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:

Prospective cohort study and Phase 3 trial design consultation:
JHAC ICTR leaders are available during consultation office hours. Email Deborah Martino to request an appointment with Neil Goldenberg, M.D., Ph.D. and Ernest Amankwah, Ph.D.

Phase 1 and Phase 2 trial design consultation: JHAC ICTR Center for Pediatric Early Phase Trials leaders are available during consultation office. Email Laurel McDevitt to request an appointment with Jonathan Metts, M.D. and Ernest Amankwah, Ph.D.
 
Studies involving biospecimen collection and storage: JHAC Pediatric Biorepository leaders are available for consultation, request an appointment with Billy Schleif, M.S., Manager,  JHAC Pediatric Biorepository.   
 

Step 2: Submission & Review

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

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