TLC Website: Internet Archive Reconstruction

The NIEHS Epidemiology Branch website that documented the Treatment of Lead-Exposed Children (TLC) trial is now offline; these pages are recovered from the Internet Archive Wayback Machine. The site moved from dir.niehs.nih.gov/direb/tlc1/ (1998–2005) to direb/studies/tlc/ (2005–2007), and many pages were edited along the way. 55 pages, 176 distinct archived versions.

Original TLC trial website (1998–2005)

The original NIEHS site at dir.niehs.nih.gov/direb/tlc1/. These pages describe the trial's design, sites, enrollment, publications, and Protocol v10.

• Protocol v.10 Protocol version 10, dated November 4, 1997, as posted on the NIEHS site. 2004-10-30 ·2×
• Enrollment & retreatment data Enrollment figures are the same in every version: 780 in total; 213, 208, 165, and 194 by clinical center. The final-assessment date changes from January to April 2000. The page gives no retreatment counts. 1998-07-171999-02-22 ·3×2000-03-092000-06-102004-10-30 ·2×
• TLC homepage From the June 2001 version on, the page reports the primary result (“no difference … on any of the psychological tests at three years”); earlier versions describe the trial as under way. Captures after 2005, which only say the page has moved, are not listed. 1998-05-09 ·2×1998-12-03 ·5×2000-05-20 ·3×2001-06-222004-10-19 ·3×
• Investigators (early) The Harvard data-coordinating center's lead investigator is listed as Dockery in 1998 and Ware from 1999. J. Julian Chisolm Jr. is listed in every version; all captures predate his death in 2001. 1998-07-171999-11-28 ·2×2000-06-10
• Sites & Investigators (final) 2004-10-30 ·2×
• Study in a nutshell / Study Operations (DSMC) The February 2001 version rewords the Data and Safety Monitoring Committee description: it adds “active,” the “(DSMC)” abbreviation, and “annual” review, and changes the wording on member attendance. The screening figure changes from “about 2,000” children (1999) to “evaluated 1,854” (2000); the 780 randomized is unchanged. 1998-07-171999-02-19 ·3×2000-03-092000-06-102001-02-252001-06-28 ·4×
• Publications The list grows from 2 entries (1998) to 9 (2004). A manuscript on treatment-phase results, listed as in review in April 1999, is absent from later versions; from April 2001 the list includes the TLC Group's 2000 Pediatric Research paper on succimer safety and efficacy. The Serwint iron-status paper and the vitamin-contamination paper appear under their submission titles (a question, and “The case of the heavy hippos…”) in early 1999 and under their published titles from November 1999. The 2001 NEJM primary-results paper first appears in the October 2004 capture; there are no captures between April 2001 and October 2004. 1998-07-171998-12-031999-02-191999-04-281999-10-091999-11-282000-06-102001-04-202004-10-19 ·5×
• Clinical sites 1998-07-171999-02-191999-11-28 ·3×
• Supplemental table X2 2001-05-132004-10-31 ·3×
• Supplemental table X3 2001-05-13 ·4×
• Supplemental table X4 2001-05-13 ·4×
• Supplemental data tables (index) 2004-10-30 ·5×
• Vitamin/mineral supplement contents 2004-10-30 ·4×

Relocated TLC site (2005–2007)

After 2005 the site moved to direb/studies/tlc/. The Questionnaires page indexes the case-report forms; the Wayback Machine did not capture the form PDFs.

• Summary (home) 2005-11-152006-06-28 ·2×2007-04-28 ·7×
• Investigators Post-2005 investigator roster; J. Julian Chisolm Jr. is marked “(deceased)” in both the clinical-center and Steering-Committee lists. 2006-06-182006-09-292007-05-03
• Publications 2006-09-29 ·2×
• Questionnaires (index of case-report forms) Lists about 37 TLC case-report forms with their version years (for example, retreat05, tx1–3_05, visit1a_04). The Wayback Machine did not capture the form PDFs. 2006-06-202006-09-292007-05-03

Investigators & the NIEHS Epidemiology Branch

Biographies, CVs, and staff pages of NIEHS Epidemiology Branch researchers, including Walter J. Rogan and N. Beth Ragan, and the branch's own pages.

