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Varsha ★ 2012-10-31 09:11 (4576 d 04:01 ago) Posting: # 9486 Views: 5,345 |
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Dear all, A subject didn't come for ambulatory samples because he got an AE after check out during washout. The question is whether his period shall be considered as completed or not. Just clarify me whether a period is considered from check-in to check-out or ambulatory samples are also considered as a part of a period. There were three ambulatory samples for the project which he didn't attended. Will these samples be considered as missing samples? Regards, Varsha |
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suchit_bhavsar ★ India, 2012-10-31 10:28 (4576 d 02:44 ago) @ Varsha Posting: # 9487 Views: 4,415 |
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Dear Varsha, Ideal it should be considered that he has not completed period as ambulatory is part of period only. For considering period it depends on the in house adverse event SOP (that all things should cover in the ADVERSE EVENT SOP) Suggestions well come Regards, Suchit Bhavsar Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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Varsha ★ 2012-11-01 12:55 (4575 d 00:16 ago) @ suchit_bhavsar Posting: # 9493 Views: 4,399 |
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thank you for the clarification regards, borsha |
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drgunasakaran1 ★★  2012-11-01 04:25 (4575 d 08:47 ago) @ Varsha Posting: # 9489 Views: 4,464 |
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Dear Mr Varsha, ❝ The question is whether his period shall be considered as completed or not. The period is not completed since ambulatory samples should be considered as part of the study period. ❝ Just clarify me whether a period is considered from check-in to check-out or ambulatory samples are also considered as a part of a period. The Period should be considered from Check-in to Last ambulatory sample collection. ❝ There were three ambulatory samples for the project which he didn't attended. Will these samples be considered as missing samples? These samples should be considered as missing samples. The reason for missing samples should be clearly denoted as "Due to Adverse Event". The adverse event form should be filled for the same. — 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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Varsha ★ 2012-11-01 12:56 (4575 d 00:15 ago) @ drgunasakaran1 Posting: # 9494 Views: 4,383 |
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thanks a lot for the clarification. |
Ing. Helmut Schütz