Dose Estimation and Reporting Clause Samples

The Dose Estimation and Reporting clause establishes the requirements for calculating and documenting the amount of a substance, such as a drug or radiation, administered or delivered during a study or procedure. It typically outlines the methods to be used for dose calculation, the frequency and format of reporting, and the responsibilities of the parties involved in ensuring accurate records. This clause ensures that all parties have a clear and consistent understanding of dosing information, which is critical for safety, regulatory compliance, and the integrity of study results.
Dose Estimation and Reporting. As directed under 42 CFR Part 82 and consistent with NIOSH technical guides, the contractor shall produce and report timely dose estimates, supporting methodology, and factual basis for each claim received by NIOSH from DOL under EEOICPA (potentially 1,500 to 8,000 dose reconstructions annually). This task will include the following: (1) The contractor shall collect and analyze all available information relevant to dose estimation/reconstruction for each individual claim and produce and transmit to NIOSH a draft report providing dose estimates, methods, and the factual basis upon which the doses were estimated, including a narrative explanation of this information understandable by claimants with a high school education. (2) Internal and external radiation dose estimates will be calculated for each organ that the claimant presents with a primary cancer. The annual dose to each organ will be calculated from the time of first exposure at a covered facility to the date of cancer diagnosis. As appropriate, a separate dose shall be computed for each type of radiation exposure received by the individual, using the exposure types provide for in the NIOSH-IREP program. These doses will be reported as equivalent dose using the weighting factors provided in the NIOSH technical guides. As part of NIOSH’s ongoing QA program, the contractor will be provided blind test claims on a periodic basis. (3) Internal dose calculations shall be performed using standard metabolic models published by the International Commission on Radiological Protection (ICRP). These calculations will be performed using a NIOSH supplied computer program entitled Integrated Module for Bioassay Analysis (IMBA). This program was specially created for NIOSH to perform internal dose calculations using the most recent physiologically based biokinetic models such as those contained in ICRP publications 56, 67 and 69. Inhalation intakes will be evaluated using the respiratory tract model contained in ICRP publication 66*. (4) Within 30 days of award, NIOSH will provide training on the internal dose assessment software for a maximum of six (6) contractor personnel as designated by the Contractor. Within thirty (30) days after receiving training from NIOSH, the contractor shall be responsible for providing and documenting training to members of their technical team involved in conducting dose reconstructions. Throughout contract performance, the Contractor shall provide this training and certification toa...
Dose Estimation and Reporting. Consistent with the technical guidelines provided by NIOSH, the contractor shall produce and report to NIOSH, OCAS dose estimates, supporting methodology, and documentation of the factual basis for each claim received by ▇▇▇▇▇ from DOL under EEOICPA.
Dose Estimation and Reporting. 3.1 As directed under 42 CFR Part 82 and consistent with NIOSH Implementation Guides for Internal and External Dose Reconstruction (located at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/niosh/ocas/ocasdose.html#process), and Technical Information Bulletins and procedures (▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/niosh/OCAS/ocastbds.html ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/niosh/OCAS/ocasppg.html ), the contractor shall produce and report timely dose estimates, supporting methodology, and factual basis for each claim received by ▇▇▇▇▇ from DOL under EEOICPA and for claims requiring re-work because of changes in claim information or changes in dose reconstruction policy (estimated at 3320 dose reconstructions and re-works annually). 3.2 The contractor shall collect and analyze all available information relevant to dose estimation/reconstruction for each individual claim and produce and transmit to NIOSH a draft report providing dose estimates, methods, and the factual basis upon which the doses were estimated, including a narrative explanation of this information understandable by claimants with a high school education. An example dose reconstruction report will be included as an attachment under Section J – J.7. 3.2.1 Internal and external radiation dose estimates shall be calculated for each organ that the claimant presents with a primary cancer. The annual dose to each organ shall be calculated from the time of first exposure at a covered facility to the date of cancer diagnosis. As appropriate, a separate dose shall be computed for each type of radiation exposure received by the individual, using the exposure types provide for in the NIOSH-Interactive Radio Epidemiological Program (IREP) program. These doses shall be reported as equivalent dose using the weighting factors provided in the NIOSH technical guides. As part of NIOSH’s ongoing Quality Assurance (QA) program, the contractor may be provided blind test claims on a periodic basis. 3.2.2 Internal dose calculations shall be performed using standard metabolic models published by the International Commission on Radiological Protection (ICRP). These calculations shall be performed using a NIOSH supplied computer program entitled Integrated Module for Bioassay Analysis (IMBA) or other NIOSH approved programs. IMBA was specially created for NIOSH to perform internal dose calculations using the most recent physiologically based biokinetic models such as those contained in ICRP publications 56, 67, and 69. Inhalation intakes shall be evaluated using the respiratory tr...

