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10-1074

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10-1074-LS

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16055 NFL Delta Gly4 Env Protein Trimer, Adjuvanted with 3M-052 AF + Alum

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2020 IND Lists of Studies having CRF/Pharmacy Records That Will Not be Stored by DAIDS

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2020 non-IND Lists of Studies having CRF/Pharmacy Records That Will Not be Stored by DAIDS

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3BNC117-LS (-J)

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426c.Mod.Core-C4b, Adjuvanted

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Abacavir Sulfate (Ziagen) Risk List

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

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Abacavir Sulfate/Dolutegravir/Lamivudine (Triumeq) Package Insert

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Abacavir/Lamivudine (Epzicom) Package Insert

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ABT-267, ABT 333, ABT-450 and Ritonavir

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Accessing and Maintaining Site Personnel Information in the DAIDS-ES

Tutorial guide, with screenshots, for the DAIDS-ES system.

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ACTG - Expedited Reporting to DAIDS and DAERS Refresher

Presentation on expedited reporting to DAIDS plus a case study on expedited reporting via DAERS.

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ACTG IND Study Financial Disclosure Form Template

ACTG IND study financial disclosure form template.

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Addendum 1, Female Genital Grading Table for Use in Microbicide Studies

Guidance table for grading the severity of adult and pediatric adverse events with female genital involvement during microbicide studies.

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Addendum 2 Male Genital Grading Table for Use in Microbicide Studies

Guidance table for grading the severity of adult and pediatric adverse events with male genital involvement during microbicide studies.

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Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012)

Guidance table for grading the severity of adult and pediatric adverse events with rectal involvement during microbicide studies.

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Algorithm for Determining Whether Site Specific Informed Consent Forms will be Reviewed at the Time of Initial Protocol Registration

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Azithromycin Package Insert

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B63521^11 gp120

BCG Vaccine

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Bedaquiline (Sirturo) Package Insert

SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (18 years and older) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. Administer SIRTURO by…

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Bedaquiline (TMC207)

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BG505 SOSIP.664 gp140, Adjuvanted with 3M-052-AF + Alum, or CpG 1018 + Alum, or GLA-LSQ, or Alum

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Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) Package Insert

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