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Etoposide (Vepesid) Soft Capsules, Package Insert

Vepesid is used in the treatment of certain types of cancer, in particular small cell lung cancer and testicular cancer.

Etravirine (Intelence) Risk List

The following serious side effects have been associated with the use of etravirine:

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Etravirine (Intelence) Risk List

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Etravirine (Intelence) Tablets, Package Insert

INTELENCE® is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor(NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older with viral strains resistant to an NNRTI and other antiretroviral agents.

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Etravirine (TMC125, Intelence) Investigator Brochure

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Example SOP for Obtaining Informed Consent

Purpose: To define general informed consent procedures. Scope: This procedure applies to all staff involved in obtaining informed consent. (Adapted from the Microbicide Trials Network)

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Example SOP for Obtaining Informed Consent in Research Involving Children

Purpose: To define informed assent/permission/consent procedures for potential participants who are children. Scope: This procedure applies to all staff involved in obtaining informed assent, parental permission, and consent when children are research participants.  (Adapted from the…

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Financial Disclosure Form for HPTN, January 2021

Clinical investigators disclosure of financial interests and arrangements.

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Financial Disclosure Form for HPTN, Sep 2019

Clinical investigators disclosure of financial interests and arrangements.

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Financial Disclosure Form for HVTN

HVTN IND study financial disclosure form.

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Financial Disclosure Form for HVTN

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Financial Disclosure Form for IMPAACT

Disclosure of financial Interests and arrangements form for IMPAACT Clinical Investigators.

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Financial Disclosure Form for IMPAACT

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Financial Disclosure Form for MTN

MTN financial disclosure/certification form.

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Financial Disclosure Form for Non-networks

Non-network financial disclosure/certification form.

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Financial Disclosure Forms for ACTG

AIDS clinical trials group network IND study financial disclosure form. .zip file includes ACTG Network IND Study Financial Disclosure Form (PDF) ACTG Network IND Study Financial Disclosure Form Template (PDF) ACTG Network IND Study Financial Disclosure Form Fillable (PDF)  

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Fluconazole (Diflucan) Package Insert

DIFLUCAN (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension.

GLA-SE

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GS-2872 (10-1074 LS)

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GS-5423 (3BNC117-LS)

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GSK1265744 (Cabotegravir)

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Guidance for DAIDS Electronic Trial Master Files

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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

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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