Collection, Management and Reporting Procedures Sample Clauses

Collection, Management and Reporting Procedures. ‌ The period of collection of adverse events starts from the time of signature of the Informed Consent Form (ICF) by the subject (and/or, for subjects who are minor, by the parents/legal representatives) until the end of the subject’s participation in the clinical study. If a Serious Adverse Event (SAE) is on-going at the final clinical trial visit, it should be followed by the Investigator until it has resolved or has reached a stable condition. After the subject completes the clinical study, the Investigator should also inform the Sponsor (see Sponsor’s contact details below) if he/she becomes aware of an SAE involving a subject who has participated in the clinical study. At each post-enrollment visit, the Investigator will question the subject about AEs using an open non-persuasive question to elicit reporting of AEs, for example “Have you noticed any change in your health since the last visit?” Direct questioning and examination will be performed when appropriate. The Investigator will obtain and maintain in the subject’s files all pertinent medical records, and (if applicable) information and medical judgment from colleagues who assisted in the treatment and follow-up of the subject. If necessary, the Investigator will contact the subject’s personal physician or hospital staff to obtain further details. As a minimum, Investigators are requested to report in the Case Report Form (CRF) and in the report all related adverse events (i.e. undesirable effects) and all Serious Adverse Events, whether related or not. 11.4.1. Management and reporting procedures for undesirable effects (i.e. related adverse events‌ Undesirable effects should be recorded in the CRF and summarized in the report in a summary table with at minimum the subject number, AE number, AE diagnosis or signs and symptoms, location, date of onset, seriousness, severity, action taken, relationship, date of resolution and concomitant treatment associated as well as a detailed narrative of the event. In addition, based on his/her medical judgment, the Investigator will assess whether an undesirable effect requires immediate (i.e. within 24 hours) reporting to the Sponsor. In such cases, the summary table will be sent to the Sponsor, along with the AE narrative and any other relevant information (concomitant treatments, product weighing, …). All undesirable effects should be appropriately documented, i.e. any relevant information such as demographics, medical history and concomitant therapies sh...
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Related to Collection, Management and Reporting Procedures

  • Safeguards Monitoring and Reporting The Borrower shall do the following or cause the Project Executing Agency to do the following:

  • Funding, Services and Reporting The HSP represents warrants and covenants that (a) the Funding is, and will continue to be, used only to provide the Services in accordance with the terms of this Agreement; (b) the Services are and will continue to be provided: by persons with the expertise, professional qualifications, licensing and skills necessary to complete their respective tasks; and in compliance with Applicable Law and Applicable Policy; and (c) every Report is accurate and in full compliance with the provisions of this Agreement, including any particular requirements applicable to the Report and any material change to a Report will be communicated to the Funder immediately.

  • Data Collection and Reporting 1. Grantee shall develop and use a local reporting unit that will provide an assigned 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: xxxxx://xxx.xxx.xxxxx.xxx/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 Xxxx/Dorm (Add/Change/Delete), Action Code 615; and h. Screen: MH Bed Allocation Exception (Add/Change/Delete), Action Code 345. 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: xxxxx://xxxxxxxxx.xxx.xxxxx.xx.xx/helpGuide/Content/16_CARE/CAREWebCARE%20Refere nce%20Manual.htm

  • Monitoring and Reporting The Programme Operator shall monitor, record and report on progress towards the programme’s outcomes in accordance with the provisions contained in the legal framework. The Programme Operator shall ensure that suitable and sufficient monitoring and reporting arrangements are made with the project promoters in order to enable the Programme Operator and the National Focal Point to meet its obligations to the Donors. When reporting on progress achieved in Annual and Final Programme Reports, the Programme Operator shall disaggregate results achieved as appropriate and in accordance with instructions received from the FMO.

  • Form of Agreement and Reporting If a vendor submitting an offer requires TIPS and/or TIPS Member to sign an additional agreement, a copy of the proposed agreement must be included with the proposal to the TIPS Member. TIPS does not require a review a TIPS Member’s Job Order contract TYPE AIA or other similar Contract provided by the TIPS Member. This clause does not relieve the Vendor from the responsibility to report the contract execution and the amount of the contract and any change orders.

  • Inspection and Reporting Each Grantor shall permit the Collateral Agent, or any agent or representatives thereof or such professionals or other Persons as the Collateral Agent may designate, not more than once a year in the absence of an Event of Default, (i) to examine and make copies of and abstracts from such 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 such Grantor from time to time, (iii) to conduct audits, physical counts, appraisals and/or valuations, examinations at the locations of such Grantor. Each Grantor shall also permit the Collateral Agent, or any agent or representatives thereof or such professionals or other Persons as the Collateral Agent may designate to discuss such Grantor's affairs, finances and accounts with any of its officers subject to the execution by the Collateral Agent or its designee(s) of a mutually agreeable confidentiality agreement.

  • Reporting Procedures Enter in the XXX Entity Management area the information that XXX requires about each proceeding described in paragraph 2 of this award term and condition. You do not need to submit the information a second time under assistance awards that you received if you already provided the information through XXX because you were required to do so under Federal procurement contracts that you were awarded.

  • PERFORMANCE MONITORING AND REPORTING Performance indicators

  • Accounting Procedures 7.3.1. Principal and Interest Computation.......................... 7.3.2.

  • Subsidy Requests and Reporting Requirements 1. The Grantee or Management Company shall complete a CRF Subsidy Request Report - Recap of Tenant Income Certification, which provides a unit-by-unit listing of all units in the Development for whom assistance is being requested and gives detailed information including the occupants’ eligibility, set-aside requirements, amount of household rent paid, utility allowance and amount of CRF Rental Subsidy requested. 2. The CRF Subsidy Request Report - Recap of Tenant Income Certification shall be prepared as of the last day of each calendar month during the period of performance and shall be submitted to XXXXxxxxxxxx@XxxxxxxXxxxxxx.xxx and Florida Housing’s monitoring agent no later than the 15th day of the following month. The December 2020 request will be due on or before December 15th. The Grantee will submit executed Coronavirus Relief Fund Rental Assistance Applications and supporting documentation to Florida Housing’s monitoring agent within 5 days upon the monitoring agent’s request.

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