Mission

The mission of the Pediatric Clinical Research Office (PCRO) is to enhance, foster and promote organized clinical research within the Penn State Children's Hospital. By stimulating clinical research, the Pediatric Clinical Research Office will help Penn State Hershey Medical Center meet its goals of patient care, teaching, service and research. The PCRO is currently and strives to continue to be active in PSU investigator-initiated research through collaborations between faculty and our office and its research staff. The PCRO helps investigators initiate new studies and provides recruitment, consent writing, regulatory, budgetary, and data collection assistance where needed. This help may also include administrative, procedural, and case report documentation. Help is also provided to investigators with industry-sponsored clinical trials. The PCRO promotes investigator initiated research within Central Pennsylvania, trains our staff to promote quality research within the Hershey Medical Center and the adoption of “Good Clinical Practices”.

Functions

1. Help. The first function of the Pediatric Clinical Research Office will be to help investigators acquire new studies, initiate studies, and provide recruitment and data collection assistance, where needed.
   
   This help will be provided in administrative, procedural, and case reports areas. Help can be provided to new investigators, pre-site visits, consent writing, study initiation, enrollment, procedural tasks, and data collection in order to facilitate new investigators commencing on a pathway of clinical research.
   
   Providing research coordinators for procedures of a study can provide assistance to established investigators in many of the same ways. This may be especially helpful for those investigators who do not have research capabilities within their home department.
    

2. Marketing. The Pediatric Clinical Research Office will promote investigator initiated research within Central Pennsylvania as well as follow advertisements for study placements of new and/or initiated studies. The office will also endeavor to develop preferred provider agreements with pharmaceutical corporations, biotech companies, and contract review organizations to act as a first line site for clinical trials.
    

3. Training. The Pediatric Clinical Research Office will train their staff to promote quality research within the Hershey Medical Center and the adoption of “Good Clinical Practices” throughout Penn State Hershey Medical Center. The office will also train research staff in regulatory affairs, protocol and consent writing, contract negotiation and budgeting.
    

4. Research. The Pediatric Clinical Research Office will be active in research with protocols using our own research coordinators and investigators. Only through active involvement in continuing clinical research can a group remain credible and attuned to the needs and changes occurring in the fields of clinical research.

What the Pediatric Clinical Research Office is Not

The Pediatric Clinical Research Office is not another roadblock in protocol development and approval. The Pediatric Clinical Research Office will not interfere with functions performed by already functioning areas of clinical research within the clinical departments. The Pediatric Clinical Research Office will not assess separate fees for its support to ongoing clinical research studies, but will endeavor to become self- sufficient through direct costs from studies conducted through our office as well as fees charged under direct costs for administrative functions to other protocols.