| Global Summary |
| 1 | | See Study Specific Assumptions and Pricing Model, herein. Budget excludes any “TBD” (To Be Determined) items. |
| Global Summary - Laboratory Testing (LT) |
| 1LT | | Quoted fees reflect Quest Diagnostics Clinical Trials’ Year 2011 Fee Schedule. |
| 2LT | | Referral test to be performed by UCF. Fee includes the referral laboratory charge plus a referral fee for sample handling, data entry and result reporting. Any fee increase imposed by the Referral laboratory will be passed on to Client. |
| 3LT | | Fees quoted for testing services performed are exclusive of any applicable added Taxes (including Value Added Tax (VAT)). |
| 4LT | | The sample testing fees include the receipt of samples into a Quest Diagnostics-owned, affiliate or alliance partner laboratory, the direct costs associated with the laboratory testing of the samples, retention of the unused samples for a maximum of fourteen (14) days, laboratory quality control and global standardisation of equipment, processes, controls and calibrators. |
| 5LT | | The sample testing fees also include the distribution of interim result reports (per patient visit) and final result reports to Investigator(s) and/or Clients/CROs as applicable and agreed in the Central Laboratory Worksheet. Any final result reports issued in hard copy will be sent via standard postal service or (within the continental United States only) Quest Diagnostics-US proprietary courier. |
| 6LT | | It is Quest Diagnostics Clinical Trials' (Quest) experience that investigator sites experience significant challenges producing a peripheral blood smear ( PBS ) of sufficient quality for an appropriate hematology laboratory PBS review. Therefore, it is standard Quest practice to not provide glass slides and to not require the sites to make PBS slides . The performance by Quest of a routine safety CBC analysis (hematology) does involve the occasional review of PBS slides for the white blood cell morphology and differential, red blood cell morphology and platelet evaluation if the instrument or the SOP flags the specimen for a PBS slide review. The PBS slide can be appropriately created and reviewed in the majority of cases by the laboratory from the submitted CBC sample if a review is required. |
| 7LT | | If the protocol requires a PBS slide review then glass microscope slides will be provided to the site(s) for each appropriate visit so that the site can create and provide a PBS to the central laboratory. Protocols where in our experience peripheral blood smears are recommended include significant hematological/bone marrow abnormalities (white or red cell, platelet abnormalities), leukaemia's, HIV clinical trials, sepsis, or other severe illnesses that would be impacting the hematological system. Our scientific affairs and medical affairs teams are available to further discuss the needs of your protocol regarding any requirements for PBS creation by the site or by the laboratory and PBS slide review by the Quest laboratory. Please could you confirm if this protocol requires a peripheral blood smear review or if subjects in this study are expected to have hematological abnormalities where we would recommend the preparation of peripheral blood smears at the investigator site. |
| 8LT | | CBC and Peripheral blood smear pricing are based on assumptions received at the point of preparing this quotation. Quest Diagnostics reserves the right to adjust these pertinent to further discussion with the customer. |
| Global Summary - Supplies (SL) |
| * | | The Supplies total for shipping containers is based on one separate shipment for each patient visit and reflects a “worst case scenario.” Shipper container costs may be dramatically reduced when sites batch specimens prior to shipment to the laboratory. |
| 1SL | | Quest Diagnostics Clinical Trials will determine the price for a 40+ Visit Specific Kit(VSP) once all tubes and details of kit components have been finalized with the sponsor. |
| Global Summary - Supplies (ST) |
| 1ST | | The “In” fee includes receipt, preparation, storage and entry of specimens into Quest Diagnostics Clinical Trials storage facility and computer system. |
| 2ST | | The “Monthly Maintenance” fee includes inventory, storage, temperature monitoring and continuous security coverage at Quest Diagnostics Clinical Trials storage facility. |
| 3ST | | The “Pull” fee includes the removal of requested specimens from storage, sorting of specimens prior to shipment (in a manner requested by client, e.g. - by patient, by visit) and the generation of a manifest. |
| Global Summary - Study Management (SM) |
| 1SM | | The Study Management set-up fees quoted include provision for our standard toxicity and exclusions flagging; and cumulative data transmissions sent weekly via email zip file or SFTP or portals in our standard data file format. The fees do not include any set-up related to storage samples, new testing method set-up's, algorithms, microbiology testing or referral lab data entry. If client requires Quest to add any of these elements or set up additional flagging options and use data files which differ to our standard format, we reserve the right to adjust our set-up fees accordingly. |
| 2SM | | The Project Management Study Set-Up fee includes an internal review of the protocol in conjunction with the client's study team and formulation of an agreed Central Laboratory Worksheet signed off by Client and Quest, which lays out detailed specifications for the set-up and management of the study. Quest will design study documents, which include Investigator Manuals in the languages specified in the budget, a Lab Requirement Summary and pictogram, and study specific test Requistion forms in accordance with these specifications, as part of this fee. The design of visit specific specimen collection kits and set-up of Investigator site information is included as part of Project Management set-up. |
| 3SM | | The fee Per Visit for Project Management covers ongoing Project Management support, 24/7 investigator assistance/support by Quest Diagnostics CRC Support Team, including the use of toll-free phone lines. Auto faxing of supply expiry details and inclusion of alerts and delta flagging are also covered by this fee. |
| 4SM | | The fee Per Visit for Data Management covers ongoing Data Management support, maintenance of the results database and the actioning and documentation of all necessary data revisions and data transfers up to once per week. |
| 5SM | | The fee Per Visit for Logistics covers the expertise and management of the ongoing study logistics, shipment tracking, processing and auditing of courier invoices and the performance management of the courier companies. |
| 6SM | | Quest Diagnostics proprietary software Result/ViewTM – web-based version shall be included for the two users per study at no additional charge, more than two users will be charged. This includes training and support by telephone. |
| 7SM | | Quest Diagnostics Clinical Trials will charge a per work order fee associated with each pull order. The purpose of this is to maximize the batching of samples whenever they are pulled for regular or ad hoc shipments from sample storage in order to create operational efficiency. |
