**Amendment #2 (Questions & Answers) -- 5th Posting**

**This Amendment provides questions submitted by potential offerors and
the responses provided by the NIAID. [The responses are offered for
information only and do not modify or become part of this
solicitation.]{.mark} This Amendment will be updated at least weekly to
add any further questions and their related responses. All potential
offerors are advised to refer back to this Amendment for additional
Q&A.**

**"Tri-Service AIDS Clinical Consortium Data Analysis**

**and Coordinating Center (TACC/DACC)"**

+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
| **Amendment No.:**                | 2 **[(5^th^ Posting)]{.mark}**    |
+-----------------------------------+-----------------------------------+
|                                   | February 4, 2005 (Questions 1 --  |
|                                   | 8)                                |
|                                   |                                   |
|                                   | March 7, 2005 (Questions 9 - 14)  |
|                                   |                                   |
|                                   | March 21, 2005 (Questions 15 -    |
|                                   | 23)                               |
|                                   |                                   |
|                                   | (Revisions to Questions 12 & 13)  |
|                                   |                                   |
|                                   | **[March 31, 2005 (Questions 29 - |
|                                   | 31)]{.mark}**                     |
+-----------------------------------+-----------------------------------+
| **Proposal Due Date/Time:**       | April 21, 2005, at 3:00 P.M., EST |
|                                   | [(Unchanged)]{.mark}              |
+-----------------------------------+-----------------------------------+
| **Issued By:**                    | Barbara A. Shadrick               |
|                                   |                                   |
|                                   | Contracting Officer               |
|                                   |                                   |
|                                   | RRCB/CMP/DEA/NIAID/NIH/DHHS       |
|                                   |                                   |
|                                   | 6700-B Rockledge Drive, Room      |
|                                   | 3214,                             |
|                                   |                                   |
|                                   | Bethesda, Maryland 20892-7612     |
+-----------------------------------+-----------------------------------+
| **Points of Contact:**            | <lkellum@niaid.nih.gov>           |
|                                   |                                   |
|                                   | Lola Kellum, Contract Specialist  |
|                                   |                                   |
|                                   | **Please also cc:**               |
|                                   |                                   |
|                                   | <lcoleman@niaid.nih.gov>          |
|                                   |                                   |
|                                   | Lisa Coleman, Contract Specialist |
+-----------------------------------+-----------------------------------+

**Offerors must acknowledge receipt of this [Amendment #2, for each
posting,]{.underline} on each copy of the proposal submitted. Failure to
receive your acknowledgment of this Amendment may result in the
rejection of your proposal.**

**The hour and date specified for receipt of proposals HAS NOT been
extended.**

**This posting includes the following Attachments:**

**Attachment 1: The SAS System, The CONTENT Procedure**

**Attachment 2: Data Dictionary for the Natural History Database**

**Attachment 3: Listing of TACC Publications**

**The following answers are provided concerning a number of inquiries we
have received for the above numbered acquisition:**

1.  The RFP provides for no restrictions on non-USA entities responding.
    Can you clarify if there will be any restrictions or prejudice to
    foreign organizations having a proposal considered for this RFP,
    such as Canada and South Africa?

> **Institutions must be in compliance with U.S. laws and regulations
> and DHHS and NIH policies in effect at the time of award and during
> the period of performance of the research. Foreign institutions are
> not eligible to apply.**

2.  Regarding the population being studied/observed, can you please
    identify responses to any of the following if not in violation of
    any legislation, regulation or consent requirement:

#### Are pediatric HIV/AIDS patients part of this cohort? *No*

#### Is HIV associated Nephropathy a material subject of study? *No*

#### Do patients in this population participate organ transplantation or 

####  dialysis as part of the study? *No* {#dialysis-as-part-of-the-study-no .unnumbered}

#### Are economic evaluations in burden of illness and resource 

####  consumption/allocation subjects of study? *No* {#consumptionallocation-subjects-of-study-no .unnumbered}

#### In the event patients are not resident at one of the 7 sites or out of the country, 

####  will the location of treatment be considered a data collection site? *No* {#will-the-location-of-treatment-be-considered-a-data-collection-site-no .unnumbered}

#### Would experience/expertise from Africa be of beneficial assistance with 

> **various patient groups in this population? *No***

3.  Can you describe the current database, or databases if they exist
    and a possible data transition process and/or if the proposed
    program will be prospective data only from the commencement of this
    contract?

