent of e-trials more and more of source information would be directly entered in to the computer systems and as long as they are 21 CFR part 11 compliant would be able to serve as both source notes and CRF if designed accordingly.

The idea is to think ahead,plan accordingly and design well and thy duplication will be done,I mean down!

I would recommend that you also check out these two very excellent ppt presentations made by Stan Woollen ,who was the director of sceintific investigations at the USFDA and a senior person at the GCP program run by the USFDA.

1.Can less really be more?Source Documentation in Clinical Trials. http://raninstitute.com/PDF_PP_Docs/Can%20Less%20Really%20Be%20More%20ACRP%20April%206,%202005.ppt

2. The facts about Source Documents. www.fda.gov/cder/present/dia-699/wollen-dia99/wollen-dia99.ppt

The poll was reflective of our discussions where majority of the voters did feel that it is alright to capture data directly on to the CRF.However, it is not as simple as that and capturing data directly on to the CRF would require some planning, incorporation in the study design and training at the investigator site before you have data that stands upto regulatory rigor.

And though the CRF may double up as source notes or vice versa,at some places they are both indespensable and the art is in making a science of that!

Will leave you till next time then and hope to keep the buzz alive.

P.S-There are some queries yet unanswered by me and will do so in a while.Todays post is dedicated to the memory of Mom,who was one of the first visitors to my blog ,but would not be coming here anymore.

To you Mom.

Vishal's Comment

noreply@blogger.com (Anupama) — Sun, 19 Aug 2007 07:41:00 +0000

Hi,
Vishal's comment on CRF and source notes appears at the end of Wednesday'S log on 'What is ICH'.

Source Notes and CRF

noreply@blogger.com (Anupama) — Sun, 19 Aug 2007 07:30:00 +0000

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 ..................

What Is ICH?

noreply@blogger.com (Anupama) — Thu, 16 Aug 2007 05:02:00 +0000

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

About the Source Document

noreply@blogger.com (Anupama) — Tue, 14 Aug 2007 10:58:00 +0000

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