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Saturday, November 1, 2008

Clinical Trial Registry India: Who takes responsibility

by Mann 0 comments

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As we know now Indian Government is planning to make mandatory the registration for CROs and clinical trials conducted by them, I decided to have a look on the current Clinical Trial Registry-India (CTRI). CTRI can be reached at www.ctri.in.

 

CTRI has setup 31 items need to be filled while registering a trial. Details can be downloaded from http://www.ctri.in:8080/Clinicaltrials/CTRI_Dataset_and_Description.pdf . Out of 31 items, 21 are WHO data set items, 1 0 additional items required by CTRI has to be filled. 7 Items are mandatory out of 31 for regis

tration process. The mandatory Items required by CTRI are as follows:

 1. UTRN

2. Public Title of Study

3. Scientific Title of Study

4. Name of Ethics Committee and approval status

5. Regulatory Clearance obtaine

d from DCGI

6. Status of Trial

7. Phase of Trial

 Now let’s have a look on this High purpose CT

RI website which, I assume, has never been reviewed by authorities after its appearance on web. CTRI is going to serve in same way as clinicaltrial.gov does in US. While going th

rough the CTRI official website, I came across many typo errors which of course put a question mark on its quality & credibility.  This is the snapshot of FAQs page of CTRI.

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In this digital era, internet has become primary and quick source of information. If I need information about any company, I‘ll search on int

ernet, want to know the price of some goods, I‘ll prefer to have an idea from e-bay or amazon. What I mean to say is a website serves as a window item in showroom which gives the visitors an idea about what quality of stuffs they can get inside the showroom. If showroom exhibit any roadside shoe in window, you don’t expec

t they are gonna provide Nike or Reebok inside.

 This one is snap shot of CTRI Dataset Description Document which anyone can download from CTRI official website. Have a Look:

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The site is on web since more than one and a half years but who the hell cares as its all about in  public interest and not any commercial entity. CTRI authorities never took care about have a close look now and then. One can say these are minor things and can be avoided but each and every mistakes have their own impacts. We can hope things will be on track shortly. 

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