suchit_bhavsar
★    

India,
2012-11-19 13:36
(4958 d 15:29 ago)

Posting: # 9551
Views: 5,505
 

 Replacement of the subject [Study Per­for­mance]

Hello to All,

If in-house SOP define that "we can replace the subject with another eligible subject after the allotment of subject no. in period 1" so what will be the procedure for the same (i.e labels of vaccute, labels of vials, label of investigational product container etc)

Suggestions well come

Thanks with Regards,
Suchit Bhavsar
drgunasakaran1
★★  
avatar

2012-11-19 14:57
(4958 d 14:09 ago)

@ suchit_bhavsar
Posting: # 9552
Views: 4,611
 

 Replacement of the subject

Dear Mr Suchit Bhavsar,
The procedure for changing the labels of vacutainers, labels of RIA vials, labels of IP container should be clearly captured in the same In-house SOP for making the above labels for the replaced subject. Usually, the replaced subject will be assigned a new subject no. S01-R, R indicating that he/she is a Replaced subject and the same Subject ID (S01-R) will be followed in the labels. The reason for replacement should be captured in the Subject ID allotment logbook/Form.

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
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