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Study
Documents
The HPTN 052 study team has made the
following study documents available. When possible, documents are
presented in both A4 and U.S. Letter paper sizes. New documents will be posted here as
they become available.
HPTN 052 Protocol
HPTN 052 Letters of
Amendment
- HPTN 052 V 3.0, LoA #4, 9 Dec 2008 (PDF)
[U.S.
Letter]
- HPTN 052 V 3.0, LoA #3, 30 Jul 2008
(PDF) [U.S.
Letter]
- HPTN 052 V 3.0, LoA #2, 20 March 2008
(PDF) [U.S.
Letter]
- HPTN 052 V 3.0, LoA #1, 7 August 2007
(PDF) [U.S.
Letter]
- HPTN 052 V 2.0, LoA #2, 13
July 2005 (PDF) [A4]
[U.S.
Letter]
- HPTN 052 V 2.0, LoA #1, 23
December 2004 (PDF) [A4]
[U.S.
Letter]
HPTN 052 Clarification
Memos
HPTN 052 Case
Report
Forms (CRFs)
These CRFs are NOT to be used for data
collection. They are for information purposes only. If you need CRFs
that may be used for data collection, please contact
Leslie
Cottle at SCHARP.
HPTN 052 Study Specific
Procedures Manual (SSP)
All SSP Sections are PDF files unless
otherwise noted.
HPTN 052 Protocol Deviation Reporting
Instructions for protocol deviation
reporting for HPTN 052 can be found in
Section 3 of the HPTN 052 SSP and in Section 16
of the
HPTN MOP. Protocol deviation reports should be sent to the following
distribution list. Click on each person's name to access his
contact information.
*If
the deviation involves an investigational product, the DAIDS protocol
pharmacist(s) should be included in the distribution list.
HPTN
052 Safety Information
HPTN
052 Source Documentation and Forms
Documents are MS Word files unless otherwise
noted.
HPTN 052 Resources
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