Activation of Clinical Trials Process Image: Long Description

Overview

The activation of clinical research studies graphic illustrates the components and relevant timelines of the contract, budget, and IRB approval process over a 65-day period.

Presentation

Within 3 business days:

• Contract: OCT negotiator reviews contract and sends to reviewing offices via electronic routing system.
• Budget: OCT negotiatior builds draft cost analysis and sends to study team and inquires about non-standard of care procedures. Negotiator reaches out to relevant support offices regarding budget needs.
• IRB: OCT Regulatory Affairs Manager reaches out to study team regarding IRB, BSO, and RSO review and submission, as applicable.

Within 15 business days:

• Contract: Contract reviews received. 
• Budget: Budget information received from ancillary offices. OCT negotiator finalizes non-standard of care billing codes finalized in coordination with the study team.
• IRB: Application submitted to local IRB after OCT review.

Within 3 business days:

• Budget: OCT negotiator adds pricing to cost analysis and budget request and sends budget response to sponsor/CRO.
• Contract: OCT negotiator incorporates contract revisions into one document and sends contract to sponsor.

Within 30 calendar days:

• OCT negotiator negotiates and finalizes the contract and budget. (Responses during negotations are completed within 2 business days).
• Local IRB approval received. 
• OCT Director signs contract.

OCT project manager checks-in weekly with all business units still involved in the activation process.

View image in context.