> Data are currently housed in an Oracle database and organized into
> relational tables. Existing data will need to be cleaned per paragraph
> 2 of Statement of Work. Prospective data will be managed and validated
> per paragraph 3 of the Statement of Work.

#### Regarding the residency of the database it is assume that FDA research database regulations at a minimum will apply, hence:

a.  If there are no restrictions to country of contractor, does this
    also apply to the country of residency of the database? ***See
    restrictions noted above.***

b.  Would Canada be an acceptable location for the database? ***No***

c.  Is it preferable for the database to be resident with the NIH or the
    U.S. Military?

> ***The database will not reside with NIH. A copy will be housed by the
> U.S. Military.***

d.  Will there be any independent audits of the database during the
    study? ***There will be data Q&A procedures performed.***

#### If this program or its investigators have published any papers based on the studied population, can these references be provided?

####  {#section .unnumbered}

#### *You can query PubMed for U.S. military publications.* {#you-can-query-pubmed-for-u.s.-military-publications. .unnumbered}

 

#### Is it possible to provide an example of one of the more comprehensive current research protocols being conducted within this population?

####  {#section-1 .unnumbered}

#### *This is a database of an observational longitudinal cohort. Although clinical trials can be nested within the cohort, the primary data queries and analyses focus on questions pertinent to critical questions that optimize the longitudinal nature of the data.*  {#this-is-a-database-of-an-observational-longitudinal-cohort.-although-clinical-trials-can-be-nested-within-the-cohort-the-primary-data-queries-and-analyses-focus-on-questions-pertinent-to-critical-questions-that-optimize-the-longitudinal-nature-of-the-data. .unnumbered}

 

#### Is U.S. Citizenship or any U.S. Military clearance or other certificates required for any individuals who will participate in this project or conduct onsite activities such as monitoring or data management?

####  {#section-2 .unnumbered}

#### *There is no special military clearance. Amendment No. 1 to this RFP has added a provision that addresses U.S. Citizenship.* {#there-is-no-special-military-clearance.-amendment-no.-1-to-this-rfp-has-added-a-provision-that-addresses-u.s.-citizenship. .unnumbered}

#### Are military data entry personnel included in the estimate of effort?

> ***No military personnel should be included in proposals.***

#### Statement of Work, paragraph 5., Cohort Study Support, Training, and Communication, subparagraph k., states: \"Provide logistical services for arranging all bi-monthly conference calls and any additional conference calls...\". Can you provide an estimate of the number of calls and number of participants per call for each month? 

> ***There will be two TACC study conference calls per month that
> involve 7 study sites, two NIAID programs, and the data center. Since
> some individuals, even within the same facility, will call from
> various offices, there may be as many as 25-30 different phone lines
> linked to these calls. In addition, there may be one or two additional
> calls per month as ad hoc working groups are convened to address
> specific research questions. About half of the number of participants
> would be expected on any working group call as is in the full
> scientific group.***

#### Statement of Work, paragraph 8., Clinical Trials Design and Analytic Support, is not entirely clear. 

-   Will the TACC DACC be responsible for the following aspects of
    clinical trials: Trial design, protocol development, power
    calculations, development of analytical plans and table shells,
    development of forms, development of and operation of data entry and
    data storage systems, randomization systems, protocol monitoring,
    systems for capturing and reporting adverse events, preparing for
    data safety and monitoring board meetings, analysis of the trial
    results, preparing study publications, overseeing study closeout?

-   What is the nature of these trials \-- Phase I/II/III/IV?

-   What is the nature of protocol training that is mentioned in item
    8d?

-   How many trials are anticipated per year?

-   Has the study initiated trials in this cohort in the past?

-   Are there any partners with whom this work will be shared?

-   Is there an anticipated FTE amount that will be devoted to the
    clinical trials work?

> ***Limited, intermittent support for clinical trials and substudies
> will be expected from the data center. This support would most likely
> include scientific consultation on feasibility of study design based
> upon inclusion and exclusion criteria, consultation on study measures,
> and development of databases to receive clinical trials data. In
> addition, the data center may be asked to provide supplemental
> training of staff on clinical trial and substudy implementation within
> the context of the cohort study protocol and procedures. All clinical
> trials monitoring, staff training, and documentation will be the
> responsibility of the NIAID Office of Clinical Research. Trials could
> be Phase I or II but will more likely be Phase III or IV. In the past,
> there has been one large randomized clinical trial. Currently, there
> is one ongoing trial and four in the pre-initiation phase. Data center
> staffing should anticipate at most 5%-10% FTE to address the limited
> additional support required for intermittent substudies and clinical
> trials.***

#### Part IV, Section L.II., General Instructions, Item 34, indicates that a subcontracting plan must be submitted with the proposal. Is the correct interpretation of this item that approximately 42% of the proposed budget should be subcontracted out to small businesses? What if the aims of the proposal can be accomplished largely within a non-small business institution?

