Case Reports Sample Clauses
The Case Reports clause establishes the requirements and procedures for documenting and sharing detailed accounts of individual patient cases encountered during a study or clinical practice. Typically, this clause outlines the format, content, and timelines for submitting case reports, as well as any confidentiality or ethical considerations involved in handling patient information. Its core practical function is to ensure that relevant clinical data is accurately recorded and communicated, supporting transparency, regulatory compliance, and the advancement of medical knowledge.
Case Reports. All Grantees shall comply with morbidity reporting requirements for reportable diseases and conditions as indicated in the Title 17 California Code of Regulations sections 2500-2505, 2641.5-2643.20, and 2800-2812. ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇.▇▇▇/Programs/CID/DCDC/CDPH%20Document%20Library/Rep ortableDiseases.pdf All Grantees will close out all cases of communicable diseases and enter final case information in the California Reportable Disease Information Exchange (CalREDIE) or in an electronic format approved by CDPH, by the close out deadline requested by CDPH. This will enable timely reporting to the CDC as well as timely completion of CDPH reports on communicable disease incidence. Unless an alternative data submission mode has been approved by CDPH, all Grantees, must enter case report data directly into CalREDIE. Data must be entered into the appropriate tabs and forms in CalREDIE. Submission of hard copy forms for data entry into CalREDIE by CDPH or scanning of case reports, laboratory results, or interview records into the electronic filing cabinet (EFC), will not be accepted in place of data entry. Grantees not entering data into CalREDIE must provide an electronic dataset in a format approved by CDPH. The CDPH CalREDIE website has extensive resources to assist LHJs with CalREDIE including frequently asked questions, manuals/guidelines, and forms/instructions. ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇.▇▇▇/Programs/CID/DCDC/Pages/CalREDIE-HELP.aspx For additional CalREDIE help, please email ▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇.▇▇.▇▇▇.
Case Reports. All Grantees shall comply with morbidity reporting requirements for reportable STDs identified in Title 17, California Code of Regulations (CCR) §2500, §2593, §2641.5-2643.20, and §2800 – 20182 Reportable Diseases and Conditions. ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇.▇▇▇/Programs/CID/DCDC/CDPH%20Document%20Library/ ReportableDiseases.pdf All Grantees, excluding Los Angeles and San Francisco, must enter STD case data for their jurisdiction directly into the California Reportable Disease Information Exchange (CalREDIE), the CDPH web-based reporting software for notifiable diseases. CDPH STD Control Branch will provide essential variables for data entry and STD case report forms. Specific case investigation and report requirements are as follows:
1. Syphilis laboratory tests and confidential morbidity reports should be processed and assigned for investigation according to the California Syphilis Reactor Alert System (SRAS). Some health jurisdictions may have a more nuanced local system for prioritizing reported reactive syphilis tests. ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇.▇▇▇/Programs/CID/DCDC/CDPH%20Document%20 Library/SyphilisReactorSRASChartAlgorithm.pdf
2. Syphilis cases and congenital syphilis case investigations are to be reported according to updated CDPH STDCB protocols on the appropriate case report forms (Syphilis Interview Record or California Congenital Syphilis-CS Case Investigation and Report) found in CalREDIE; samples of these forms can be viewed at ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇.▇▇▇/Programs/PSB/Pages/CommunicableDiseaseCo ntrol.aspx. Grantees will submit complete case reports into the CalREDIE Electronic Filing Cabinet within 45 days of initial report to local health department.
3. Chlamydia and gonorrhea reports are automatically initiated through CalREDIE with electronic laboratory report information, data entry of laboratory, or provider report.
4. Cases of gonorrhea with suspected treatment failure or with high minimum inhibitory concentrations (MIC) to CDC-recommended treatment should be reported to CDPH STDCB within 24 hours of initial report to local health department. Reports should be conveyed by calling the CDPH STDCB Office at (▇▇▇) ▇▇▇-▇▇▇▇.
5. Suspected or confirmed cases of granuloma inguinale, lymphogranuloma venereum, and chancroid should be reported to CDPH STDCB within 24 hours of initial report to local health department. Reports should be conveyed by calling the CDPH STDCB Office at (▇▇▇) ▇▇▇-▇▇▇▇. Grantees will participate in STD-specific CalREDIE trainings and cond...
Case Reports. Primary adenoid cystic carcinoma of the breast: Case report and review of the literature 83
Case Reports. All case reports to TANTAU's Technical Support Department shall include the following: - The name and version of the Licensed Products and version number being used. - Platform(s) on which the Licensed Products is running. - A general description of the operating environment. - A list of relevant hardware components in the environment. - List of operating system versions of all hardware components. - A description of the problem and expected results. - System generated error messages or diagnostics where available. - Date and time stamp - Priority level (see Section 5.a.) - User Status relating to Trial, Production or Demo. - Method of preferred communication to be via phone or email - Name of system issue is occuring on (if applicable) - Any additional contact information for additional contact names, email addresses, numbers or if applicable after hours contact information.
(a) TANTAU's Undertaking: For each Technical Support Case reported by Licensee, TANTAU undertakes to:
(i) Maintain and monitor published support mechanisms as well as a telephone number, for Licensee to call , to report a problem and receive assistance.
(ii) Confirm by e-mail, internet or phone the receipt of all reports to TANTAU. The confirmation shall include the unique Licensee Case Identifier, which will be used in all related communications.
(iii) Analyze the report and verify the existence of the problem.
(iv) Provide Licensee direction and assistance in resolving technical issues.
Case Reports. 6.1 at the conclusion of any case under the Code, the panel shall advise the complainant and the respondent of the outcome and a report shall be published summarising the details of the case.
6.2 in a case where the complaint was initiated by an individual, other than in those circumstances where an anonymous or confidential complaint is accepted for adjudication, that individual shall be named in the report.
6.3 in a case where the complaint was initiated by a company or by an organisation or official body, that company or organisation or official body shall be named in the report. the respondent company and the product(s) concerned will usually be named in the report unless the Chairman in his discretion deems this inappropriate. any information given must not, however, be such as to identify any individual person within such company, organisation or official body.
6.4 Where expert assistance has been obtained by the panel, the report will include the name and qualifications of the expert concerned.
6.5 Where guidance has been sought from eucomed, the question raised by the Chairman or the panel and the guidance received from eucomed shall be included in the report.
6.6 Where a company has been required to issue a statement of its corrective actions, the report will reproduce its text and provide details of how the corrective actions statement was disseminated.
6.7 a copy of the report on a case is made available to both the complainant and the respondent company prior to publication. any amendments to the report suggested by these parties are considered by the Chairman, consulting with the other party where appropriate. the Chairman’s decision is final.
6.8 full case reports will appear on a specified section of the abHi website. access to the relevant section of the relevant abHi website referring to cases or decisions is unrestricted.