Clinical Research Center: Application for CRC Scientific Review

All studies carried out in the CRC must be approved by the Penn State Health Milton S. Hershey Medical Center Human Subjects Protection Office (HSPO/IRB) and the CRC Advisory Committee. 

The CRC Advisory Committee meets the first Wednesday of each month. Complete applications must be received by the fifteenth of the month to be included on the next month’s agenda.

Project Background

Study Team Members
Please enter the information for each investigator/coordinator who will directly supervise the research and respond to patient problems. Click "Add another study team member" to add additional members.

Protocol Information

The following are the items that will be reviewed with a brief explanation of what the reviewer will expect. Please indicate the page number where each section may be found.
A brief review of the problem to be studied and of related studies that generated the rationale and the central idea of the proposed study. Pertinent references should be provided.

The problem(s) stated in the background may generate a primary hypothesis and possibly one or two secondary hypotheses. A hypothesis is often stated in the null, i.e. "No difference between treatments A and B is anticipated" or "No association between X and Y exists." Alternatively, it can be stated according to what one expects, i.e. "A will be more effective than B in reducing levels or symptoms of C," or "X will be associated with Y."

In case of clinical studies, the potential value in the understanding diagnosis, and management of a clinical condition or pathologic state should be formulated.

These are the endpoints of the research intended. There may be several specific aims in a given study.

Should validate the hypothesis and specific aim(s) using procedures consistent with sound scientific study design, including nature and size of the subjects studied, recruitment, screening and enrollment procedures, inclusion and exclusion criteria, treatment schedules, and follow-up procedures, if applicable. A chart of the examinations or studies to be performed at each visit and the time of each visit and test is needed.

Measures include both independent (predictor) and dependent (outcome) variables. Outcomes include what the investigator is trying to predict, i.e., new or recurrent onset of a disease state, survival, or lowering of a biochemical parameter as a result of a drug or procedure. The measures and outcomes are reasonably expected to answer the proposed question(s) and the importance of the knowledge expected to result from the research.

A power/sample size analysis should include an estimate of minimum effect or difference expected at a given level of power when the sample size is fixed or a projection of the number of subjects needed to achieve an important difference in what is being examined in the hypotheses and the specific aims. Power analysis is not required for pilot studies; please enter "N/A" if a pilot study.

Data management includes how data will be captured for analysis and the tools that will be utilized while capturing the data.

Data management includes how data will be captured for analysis and the tools that will be utilized while capturing the data.

Source of Research Support for Project

By submitting this form, I assure that I am the Principal Investigator for this project or an approved designee and that the Principal Investigator has approved all content in this submission.