Clinical Research Lifecycle

Development

From study conception through development of a completed protocol
 

Researchers conducting human subjects research at JHACH or in collaboration with any JHU Affiliated / Integrated sites agree to follow JHAC Standard Operating Procedures (SOPs) and JHM IRB Policies and Guidelines.
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:

For Johns Hopkins employees only:

Step 2: Submission & Review

From submission through approval by all applicable internal and external committees. 

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