Abstract
This chapter will take you through all of the key components to evaluate selecting an imaging core laboratory for a clinical trial from the sponsor perspective. There is a corresponding checklist that will ensure none of the key components are overlooked during the selection process.
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Reference
Yu HJ, Miller CG, Flitcraft D. Metrics in medical imaging: changing the picture. ACRP: The Monitor. Aug 2012. p. 36–40.
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Appendix 7.1: Checklist for Selecting an Imaging Core Lab
Appendix 7.1: Checklist for Selecting an Imaging Core Lab
Imaging core lab capabilities | Yes | No | Not required | Comments |
|---|---|---|---|---|
Is there global infrastructure? | □ | □ | □ | |
Is there a sufficient amount of employees? | □ | □ | □ | |
Is there a high turnover rate? | □ | □ | □ | |
Is this an established organization (How many years have they been in business)? | □ | □ | □ | |
Is the organization financially stable? | □ | □ | □ | |
Is imaging an established core competency of the organization? | □ | □ | □ | |
Is there ready access to senior management within the organization? | □ | □ | □ | |
Does the organization have well-established SOPs that are reviewed and updated on a regular basis? | □ | □ | □ | |
Does the organization have current investment in R&D? | □ | □ | □ | |
Does the organization have a track record with successful health authority approvals? | □ | □ | □ | |
Does the organization have relationships with key imaging leaders within the FDA and EMA? | □ | □ | □ | |
Does the organization have experienced and sufficient medical and scientific staff? | □ | □ | □ | |
Does the organization have the capabilities to capture, track, analyze, and take appropriate actions from MCC metrics or a variation of MCC metrics? | □ | □ | □ | |
Does the organization have sufficient training methods for the investigational sites, CRAs, and sponsor? | □ | □ | □ | |
Does the organization have an in-house electronic solution for transmitting image data? | □ | □ | □ | |
Is the database tracking system and independent read system 21 CFR part 11 compliant? | □ | □ | □ | |
Does the organization’s study team at the organization have sufficient experience? | □ | □ | □ | |
Does the organization have a dedicated experienced team developing imaging charters? | □ | □ | □ | |
Does the organization’s study team develop a risk mitigation plan as a standard practice? | □ | □ | □ | |
Does the organization have experience with the required specification of the view system used by the health authority reviewers? | □ | □ | □ | |
Does the imaging core lab have the ability to apply a governance structure via a relationship/alliance director? | □ | □ | □ |
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Forsthoffer, E.S., Krasnow, J. (2014). Evaluating and Working with an Imaging Core Laboratory. In: Miller, C., Krasnow, J., Schwartz, L. (eds) Medical Imaging in Clinical Trials. Springer, London. https://doi.org/10.1007/978-1-84882-710-3_7
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DOI: https://doi.org/10.1007/978-1-84882-710-3_7
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