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Process for collection of financial disclosure by clinical investigators conducting DAIDS-sponsored IND trials.
Guidance for implementing protocol clarifications or changes.
DAIDS Memo Regarding Timing of Consent and Re-Consent with Updated IRB/EC/RE-Approved Informed Consent Forms.
DAIDS protocol registration basic training.
DAIDS protocol risk ranking data capture and distribution standard operating procedure, worksheet and flow chart.
Worksheet designed to assign risk levels to protocols for prioritizing clinical site monitoring resources.
Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.
DAIDS expedited adverse event (EAE) reporting template.
DAIDS final protocol template language for protocol registration (April 2010).
Division of AIDS review of imformed consent forms, impact of the HIPAA privacy rule.
Definitions of the types of safety information distributed by DAIDS and methods of distribution.
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
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
DAIDS sample Informed consent template, stored samples and associated health information for future research use.
Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.
DAIDS Therapeutic Research Program protocol eligibility criteria for pregnancy prevention.