Developing a Site Plan Essay

Developing a Site Plan Essay

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Thoughtful, detailed planning significantly improves the likelihood that the study budget addresses all foreseeable conditions for timely implementation, conduct, and analysis of the clinical trial (study). Using reasonable projections during study preparation avoids and/or reduces budget add-ons and study timeline modification(s). Sponsors anticipating add-on or “out of scope” costs may include these expenses as part of the initial budget to avoid delays resulting from budget modifications and approvals necessary for implementation of said modification(s).

FACTORS TO CONSIDER

Primary to budget design and development, the sponsor conducts a detailed evaluation for study budget optimization. Increased spending during the design, development, and preparation stages potentially saves money during conduct and analysis. Study budget and budget justification must be appropriate for the aims and timeline of the clinical trial.

Costs are associated with the following:


1. STUDY STARTUP: Protocol/study document development; Site identification, recruitment, and selection/site pre-qualification visits; Study site number estimation; Protocol feasibility assessment; SOP development; Contract/budget negotiation; Essential document acquisition and review; Facilities review; Vendor and manufacturing site selection; Draft document IRB review; Essential staff determination; Study supplies/product arrangement; Regulatory documentation management; Study binder distribution; and, other preparatory tasks.
Sponsor resources utilized during the protocol development phase to create a scientifically valid design/good research methodology and user-friendly CRFs may avoid pitfalls and delays during the conduct of the study.

The protocol feasibility as...


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...nitoring at study site, closeout, and associated meeting costs) and include transportation, accommodations, per diem, meeting registration (if applicable), and other associated fees. If possible, sponsor/CRO personnel may utilize refundable airline tickets to accommodate unexpected schedule changes.

International Considerations: Costs for conducting a clinical outside the United States include fees for country and local regulatory review, site initiation, training, shipping and handling study product/test article, monitoring, and compliance.

Other: Manufacturing costs.


In summary - time is money. Good planning, study design and development, site and personnel selection, training, communication, timely conduct, compliance, and data management ensures that the clinical trial is optimally managed to successful completion. Timely, successful completion saves money.

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