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1. Protocol Design

1.1 Study Summary

    • Protocol Title
    • Duration of the study
    • Methodology: injection/administration tracer/drug, scanning method, scanning schedule
    • Approximate number of subjects
    • Coordinates Principle Investigator (PI), co-PI, study coordinators
    • Pilot study information: durtions, number of subjects, number of scans,...
    • Discussion of the project feasibility
    • Details of resources, skills and experience

1.2 Research Question

    • A detailed description of the objectives and the purpose of the study

1.3 Preclinical Study Design

    • Endpoints, if any, to be measured during the study
    • What information is needed to answer the research question
    • Injection/administration tracer/drug, scanning method, scanning schedule
    • Order, storage and administration of drugs/tracers
    • Expected duration of the study and description of the sequence/ duration of individual study periods if any
    • Possibility of follow up studies
    • Confidentiality
    • Potential risks and steps taken to minimize the risks
    • Ethical Committee
    • Reporting of adverse events/ anticipated adverse events

1.4 Data Collection 

    • Database: Filemaker Pro.

1.5 Data Access

    • Who will have access to the data and how will the data be used. 

1.7 Publication and Presentation 

    • Intellectual property
    • Meetings or conferences where data and/ or results of the study will be presented.

1.8 Confidentiality Disclosure Agreement (CDA)

    • Negotiated by UGent Tech Transfer (http://www.techtransfer.ugent.be/en/)

2. Study Management

  • Appointment of the study manager
  • Study management software: Filemaker Pro

3. Image processing

  • Can be done by Infinity or can be outsourced, depending on the type of processing and complexity, for an optimal result

4. Reporting

  • Infinity delivers a full report comprising all above information and additionally study results, reconstructed images and an answer to the original research question or study hypothesis if one is possible. 

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