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Articles from BioResearch Compliance Report (January 1, 2006)

1-11 out of 11 article(s)
Title Author Type Words
2 SFBC execs quit as Sen. Grassley seeks answers in alleged mistreatment of subjects. Pickett, Joseph 527
2,200 FWAs renewed/updated in 2005; no extensions planned by OHRP. Pickett, Joseph 289
BiMo inspection FOIA log. 171
Clean report for clinical investigator Gonzales. Gonzales, Christine Brief article 315
Consent, documents, missing signatures, top clinical site faults: Quintiles exec. Pickett, Joseph 534
Coury cited in 2-item 483 for not following investigational plan. Coury, Daniel 633
FDA releases 2 guidance docs to improve efficiency of early-stage drug development. Pickett, Joseph 1031
Getting letter in file helpful in case FDA changes mind or audits site. 607
Minor documentation errors noted for Lesem, but no 483 issued. Lesem, Michael 378
Strong QA system improves data, which in turn boosts performance of entire trial site. 464
Warning letters. 257

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