Document bObojVZawdQR472vrBNn4M333

rt tl" i UC.1 l Ui_JU r ' --0C f" U*4 (AddendumA, Pag< l of 3) VCHC*4.0-EPI*UPDATE January 15, 1996 ADDENDUM A Data Transfer Delays and Replacement of Missing Study Materials Background: As described in detail in a letter dated August 29, 1995 from Dr. Kenneth A. Mundt of Applied Epidemiology, Inc. (AEI) to Dr. Hasmukh C. Shah of the Chemical Manufacturers Association (CMA), substantial delays in the transfer of materials critical to conducting the Update of Mortality Among Vinyl Chloride Workers have resulted in unanticipated increases in personnel costs to AEI. Additionally, the previous contractor has been unable to deliver pan of these materials, including an estimated 1,000 death certificates for deaths occurring among cohort members prior to 1983. Replacing these death certificates and outer records at this time will require additional effort and resources. This addendum to the original agreement describes: 1) the added expenses incuiTcd by AEI resulting directly from the data transfer delays; and 2) the additional time and resources required to a) replace the missing materials, b) organize the collection ofpaper and electronic records received from the previous contractor into a useable archive, and c) identify information necessary to reconstruct some of the missing records and files. A new time line for the mortality update is also provided. Data Transfer Delays and Reconstruction ofthe Study Archive: According to the original agreement between CMA and AEI, all study materials and data were to be transferred to AEI from the previous contractor by May 1,1995. As ofJanuary 1,1996, the delay reached eight months, during which time AEI retained staff exclusively for the purposes of this study. Two months of this time were required for preparing the detailed protocol, leaving six months of unanticipated delays. Mining Materials: Materials critical to meeting the terms of the original agreement, but not received by AEI include an estimated 1,000 death certificates: 829 from the previous update, and up to 200 missing from the batch of older death certificates. The most straightforward of these to replace are the estimated 360 identified using the National Death Index (NDI), which began registering deaths in 1979. Certificates for deaths occurring prior to 1979 may be much more difficult to obtauit and consequently, all lost certificates may not be replaced. CMA 112597 * I J. t-KLi'i Hi-r.icu tr iLtlUuUJji i-0c- P.Q5 (Addendum A, Page 2 of3) Other missing information is the standard documentation and coding manuals to the previous contractor's data files. Although several tapes have been received, none were accompanied by such necessary information. Also, no files with death information have been received. Total Delays and Budget for Added Costs: Of the study milestones, AE1 prepared a peer-reviewed protocol during the delay period. This effort represented a two-month personnel effort, leaving a six-month period of unanticipated staffing costs. Costs associated with the replacement of missing death certificates will be limited to searches and requests for copies of death certificates. Extending the NDI search back to 1979 will be unnecessary, as the tape containing the results of the previous NDI submission has been located and successfully read. Thus, expenses will be incurred for study staff, death certificate searches (if state of death known or suspected), death certificate copy charges and nosological coding. The personnel effort for this part of the project is estimated to be two months, for a total of eight months. Because CMA has diligently attempted to obtain the missing materials and assisted AEI with the preparation of releases for ail states, AEI will absorb two months of payroll. Other expenses are limited to cost, and the discounted overhead rate as in the original agreement: Personnel (six months study staff) $61,422 Death certificate charges (1,000 x $9) Death certificate searches (additional fee of charged by states if certificate number unknown) (300 x $5) Coding of death certificates by nosologist (1,000 x $2.50) 9,000 1,500 2.500 Total direct costs Overhead (10%) $74,422 7.442 TOTAL ADDENDUM A $81,864 This estimated budget is made in good faith based on facts known at this time. Applied Epidemiology, Inc. reserves the right to revise this budget ifadditional delays occur, or ifthe minimal information necessary to replace the lost materials is not made available. No guarantee that all missing death certificates can be replaced can be made. Time Line: Given the data transfer delays resulting in six months' lost time, and the additional two months required to obtain missing death certificates and creating the study archive, the total CMA 112598 ('Addendum A, Page 3 of3) additional time required to complete the update is approximately eight months However, AEI will expedite die completion of the study by requesting an extension ofonly six months, which would move the targeted project completion date forward to October 1. 1997. All milestone, deliverable and invoicing dates are accordingly extended six months The next payment under the original contract will be due May 1, 1996. Payment for the additional services described in this addendum shall be made in two installments of$40,932 each, the first to be invoiced upon execution of this addendum (by February 1, 1996), and the second on or about March 15,1996. To date, two interim reports have been submitted (Interim Report 1 on July 1 1995, and Interim Report 2 with the study protocol on August 1,1995). Note that the second interim report was submitted ahead of schedule. Given the delays in transferring materials to AEI, the following schedule of interim reports will replace that in the original agreement: Interim Report 3 Interim Report 4 February 1,1996 May 1,1996 Interim Report 5 September 1,1996 Interim Report 6 January 1,1997 Interim Report 7 May 1,1997 This new schedule includes two additional interim reports than in the original agreement Accepted; The signatures below indicate acceptance ofthis addendum: For CMA; For Applied Epidemiology, Ins: NAME: TITLE: date Kenneth A. Mundt, PhD. President date CMA 112599