Annual Comprehensive Site Compliance Evaluation Form 12-3: Fill & Download for Free

Developing a clinical trial budget can be a confusing exercise for sponsors and CROs. There are too many cost variables to account for.This post covers the key cost drivers for medical device clinical trials. If you are a researcher or financial analyst working in clinical trial space or simply curious about clinical trial costs, this post will serve you well.So let’s get started.1. PATIENT GRANTPatient grant costs are broken down into screening, baseline and follow-up visits and medical imaging costs.A. SCREEN FAILURESClinical trial protocols have inclusion and exclusion criteria to qualify patients. Strict inclusions and exclusion criteria reduce the available patient pool for trial enrollment. Clinical sites spend physician and site coordinator time to screen for potential patients.During the budgeting process, map out the complete patient screening workflow. Speak with a few clinical sites to understand how many patients they would have to see in order to find one qualified patient. For example, a site may need to screen four patients to find one qualified patient. Understand how many hours the site is spending on screening activities and reimburse accordingly. It is not unusual to reimburse sites anywhere between $50 to $250+ per screen failure.B. BASELINE/INDEX PROCEDURE AND FOLLOW-UP VISITSDepending on the clinical trial design, data is collected at baseline/index procedures and follow-up visits. The site coordinator is generally responsible for entering the data in the case report form. Sites are reimbursed for the time spent to collect clinical trial data.Based on number and type data fields you are collecting, you’ll want to estimate the site coordinator time needed to collect and input trial data. Multiply the estimated coordinator time by the hourly bill rate to obtain the fair market value for each patient visit.In some cases, sponsors may choose to reimburse patients. Reimbursement for patients can include paying for their participation, reimbursement for travel, meals or overnight hotel stays.C. NON-STANDARD OF CARE TESTSMedical device trials may require non-standard of care tests such as medical imaging scans. These costs are generally not reimbursed by insurance companies or medical care agencies and should be budgeted as part of the clinical trial cost.D. PROCEDURE COSTSIf the clinical trial procedure is reimbursed, you don’t need to budget for the procedure cost. Insurance or medical care agencies will pay for the procedure. In case a brand new procedure where no reimbursement available, budget for the procedure costs.2. SITE COSTSA. START-UP FEESClinical sites spend significant time to initiate a new clinical trial. Sites are responsible for site specific informed consent development, Ethics Committee (EC)/ Investigational Review Board (IRB) submissions, staff training including participation in investigator/ site coordinator meetings and site initiation visits and execute a clinical trial contract. It is typical for sponsor to pay anywhere between $2000 – $5000+ in site start-up fees.B. EC/IRB FEESEC/IRB fees are in addition to site start-up fees. These fees cover the time spent to by EC/IRBs to plan and conduct review of the clinical trial protocol and other associated materials. Many EC/IRBs update and publish their rates annually.C. CLOSE-OUT FEESClose-out fees include time spent by site staff to reconcile clinical trial data, finances and regulatory documents during study closure. Not all sites require this payment but has started to become a more common practice in recent years.D. STORAGE FEESGovernment regulations require that clinical trial data be stored after study close-out. The duration for storage can range from 2-years to permanent storage. It is not uncommon for sites to have boxes of regulatory paperwork that needs to be stored once a clinical trial ends. The storage fees vary by country and site.Some sponsors make arrangements for site to send trial documents to an offsite storage location. Due to country specific regulations, a site might be unable to move documents outside their country.E. ADMINISTRATIVE OVERHEADClinical sites may require as much as 30% administrative overhead in addition to per patient grant amount. This cost covers management and legal resources needed to provide clinical research oversight and legal review of clinical contracts respectively.F. SITE MANAGEMENT ORGANIZATION (SMO)In certain countries such as Japan, data entry and collection tasks are outsourced to SMOs. For post approval studies, sites do not research coordinator support. Sponsors are expected to hire SMOs to support the site or pay the sites to hire their preferred SMOs.3. NON-PATIENT COSTSA. CLINICAL EVALUATION COMMITTEE (CEC)Adverse event and endpoint data is adjudicated by a non-biased, independent CEC. CEC is generally composed 3 or more physicians. CEC members review adverse events and trial endpoints in a team setting or independently.A sponsor can hire physicians to serve as the CEC and reimburse them at fair market value rates. It is more cost effective for sponsor to contract with physicians directly. However the sponsor has to assign its own resources to manage the CEC.The other option is for the sponsor to outsource management and conduct of CEC activities. This option is more expensive because you are hiring professionals to manage the CEC.CEC is a very important component of medical device clinical trial. Adjudicated adverse event data is highly regarded by regulatory agencies and the physician community. In many cases, it is a requirement to have adjudicated adverse event data in order to get the product on market.B. DATA SAFETY MONITORING BOARD (DSMB)DSMB is also known as the Data Monitoring Committee (DMC). According to IMARC research, the purpose of the DMC is to advise the sponsor on continuing safety of the trial subjects and those yet to be recruited and provide continuing validity and scientific merit of the study.For budgeting purposes, it is important to know that DSMB is required during trial enrollment phase and in some cases till all patients have reached their primary endpoint. The decision of whether or not to conduct DSMB meetings after the primary endpoint is reached, is up to the sponsor.C. PHYSICIAN CONSULTINGPhysicians are consulted during all phases of a clinical trial. Physician guidance is needed to develop clinical trial strategy, enrollment plan, final data analysis and