> ***FAR Part 19.702 states that, as required by statute, "Any
> contractor receiving a contract for more than the simplified
> acquisition threshold must agree in the contract that small business,
> veteran-owned small business, service-disabled veteran-owned small
> business, HUBZone small business, small disadvantaged business, and
> women-owned small business concerns will have the maximum practicable
> opportunity to participate in contract performance consistent with its
> efficient performance. It is further the policy of the United States
> that its prime contractors establish procedures to ensure the timely
> payment of amounts due pursuant to the terms of their subcontracts
> with small business, veteran-owned small business, service-disabled
> veteran-owned small business, HUBZone small business, small
> disadvantaged business, and women-owned small business concerns.
> Therefore, the any contractor receiving an award as a result of this
> solicitation, must submit an acceptable subcontracting plan that meets
> or exceeds the goals identified in Item 34 of the General
> Instructions.***

#### Among TACC investigators/collaborators, are there enough epidemiolgists to initiate epidemiological studies?

***Revised Response: The TACC investigative team has a*** ***limited
number of clinical researchers with expertise in clinical trials and
epidemiology research.***

#### In the Statement of Work, paragraph 7.a.(2), it requires DACC to provide expertise of epidemiology. Does this mean that DACC needs to provide epidemiologists to initiate epidemiological studies, or only to provide statistical expertise to assist TACC epidemiologists with epidemiological data modeling and analysis, or both?

***Revised Response: The DACC will be expected to provide scientific
consultation in epidemiology methods and research study design as well
as statistical expertise in data modeling and analyses.***

#### Is there an existing data base of information, and if so where does is reside?

> ***The existing database is held by the U.S. Military and is not
> publicly accessible.***

#### Can you please supply the current data variables and the Oracle database data model?

> ***This information is provided with this Amendment as Attachment
> 1.***

#### Is there an existing data base of information, and if so where does is reside?

> ***A data dictionary is provided with this Amendment as Attachment 2,
> to familiarize offerors with the content of the current database.***

#### Can you please describe the state of cleanliness of the current data as per paragraph 2 of the statement of work and what cleaning procedures, if any have been conducted to date?

> ***Data are double entered into the database from case report forms.
> No other data cleaning is performed on a systematic basis but data
> have been reviewed and corrected as a result of data queries and
> analyses for specific projects.***

#### Regarding the 300 major publications, referred to in the Background section of the RFP, by U.S. Military produced from the pre-existing program, very few (\< 5) are identifiable under related PUBMED searches, can you provide a list of these 300 major publications or the specific PUBMED search criteria?

> ***This listing is included with the Amendment as Attachment 3.***

#### Regarding the 300 publications referred to in the RFP and the requirements for cleaning data, can you please describe the extent to which the data had been cleaned for purposes of these publications, up to which date it has been cleaned, and if it had been cleaned for use in these publications, why it needs to be re-cleaned? If the data needs to be re-cleaned, is the data available as the original data or the cleaned data?

> ***Data modifications are verified from source documents. Data
> provided will reflect such edits and documentation.***

#### The list of requirements for Facilities and Resources in the TOC portion of Section M has 4 items; the list in the evaluation criteria of Section M has 5 items - additional item is \"data storage and maintenance capabilities and establishment of security systems to insure confidentiality and protection of data\". Which is correct?

> ***The purpose of Appendix A, Table of Contents, is to provide
> offerors with a template to guide them in preparing their proposal in
> response to this solicitation. You are correct that reference to this
> one item, listed in Criterion D, Facilities and Resources, of Section
> M, was inadvertently omitted from the Appendix A and if you want
> consideration for your response to this capability, you should address
> it in your proposal.***

#### Item 40 of Section L indicates that past performance references are part of the BUSINESS Proposal and Section M includes #14 \"Past Performance Reference Material\". Please explain.

