Document n9V5Jooppp93e3zKm43DGZkdz

A 1 Topic Area Description of Issue(s) B BHRC Financial Audit Recommendations and Action Plan C Recommendation Action Plan D EF G Responsible Person Due Date Imple - mented Contracts / 2 Grants 3 4 5 Per confinnation with Lorraine Twerdok, contractnal!grants agreements exist between API on behalf of the BHRC consotium 1. To bring BHRC up to date, do a paper explaining budget changes from Jan 01 to Dec 01 Budget. and the various stndieslitems listed above with the exception of 2. For future budget changes, the Fudan University - Epidemiology Case Control Stndy and process will be: (1) written request QAlQC Support. Outside Legal Counsel costs are contracted separately through API and charged back to the stndy. Although there was not enough time to review individual contracts, an overview of project activities, estimated costs, contract time period, milestones, and other associated activities should be Review and or rewrite (if necessary) the stated in each contract. API and BHRC Committee should contracts to include and/or exclude from contractor (2) brought to TC Budget Work Group for a recommendation to the OC (3) OC approves/does not approve, (4) decision communicated to contractor via writing and communication attached to contract and API takes 1. History paper: Bruce 2. Future Process: OC API staff person 3. consider reviewing all contracts and obtaining contracts for addendums, attachments, letters, etc. appropriate contractural actions. OC review Sept 30 Fudan University and QAlQC Support. related to the SHS. 3. Review all contracts. contracts 03 Contract should be obtained for Fudan Contract in place for 42K. Need to University revise contract for full amount. Bruce YE03 1. Complete 2. Process agreed 3. Contracts reviewed; will be amended at renewal date Contract should be obtained for QA/QC (External Pathology Review) support. Not applicable - In UCSHC grant Not actionable To further assist in obtaining confidence Technical Committee has and controls that the approved budgeted responsibility to monitor research and project will not exceed $22,789,300, the OC the legal, PR and API expenses. committee may want to consider API has responsibility to provide data for review. OC has overall obtaining a letter/agreement from API responsibility for budget. stating such and list the possible Need to formally communicate to activities and costs that may exceed the contractors the need to stay within current approved budget. budget. OC has responsibility to communicate to Pis (Irons, Wong and Fu). Don YE03 University of Colorado 6 (UCHSC) 7 8 The University of Colorado (UCHSC) stndy operates under a grant which encompasses the DP and ME stndies which totals $15,258,000. This represents approximately 67% of total project costs. As of December 2002, API has paid on behalf of the consortium $7,515,759, as agreed, with another scheduled Although grants are regarded differently, payment of$5,040,261 due August 2003. As of March 2003, API and BHRC committee should API reports UOC has spent $4,136,955 leaving UOC with a consider addressing the following balance of $3,378,795. questions: Will projected funds be used? Should payment schedule be revised so that UOC is not holding large cash balances? Sept 30 OC 03 &[DATE] &[FILE] SH ELL-MCCLU RG-066099 BHRC Financial Audit Recommendations and Action Plan A 9 10 11 B C D EF G Is interest collected on excess funds and are they contributed back to the study as to supplement costs? Actioned Is UOC able to provide specific documentation, such as invoices, etc. if needed? Ann Louden - U C Bruce Bruce Sept 30 03 Interest is collected. Bruce has action to request that $ be applied to study costs. Sept 30 03 Who audits the UOC financial tracking of study? Ask if UC is audited and, if so, may we have a copy of report? Grant specifies right to look at financial records. Bruce OC will decide whether to audit or not. Sept 30 03 University of Colorado 12 (UCHSC) It is recommended that API, as project administrator, validate the expenses incurred as reported from UOC's progress reports via an audit proposed Progress reports are sent to API twice a year. Costs for a separate Fudan University project, Richard Irons project and EMBSI costs are currently included and tracked by UOC. API by the consortium. To avoid possible duplication of costs, validation is required to make sure the same type of Need to distinguish details of work effort between Fudan contract and the UC subcontract with Fudan. Need mirrors the data reported by UOC and has no means of validating cost included in UOC's project is not the specific invoices