publication plans.Depending on the physician’s medical expertise and geographical location, consulting costs can be anywhere between $150 – $600+ per hour. If a clinical trial is interesting to the physician, he or she may be willing to provide consulting services at no cost.D. INDEPENDENT CORELAB ANALYSISMany medical device trials collect imaging data such as angiograms, CT scans and X-Rays. Since this data comes from multiple sites, variability is expected. An independent corelab standardizes the collection and analysis of imaging data.Corelab costs can add up quickly. Costs depend upon the number of images analyzed per patient, the time it takes for the corelab to analyze the data, and the duration of the trial.Corelabs usually hire analysts to collect and calibrate data from different sites. The final analysis is usually done by a physician. Given the complexity of imaging data collection and analysis combined with the importance of corelab data to regulatory agencies, it is important that adequate and accurate budget is allocated for independent corelab analysis.E. MEDICAL DEVICE COSTOnce you are ready to enroll patients in the clinical trial, you’ll need to ship medical devices to the sites. Most sites will expect to receive these devices for free. The only exception is when conducting post approval trials for commercially available devices.Medical device manufacturers conduct trials for indication expansion. For example, a stent company may conduct a trial to get their heart stent approved for use in a different anatomy. For such expansion trials, sponsors may need to provide commercially available devices to sites at no cost.Whether or not you want to provide devices at no cost is a business decision. When investigational medical devices are provided at no cost, sites enroll faster and have a much stronger, collaborative relationship with the sponsor.4. LABOR COSTSIn order to conduct a clinical trial, you need to hire people that have expertise in clinical research and clinical trial management. Depending on the size of the trial and the number of trials conducted, resource allocations vary. Therefore amount of labor needed to run a study also varies.A. CLINICAL RESEARCH ASSISTANTS OR ASSOCIATES (CRAS)CRAs are primarily responsible for monitoring clinical trial data that is collected during the course of the study. They visit clinical research sites to ensure data is collected in a compliant manner.B. PROJECT MANAGER (ALSO KNOWN AS CLINICAL TRIAL MANAGER OR STUDY MANAGER)A project manager’s responsibilities can vary from one organization to another. Project managers are like “general contractors.” A project manager is responsible for managing the clinical trial budget, resources and timelines. The core function of a project manager is to resolve or escalate issues that come up during the course of a clinical study.C. DATA MANAGERA data manager’s job is to address data discrepancy issues by generating queries to sites. Data managers may also be responsible for implementing electronic data capture system or paper case report forms needed to collect trial data.D. SCIENTISTThe scientist is primarily responsible for developing the clinical strategy for a trial. Individuals with Ph.D. or M.D. degrees are usually the right fit for this role. In some organizations, the project manager also play the role of the scientist.E. BIOSTATISTICIANA biostatistician is responsible for developing a statistical analysis plan (SAP). The SAP documents on the data will be analyzed during the course of the study. A statistician or statistical programmer is also responsible for programming data tables that are incorporated in the final clinical study reports.F. QUALITYClinical research is a regulated industry. Quality plays an important role in ensuring sponsors, CROs, and clinical sites are conducting the trial in a compliant manner. A quality associate or manager helps an organization create and implement standard operating procedures (SOPs).Salaries for these roles can vary by geography and experience. The above list is not comprehensive. However it should give you an idea of the core resources needed to conduct a medical device clinical trial.5. SITE MANAGEMENTA. PRE-STUDY VISITSPrior to inviting any site to participate in a clinical trial, you want to conduct pre-study visit, also know as the site assessment visit. This visit becomes even more important if you don’t have any prior experience working with the site in a clinical or commercial setting.Although sites don’t charge for this visit, the sponsor will need to pay for travel and CRA labor costs.B. SITE INITIATION VISITS (SIV)Once the site has received Institutional Review Board (IRB) approval and the trial contract has been signed, it’s time to activate the site for patient enrollment.A SIV is conducted once you are ready to activate the site. SIV involves training the site on the clinical protocol and any other study-specific requirements.Similar to the a pre-study visit, the sponsor will need to pay for travel and CRA labor costs.C. MONITORINGOnce patients are enrolled in the study, you want to ensure data is collected in a compliance with regulations and the clinical study protocol. This is when monitoring comes into play.A CRA, sometimes known as the site monitor, visits clinical sites at regular intervals to ensure compliance.In recent years, due to push for reduction in clinical trial costs, several sponsors have started to monitor remotely rather than conducting an in-person monitoring trip.D. CLOSE-OUTOnce all patients at a site have completed their follow-up visits, it’s time to conduct a close-out visit. Any open items related to study conduct are addressed during the close-out visit.Although it’s always nice to have in-person close-out visits, it’s acceptable to close trials via remote close-out calls.6. MISCELLANEOUSA. INVESTIGATOR MEETINGSInvestigator Meetings usually serve to kick-off a new clinical trial. Investigators and research coordinators participating in the study are invited to participate in a 1-2 day meeting. The purpose of these meetings is to educate site personnel on the clinical trial protocol and any other specific trial requirements.These meetings can be quite expensive as airfare, hotel and meals are usually provided by the sponsor.B. TRAVELPlan and budget for adhoc travel. Since clinical trials are heavily regulated, you may need to visit a site to address a compliance issue or help them prepare for an audit. In other cases, you may want to visit a