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Guidelines for Electronic Submissions Via Email-EPR Guidelines

Guidelines for Electronic Submissions Via Email-EPR Guidelines

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HEC Placebo Gel

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Hepatitis B Vaccine Recombinant (Engerix-B)

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Hepatitis B Vaccine Recombinant, Adjuvanted (Heplisav-B)

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Hepatitis B Vaccine Recombinant, Adjuvanted (Heplisav-B) Investigator's Brochure

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High Level Summary of Changes for the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0

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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HIV-1 Multiantigen pDNA Vaccine and Human IL-12 pDNA

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HPTN - Expedited Reporting to DAIDS and DAERS Refresher

.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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HVTN - Expedited Reporting to DAIDS and DAERS Refresher

.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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IBC RAC Guidance

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

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IHV01

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Imatinib Mesylate Package Insert

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IMPAACT - Expedited Reporting to DAIDS and DAERS Refresher

.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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IND Protocol Lists

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

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Instructions for Authorization and Transfer of CRFs and Pharmacy Records to the DAIDS RSC

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Instructions for Authorization and Transfer of CRFs and Pharmacy Records to the DAIDS RSC

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

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Instructions Page for the DAIDS Protocol Specific Informed Consent Template 2/23/2016

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

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Instructions Page for the DAIDS Protocol Specific Informed Consent Template 7/24/2013

DAIDS protocol specific informed consent template—general use.

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Instructions Page for the DAIDS Sample Informed Consent Template - Stored samples and Associated Health Information for future Research Use

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

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Intralipid

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Isentress (raltegravir) Tablets, oral suspension, Package Insert

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

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Isoniazid Tablet Package Insert

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Isoniazid Tablets, USP Package Insert

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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Lamivudine (Epivir)

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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