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kiranActimus ☆ India, 2009-07-21 12:41 (5775 d 19:07 ago) Posting: # 3972 Views: 5,432 |
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Dear All During the screening of volunteers, does the screening tests (like Clinical chemistry, Hematology, serology and other study specific tests) need to be performed in a accredited Diagnostics or we can perform the tests at inhouse diagnostics? Kindly suggest me if there are any specific regulatory requirements for performing screening tests of volunteers Thanks in advance Regards Kiran |
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khorjuvekar ☆ India, 2009-08-09 22:12 (5756 d 09:37 ago) @ kiranActimus Posting: # 4024 Views: 4,133 |
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Dear Kiran, NABL is mandatory for trials as the clinical consistency in the results would be comparable to global labs. Central Laboratory Services are a paramount component of a clinical trial. Although there is no regulatory requirement for central laboratory, the requirements of ICH GCP (data quality, documentation of procedures and document control) mean that central laboratory facilities are useful as part of integrated clinical trial procedures. The criteria for selecting central laboratory are: * Adherence to Good Laboratory Practice (GLP) * Accreditation by a reputed international organisation eg. College of American Pathologists (CAP) * Accreditation in India by National Accreditation Board for Testing and Calibration Laboratories (NABL) * Quality assurance * Staff training * Efficiency of processing samples * Speed of services * Networking and transport of samples * Past track record/ experience in a clinical trial. You can perform the testing inhouse provided your laboratory is having NABL accreditation. 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! [Helmut] |
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kiranActimus ☆ India, 2009-08-10 12:17 (5755 d 19:32 ago) @ khorjuvekar Posting: # 4028 Views: 4,018 |
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Dear Khorjuvekar, Thanks for your valuable suggestion. Thanks& regards KK |
Ing. Helmut Schütz