site to motivate them to enroll patients. Whatever the case may be, it’s always good to have some money set aside for travel.C. DOCUMENT TRANSLATIONSDocument translations costs can increase significantly depending on the countries in which the clinical trial is conducted. Sites where English is not the primary language, you may receive request for translation of key documents such as the protocol and site specific informed consent in the local language.Also if the adverse event source documents from non-English speaking sites are in their native language, additional costs will incur to translate documents into English for event adjudication purposes.D. TECHNOLOGY SOLUTIONSClinical Trial Management System (CTMS), Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), Interactive Voice/Web Response System are a few common technology solutions implemented when conducting a clinical study. These systems are needed to manage site contact information, collect clinical data and maintain clinical trial records. There is a monthly or annual license fee associated with these systems. Additionally staff is needed to manage and maintain these systems.E. REGULATORY FILING FEESRegulatory filing fees should not be overlooked as these can run into thousands of dollars. Depending on the class of medical device, different applications need to be filed with regulatory agencies, competent authorities and notified bodies.7. OTHER FACTORS:A. PROTOCOL AMENDMENTSDue to unforeseen circumstances, a clinical protocol amendment may be necessary. A protocol amendment has many downstream effects that can increase the cost of a clinical trial.A protocol amendment usually leads to additional IRB/EC fees, site costs, regulatory re-submissions and more.B. INFLATION, VALUE ADDED TAX (VAT) AND FOREIGN EXCHANGEInflation should be factored in for multi-year clinical trials. In the US, a minimum 3% inflation is expected.Sites in countries such as Australia and Europe, add VAT for the research services. VAT can be upwards of 12% on all research services.For trials conducted in multiple countries, paying attention to foreign exchange rates. At a minimum, annual review of exchange rates is advised. Clinical trial cost projections should be adjusted based on exchange rates.C. TRIAL ENROLLMENT DELAYSEnrolling in trials is tricky business. It takes longer to complete enrollment and initial projections are overly optimistic. Account for these delays when you develop your clinical trial budget.[1]To summarize, you should now have a solid understanding of these factors that impact clinical trial costs:Patient grant amount such as screen failure costs, data entry costs and travel reimbursementSite costs such as site start-up fees, EC/IRB fees, close-out and storage feesNon-patient costs such as core labatory fees, clinical events committee and data safety monitoring boardLabor costs – clinical research employee salaries or contractor paymentsSite management costs such as pre-study, site initiation, monitoring and close-out visitsMiscellaneous costs such as travel, technology solutions and regulatory filing costsOther factors such as value added tax, inflation, protocol amendment and delays in enrollmentFootnotes[1] Ultimate Guide to Clinical Trial Costs - Clinical Trial Podcast

“ Internal Audit MICS Compliance Reporting Guidelines ““ NIGC: National Indian Gaming CommissionINTERNAL AUDIT MICS COMPLIANCE REPORTING GUIDELINES(Refer 542.22; 542.32; 542.42)August 12, 2005INTRODUCTIONEach tribe or its designated tribal gaming regulatory authority shall, in accordance with the tribal gaming ordinance, establish and implement tribal minimum internal control standards that shall:1. Provide a level of control that equals or exceeds those set forth in Section 542;2. Contain standards for currency transaction reporting that comply with 31CFR part 103;3. Establish standards for games which are not addressed in Section 542; and4. Each gaming operation must be in compliance with the tribal internal control standards within nine (9) months from June 27, 2002. However, the tribal gaming regulatory authority may extend the deadline by an additional six (6) months if written notice is provided to the NIGC no later than two weeks before the expiration of the nine (9) month period.Each tribe or its designated tribal gaming regulatory authority shall, in accordance with the tribal gaming ordinance, establish and implement tribal internal control standards that equal or exceeds the revised standards published on August 12, 2005 that shall include the following on internal audit guidelines:1.The NIGC MICS Section 542.22 (g), 542.32 (g), and 542.42 (g), states:(g) Internal Audit Guidelines. In connection with the internal audit testing pursuant to paragraph (b)(1) of this section, the Commission shall develop recommended Internal Audit Guidelines, which shall be available upon request.2. Each gaming operation must be in compliance with the revised tribal internal control standards within four (4) months from August 12, 2005. However, the tribal gaming regulatory authority may extend the deadline by an additional sixty (60) days if written notice is provided to the NIGC no later than December 12, 2005.These guidelines are developed to ensure that all gaming operations that are required to provide for an internal audit function are performing a minimum amount and similar types of internal audit compliance procedures pursuant to the NIGC Minimum Internal Control Standards (MICS).Objectives25 CFR Part 542 (MICS) requires the gaming operation’s internal auditor to perform observations, document examinations and inquiries of employees to determine compliance with applicable minimum internal controls standards. The NIGC publishes recommended checklists, programs and guidelines for use in satisfying this regulatory requirement. The primary objective of these checklists, programs and guidelines is to provide guidance on what is necessary to comply with 25 CFR Part 542 (MICS). A secondary objective is to provide some consistency among internal audit departments and other individuals performing internal audit work by providing recommendations on standardizing the document examination sample sizes and the scope of the work to be performed. Standardization requirements ensure that all internal audit departments are performing a minimum amount of work and are performing the same required procedures. Finally, by standardizing the questionnaires, the NIGC is able to review any internal auditor’s workpapers