Resources

Guidelines for Electronic Submissions Via Email-EPR Guidelines

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 (…

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

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

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

.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.

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

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

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

DAIDS protocol specific informed consent template—general use.

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

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…

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.

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…

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).