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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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Clinical Trial Application Submission Guidance

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ClinicalTrials.gov Flowcharts

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CRS Leader and CRS Coordinator User Guides

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DAIDS CRSS ClinicalTrials.gov Initial Registration Process

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DAIDS Memo Regarding New DAIDS Requirements: Informed Consent Process

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DAIDS Protocol Registration Basic Training

DAIDS protocol registration basic training.

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DAIDS Protocol Registration Policy and Manual Training 2019 - PowerPoint

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DAIDS Safety Workshop Durban SA (Nov 2015)

Training workshop in Durban, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

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DAIDS Safety Workshop Johannesburg SA (Nov 2015)

Training workshop in Johannesburg, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

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DAIDS TMF Index Guiding Principles

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DAIDS TMF Index Recording

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Guidance for DAIDS Electronic Trial Master Files

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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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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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MTN - Expedited Reporting to DAIDS and DAERS Refresher March 2016

Contains training materials from MTN annual meeting including presenation slides and case study. Meeting was held in March 2016.

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Relevant Communications and Vendor Oversight Communication

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Safety Workshop October 2016

.zip file contains: Case review on adverse events Safety training presentations on adverse events, expedited reporting and assessment, Expedited reporting via DAERS a safety training case study handout Training given in the Republic of South Africa in October 2016.

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Signature Requirement Guidance

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Uganda - DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events

Presentation from webinar on using the Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0.

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Uganda - Expedited Reporting to DAIDS and DAERS Refresher June 2014

Zip file contains: Presentation slides from ACTG June 2014 network meeting Presentation to ACTG about expedited reporting on Adverse Events Presentation to ACTG about reporting via DAERS Case study on Adverse Events Case Study on chest pain

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Uganda - Expedited Reporting to DAIDS and DAERS Refresher November 2014

.zip file contains: Presentation slides from November 2014 webinar training on adverse events Study handout accompanying training Presentation about expedited reporting on Adverse Events Presentation about reporting via DAERS Case study on Adverse Events Case Study on chest pain

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