Document baDD6bqXJQNqvkx9Na6bqZO6o

CONCAWE meeting report Telephone conference: Date and time: File number: Benzene DCR Task Force 5 September 2003 (17:00-19:00 CET) M.4.1.2 Project: Benzene Epidemiology Data Consistency Review Participants: S. Tsai (Shell); K. Satin (ChevronTexaco); L. Bloemen (Dow- chair); J. Urbanus (Concawe- report) 1. Adoption agenda: as circulated by e-mail of 4 September 2. Introduction task force members: Participants briefly introduced themselves as this was the first proper discussion, all previous communication having taken place via electronic mail exchanges. Due to the short notice organisation of the telephone conference there had been no contact with K. Hommes (Shell), absent from his office. 3. Project background: A brief discussion took place around the published studies included in the project. 4. Mandate and supporting groups: ru clarified that since formal approval by the Concawe Scientific Council and discussion of the project plan in the Health Management Group (HMG), contacts had been made with other oil and chemical associations to solicit co-funding and participation. This had in all cases been successful (API, AlP, IP, CPPI, APA). In addition, nominations for the liaison group and the scientific advisory board had been received. Concawe's HMG was the first referent for the TF. 5. Project expectations: A brief discussion took place on activities that were expected to take place under the project and what exactly the outcome would be [in addition to the text recorded in the Project Description]. In essence, it was understood that the study try to reconstruct what was actually done with (raw) data, which procedures and protocols had been followed, and characterise in particular a number of aspects not written up in the publications; that the possibility to reconcile the differences would be examined; and that the basis for a possible pooled analysis be explored. The contractor is not expected to make a recommendation on the feasibility of the pooled analysis. 6. Timing and project plan: It was agreed that before the RfP could be issued it would be necessary to have a better idea of where and how raw data, protocol, procedures were stored. LB agreed to draft a letter to the 4 study directors (or sponsors -to be clarified by JU). The composition of the SAB was discussed. P. Boffetta and D. Verma are confirmed members; N. Pearce had been contacted (formal response awaited). CGU BEN0000424 J. Cherrie ofiOM was considered a good SAB candidate for exposure matters, but 10M was also considered a candidate contractor. LB agreed to verify Cherrie interest. The haematologist candidate Maynadie appeared acceptable - LB would contact him. Terms of Reference for the SAB needed to be established and would be based on ToR's of other projects if possible. SAB duties would include review/comment ofthe Technical Annex ofthe RfP, review of protocol (possibly in a meeting) and report, and generally be available for advice. A SAB chair should be elected. 7. Technical Annex development: Most of the attention to-date of the TF had gone to the Technical Annex, viewed as critical for a successful project. ST had provided anew draft, but without some mexposure elements suggested earlier by ru. would now prepare a final draft for 1 week group review, then internal HMG review. 8. Project funding: None ofthe participating organisations had been invoiced yet, pending a commitment from Concawe to issue a contract. It was considered essential however to notify these organisations that 2003 monies will still be needed (ru). 9. Progress reporting: It was considered necessary to start issuing progress reports to funding organisations; a first report would be drafted (ru), and reviewed (TF, 1 week). 10. Candidate contractors for Data Consistency Review: Candidates currently considered potentially acceptable are Manchester University; Institute of Occupational Medicine; Rotterdam University; Maastricht University; and Finnish Institute for Occupational Health. Informal contacts have been made with most of them to check their availability. KS agreed to initiate the drafting of the RfP letter for review by the group. 11. Recap of actions (all to be completed by end of September) What Check with J Cherrie (IOM) SAB or DCR investigator Check availability SAB ofDr. Maynadie (Univ. Dijon) Develop ToR for SAB, basis other projects Finalise Technical Annex, version Tsai 4 Sept.2003, incorporate exposure comments, circulate for 1 week final TF review, then to HMG Prepare 1st progress for 1 week review TF, then distribute to project partners via liaison group Draft letter for Request for Proposal for TF review By who LB LB ST m m KS CGU BEN0000425