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Friday September 3, 2010

  • Reporting Information Regarding Falsification of Data

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  • Guidance for IRBs, Clinical Investigators, and Sponsors

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  • Guidance for the conduct of GCP inspections

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  • 21 CFR Part 50 Informed Consent Elements

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  • EMEA-FDA GCP Initiative

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  • FDA IRB Registration Rule

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  • Study data may be fake.

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  • Biosearch Moniotring Information System (BMIS) File.

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The Clinical Research Quality Assurance Expert's Expert Sourcesm

Lodging

Hotels for Scheduled Dates in Clark, NJ

Crowne Plaza
36 Valley Road
Clark, NJ 07066
Tel: 732-574-0100
Fax: 732-815-0661

Room rates are $139.00 per night and should be booked directly with the hotel. Please make your reservation 21 days in advance and mention The Quality Research Training Institute to take advantage of the reduced rate.

Directions:

From New York - Take the NJ Turnpike to exit 14. Take Route 78 West to the Garden State Parkway South to exit 135. Bear left off exit; go around the circle to the fourth exit on the right to Valley Rd. (towards Linden/Rahway). The Crowne Plaza is on your left.

From the Garden State Parkway: North or South

Take Exit 135 stay left - Northbound, take 2nd exit off circle - Southbound, take 4th exit off circle, Crowne Plaza is on your left.

From the NJ Turnpike - North or South

Take exit 11 to GSP North and follow above directions.