> ***The Past Performance Information included in Section M represents
> an evaluation factor, as described in paragraph 1. GENERAL, under this
> Section. In accordance with FAR, this is only evaluated following the
> initial peer review and is part of the determination to include an
> offeror in the competitive range, but only if the peer review panel
> has determined that proposal to be "acceptable." Because past
> performance information is evaluated by the Project Officer and
> Contracting Officer, and requires no input from the peer review panel,
> offerors are requested to include in their business proposal. This
> allows offerors better use of the page limitation by not requiring
> information in the technical proposal that will not be looked at by
> peer reviewers. This also applies to the offerors' response to
> cost/price and SDB Participation.***

#### Can you describe who will direct, lead or influence the research agenda over the course of the contract, e.g. current investigators, contractor, others or any combination, etc.? 

> ***The Coordinating Team is described in the background. What we did
> not describe was the TACC "Executive Committee" which is comprised of
> the TACC investigators and select persons from the NIAID Office of
> Clinical Research, NIAID Division of AIDS, and the Henry M. Jackson
> Foundation. This working committee leads and implements the research.
> The TACC DACC will collaborate with the EC to influence and advise the
> research agenda.***

 

#### Can you describe the sample types currently stored and their storage methods, including serum and cells?  If cells are not currently stored, will they be stored under this contract?

> ***Plasma, serum, and cells are stored in repositories maintained by
> military research facilities. Contractor responsibilities are
> specified in the SOW:***
>
> ***SOW 2. d. "The database and data management system shall include...
> a specimen inventory and monitoring system that links study personal
> identification numbers (PIN) to bar-coded specimens within the
> specimen repository and that follows the selection and use of various
> specimens for specific TACC CT-approved projects;"***
>
> ***SOW 3.e. "The Contractor shall develop systems that provide for:
> ...A dedicated computerized inventory and distribution system
> documenting requests for data and specimens and programming for all
> data retrievals and analyses."***

#### Is the PIN utilized in the database an anonymous identifier?

***Yes.***

#### Is the PIN utilized by repositories when reporting data?

> ***The PIN is utilized by the repositories as a unique anonymous
> identifier.***

#### Statement of Work Section 3, Ongoing Data Validation, ... states that \"The contractor shall receive raw data from the USMHRP datacenter in real time, \...\" while subsection b states that \"Evaluation and implementation, in collaboration with the USMHRP data group, of computerized study forms and systems for remote entry and secure transmission of participant data from clinical sites to the central data management facility.\" These two appear to be contradictory: the first appears to imply that data shall first be submitted to USMHRP, while the second implies that data will be submitted directly to the DACC. Which is true? Is the \"central data management facility\" the \"USMHRP datacenter?\"

> ***The Contractor shall receive raw data from the USMHRP datacenter in
> real time, so that final data validation can begin after the
> conclusion of the six month study visit window.***
>
> ***This statement above acknowledges the current process in which the
> USMHRP data center receives hard copy forms and conducts data entry.
> For a time during the initial months of the contract, it is likely
> that the Contractor will receive updated electronic data at the end of
> each 6-month visit cycle that have been generated through this process
> at the USMHRP data center.***
>
> ***However, the section in the SOW continues (see below) with the
> expectation that the Contractor will develop systems for direct,
> remote data entry and transmission from clinical sites to the
> Contractor's data management facility.***
>
> ***The Contractor shall develop systems that provide for: ...***

b.  ***Evaluation and implementation, in collaboration with the USMHRP
    data group, of computerized study forms and systems for remote entry
    and secure transmission of participant data from clinical sites to
    the central data management facility.***

#### The clause \"Specific Copyright Provisions Applicable to Software Development and/or Enhancements\" in Section L states that \"the government intends to assert additional copyright permissions under the contract.\" What additional permissions may the government claim?

> ***The government will reserve the right to make that determination
> during negotiations of any resultant contract based on what is
> proposed by potential offerors.***

#### Subsection j of section 5 of the statement of work states:

> \"Provide written and verbal feedback to sites after the completion of
> a 6-month study visit for all areas of study monitoring, including
> recruitment and retention of study participants and completeness and
> validity and reliability of data.\" Under what circumstances would
> \"6-month study visit(s)\" be conducted?
>
> ***Routine study visits occur at six-month intervals for the purpose
> of providing research data and specimen samples. These visits are
> concurrent with a participant\'s routine clinical HIV evaluation and
> follow-up as mandated and supported by the military.***

#### What is the demographic distribution of the cohort (Age, Race, Ethnicity, Sex) by calendar year of enrollment or some other denominator?

