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Questions and Answers
What is included in the site preparation phase of site set up?
Which of the following best describes an environmental impact assessment (EIA) in site set up?
What role does sign usage play in site safety measures?
What is a key component of establishing infrastructure during site set up?
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Which of the following is NOT a key component of project management in site set up?
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What is site set up in the context of clinical trials?
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Which of the following can help identify potential research sites?
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A participant identification centre (PIC) requires a site initiation visit (SIV).
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Match the following steps of contract progression with the appropriate action:
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The organization document and the schedule of cost attribution template (SoECAT) should be included in the local information pack for ______.
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Study Notes
Site Set Up
1. Definition
- Site set up refers to the process of preparing a physical location for construction or operation.
2. Key Components
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Surveying
- Assess topography, boundaries, and existing structures.
- Conduct soil testing for stability and suitability.
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Permitting and Approvals
- Obtain necessary permits from local authorities.
- Ensure adherence to zoning laws and regulations.
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Site Preparation
- Clear vegetation and debris.
- Level the ground and address drainage issues.
3. Infrastructure
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Access Routes
- Create temporary roads for construction vehicles.
- Ensure accessibility for emergency services.
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Utilities
- Establish water, electricity, sewage, and communication lines.
- Plan for future connections where applicable.
4. Safety Measures
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Site Fencing
- Install barriers to restrict unauthorized access.
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Signage
- Use clear signs to communicate hazards and safety protocols.
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Emergency Procedures
- Develop and communicate evacuation plans.
5. Environmental Considerations
- Conduct an environmental impact assessment (EIA).
- Implement erosion and sediment control measures.
6. Equipment and Materials
- Set up storage spaces for construction materials.
- Arrange for equipment mobilization and logistics.
7. Project Management
- Develop a site layout plan detailing equipment placement, material storage, and work areas.
- Assign site roles and responsibilities to team members.
8. Communication
- Establish reporting systems for daily progress and safety updates.
- Maintain clear lines of communication among stakeholders.
Site Set Up Definition
- Site set up involves preparing a physical location for construction or operation.
Key Components
- Surveying includes assessing topography, boundaries, and existing structures.
- Soil testing is conducted for stability and suitability.
- Permitting and Approvals involve obtaining necessary permits from local authorities to ensure adherence to zoning laws and regulations.
- Site Preparation includes clearing vegetation and debris, levelling the ground, and addressing drainage issues.
Infrastructure
- Access routes are created for construction vehicles, ensuring accessibility for emergency services.
- Utilities such as water, electricity, sewage, and communication lines are established.
- Planning for future connections where applicable is crucial.
Safety Measures
- Site fencing is installed to restrict unauthorised access.
- Signage communicates hazards and safety protocols clearly.
- Developing and communicating evacuation plans ensures emergency procedures are in place.
Environmental Considerations
- An environmental impact assessment (EIA) is conducted.
- Erosion and sediment control measures are implemented.
Equipment and Materials
- Storage spaces are set up for construction materials.
- Equipment mobilization and logistics are arranged.
Project Management
- A site layout plan details equipment placement, material storage, and work areas.
- Roles and responsibilities assigned to team members ensure effective team management.
Communication
- Reporting systems are established for daily progress and safety updates.
- Clear lines of communication are maintained among stakeholders.
What is Site Set Up?
- A clinical trial site is a controlled environment where clinical research, development, and testing are executed safely under supervision.
- Patients participate in supervised clinical trials and research activities.
Site Selection
- Potential sites are identified using feasibility questionnaires, professional groups, publications, and recommendations from colleagues.
- Feasibility questionnaires are initiated by the CTU team and CI (Chief Investigator) and are forwarded onto potential recruiting sites.
- The Clinical Research Network (CRN) across the UK may also identify potential sites.
- It's recommended to review the feasibility forms with the Trial Management Group (TMG) to confirm the acceptance or rejection of a potential site.
Site Set Up
- All clinical research studies receive ethical and site-level approvals through the Health Research Authority (HRA) approval system.
- Once approvals are in place, recruited sites are added using the IRAS amendment tool.
Hospital Sites
- A local information pack contains the organisation information document and a schedule of cost attribution template (SoECAT).
- The local information pack should be emailed to the following individuals after the sponsor receives an initial assessment letter of approval from HRA/HCRW:
- NHS R&D Offi ce
- LCRN contact
- Local Research Staff
- PI (Principal Investigator)
- OID (Organisation Identifier)
Participant Identification Centres (PIC)
- PICs are organizations that identify potential research participants for a trial.
- PICs can be NHS organizations or GP practices with no additional involvement with the research.
- While PIC sites require an mNCA (model Non-Commercial Agreement), they do not require an SIV (Site Initiation Visit).
- An initial meeting is recommended to determine what is required for PIC sites.
Progression of Contracts with Site
- The process involves eight steps:
- Completion of a modelo Non-Commercial Agreement (mNCA)
- Site reviews the mNCA, localizes the details, and returns to the CTU
- The localized mNCA is reviewed by the CTU and sent to the Sponsor
- The Sponsor reviews and signs the mNCA and returns to the CTU
- The CTU sends the signed agreement to the site
- Site representatives sign the agreement and return to the CTU
- The CTU then converts the final signed version to PDF and sends a copy to the site and Sponsor
- The CTU follows up with the Sponsor regarding payment
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Description
This quiz focuses on the essential components involved in site set up for construction, including surveying, permitting, preparation, and infrastructure. Test your knowledge about the safety measures and utilities required for successful site management.
