The Office of Clinical Trials

Below is a checklist of information for industry-sponsored clinical trials. Printable checklists are also available. 

1. Protocol Selection/Site Feasibility Assessment

Confidentiality Disclosure Agreement (CDA): A CDA is an agreement between the study sponsor and the institution that governs the access and use of confidential information. The Office of Research Administration (ORA) will review and sign on behalf of the institution. Some sponsors will require this agreement be signed before the full protocol is provided.

• Email an editable version of the document with the sponsor’s contact information to the ORA Sponsored Project Specialist assigned to your department
  • Office of Research Administration Contact Information | School of Medicine Office of Research & Administration (jhmi.edu)
  • CDA’s / Confidentiality Agreements / Nondisclosure Agreements | School of Medicine Office of Research & Administration (jhmi.edu)
• Approved CDA (approved by ORA/sponsor) signed by PI and returned back to ORA for final execution

Study Consideration: Does the site have the patient population, staff, expertise, equipment etc. to conduct the study?

• Necessary equipment to run the study per protocol is available
• There is sufficient staff support and the staff are experienced and trained to run the particular study
• The PI has time to devote to the management and oversight of the study
• There are no conflicting studies which would impact enrollment
• Available cohort of patients needed for the study

To identify the number of potential participants for a clinical trial, investigators can quickly access Epic SlicerDicer or TriNetX with more detailed information available through collaboration with the CCDA.

• Epic SlicerDicer. Investigators with access to Epic can use Epic’s SlicerDicer to get rough patient counts. To find SlicerDicer in Epic, go to the Epic search bar and type in SlicerDicer. IRB approval is needed prior to using these data for recruitment or to conduct your research or publish.
• TriNetX is a self-service web-based data exploration tool that helps clinical researchers to define a patient cohort using inclusion and exclusion criteria and to explore cohort attributes.
• Core for Clinical Research Data Acquisition (CCDA). When investigators have sophisticated inclusion and exclusion criteria that cannot be satisfied by using SlicerDicer or TriNetX, we recommend that they contact the CCDA for assistance. Investigators receive 2 initial hours of service subsidized by the ICTR, during which we are often able to complete simple feasibility queries.

Process Summary

PRA Initiation

eIRB/CRSS have an integrated workspace in which all studies enter the CRSS workspace for PRA determination.

Budget Development Request

• IRB application must be started in order to obtain an IRB#.
• Principal investigator (PI) sends a budget development request and the required documents to CRSS (CRSS@jhmi.edu ).
• Study may remain in “Researcher Prep” until ready for full IRB submission

CRSS Analyst Assigned

• CRSS analyst is assigned
• CRSS analyst require the following documentation:
  • Most recent protocol;
  • Draft contract and sponsor budget;
  • Proposed ICF cost language;
  • NOGA (if the study is government funded);
  • Investigator’s Brochure (IB) (if applicable); and
  • Any information regarding the FDA status of the investigational item(s) (if applicable).

PRA Development

CRSS Analysis

• Training checked / Notifications sent
  • Clinical Research Billing Orientation (CRBO) – PI and consenting study team members [online available through MyLearning Website]
  • Clinical Research Management System (CRMS) - PI
• Creates PRA Memo
• PRA Billing Grid delineation of charges for items and services.

Review and Approval

• Draft PRA to PI/Research team for review. 

PI may request/suggest revisions:

1. Revision of the PRA in consultation with the PI as necessary.
2. Revised draft(s) to the PI for review and approval.
3. Process repeats until the PI approves the draft.

When PI approval is granted:

1. PI approved draft PRA forwarded to IRB.

If budget development is requested, please send a message to CRSS@jhmi.edu

• The budget will be developed using the PI approved PRA.

NDAs or CDAs must be submitted to the Office of Research Administration for negotiation.

Email an editable version of the document to the ORA Sponsored Project Specialist assigned to your department. If no document is available, ORA has templates for use. Find your assigned ORA Sponsored Project Specialist.

Provide the contact information (name, title, email address, phone #, mailing address, etc.) for the Sponsor; and identify the purpose of the NDA/CDA and your timeline.

Clinical trials agreements should be submitted to the Office of Research Administration as soon as they are received from the Sponsor. IRB approval is not required to begin CTA review and negotiations which should occur in parallel with the IRB review of the study. The clinical trial agreement must be submitted via COEUS with the Activity Type “Clinical Research.” For the COEUS submission, the IRB application number can be generated by initiating the IRB submission in eIRB but approval is not necessary to initiate the review.

For an initial or original agreement, you will need the following documents:

• Editable version of the Agreement (preferably MS Word), if one is available. If no agreement is available, ORA has templates for use.
• Supplemental Information Sheet (“SIS”) for Commercial Agreements
• Proposed Budget, when applicable. No budget is required for unfunded studies.
• Statement of Work or Scope of Work
• IRB application number, if applicable (and other applicable compliance, like ISCRO). If the IRB approval is pending, please indicate.