suchit_bhavsar ★ India, 2012-11-19 13:36 (4556 d 23:39 ago) Posting: # 9551 Views: 4,492 |
|
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 ★★ ![]() 2012-11-19 14:57 (4556 d 22:19 ago) @ suchit_bhavsar Posting: # 9552 Views: 3,811 |
|
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 |