Related to Dose Estimation and Reporting

  • Inspection and Reporting Each Grantor shall permit the Collateral Agent, or any agent or representatives thereof or such attorneys, accountant or other professionals or other Persons as the Collateral Agent may designate (at Grantors’ sole cost and expense) (i) to examine and make copies of and abstracts from any Grantor’s Records and books of account, (ii) to visit and inspect its properties, (iii) to verify materials, leases, Instruments, Accounts, Inventory and other assets of any Grantor from time to time, and (iv) to conduct audits, physical counts, appraisals, valuations and/or examinations at the locations of any Grantor. Each Grantor shall also permit the Collateral Agent, or any agent or representatives thereof or such attorneys, accountants or other professionals or other Persons as the Collateral Agent may designate to discuss such Grantor’s affairs, finances and accounts with any of its directors, officers, managerial employees, attorneys, independent accountants or any of its other representatives. Without limiting the foregoing, the Collateral Agent may, at any time, in the Collateral Agent’s own name, in the name of a nominee of the Collateral Agent, or in the name of any Grantor communicate (by mail, telephone, facsimile or otherwise) with the Account Debtors of such Grantor, parties to contracts with such Grantor and/or obligors in respect of Instruments or Pledged Debt of such Grantor to verify with such Persons, to the Collateral Agent’s satisfaction, the existence, amount, terms of, and any other matter relating to, Accounts, Instruments, Pledged Debt, Chattel Paper, payment intangibles and/or other receivables.

  • Accounting and Reporting I. The Agent shall establish separate accounts for the trust assets, the assets obtained as a result of managing and utilizing the trust assets, its own assets, and other trust assets. II. The Agent shall prepare and send monthly an comprehensive statement in writing, via email or text message to the Principal. The comprehensive statement will provide to the Principle in accordance with the law, agreement or on a basis of risk management. The content states the Pinciple’s business dealing with the Agent, including deposits, loans(foreign currency loans、overdue receivables、bad debts and credit card debt excluded), non-discretionary monetary trust, insurance and other business information or activities related to financial products(charitable trusts, individual or corporate trusts, SWIFT, financial, credit card and securities business statements excluded). The Agent may engage a third party to prepare and send comprehensive statements according to the law. The Principal shall check the content upon receiving the comprehensive statement.The Principal understands and agrees that, when constitutions of the transaction and/or trust, completion of changes of conditions and/or other agreements, and/or proportional changes of investment gains and losses, the Agent may send the comprehensive statement and/or text message, email and/or related transaction information to the Principal for his/her understanding using latest contact information retained by the Agent when the Principal applies for any business (including, but not limited to, deposits or credit cards).The Agent will not provide comprehensive statements to the Principle, once private banking department reach the agreement with the Principle to provide exclusive statements. III. When authorized to invest in offshore structured notes, the Agent shall prepare and send a written or electronic transaction confirmation notifications within three business days from the day a subscription, redemption, conversion, or early redemption confirmation notification is received from the issuer or the general agent (excluding distribution of dividends and bonuses) to the Principal. Additionally, the Agent shall prepare and send monthly a written or electronic statement or another document disclosing the most recent reference price to the Principal for his/her reference. IV. If the Principal’s comprehensive statement, transaction notice and transaction confirmation are rejected or returned after being mailed/sent to the address/number specified in the Agreement or the last known address/number of the Principal shall be handled according to the following principles: (I) If the Principal does not make any new transactions before the closing date of the current comprehensive statement, the Agent may send a return notification in a way agreed upon between the Agent and the Principal from the date the mail/text message is rejected or returned to the date the Principal changes the mailing address, e-mail address、phone number in accordance with the Agent's regulations.If the method of sending the comprehensive statement is paper ,the paper comprehensive statement will be stopped and a text message of return notification will be sent when the comprehensive statement should be sent in the next period; If the method of sending the comprehensive statement is e-mail or text message, the electronic comprehensive statement will continue to be sent and a text message or e-mail of return notification will be sent when the comprehensive statement should be sent in the next period.However, when the Principal requests that the Agent resend the comprehensive statement, the Agent may provide the statement to the Principal using a feasible method at the time, and the Principal must change the mailing address, e-mail address or phone number according to the Agent's regulations. (II) If the Principal’s comprehensive statement, transaction notice and transaction confirmation are rejected or returned, the Principal understands and agrees that the Agent may notify the Principal in accordance with the Article 10 aforementioned and implement transaction monitoring measures to protect the Principal's rights in accordance with the Agent’s regulations.