from Fudan for OC will decide actual expenses to make sure the consortium is not charged same as the projects costs tracked contract. Need this information to whether to twice. individually by API. finalize Fudan contract. audit or not. YE03 Financial 13 Tracking Currently API uses a contract management tool to track costs associated with the study, which is updated by the financial department at API. Once updated, Paula Podasky receives the data from finance and uses the data to report costs that go against the contracts for reporting actual expenses incurred for all studies except for UCHSC (explained above). Currently there are various formats and time periods used to report various financial study data and project financial summaries. Currently it is difficult to get a financial picture at any given time. Actual as well as budgeted data constantly changes. This information should be tracked monthly or quarterly to maintain stability. A financial tracking tool or format is necessary that can easily be It is recommended BHRC committee set TC will recommend to OC a quarterly a specified time frame for periodic schedule for financial reporting for reports as of March 31 (due April 1), updates (monthly, quarterly, etc.) and an June 30 (due Aug 1), Sept 30 (due API generates reports; TC reviews and updated by a finance person. Note: During the review there was agreed upon format for each Benzene Nov 1), and Dec 31 (due Feb 1). A provides to OC not an opportunity to address who reviews/approve expenses Study item which will present a financial spreadsheet workbook format will be for review and 1st report associated with the study under API's responsibilities. picture at any specified time. recommended to OC. approval. for 3Q03. &[DATE] &[FILE] 2 SHELL-MCCLURG-066100 A 14 BHRC Financial Audit Recommendations and Action Plan B C D EF G (See attached file entitled "Benzene-API Executive Summary" Exhibit A for suggested Executive Summary fonnat for overall project and file "BenzeneAPI - Applied Health Study" - Exhibit B is a suggested fonnat for reporting individual project items - example is for Applied Health Sciences Study.) It is further recommended, if necessary, 1, API process: Invoice comes to an additional process audit review to contract manager to approval and interview API finance department to coding. Invoice sent to API finance understand processing of expenses under department for check to be paid. API's responsibilities. This includes all Entered into API financial records. except UCHSC. There does not seem to Contract manager gets copy of API b d '11 d financial reports. Action: OC decide e an easy way to get n own to accept process or commission a infonnation on any of expenses paid. validation. 2. Backup of expenses paid on the project Do not change financial records: 1. 3Q03 2, Impleme nt should be easily identifiable as to what make adjustments in next report with 1. OC 2. immediat 15 was spent on the project. a note explaining change. API ely Various budget changes have occurred since the beginning of project in 2001, with the most recent changes documented via e- mail dated June 19, 2003 from Lorraine Twerdok to the BHRC Oversight and Technical Committees. Some committee members were not aware of the changes. For example Fudan University cost went from $190,555 to $661,000. Although the It is recommended a mechanism for overall budget did not change, there was no approval process by documenting changes be implemented the committee to accept changes. API received a one-page immediately that has the approval of the summary of figures with no clear explanations for increases from committee in writing to API before 16 Budget Revisions Fudan. budget changes are made. For future budget changes, the process will be: (1) written request from contractor (2) brought to TC Budget Work Group for a recommendation to the OC (3) OC approves/does not approve, minutes will serve as documentation. (4) decision communicated to contractor via writing and communication attached to contract and API takes appropriate contractural actions. OC Record keeping at API is based largely on manual data received. Documentation / API should have a contingency plan in place to back up manual It is recommended API review and 17 Backup and system data in cases of emergency. validate data backup process. API maintains a paper copy master file; Electronic copies are maintained and API does daily electronic backups. Process has been written and put on the web. No Action. Process agreed. Impleme Needs to be nt formally immediat captured in ely minutes. Complete &[DATE] &[FILE] 3 SHELL-MCCLURG-066101