in a more efficient and time saving manner without having to adjust to the myriad of internal audit department and accounting firm styles.Each checklist provided by the NIGC contains meaning of terms used including sample size and a testing program. Although the checklists are not to be considered all-encompassing, they address the Minimum Internal Control Standards that became effective on June 27, 2002 and revised on May 4, 2005, August 12, 2005, and May 11, 2006. As the information changes due to the adoption of new regulations, internal auditors are expected to develop their own testing procedures until updated versions of the checklists are distributed. Additionally, these Guidelines are not intended to limit the internal auditor to the performance of only the above-specified procedures. If additional procedures are performed (e.g., expanded document testing), the results obtained should be included in the internal auditor’s report pursuant to 25 CFR Part 542 (MICS). The internal auditor may also develop compliance checklists appropriate for a Tier A, Tier B, or Tier C gaming operation that at a minimum address the MICS.In connection with the issuance of the NIGC MICS Sections 542.22; 542.32; and 542.42 the Internal Auditor is offered the following information as recommended guidance:Requirement for Internal Audit FunctionInternal Audit Minimum Internal Control Standard (a)(1) requires that a separate internal audit department be maintained whose primary function is performing internal audit work and that is independent with respect to the departments subject to audit. Pursuant to (a)(1), for gaming operations who meet the requirements of a Tier A or Tier B gaming operation who are not required to maintain a separate internal audit department, personnel who are independent with respect to the departments/procedures being examined perform internal audit work.Additionally, all Tier A, B, and C gaming operations, as defined in Section 542.2, must provide for an internal audit function. The following are definitions of the different Tier classifications:Tier A means gaming operations with annual gross gaming revenues of more than $1 million but not more than $5 million.Tier B means gaming operations with annual gross gaming revenues of more than $5 million but not more than $15 million.Tier C means gaming operations with annual gross gaming revenues of more than $15 million.Independent Accountant Performs Internal Audit FunctionGaming operations may elect to have an independent accountant perform the internal audit function rather than using its own internal auditors. If the independent accountant is engaged to perform the internal audit procedures, the required observations of the table games/gaming machine drops and counts must be separately performed to satisfy the internal audit observation requirements and independent accountant tests of controls as required by the American Institute of Certified Public Accountants guide which satisfies the Internal Audit Minimum Internal Control Standard (b)(3).When the same CPA firm performs the procedures required by Section 542.22; 542.32; or 542.42 and Section 542.3(f), it is recommended that the individual(s) performing the Section 542.22; 542.32; or 542.42 procedures cannot also perform Section 542.3(f) drop and count procedures.Independent Accountant Reliance on Internal Auditors – Section 542.3(f)(3)The CPA firm may rely on the work of an internal auditor, to the extent allowed by the professional standards, for the performance of the recommended procedures specified in paragraphs at Section 542.3(f)(1)(iii)(B), (C), and (D), and for the completion of the checklists as they relate to the procedures covered therein provided that the internal audit department can demonstrate to the satisfaction of the CPA that the requirements contained within Section 542.22, 542.32, or 542.42, as applicable, have been satisfied.Agreed-upon procedures are to be performed by the CPA to determine that the internal audit procedures performed for a past 12-month period (includes two 6-month periods) encompassing a portion or all of the most recent business year has been properly completed. The CPA will apply Agreed-Upon Procedures to the gaming operation’s written assertion as specified in paragraphs at Section 542.3(f)(3)(ii)(A), (B), (C), (D), (E), and (F).ProceduresIt is recommended that the internal auditor perform the following:1. Complete the applicable testing procedures checklist by performing inquiries and observations during the period under review, and perform document compliance testing for dates within the period under review. Within the checklists provided by the NIGC unless specified otherwise, the standard document testing for gaming machines and table games involves a sample size of two (2) days, all shifts. One test date should be selected from the first six (6) months of the audit period and the second test date selected from the six (6) month period immediately preceding the examination. Standard document testing for all other areas involves a sample selection of one (1) day, all shifts, from the twelve (12) month period immediately preceding the audit. The days are to be randomly selected. Where monthly testing is required, the months used will be the months that include the selected test dates.2. A separate checklist must be completed for each major gaming area of the gaming operation which satisfies the Internal Audit Minimum Internal Control Standard (b)(1). Theses gaming areas include, but are not limited to, bingo; pull tabs; card games; keno; pari-mutual wagering; table games; gaming machines; cage and credit procedures; information technology functions; and complimentary service or items. These checklists are used to determine if the gaming operation’s procedures in effect and the documents in use comply with the MICS. Each checklist must at least be completed once each year in accordance with the MICS.Performance and CompletionIt is recommended that the internal auditor perform and complete procedures in accordance with the following requirements:1. All questions on each applicable checklist must be completed. Detailed explanations must be provided for all “no” responses and for exceptions noted during document testing.2. Observations must be performed on an unannounced basis and, whenever possible, are to be performed without the employees being aware that their activities are being observed. For purposes of these procedures, “unannounced” means that no