vish14184
★    

India,
2008-01-17 14:43
(6740 d 06:30 ago)

Posting: # 1519
Views: 5,320
 

 Archival Period of Study data [Regulatives / Guidelines]

Post reply
Dear All,

I want to know that what is the archival period of Study documents as Per FDA, ANVISA, EMEA guidelines of BA/BE study?


Regards
Vishal Nakrani
 
MGR
★    

India,
2008-01-17 15:06
(6740 d 06:07 ago)

@ vish14184
Posting: # 1520
Views: 4,628
 

 Archival Period of Study data

Post reply
Dear Vishal Nakrani,

All documents related to the clinical phase of a BA/BE study shall be retained for at least 15 years (as per ANVISA)(ref: ANVISA guideline "volume 1, Module 1: Clinical Step, Page 23 of 25).

Thank you.
—
Regards,
MGR
 
Ohlbe
★★★

France,
2008-01-17 16:11
(6740 d 05:02 ago)

@ vish14184
Posting: # 1521
Views: 4,655
 

 Archival Period of Study data

Post reply
Dear Vishal,

For FDA and EMEA have a look at section 4.9.5. in the ICH GCP guideline.

In addition for Europe look at Directive 2003/63/EC, Part 1, section 5.2.c. (sorry I couldn't make a link to the PDF document).

Regards
Ohlbe
 
vish14184
★    

India,
2008-01-18 07:22
(6739 d 13:51 ago)

@ Ohlbe
Posting: # 1524
Views: 4,508
 

 Archival Period of Study data

Post reply
Dear Ohlbe/MGR

Thanks for reply.

Canada Guideline suggested 25 yr Archival period of study data. IT is possible to maintain good quality of documents for 25 years. I think it is very difficult.
I want to know that what is logic behind the archival period so long as per Canada guidelines?

Thank you

Regards
vishal Nakrani
 
UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
329 visitors (0 registered, 329 guests [including 29 identified bots]).
Forum time: 22:14 CEST (Europe/Vienna)

Try to learn something about everything
and everything about something.    Thomas Henry Huxley

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5