Protocol Development

Study Registration in PennCTMS

All Penn studies in fitting with SOP 400 should be registered in the PennCTMS. Registration can take place well in advance of IRB submission during the planning stage of the study. If the study does not move forward the record can be closed.

If the study does continue, then the record can be linked to PennChart and patient status information will be shared between the two systems.

For more information on PennCTMS

Recruitment Strategy Development and Options (this will take you to the Penn Manual of Clinical Research)

Click here for Recruitment Resources Available @ Penn Medicine

IRB Submission Process 

Contracting/ ORS

Study Record Creation in PennChart 

Electronic Trial Documentation Tools

For more information on data classification and sensitivity please review the following policy, PSOM IS Data Classification policy

For more information on data handling requirement, sensitivity and security, please review the following PSOM Data Handling Policy