officers, directors, or employees are given advance information regarding the specific dates or times of such observations. Such observations may be performed from the surveillance room if practical. If advance arrangements for count room access are necessary between the gaming operation and the internal auditor, the arrangements indicating the method that will be used to allow the internal auditor access to the gaming operation’s count rooms should be made. Documentation should be prepared by the internal auditor indicating the date the arrangements were made, the time period the arrangement is in effect, procedures to allow the internal auditor prompt access to the gaming operation’s count room and the method to ensure proper identification of the internal auditor. These arrangements should allow the internal auditor prompt access to the count rooms at any time without prior notification to any gaming operation personnel. Any subsequent updates to these arrangements (e.g., personnel updates) should be made on a regular basis (e.g., quarterly) to avoid alerting the gaming operation of an upcoming observation.Observations may be performed live using surveillance equipment. However, because the internal auditor must observe the count until the monies are transferred to the vault/cage and accepted into the vault/cage accountability, it is recommended that any change in viewing location (i.e., from the count room to the surveillance room) will necessitate reviewing the surveillance tapes for the time period during which the auditor was in transit.3. The gaming operation’s written system of internal control must be compared by the internal auditor against actual control procedures in effect as they relate to compliance with the NIGC MICS and approved MICS variances. The internal auditor must also compare the written system of internal control to the gaming operation’s policies and procedures.4. The internal auditor performs compliance testing of various departments referred to in the checklists to determine compliance with the NIGC MICS and to determine if the gaming operation’s recording and reporting procedures are adequate and accurate. The scope of such testing is indicated on the checklist where applicable. When multiple test dates are required to be selected, the days are to be randomly selected. The checklists and/or back-up workpapers must include documentation of the original document examined by either explicitly identifying the form(s) (e.g., document # of slot jackpot form) examined or including a copy of the document(s) examined.5. Documentation should be prepared to evidence all internal audit work performed, including all instances of noncompliance.6. All material exceptions resulting from internal audit work are investigated and resolved with the results of such being documented. Documentation should include the names of individuals with whom inquiries were made and how the investigation was conducted.7. The results of internal audit work should be reported directly to the Tribe, Tribal gaming regulatory authority, audit committee, or other entity designated by the Tribe and to management personnel who are independent of the departments under review. Internal audit findings are properly communicated to the appropriate employees of the gaming operation.8. Follow-up inquiries, observations, and examinations are performed to verify that corrective action has been taken regarding all instances of noncompliance cited by internal audit, the independent accountant, and/or the Commission. The verification is performed within six (6) months following the date of notification.9. Although not required by Section 542.22; 542.32; or 542.42, it is recommended that the internal auditor perform testing for compliance with 31 CFR Part 103 and other such Bank Secrecy Act regulations specific to the reporting of income recognition transactions. Sample size should consider the frequency of transactions subject to the referenced reporting requirements.The above procedures are the recommended minimum procedures to be performed.These recommended guidelines are not intended to limit the internal auditor to the performance of only the above-specified procedures. If additional procedures are performed (e.g., expanded document testing), the results should be included in the internal audit report.Report Submission RequirementsA copy of the internal auditor’s report identifying procedures required by the NIGC and any additional gaming-related compliance audit procedures not required by the NIGC, a reference to the applicable internal audit checklists completed, all instances of noncompliance noted (regardless of materiality), the review period, and management personnel responses to the noted noncompliance should be available for review by the Tribal gaming regulatory authority. Additionally, regarding noted noncompliance, the report must describe all instances of procedural noncompliance (regardless of materiality) with the regulations, Tribal MICS, NIGC MICS or approved MICS variances, and all instances where the gaming operation’s written system of internal control does not adequately reflect the gaming operations actual control procedures in effect as they relate to compliance with the NIGC MICS and approved MICS variances.It is recommended that the following information be included in the audit report:a. Audit objectives.b. Audit procedures and scope.c. A narrative description of the noncompliance, including the number of exceptions.d. The citation of the applicable National Indian Gaming Commission Minimum Internal Control Standard, Tribal Internal Control Standard, and State Compact, as applicable, for which the instance of noncompliance was noted.e. Recommendations, if applicable.f. Management’s responses to the noted instances of noncompliance.g. If the instance of noncompliance is determined to be immaterial, a broad management response acknowledging the instances of immaterial noncompliance is acceptable. The immaterial instances of noncompliance may be disclosed as a separate section of the report.h. Instances in which the written system of internal control does not reflect the actual control procedures in effect as they relate to compliance with the NIGC MICS and approved MICS variances.Please contact the NIGC’s Audit Division if you require clarification of the preceding guidelines.Traci SantillanesAudit ManagerNational Indian Gaming Commission(208) 220-5389 [email protected] ““Internal Control Assessment”“Our Internal Control Assessment (ICA) testing can be a comprehensive review of a tribal gaming facility’s entire system of internal controls or a specific examination of a single gaming activity such as Bingo, Table Games, Gaming Machines, among others. The ICA can be tailored to meet the needs of the tribal gaming operation and will provide a level of assurance commensurate with industry standards.The ICA testing consists of a thorough examination of gaming related documentation, observation of control procedures, performs interviews of the operation’s personnel, and assessment and evaluation of the implementation of TICS/SICS and processes employed by the tribal gaming facility. The examination and testing can be tailored to the tribal regulator’s Tribal Internal Control Standards (TICS), Part 543 Minimum Internal Control Standards (MICS) or any other internal control standards requested. The ICA report and recommendations will be forwarded to the tribe and tribal regulators. The NIGC will also be available to assist in any remediation and/or onsite training as determined by the tribe and tribal regulator.The services will be performed by a team of NIGC auditors on-site who will conduct the ICA in coordination with casino and tribal regulatory personnel.The ICA testing can include, but may not be limited to the following items:Detailed examination of casino and accounting records and documentation;Observation of critical procedures such as drop and count, cage, etc.;Interviews of casino personnel in performance of Policies and Procedures;Review of the tribal gaming facility’s TICS and SICS;Identification and reporting of any documented deficiencies resulting from the testing of the TICS, SICS, MICS or other internal control standards;Recommendations for remediation of any findings and any updates to TICS or SICS;Advisory comments for increased efficiency and security of internal control processes;At the conclusion of the ICA, a detailed report will be provided that summarizes the methods of testing and the results, which include:Objectives – A summary of the overall objectives of the ICA;Procedures and Scope – A summary of the testing methods performed;Findings – A detailed report containing the results of the testing performed and identification of any deficiencies;Recommendations – Provide recommendations to help improve the deficiencies identified and other areas of concern;Advisory Comments – A report of items that do not constitute findings but include recommendations intended to increase efficiency and security of the internal control processes.ContactDivision of ComplianceEmail: [email protected] InformationAn IT Vulnerability Assessment can also be performed in conjunction with your ICA.”“ Financial Submissions ““ Financial Statement Audits and AUP’sFor each fiscal year of the gaming operation(s) a tribe shall engage an independent certified public accountant to provide an annual audit of the comparative financial statements of each Class II and Class III gaming operation on Indian lands (25 CFR § 571.12 ) and, if applicable, agreed-upon procedures (AUP) report(s) (25 CFR § 543.23(d)).Tribes may submit one electronic copy, or two paper copies, of the financial statements and audits together with management letter(s) and, if applicable, the AUP report(s). Copies of the audit report(s) and management letter(s) and, if applicable, the AUP report(s) setting forth the results of each annual audit of a gaming operation are to be submitted by the tribes to the NIGC within 120 days after the end of each fiscal year (25 CFR § 571.13 and 25 CFR § 543.23(d)).Electronic submission:[email protected] mail/overnight:NIGC Attn: Financec/o Department of the Interior1849 C Street, N.W.Mail Stop # 1621Washington, DC [email protected] ““Internal Audit MICS Compliance”“Minimum Internal Control Standards (25 CFR part 542)25 CFR part 542 (This link will take you to GPO's Electronic Code of Federal Regulations (e-CFR) website.)MICS ChecklistsMinimum Internal Control Standards (25 CFR part 543)25 CFR part 543 - Helpful Hints25 CFR part 543 (This link will take you to GPO's Electronic Code of Federal Regulations (e-CFR) website.)25 CFR part 543 - Minimum Internal Control Standards-KiosksRecommended Report Formats for Section 542.3(f)(4)(i)Applying Agreed-Upon ProceduresProfessional Standards AT 201 Agreed-Upon Procedures EngagementsInternal AuditsInternal Audit MICS Compliance Reporting GuidelinesVarianceHow Do I Request A Concurrence”?

Angela, thank you for your question.I understand where you are coming from totally.Agents are compensated for their expertise and time in assisting Sellers and Buyers in real estate transactions. The agent (Buyer) of your home should deserve compensation because he/she (as the Buyer) would still be assisting you with the whole transaction process. Unless you are representing yourself as well as the Agent Buyer with the whole process like; in writing your own contracts, negotiating, processing your own paper works, dealing with inspectors, lenders, escrow companies, termite companies, arranging for repairs, tracking the transaction process to stay on top of things, dealing with City or County inspectors….etc…then perhaps you have a valid reason to not pay. Agents are trained professionals however and it’s worth taking advantage of their skills to help you through your process.It is common for agents to apply their commissions towards either their down payment or closing costs when buying a home. This is not public knowledge, so I don’t expect you to know.There is a belief that agents don’t do enough to justify their commissions and rightly so in my opinion. The reason for that is because agents don’t advertise ALL of the things they do for their clients every time they go out to show homes or take listings. So, I’m here to debunk the belief.Agents are trained professionals just like ANY trained professionals in their respective jobs. Some professionals receive W2 wages while others, like for instances Real Estate Agents, gets paid in commissions. Agents are compensated for their expertise and all that is they do in real estate in assisting clients, in making sure that:Their transaction goes smoothly and completedThat all the right documents are completed, processed, and disseminated properlyThat nothing about the sale of the home comes back to haunt you in the future in the form of lawsuits.Agents work 60 hours weeks and do many duties that the public don’t realize they do because a LOT of what they do is usually done behind the