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kaushik089 ★ India, 2012-06-15 10:17 (4711 d 18:02 ago) Posting: # 8740 Views: 10,661 |
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Hello all, How does the validity of the volunteers lab records are determined? I mean the validity of reports are given a 21 or 28 days time for expiry??? Is there any specific guidelines for this? If yes, how it is justified that within these period the volunteer is healthy and can be recruited in a study??? THANK YOU ALL IN ADVANCE. Kaushik Panigrahi Edit: Category changed. Some of your keys seems to be jammed (?, ↑). [Helmut] |
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Helmut ★★★   Vienna, Austria, 2012-06-16 17:46 (4710 d 10:33 ago) @ kaushik089 Posting: # 8759 Views: 9,415 |
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Dear Kaushik! Three to four weeks is by far too long, IMHO. Most European CROs set a limit of ≤14 days; some even to ≤4 [sic] days. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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kaushik089 ★ India, 2012-06-18 08:00 (4708 d 20:19 ago) @ Helmut Posting: # 8765 Views: 9,172 |
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Dear HS, I totally agree with u Mr.HS, but we are following 28 days lab validity period is it acceptable as our SOP supports the same. thanks in advance. kaushik panigrahi |
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drgunasakaran1 ★★  2012-06-18 08:49 (4708 d 19:31 ago) @ kaushik089 Posting: # 8766 Views: 9,215 |
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Dear Mr Kaushik panigrahi, Most of the Indian CROs have either 21 days or 28 days as Screening validity period in their SOP. Since, most of laboratory investigations done during the screening period will not change drastically within a period of 28 days, the validity for Screening Lab Report was kept as 28 days maximum validity period. However, during the Check in period, while performing the clinical examination, if the Investigator finds anything abnormal and if he wants to repeat the laboratory investigations to confirm the clinical findings, the lab reports will be repeated within a period of 28 days. This procedure of repeating the screening lab parameters by Investigator within a period of 28 days need to be captured in your SOP. None of the Regulatory Guidance specify about the screening validity period. — 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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Ohlbe ★★★ France, 2012-06-18 13:49 (4708 d 14:31 ago) @ kaushik089 Posting: # 8767 Views: 9,124 |
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Dear Kaushik, I would agree with Helmut: 28 days is a far too long period. This is a risk both for the study and for the trial subjects. ❝ ...but we are following 28 days lab validity period is it acceptable as our SOP supports the same. Revise your SOP... Regards Ohlbe — Regards Ohlbe |
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kaushik089 ★ India, 2012-06-19 08:23 (4707 d 19:57 ago) @ Ohlbe Posting: # 8786 Views: 9,103 |
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Dear Ohlbe, ❝ Revise your SOP... thank u for your suggestion. Dear Dr. Gunasakaran, HS & others, I want your opinion regarding Mr. Ohlbe's post. thanks in advance, kaushik panigrahi |
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Helmut ★★★ Vienna, Austria, 2012-06-19 17:25 (4707 d 10:54 ago) @ kaushik089 Posting: # 8792 Views: 9,110 |
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Dear Kaushik! ❝ I want your opinion regarding Mr. Ohlbe's post. Totally agree with Ohlbe (as you might have read between the lines in my first post). Think about the tighter limits set by European CROs despite a much lower incidence rate of TB and other infectious diseases (latency period!) than in India. If the lab exam was done four weeks before the first administration a physical exam at hospitalization might not show anything abnormal. Don’t jeopardize the health of volunteers – revise your SOP! — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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kaushik089 ★ India, 2012-06-20 07:39 (4706 d 20:41 ago) @ Helmut Posting: # 8811 Views: 9,129 |
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Thank u Mr. Hs for your valuable opinion, Instead of revising our SOP can we incorporate this in our protocol? Based on the indication of a trial we can set the validity period as of now we only conduct BA/BE studies in healthy population. regards & thanks in advance, kaushik panigrahi. |
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Helmut ★★★ Vienna, Austria, 2012-06-20 16:11 (4706 d 12:09 ago) @ kaushik089 Posting: # 8816 Views: 9,104 |
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Dear Kaushik! ❝ Instead of revising our SOP can we incorporate this in our protocol? Yes, you can. The protocol overrules SOP(s). But this should only be done if the procedure is not Standard. It doesn’t make sense to keep an SOP and define something different in the majority of protocols. In this case: revise your SOP.  ❝ Based on the indication of a trial we can set the validity period as of now we only conduct BA/BE studies in healthy population. You got me wrong. How do you know that subjects are healthy if the pre-study exam was done four weeks before the first administration? If a volunteer acquired an infection in the meantime with no manifest symptoms (i.e., not detectable in the physical exam immediately before the 1st administration) he/she may contract it to other volunteers and/or study personnel. IMHO a screening period of 28 days is unethical. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz