SSP Manual Development Sample Clauses

SSP Manual Development. In addition to study protocols, SSP manuals (generally referred to as just SSP) are prepared as stand-alone instructional and reference resources to guide conduct of HPTN studies at each site. SSP manuals contain links to applicable DAIDS policies and manuals (such as the DAIDS SCORE Manual and the Manual for Expedited Reporting of Adverse Events to DAIDS) and provide detailed standardized instructions for conducting protocol-specified procedures. The manuals are available upon request to the US FDA, other government and regulatory authorities, and site IRBs/ECs. Development of SSP manuals proceeds in parallel with eCRF development beginning when a protocol is nearly finalized. Manuals are generally finalized shortly after the first study-specific site training. All manuals should be finalized prior to activation of the first participating site. The LOC CRM is responsible for posting the manuals in an accessible location for the study team and study leadership; however, assembling and finalizing the individual manuals is the responsibility of the responsible network partner. For example: • The SDMC CDM is responsible for the manual related to data collection/management, randomization, any additional methods of data collection (e.g., ACASI) developed by the SDMC and the protocol reporting plan • The LC and/or other representative are responsible for the manual related to laboratory processing, testing, etc. • The LOC will develop and manage the Study Management Overview; Accrual, Follow-up and Retention; and Clinical, Safety and AE Management manuals • The DAIDS PAB protocol pharmacist is responsible for the development of the Pharmacy Study-Specific Procedures (SSP) Manual related to study product management by the site pharmacist. The PAB protocol pharmacist also provides significant input on other SSP manuals related to participant study product use. See Section 23 for responsibilities of the HPTN Pharmacist. All manuals follow a common template table of contents that is tailored to the needs of each study. Regardless of primary authorship assignments, every SSP manual must be circulated for review by study leadership (e.g., network resources, sponsor, and protocol chair) prior to finalization to ensure clarity, consistency, and compliance across all aspects of the study. After incorporating all team and site input as needed, the primary author of each manual will send a finalized Version 1.0 (following good documentation practices for versioning and dat...
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SSP Manual Development. In addition to study protocols, an SSP manual is prepared as an instructional and reference resource to guide conduct of HPTN studies at each site. SSP manuals contain links to applicable DAIDS policies and manuals (such as the Manual for Expedited Reporting of Adverse Events to DAIDS) and provide detailed standardized instructions for conducting protocol-specified procedures. The manuals are available upon request to the US FDA, other government and regulatory authorities, and site IRBs/ECs. Development of SSP manuals proceeds in parallel with CRF development beginning when a protocol is nearly finalized. The LOC CRM is responsible for assembling the manual in close cooperation with the SDMC and LC, as well as other key protocol team members. All manuals follow a common template table of contents that is tailored to the needs of each study. The LOC CRM is responsible for coordinating the development of the SSP manual; however, other protocol team members are assigned authorship and review responsibilities for certain sections. For example: • The SDMC CDM is responsible for sections of the manual related to data collection/management, randomization, any additional methods of data collection (e.g., ACASI) developed by the SDMC and the protocol reporting plan • The LC and/or other representative are responsible for sections of the manual related to laboratory processing, testing, etc. • The DAIDS Medical Officer and other clinically-trained team members often are required to develop and/or carefully review sections of the manual related to clinical procedures • The DAIDS PAB protocol pharmacist is responsible for sections of the manual related to investigational product management by the site pharmacist. The PAB protocol pharmacist also provides significant input on other sections of the SSP Manual related to participant study product use Regardless of primary authorship assignments, the LOC CRM is responsible for coordinating the development of all sections, reviewing all sections, and incorporating all sections into the manual. As the manual is developed, the LOC CRM will forward it for review by other team members as needed, collect comments, and incorporate these into revised draft versions of each section. Input may also be sought from site staff prior to finalization of the manual, both by requesting review
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Related to SSP Manual Development

  • Staff Development ‌ The County and the Association agree that the County retains full authority to determine training needs, resources that can be made available, and the method of payment for training authorized by the County. Nothing in this subsection shall preclude the right of an employee to request specific training.

  • Skills Development The Company acknowledges the changing pace of technology in the electrical contracting industry and the need for employees to understand those changes and have the necessary skill requirements to keep the Company at the forefront of the industry. The Parties to this Agreement recognise that in order to increase the efficiency, productivity and competitiveness of the Company, a commitment to training and skill development is required. Accordingly, the parties commit themselves to:

  • Project Development a. Collaborate with COUNTY and project clients to identify requirements and develop a project Scope Statement.

  • Curriculum Development This includes the analysis and coordination of textual materials; constant review of current literature in the field, some of which are selected for the college library collection, the preparation of selective, descriptive materials such as outlines and syllabi; conferring with other faculty and administration on curricular problems; and, the attendance and participation in inter and intra-college conferences and advisory committees.

  • Program Development NWESD agrees that priority in the development of new applications services by XXXXX shall be in accordance with the expressed direction of the XXXXX Board of Directors operating under their bylaws.

  • Professional Development Plan Professional Development Plan (PDP) refers to plans developed by faculty members addressing the criteria contained in Article 22 and Appendix G.

  • Job Development Job development/placement is individualized and shall include weekly person-to-person job search assistance, assistance with identifying job leads, interview coaching and support, and maintaining a log of job search activities for the purposes of obtaining competitive integrated employment. By mutual consent of the consumer and the KARINA ASSOCIATION, INC. , these services may be provided in-person or by Skype, FaceTime, or other online communication tools. Job development/placement may also include arranging job trials/job shadowing for individuals with a DORS Trial Work Experience Plan, assistance with completing applications, assistance with employer follow-up after interviews, use of personal employment networks in job search, and resume update. It would include time spent calling employers, visiting and educating employers and similar activities. Job development/placement shall not be paid for using supported employment funding and shall not include the Discovery process, which is pre-vocational in nature and may be completed prior to job development. Up to 60 hours for job search assistance, authorized in 20-hour increments, may be used for job development. Additional hours of job development may be requested and require written justification by KARINA ASSOCIATION, INC. and approval of the DORS regional/program director. Authorizations for Job Development. DORS only pays for job development services which have been previously authorized by a DORS official. Job Development Reporting. The Employment Service Progress Form is expected to be submitted to DORS on a monthly basis per consumer. This form is available on the DORS website (xxx.xxxx.xxxxxxxx.xxx).

  • Policy Development 2.2.1 LIDDA shall develop and implement policies to address the needs of the LSA in accordance with state and federal laws. The policies shall include consideration of public input, best value, and individual care issues.

  • Design Development An interim step in the design process. Design Development documents consist of plans, elevations, and other drawings and outline specifications. These documents will fix and illustrate the size and character of the entire project in its essentials as to kinds of materials, type of structure, grade elevations, sidewalks, utilities, roads, parking areas, mechanical and electrical systems, and such other work as may be required.

  • Training and Professional Development C. Maintain written program procedures covering these six (6) core activities. All procedures shall be consistent with the requirements of this Contract.

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