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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.
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
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
Complete thread:
- volunteers lab data validity period kaushik089 2012-06-15 08:17 [GxP / QC / QA]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- As short as possible Helmut 2012-06-16 15:46
- As short as possible kaushik089 2012-06-18 06:00
- As short as possibledrgunasakaran1 2012-06-18 06:49
- As short as possible Ohlbe 2012-06-18 11:49
- As short as possible kaushik089 2012-06-19 06:23
- As short as possible Helmut 2012-06-19 15:25
- As short as possible kaushik089 2012-06-20 05:39
- As short as possible Helmut 2012-06-20 14:11
- As short as possible kaushik089 2012-06-20 05:39
- As short as possible Helmut 2012-06-19 15:25
- As short as possible kaushik089 2012-06-19 06:23
- As short as possible kaushik089 2012-06-18 06:00
- As short as possible Helmut 2012-06-16 15:46
Ing. Helmut Schütz