Clinical Research Lifecycle


From study conception through development of a completed protocol

Researchers conducting human subjects research at Johns Hopkins All Children's Hospital or in collaboration with any Johns Hopkins University Affiliated / Integrated sites agree to follow Standard Operating Procedures (SOPs) and 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 Johns Hopkins All Children's Hospital . 

When a protocol is investigator-initiated and developed, several Johns Hopkins All Children's Hospital resources and support services may be accessed during this phase. 
  • Clinical Research Coordination and Clinical Research Nursing:  available for consult on efforts and skillsets available for support with patient screening, enrollment, research-based procedures, specimen collection and data collection, as delegated responsibilities from the principal investigator
  • Biospecimen Processing and Storage:  available for consult on biospecimen processing and storage needs and associated efforts, capabilities, and facilities available
  • 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
More information on the above centralized support groups may be accessed via the following links:

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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