Protocol Checklists for Research Study Start Up

As discussed at the Research Town Hall Meeting on Wednesday, Sept. 9, 2015, effective immediately, all clinical human research studies will be tracked in OnCore using protocol checklists. OnCore is GRU’s clinical research management system of record. OnCore offers real-time insight into all protocol activity by providing a central place for tracking tasks from study start-up to closeout.

Tracking start-up activities is a team effort, and the protocol checklist will be used to track these activities. Start-up activities include confidentiality agreement (CDA), site feasibility assessment, sponsor visits, contract, budget, IRB and ancillary services such as Hospital Services, Pharmacy, IBC, Radiation Safety, etc. Representatives from the above service areas will be responsible for updating activities associated with their area of responsibility. It will be the responsibility of each Investigator to ensure that each of their protocols are entered into the OnCore Protocol Checklists.

Please reference the instructions, training dates below and the OnCore website for additional information.

What Do I Need To Do?

1. Attend Training
Attend an instructor-led class (full training schedule is available below) OR
Complete Training Online.

• Checklist Training 
• Investigator Training
• Biostatisticians Training

2. Complete an OnCore User Access Request
The Access Request Form for GRU/GRMC employees is available online.
3. Register your protocol in OnCore by submitting “Protocol Registration Form – Study Start Up” found on the GRU OnCore website.
4. Begin using the Protocol Checklist for protocols registered in OnCore.

For additional information, please contact the OnCore Office at 1-5476 or oncore@gru.edu.

Presented by the Office of the Senior Vice President for Research,
Dr. Michael P. Diamond, MD