General Clinical Research Center

Janine E. Janosky, Ph.D. - Statistician

The General Clinical Research Center (GCRC) was established at the Children's Hospital of Pittsburgh in 1962 through funding from the National Institutes of Health (NIH) and was recently recommended for continued funding through 2004. The center provides opportunities to conduct clinical research under controlled circumstances and encourages collaboration among basic and clinical scientists through studies that may translate into new or improved patient care methods. The GCRC pays for costs that are attributed to research including inpatient days and outpatient visits and ancillary costs.

The GCRC is located on the 8th floor of the Main Tower and is part of a 28-bed unit. The GCRC provides a four-bed inpatient unit, a blood processing laboratory, three outpatient testing rooms and the services of specially trained research nurses.

The program direction is provided by Drs. Peter Lee and Silva Arslanian who are responsible for the overall operations of the center. The directors are familiar with all research projects conducted on the center and provide guidance to GCRC investigators. The GCRC advisory committee meets monthly to review protocols for scientific merit, validity, significance, relevance and feasibility. All protocols must be reviewed annually and must have Human Rights Committee approval.

Administrative support is provided by the GCRC manager Diane Cline. who is responsible for the day-to-day management of the GCRC administrative and fiscal matters. The manager also provides assistance to GCRC investigators while preparing proposals to ensure compliance with NIH guidelines.

Inpatient nursing support is provided by the 8 south unit. Nurses are supervised by the GCRC nurse manager, Janet Bell. Investigators meet with the nurse manager to discuss implementation of protocol specifics. All staff nurses are specifically trained and oriented to the GCRC. Nursing co-protocols are developed by the GCRC nurse manager. All research admissions are supervised by the GCRC nurse manager.

Outpatient nursing support is provided by the GCRC outpatient nurse, Amy Gilliland. She is responsible for coordinating the outpatient component of the GCRC. She works closely with investigators and ensures that protocols are implemented in accordance to physician orders.

The GCRC also provides to its investigators statistical guidance and consultation. The biostatistician, Dr. Janine Janosky, reviews all submitted protocols for their statistical integrity, including appropriateness of design with respect to the aims of the study, proposed hypothesis testing and generation, sample size, methodology and study feasibility. She meets with investigators offering support in statistical and computer operation of the GCRC. Computer and programming support is provided by the GCRC systems manager, Dr. Patricia Nixon- She works with the GCRC statistician and provides support to GCRC investigators.