scenes. To put this in perspective, here’s a list. It’s very comprehensive as you can see but I feel it warrants highlighting.Pre-Listing (before taking a listing)Property InformationTitle searchMLS search for COMPS ( similar homes sold)Active listings searchPending listings searchCancelled and Withdrawn listings search - for last 3-6 months (depending on market activities, hyper or slow)Search for withdrawn listings that ended up being rentedSearch for Listings that fell out of escrow and re-listedSearch for Listings that fell out of escrow and withdrawnAverage listing market days searchAverage sold market days searchAverage listing to sold dayssearchAverage listing to pending days searchAverage pending to sold days searchThese are typically things agents do before they even secure a listing, and they may not even get the listing.I like to include in my searches the following:Demographics searchAverage median family income searchMost used mortgage type search for the zip code the home is located inWhy?The demographic search provide information on what the dominant demographic is for that specific zip code. This gives an agent an educated idea as to who would most likely be the ideal buyer for the house.Search for the median family income. This search gives the agent an idea on how much home a Buyer from within the zip code can buy. This information gives the agent a sense of where the listing price of the home needs to be at. I try to keep it in line with the affordability range for the zip code.Search for the “most used mortgage type” . This search allows the agent to foresee as to the type of Buyer/s that would most likely be making offers on the home and what type of loan the offer would most like have.Having insight into these aspects prepares the agent for the types of negotiations he/she might expect to be engaging in.Here are more duties that agents perform as part of their occupation norm.Listing presentation - prepare and gather informationSet listing appointment & presentation with sellerConfirm listing appointment - call or email.Review property tax roll information.Neighborhood Drive - check neighborhood activities and traffic impact"Comparable Market Analysis" (CMA) - prepareObtain copy of subdivision plat/complex lay-out.Property's ownership and deed type - research and verify.Lot size and dimensions - research public recordLegal description - research and verify.Land Use - Deed restrictions- and Codes - researchLand Use and Zoning - researchOwnership Verification - research public property records.Prepare listing presentation packageEvaluate exterior Curb AppealCompile and assemble formal file on property.Confirm current public schools and explain impact of schools on market value.Review listing appointment checklist to ensure all steps and actions have been completed.Present Listing Presentation to SellerGive seller an overview of current market conditions and projections.Present CMA Results To Seller, including Comparables, Solds, Current Listings and Expireds.Offer pricing strategy based on professional judgment and interpretation of current market conditions.Discuss goals with seller to market effectively.Explain benefits of Multiple Listing Service.Explain the work the brokerage and agent do behind the scenes and agent's availability on weekends.Explain importance of agent taking and screening calls to protect seller privacy.Present and discuss marketing plan.Explain agency relationships.Explain the Listing ContractSecure seller's signature.Assess property condition - does it have deferred, if so whats the planProperty Under Listing Agreement - perform full Agent inspection and verification of informationsReview current title profile.Measure interior room sizes.Confirm lot size via owner's copy of certified survey, if available.Note any and all unrecorded property lines, agreements, easements.Obtain house plans, if applicable and available.Review house plans and make copy.Order plat map for record keepingDiscuss and Prepare showing instructions .Obtain current mortgage loan(s) information: companies and loan account numbers.Verify current loan information with lender(s).Discuss all financing options.47. Review current appraisal report if any.48. Gather Home Owner Association information.49. Verify Home Owner Association Fees with manager - mandatory or optional and current annual fee.50. Order copy of Homeowner Association bylaws51. Request and and retain copies of all utility bills with supplier's names and contact information.52. Calculate average utility usage from last 12 months of bills.53. Research and verify city sewer/septic tank system.54. Water Bill - Calculate average water usage and fees or rates from last 12 months of bills.55. Well water - Confirm well status, depth and output from Well Report.56. Natural gas -: Research/verify availability and supplier's name and contact57. Verify security system, current term of service and whether owned or leased.58. Solar panels - Verify if owned or leased59. Lead based paint - Ascertain need for disclosure.60. Prepare detailed list of property amenities and assess market impact.61. Prepare detailed list of property's "Inclusions & Conveyances with Sale."62. Compile list of completed repairs and maintenance items.63. Send "Vacancy Checklist" to seller if property is vacant.64. Explain benefits of Home Owner Warranty to seller.65. Assist sellers with completion and submission of Home Owner Warranty Application.66. Have extra key made for lock box.Does property have rental units - If so:Make copies of all leases for retention in listing file.Verify all rents and deposits.Inform tenants of listing and discuss how showings will be handled.Arrange for installation of yard sign(s).73. Assist seller with completion of Seller's Disclosure form.74. Complete "New Listing Checklist."75. Discuss Curb Appeal and provide suggestions for improvements76. Discuss needed work if any and benefits to the sale77. Prepare MLS Profile Sheet79. Input listing data into MLS80. Proof and verify all information is accurate81. Pitch listing to in house agents and add to company's Active Listings list.82. Provide seller within 48 hours signed copies of Listing Agreement and MLS Profile Sheet information83. Take photos for MLS and use in flyers.84. Discuss virtual tour photography as optionMarketingCreate blue print for marketing plan - discuss with Sellers - request their inputCoordinate and communicate showings with owners, tenants, and Realtors.Lock Box - Install if authorized