***(See Table below -- data as of 12/2003)***

> ***Table 1 Demographics of TACC HIV-1 Natural History Study 1986-2003
> by Categorized***
>
> ***Enrollment Years***

+------------+---------+---------+---------+--------+-------+--------+
| **         | **1986  | **1989  | **1993  | *      | **2   | **Ove  |
| Enrollment | -1988** | -1992** | -1996** | *1997- | 001-2 | rall** |
| Years**    |         |         |         | 2000** | 003** |        |
|            | N=1843  | N=1107  | N=646   |        |       | N=4423 |
|            |         |         |         | N=503  | N=324 |        |
+------------+---------+---------+---------+--------+-------+--------+
| **V        | N (Col  | N (Col  | N (Col  | N (Col | N     | N (Col |
| ariables** | %)      | %)      | %)      | %)     | (Col  | %)     |
|            |         |         |         |        | %)    |        |
+------------+---------+---------+---------+--------+-------+--------+
| **Died**   | 97      | 29      | 48(     | 8(     | (     | 1329   |
|            | 5(52.9) | 8(26.9) | 7.4)    | 1.6)   | 0.0)  | (30.1) |
|            |         |         |         |        |       |        |
|            | (row    | (row    | (ro     | (row   |       |        |
|            | %=73.4) | %=22.4) | w%=3.6) | %=0.6) |       |        |
+------------+---------+---------+---------+--------+-------+--------+
| **Gender** | 174     | 96      | 55      | 451    | 303(  | 4021   |
|            | 9(94.9) | 4(87.1) | 4(85.8) | (89.7) | 93.5) | (90.9) |
| Males      |         |         |         |        |       |        |
|            | 94(5.1) | 14      | 9       | 52(    | 21(   | 402(   |
| Females    |         | 3(12.9) | 2(14.2) | 10.3)  | 6.5)  | 9.1)   |
+------------+---------+---------+---------+--------+-------+--------+
| **Age at   | 32(     | 33(     | 15(     | 28(    | 12(   | 120(   |
| First      | 1.7)    | 3.0)    | 2.3)    | 5.6)   | 3.7)  | 2.7)   |
| Positive   |         |         |         |        |       |        |
| HIV Test** | 114     | 64      | 34      | 221    | 148(  | 2507   |
|            | 4(62.1) | 5(58.3) | 9(54.0) | (43.8) | 45.7) | (56.7) |
| ≤19 years  |         |         |         |        |       |        |
|            | 53      | 29      | 20      | 189    | 112(  | 134    |
| 20-29      | 8(29.2) | 6(26.7) | 6(31.9) | (37.6) | 34.6) | 1(30.3 |
| years      |         |         |         |        |       |        |
|            | 107(    | 82(     | 51(     | 45(    | 43(   | 328(   |
| 30-39      | 5.8)    | 7.4)    | 7.9)    | 9.0)   | 13.3) | 7.4)   |
| years      |         |         |         |        |       |        |
|            | 22(     | 51(     | 25(     | 20(    | 9(    | 127(   |
| 40-49      | 1.3)    | 4.6)    | 3.9)    | 4.0)   | 2.8)  | 2.9)   |
| years      |         |         |         |        |       |        |
|            | 28.7±   | 2       | 2       | 30.7   | 30.9  | 29     |
| ≥50 years  | 6.7     | 9.7±8.8 | 9.8±8.4 | ±8.7   | 9.0   | .5±8.0 |
|            |         |         |         |        |       |        |
| Mean Age ± | 27.0    | 28.0    | 28.0    | 30.0   | 30.0  | 28.0   |
| SDEV       |         |         |         |        |       |        |
|            | 11-69   | 17-74   | 18-67   | 18-67  | 15-71 | 11-74  |
| Median Age |         |         |         |        |       |        |
|            |         |         |         |        |       |        |
| Range      |         |         |         |        |       |        |
+------------+---------+---------+---------+--------+-------+--------+
| **Race/E   | 82      | 51      | 27      | 192    | 140(  | 1945   |
| thnicity** | 6(44.8) | 8(46.8) | 0(41.9) | (38.2) | 43.2) | (44.0) |
|            |         |         |         |        |       |        |
| Caucasian  | 82      | 47      | 31      | 237    | 133(  | 1984   |
|            | 7(44.9) | 7(43.1) | 0(48.0) | (47.1) | 41.1) | (44.9) |
| African    |         |         |         |        |       |        |
| American   | 144(    | 71(     | 50(     | 49(    | 30(   | 344(   |
|            | 7.8)    | 6.4)    | 7.8)    | 9.7)   | 9.3)  | 7.8)   |
| Hispa      |         |         |         |        |       |        |
| nic/Puerto | 21(     | 19(     | 11(     | 8(     | 10(   | 69(    |
| Ric        | 1.1)    | 1.7)    | 1.7)    | 1.6)   | 3.1)  | 1.6)   |
| an/Mexican |         |         |         |        |       |        |
|            | 7( 0.4) | 12(     | 1( 0.2) | 1(     | 1(    | 22(    |
| Asi        |         | 1.1)    |         | 0.2)   | 0.3)  | 0.5)   |
| an/Pacific | 19(     |         | 3( 0.4) |        |       |        |
| Islander   | 1.0)    | 10(     |         | 16(    | 10(   | 59(    |
|            |         | 0.8)    |         | 3.2)   | 3.1)  | 1.3)   |
| Native     |         |         |         |        |       |        |
| American   |         |         |         |        |       |        |
|            |         |         |         |        |       |        |
| Other      |         |         |         |        |       |        |
+------------+---------+---------+---------+--------+-------+--------+
| **CD4 Cell | 163(    | 107(    | 55(     | 47(    | 26(   | 398(   |
| Count at   | 9.0)    | 9.7)    | 8.6)    | 9.4)   | 8.1)  | 9.1)   |
| First      |         |         |         |        |       |        |
| Positive   | 29      | 18      | 12      | 110    | 59(   | 768    |
| Test\***   | 0(16.0) | 1(16.4) | 8(19.9) | (21.9) | 18.3) | (17.5) |
|            |         |         |         |        |       |        |
| \<200      | 43      | 24      | 16      | 133    | 78(   | 1048   |
|            | 2(23.8) | 5(22.5) | 0(24.9) | (26.5) | 24.2) | (23.9) |
| 200-349    |         |         |         |        |       |        |
|            | 93      | 56      | 29      | 212    | 159(  | 2168   |
| 350-499    | 0(51.2) | 8(51.4) | 9(46.6) | (42.2) | 49.4) | (49.5) |
|            |         |         |         |        |       |        |
| ≥500       | 542.5   | 531.5   | 503.8   | 467.6  | 504.9 | 522.7  |
|            |         |         |         |        |       |        |
| Mean       | ±292.5  | ±286.2  | ±257.3  | ±223.7 | ±     | ±275.6 |
|            |         |         |         |        | 232.6 |        |
| ± STDEV    | 506     | 506.5   | 478.5   | 453.0  |       | 495    |
|            |         |         |         |        | 495.5 |        |
| Median     | 3-2166  | 0-1829  | 6-2412  | 7-1313 |       | 0-2412 |
|            |         |         |         |        | 9     |        |
| Range      |         |         |         |        | -1310 |        |
+------------+---------+---------+---------+--------+-------+--------+
|            |         |         |         |        |       |        |
+------------+---------+---------+---------+--------+-------+--------+

