From study conception through development of a completed protocol
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Researchers conducting human subjects research at JHACH or in collaboration with any JHU Affiliated / Integrated sites agree to follow and .
When a protocol is sponsored by an external sponsor (e.g. pharmaceutical company, consortium, etc.) the development stage is conducted by the sponsor and does not occur at JHACH.
When a protocol is investigator-initiated and developed, several JHACH resources and support services may be accessed during this phase.
- i2b2: resource able to provide census type information (de-identified) that can determine if JHACH has the population targeted in the protocol
- Honest Brokers: can build on the information gathered from I2B2, as needed, for your project
- Clinical Data Extract Team: able to access available clinical data
- Database Design & Data Management: available for consult and collaboration on data collection needs and design of tools
- Machine Learning & Predictive Analytics: available for consult on use of predictive analytics on current and historical data
- Research & Grants Administration: available to help with identifying funding opportunities, budget development, and grant and proposal development
During this stage, the following centralized support groups or share services may be engaged:
- Honest Brokers
- Clinical Data Extract Team
- Epidemiology & Biostatistics Team
- Database Design & Database Management Team
- Machine Learning & Predictive Analytics Scientists
For Johns Hopkins employees only:
- Data Imports
- Data Quality Rules
- JHM IRB – for eIRB studies
- JHM IRB – for retrospective chart reviews
- JHM IRB
- – one-stop source to request and receive data and analytics
Step 2: Submission & Review
From submission through approval by all applicable internal and external committees.
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