by Seller.Prepare mailing and contact list..Generate mail-merge letters to contact list.Order "Just Listed" labels and reports.Prepare flyersRegularly review MLS market activities - make recommendations to change things if needed.Brochures - invite sellers to review.Print and distribute brochures or flyers.Upload listing to company and agent Internet site, if applicable.Mail Out “Just Listed” notice to all neighborhood residents.Advise Network Referral Program of listing.Provide marketing data to buyers coming through international relocation networks.Provide marketing data to buyers coming from referral network.Provide “Special Feature” cards for marketing, if applicable.Submit ads to company’s participating Internet real estate sites.Immediate communication of price or any changes to the listingReprint/supply brochures promptly as needed.Review loan informationReceive Feedback e-mails/faxes from agents after showings.Review weekly Market activities.Review lockbox reports to study home showing traffic.Discuss lockbox showing reports and feedback from showing agents with seller to determine if changes will accelerate the sale.Place regular weekly update calls to seller to discuss marketing and pricing.Promptly enter price changes in MLS listing database.The Offer And ContractReceive, review and communicate to Seller all Offers to submitted by buyers or buyers’ agents.Evaluate offer(s)Draft a “net sheet”Counsel seller on offers. Explain merits and weakness of each component of each offer.Contact buyers’ agents to review buyer’s qualifications and discuss offer.Fax/deliver Seller’s Disclosure to buyer’s agent or buyer upon request and prior to offer if possible.Call Buyers lender to confirm buyer is pre-qualificationRequest and receive Buyer pre-qualification letter lender.Negotiate all offers on seller’s behalf, setting time limit for loan approval and closing date.Prepare and convey any counter offers, acceptance or amendments to buyer’s agent.Fax copies of contract and all addendums to closing attorney or title company.Deliver to Buyers agent accepted offer for Buyer’s signatureIf received deposit money from buyer record in Trust Fund account.Deliver copies of fully signed Offer to Purchase contract to seller.Fax/deliver copies of Offer to Purchase contract to Selling Agent.Fax copies of Offer to Purchase contract to lender.Provide copies of signed Offer to broker file.Discuss action required on offers received after acceptance of anotherChange status in MLS to “Sale Pending.”Update MLS and transaction management program to show “Sale Pending.”Review buyer’s credit report results -- advise seller of worst and best case scenarios.Provide credit report information to seller if property will be seller-financed.Assist buyer with obtaining financing, if applicable and follow-up as necessary.Coordinate with lender on discount points being locked in with dates.Deliver unrecorded property information to buyer.Order septic system inspection, if applicable.Receive and review septic system report and assess any possible impact on sale.Deliver copy of septic system inspection report lender and buyer.Deliver Well Flow Test Report copies to lender and buyer and property listing file.Verify termite inspection ordered.Verify mold inspection ordered, if required.Loan TrackingRequest from lender copy of Buyers loan approval letterDiscuss with Lender Buyers strength in securing the loanFollow loan processing through to the underwriter.Add lender and other vendors to transaction management program so agents, buyer and seller can track progress of sale.Contact lender weekly to ensure processing is on track.Relay final approval of buyer’s loan application to seller.Home InspectionCoordinate buyer’s professional home inspection with seller.Review home inspector’s report.Enter completion into transaction management tracking software program.Explain seller’s responsibilities with respect to loan limits and interpret any clauses in the contract.Ensure seller’s compliance with Home Inspection Clause requirements.Recommend or assist seller with identifying and negotiating with trustworthy contractors to perform any required repairs.Negotiate payment and oversee completion of all required repairs on seller’s behalf, if needed.The AppraisalSchedule appraisal.Provide comparable sales used in market pricing to appraiser.Follow-Up on appraisal.Enter completion into transaction management program.Assist seller in questioning appraisal report, if questions arise.Closing PreparationsEnsure contract is signed by all parties.Coordinate closing process with buyer’s agent and lender.Update closing forms and files.Ensure all parties have all forms and information needed to close the sale.Select location where closing will be held.Confirm closing date and time and notify all parties.Assist in solving any title problems (boundary disputes, easements, etc) or in obtaining Death Certificates.Work with buyer’s agent in scheduling and conducting buyer’s final walk-through prior to closing.Research all tax, Home Owner Association, utility and other applicable prorations.Request final closing figures from closing agent (attorney or title company).Receive and carefully review closing figures to ensure accuracy of preparation.Forward verified closing figures to buyer’s agent.Request copy of closing documents from closing agent.Confirm buyer and buyer’s agent have received title insurance commitment.Provide Home Owners Warranty for availability at closing.Review all closing documents carefully for errors.Forward closing documents to absentee seller as requested.Review documents with closing agent (attorney).Provide earnest money deposit check from escrow account to closing agent.Coordinate this closing with seller’s next purchase and resolve any timing problems.Have a “no surprises” closing so that seller receives a net proceeds check at closing.Refer sellers to a Realtor at their destination, if applicable.Change MLS status to Sold. Enter sale date, price, selling broker and agent’s ID numbers, etc.Close out listing in transaction management program.After Closing Follow UpAnswer questions about filing claims with Home Owner Warranty company, if requested.Attempt to clarify and resolve any conflicts about repairs if buyer is not satisfied.Respond to any follow-on calls and provide any additional information required from office files.As you can see, this is a very comprehensive list and I may have overlooked other items but I hope this helps with your question…Cheers