> ***\*Missing CD4 cell count n=41***

#### The background states that 4,400 individuals were enrolled in RV1, RV2, RV122 of which only 1550 are alive and in active follow up. 

> **a. What proportion of the 1550 individuals who are in active follow
> up have been medically discharged and are continuing to receive
> medical care at an active duty care facility?**
>
> ***Data cannot be readily accessed to determine proportions
> requested.***
>
> **b. What is the distribution of CD4 cell count levels (most recent or
> last in 2004) among the 1550 active individuals (\>500, 500-350,
> 349-200, \<200)?**
>
> ***Data of most recent or last CD4 cell counts are not readily
> available for 1550 active individuals. Table below provides
> distribution of CD4 cell counts at study entry.***
>
> **c. What proportion of the 2850 individuals who are not active have
> died?**
>
> ***(see Table -- data as of 12/2003)***
>
> **d. Approximately how many individuals who are alive, but not active,
> are receiving medical care in the VA system?**
>
> ***This information is not readily accessible and may not be available
> due to informed consent and privacy issues. The VA and the TACC are
> entirely separate entities.***

#### The background states that the RV122 study is planning implementation of data capture from \"other electronic databases in the US military health system\". What type of databases are these? Are any electronic medical records used to provide care in some sites? 

####  {#section-3 .unnumbered}

#### *Other electronic databases include a pharmacy database of prescriptions and refills and a laboratory database of test results. Comprehensive electronic medical records are not used at any TACC site for documenting and monitoring clinical care.* {#other-electronic-databases-include-a-pharmacy-database-of-prescriptions-and-refills-and-a-laboratory-database-of-test-results.-comprehensive-electronic-medical-records-are-not-used-at-any-tacc-site-for-documenting-and-monitoring-clinical-care. .unnumbered}