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Comment Period for New DAIDS Policies

DAIDS is happy to announce that three new policies are now available for comment. The following links policies and associated appendices:

  1. Storage and Retention of Clinical Research Records (PDF)
  2. Enrolling Children (including Adolescents) in DAIDS-Funded and/or Sponsored Human Subject Clinical Research: Clinical Research Site Requirements (PDF)
  3. Enrolling Children (including Adolescents) in DAIDS-Funded and/or Sponsored Human Subject Clinical Research: Protocol Document Requirements (PDF)

Comments may be submitted to NIAIDOPCROPOLICYGROUP@mail.nih.gov. Please include the name of the document (Policy/Appendices), and line number(s) that correspond to your comments.

The comment period will be open until October 24, 2008.

About the Clinical Research Policies and Standard Procedures Documents

Information addressing the scope and effective dates for the policies and standard procedures and how to obtain additional information.

Protocol and Informed Consent

Links to policies and standard procedures relating to the content of protocol and informed consent documents for DAIDS funded and/or sponsored clinical research

Clinical Site

Links to policies and standard procedures relating to site operations, monitoring, quality management, and training at clinical research sites conducting DAIDS funded and/or sponsored clinical research.

Safety

Links to policies and standard procedures relating to the reporting and monitoring of study progress and safety in DAIDS funded and/or sponsored clinical trials.

Laboratories

Links to policies and standard procedures relating to requirements for laboratories associated with DAIDS funded and/or sponsored clinical trials.

Regulatory

Links to policies and standard procedures for determination of Investigational New Drug Applications, maintenance of essential documents files, and protocol registration for DAIDS funded and/or sponsored clinical research.

Pharmacy

Links to policies and standard procedures relating to requirements for pharmacies associated with DAIDS funded and/or sponsored clinical trials.

Data Management and Statistics

Links to policies and standard procedures relating to the management and analysis of data in DAIDS funded and/or sponsored clinical trials.

Glossary of DAIDS Terms

(Currently under revision)
Definitions of clinical research terms used by DAIDS.

Frequently Asked Questions

A list of Frequently Asked Questions (FAQs) and DAIDS responses.

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See Also

Division of Acquired Immunodeficiency Syndrome

Investigator-Initiated Clinical Trial Planning and Implementation Grants

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See Also

Division of Acquired Immunodeficiency Syndrome

Investigator-Initiated Clinical Trial Planning and Implementation Grants