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Guidelines for Electronic Submissions Via Email-EPR Guidelines

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The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 contains a number of changes detailed below when compared with the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 – December 2004 (…

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.zip files contains Presentation to HPTN/IMPAACT Annual Meeting on Expedited Reporting to DAIDS and DAERS refresher course Expedited reporting via DAERS - Case Study

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.zip file contains: Presentation to HVTN Annual Meeting on Expedited Reporting to DAIDS and DAERS refresher course; Expedited reporting via DAERS - Case Study

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Guidance and requirements for daids-supported research involving recombinant DNA.

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.zip files contains: Safety training presentation on expedited reporting to DAIDS and a refresher on DAERS Case study handout Meeting for HPTN and IMPAACT networks was held June 2016.

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List of IND protocols having CRF/Pharmacy records that will not be stored by DAIDS.

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Instructions for the transfer of case report forms, (CRF) and pharmacy records to the DAIDS regulatory support center, (DAIDS RSC).

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Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.

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DAIDS protocol specific informed consent template—general use.

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Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.

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ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated: * In combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 4 weeks of age and older (1). The use of other active agents with ISENTRESS is associated with…

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Isoniazid is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, lactose monohydrate, pregelatinized starch (corn), povidone and stearic acid.

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The following side effects have also been associated with use of lamivudine: If you are infected with both Hepatitis B and HIV, you should be aware that your liver function tests may increase, and symptoms associated with hepatitis (an acute inflammation of the liver) may worsen if lamivudine is…

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HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV).

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