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DAIDS Investigator of Record (IoR) Formpdf

DAIDS investigator of record form (7/2020).

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DAIDS Protocol Risk Taking Data Capture and Distribution Standard Operating Procedurepdf

DAIDS protocol risk ranking data capture and distribution standard operating procedure, worksheet and flow chart.

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DAIDS Protocol Risk Worksheet Guidelinespdf

Worksheet designed to assign risk levels to protocols for prioritizing clinical site monitoring resources.

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DAIDS Review of Informed Consent Forms: Impact of the HIPAA Privacy Rulepdf

Division of AIDS review of imformed consent forms, impact of the HIPAA privacy rule.

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Division of AIDS Safety Office Expedited Adverse Event (EAE) Formdocx

Expedited reporting form for Adverse Events fillable using Microsoft Word.

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Financial Disclosure Form for HPTN, January 2021pdf

Clinical investigators disclosure of financial interests and arrangements.

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Financial Disclosure Form for HPTN, Sep 2019docx

Clinical investigators disclosure of financial interests and arrangements.

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Financial Disclosure Form for HVTNpdf

HVTN IND study financial disclosure form.

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Financial Disclosure Form for HVTNpdf

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Financial Disclosure Form for IMPAACTpdf

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

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Financial Disclosure Form for IMPAACTpdf

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Financial Disclosure Form for MTNpdf

MTN financial disclosure/certification form.

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Financial Disclosure Form for Non-networkspdf

Non-network financial disclosure/certification form.

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Financial Disclosure Forms for ACTGzip

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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Required Documentation Based on 45 CFR 46pdf

Required documentation of risk/benefit category and approval of clinical studies for inclusion of children by institutional review boards/ethics committees based on 45 CFR 46, Subpart D.

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RSC Veeva Vault eTMF Submission Formxlsx

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Study Physician Attestation and Agreement for Electronic Signaturespdf

This form is to document that the signator of this document is authorized to use the DAIDS-ES system, and understands that their electronic signature (eSignature) is used to electronically sign database records.

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Translation Confirmation Documentpdf

DAIDS protocol registration translation confirmation document.

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