• CV — Matthew P. Longnecker 1998-05-09 ·4×1999-11-282000-03-07 ·2×
• Bio sketch — Stephanie J. London 1998-05-09 ·2×1998-12-061999-10-07 ·2×
• CV — Walter J. Rogan Rogan's CV lists him as NIEHS IRB founding chair (1980–1983) and chair (1992–1993). 1998-05-091998-07-171999-10-07 ·2×2000-03-07 ·2×
• Epidemiology Branch — home/mission 1998-05-081998-07-171998-12-021999-01-17 ·2×1999-02-101999-04-23 ·2×2000-03-022000-05-20 ·2×2000-08-162001-02-212001-04-142001-06-222004-10-29 ·4×2005-04-112005-09-072005-11-15 ·3×2006-06-19 ·6×2006-10-07 ·6×2012-03-08
• Ragan bio (legacy) Describes N. Beth Ragan as “alternate project officer” on the Coordinators' and Environmental Subcommittees, and notes that she designed and maintained the NIEHS IRB website. 1998-05-08 ·2×1999-02-181999-05-051999-10-081999-11-282000-03-082000-06-092004-10-29 ·3×
• Rogan bio (legacy) Versions through April 2001 describe Rogan as “project officer” for the trial; the October 2004 version reads “project officer and one [of] the principal investigators.” 1998-05-08 ·2×1998-12-02 ·2×1999-10-081999-11-282000-03-09 ·2×2001-01-18 ·2×2001-04-142004-10-29 ·3×
• Epidemiology Branch — Staff roster (1999) 1999-10-081999-11-282000-03-092000-06-092000-08-242004-10-18 ·4×
• Epidemiology Branch — Staff roster (modern) 2005-10-29 ·2×2006-06-172006-08-19 ·3×2006-10-072006-12-09 ·9×
• Ragan CV (PDF) 2006-09-29
• Ragan staff — Research Statement Reads: “Ms. Ragan was a project officer for the Treatment of Lead-exposed Children (TLC) Trial.” 2006-09-29
• Ragan staff — Studies (TLC) 2006-09-29 ·2×
• Rogan CV (17pp PDF; ACCLPP/NTP roles) 17-page CV listing Rogan's ACCLPP liaison and NTP lead-carcinogenicity roles, and an April 2001 NIEHS seminar titled “Treatment of Lead-exposed Children.” 2006-01-302006-09-29
• Rogan staff — Education & Employment 2006-08-27
• Rogan staff — Research Statement 2006-09-29 ·2×
• Rogan staff — Studies (describes TLC) 2006-09-29 ·2×
• Epidemiology Branch — Studies index 2006-06-192006-09-292007-03-02 ·3×
• TLC study — directory listing 2006-09-29

TLC publications — full text hosted by NIEHS

Full-text papers hosted on the NIEHS Epidemiology Branch site, including the 2001 NEJM TLC results paper and its editorial.

• Serwint 1999 — iron status (J Pediatr) 2004-10-30 ·4×
• Dietrich 2000 — symptomatic lead poisoning (J Pediatr) 2004-10-30 ·2×
• Gladen/Ragan/Rogan 2000 — PCB-DDE pubertal growth (J Pediatr) 2004-10-31 ·2×
• Rogan 2001 — primary TLC results (NEJM) 2004-10-30 ·2×
• NEJM 2001 editorial 2004-10-30 ·4×
• TLC Group 2000 — succimer safety/efficacy (Pediatr Res) 2004-10-30 ·3×

NIEHS IRB & conflict-of-interest records

Pages from the NIEHS Institutional Review Board section: guidance, forms, bulletins, meeting schedules, and rosters.

• COI Guide — financial & non-financial (Oct 2006, 10pp) NIH guide to financial and non-financial conflicts of interest, including IRB-member recusal rules (October 2006). One Wayback capture. 2007-02-21
• Protocol Conflict of Interest Statement form 2007-02-21
• IRB accreditation page ('last updated June 11 1999') 2006-06-222006-09-30 ·3×
• IRB Bulletin #1 — submitting applications Lists the clearances an application needs; scientific approval comes from the Deputy Scientific Director or, for Epidemiology Branch studies, the Acting Chief of the Epidemiology Branch. 2005-02-012005-10-29 ·2×2006-06-182006-09-29 ·4×
• IRB Bulletin #2 2005-02-012005-10-29 ·2×2006-06-182006-08-182006-09-29 ·4×
• IRB Bulletin #3 2005-02-012005-10-292006-02-202006-06-182006-08-182006-09-29 ·2×
• IRB Bulletin #4 — studies involving genes (Apr 2000; signed by chair) 2005-02-012005-10-292006-02-202006-06-182006-08-182006-09-29 ·4×
• IRB Bulletin #5 — scientific review of Epidemiology Branch projects States that scientific review of Epidemiology Branch projects before IRB submission is “typically done by the Branch, and this review is accepted by the Deputy Scientific Director.” 2005-02-01
• IRB basic information sheet 2005-01-14 ·2×2005-10-29 ·3×2006-06-18 ·2×2006-09-29 ·3×
• IRB meeting schedule New protocols need sign-off from scientific review, the Clinical Director, and a statistician (non-Epidemiology Branch protocols); for Epidemiology Branch protocols, the page says to contact the branch chief. 2005-01-14 ·2×2005-10-29 ·2×2006-06-18 ·2×2006-09-292007-02-12 ·3×
• IRB Membership Roster Epidemiology Branch members on the IRB: Baird and London (2004 roster); Baird and Longnecker (2006). 2005-02-012005-10-29 ·2×2006-06-18 ·2×2006-09-292007-02-122007-05-17 ·2×
• IRB Staff / officers 2005-02-012005-10-29 ·2×2006-06-182006-08-182006-09-292007-02-122007-05-17 ·2×
• IRB Standard Format for Protocols (Nov 1999) The IRB's standard format for protocol submissions, dated November 1999. 2006-06-222006-09-30 ·3×

Media & file index

An NIEHS index of video interviews with Joseph Graziano (the videos were streamed and not archived), and a PDF of follow-up questions from Joseph Graziano and Joshua W. Hamilton.

• Joseph Graziano video index (listallvideos.cfm) 2014-11-232015-03-22
• Graziano & Hamilton — follow-up questions (Q&A PDF) 2012-01-27 ·29×