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Presentation on expedited reporting to DAIDS plus a case study on expedited reporting via DAERS.
Lists of IND and non-IND protocols having case report forms (CRFs) and pharmacy records that will not be stored by DAIDS .
Quick reference card for creating a new submission in the DPRS.
Process for collection of financial disclosure by clinical investigators conducting DAIDS-sponsored IND trials.
Guidance for implementing protocol clarifications or changes.
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.
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.
Non-network financial disclosure/certification form.
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)
List of IND protocols having CRF/Pharmacy records that will not be stored by DAIDS.
Instructions for the transfer of case report forms, (CRF) and pharmacy records to the DAIDS regulatory support center, (DAIDS RSC).
Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.
DAIDS protocol specific informed consent template—general use.