  • Information and Reporting The Adviser shall provide the Trust and its respective officers with such periodic reports concerning the obligations the Adviser has assumed under this Agreement as the Trust may from time to time reasonably request.

  • Record Keeping and Reporting 7.1 The Supplier must ensure that suitably qualified representatives attend progress meetings with the Buyer and provide progress reports when specified in the Order Form. 7.2 The Supplier must keep and maintain full and accurate records and accounts on everything to do with the Contract for 7 years after the date of expiry or termination of the Contract and in accordance with the UK GDPR or the EU GDPR as the context requires. 7.3 The Supplier must allow any auditor appointed by the Buyer access to its premises to verify all contract accounts and records of everything to do with the Contract and provide copies for the Audit. 7.4 During an Audit, the Supplier must provide information to the auditor and reasonable co-operation at their request. 7.5 The Parties will bear their own costs when an Audit is undertaken unless the Audit identifies a material default by the Supplier, in which case the Supplier will repay the Buyer's reasonable costs in connection with the Audit. 7.6 If the Supplier is not providing any of the Deliverables, or is unable to provide them, it must immediately: (a) tell the Buyer and give reasons; (b) propose corrective action; and (c) provide a deadline for completing the corrective action. 7.7 If the Buyer, acting reasonably, is concerned as to the financial stability of the Supplier such that it may impact on the continued performance of the Contract then the Buyer may: (a) require that the Supplier provide to the Buyer (for its approval) a plan setting out how the Supplier will ensure continued performance of the Contract and the Supplier will make changes to such plan as reasonably required by the Buyer and once it is agreed then the Supplier shall act in accordance with such plan and report to the Buyer on demand; and (b) if the Supplier fails to provide a plan or fails to agree any changes which are requested by the Buyer or fails to implement or provide updates on progress with the plan, terminate the Contract immediately for material breach (or on such date as the Buyer notifies). 7.8 If there is a material default, the Supplier must notify the Buyer within 3 Working Days of the Supplier becoming aware of the material default. The Buyer may request that the Supplier provide a Rectification Plan within 10 Working Days of the Buyer’s request alongside any additional documentation that the Buyer requires. Once such Rectification Plan is agreed between the Parties (without the Buyer limiting its rights) the Supplier must immediately start work on the actions in the Rectification Plan at its own cost.

  • Data Collection and Reporting 1. Grantee shall develop and use a local reporting unit that will provide an assigned Hospital location for all clients served within the Hospital. This information shall also be entered into Client Assignment and Registration (CARE) when reporting on beds utilized at the Hospital. 2. Grantee shall budget and report expenditure data on the CARE Report III, incorporated by reference and posted at: ▇▇▇▇▇://▇▇▇.▇▇▇.▇▇▇▇▇.▇▇▇/doing-business-hhs/provider- portals/behavioral-health-services-providers/behavioral-health-provider- resources/community-mental-health-contracts, within the Community Hospital strategy C.2.1.1 using line 764 - Project Private Beds. 3. Grantee shall ensure that patient registration, diagnostics, admission and discharge data is reported by using the CARE screens and action codes listed below: a. Screen: Campus-Based Assignments (Add/Change/Delete), Action Code: 305; b. Screen: Campus-Based Discharge/Community Placement (Add/Change/Delete), Action Code: 310; c. Screen: Joint Community Support Plan (Add/Change/Delete), Action Code: 312; d. Screen: Register Client, Action Code: 325; e. Screen: Diagnostics (Add/Change/Delete), Action Code: 330; f. Screen: Voluntary Admission and Commitment (Add/Change/Delete), Action Code 332; g. Screen: Campus-Based Residential ▇▇▇▇/Dorm (Add/Change/Delete), Action Code 615; and h. Screen: MH Bed Allocation Exception (Add/Change/Delete), Action Code 345. 4. For details related to the use of these screens and action codes, Grantee can refer to the CARE Reference Manual which can be found under the CARE (WebCARE) section on the portal at: ▇▇▇▇▇://▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇▇▇▇.▇▇.▇▇/helpGuide/Content/16_CARE/CAREWebCARE%20Refere nce%20Manual.htm