Protocol Development

Penn State Hershey Cancer Institute CTO personnel play a key role in assisting investigators with the development of new investigator-initiated trials. Their review and critique on draft versions of the protocol eliminates the need for modifications and amendments before or after the regulatory approval and/or study initiation and implementation. CTO responsibilities include:

  • Providing guidelines and templates for clinical research studies at the outset of trial development.  This includes working with relevant industry support to obtain an appropriate template, use of the PSHCI protocol template, or use of an appropriate template from NCI/CTEP’s guidelines (links below).
  • Ensuring that the protocol is written in a way that utilizes appropriate resources and simultaneously facilitates the involvement of appropriate personnel.
  • Ensuring consistency throughout various sections of the protocol (e.g., protocol narrative, study calendar, dose modifications).
  • Developing protocol tools and case report forms for data capture; working with the biostatistician to ensure the appropriate data capture to meet the endpoints of the trial.
  • Preparing protocol summaries, consent forms and other necessary documentation for internal and external review (i.e., IRB, GCRC, FDA, NCI/CTEP). 

All documents are discussed with and approved by the principal investigator.  In some instances, meetings are facilitated by CTO staff to work through protocol revisions. Meeting attendance includes the principal investigator, co-investigators, fellows, biostatistician, clinical research coordinator, data manager and a regulatory specialist.  Such a meeting provides an efficient way to collaborate on the protocol updates with action by the regulatory specialist after the meeting to ensure the prompt processing of the protocol through the review process.  The master file on the protocol is maintained by CTO regulatory staff. 

Cancer Institute protocol development tools: