Clinical Research Center

Penn State College of Medicine’s Clinical Research Center provides research infrastructure for investigators who conduct research with human subjects.

Investigations carried out can include studies of normal and abnormal human function and studies of cause, progression and cure of diseases.

The CRC is part of Penn State Clinical and Translational Science Institute’s clinical services function and was funded by the National Center for Research Resources in July 1995 (Grant Number M01RR10732). Clinical Research Centers are located at Penn State Health Milton S. Hershey Medical Center in Hershey, PA, and the Elmore Wing of the Clinical Research Center in University Park, PA.

Oversight of the Center is provided by a Clinical Research Center Advisory Committee, and all protocols are approved by this committee before work begins. Institutional Review Board approval is also required before work begins.

For details, email head nurse Shirlynn Motilla at smotilla@pennstatehealth.psu.edu or Charity Sauder, CTSI Administrative Director, at csauder@pennstatehealth.psu.edu.

  • More information about the CRC in Hershey is available below.
  • More information about the CRC in University Park is available here.
  • Information for potential research volunteers is available on StudyFinder.

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Meet the CRC Teams

Program Direction and Administration Expand answer
Nursing and Support Staff Expand answer

CRC Application Process

CRC and Scientific Review Applications Expand answer

To apply to use the Clinical Research Center, please complete the application forms here. If you have any questions regarding the CRC application or scientific review application process, please email crc@pennstatehealth.psu.edu.

Applications for both Clinical Research Center and Scientific Review are due the 15th of each month for review at the beginning of the following month.

Complete the CRC Application here

Complete the Scientific Review Application here

CRC Advisory Committee Meeting Dates Expand answer

The Clinical Research Center Advisory Committee meets regularly in Hershey and University Park.

Upcoming events are listed here; click any event for details or to add it to your Outlook calendar.

CRC Services

Nursing Expand answer

The CRC nursing staff members welcome the opportunity to work in partnership with investigators throughout Penn State to implement and complete clinical research protocols.

The nurse works as a clinical research facilitator to coordinate interdepartmental aspects of the protocol; draft standard forms and flow sheets; ensure availability of necessary equipment and supplies; prepare for study-specific procedures; and set up methods for participant screening, enrollment and follow-up.

The clinical scientist and the CRC nurse work closely throughout the study to ensure proper and complete implementation of the protocol, precisely documenting interventions and participant response. A permanent CRC-based medical record is maintained as a source document for each participant. Research participants are seen in the CRC for research-related visits, not routine clinical care, but the facilitator provides professional nursing assessment, education and referral, as needed, for the participant’s concurrent health needs.

CRC nursing staff members are available on a regular basis 7:30 a.m. to 4:30 p.m. weekdays.

Biostatistics Expand answer

Penn State has biostatisticians, epidemiologists and methodologists with a diverse set of expertise located within several departments and centers in both Hershey and University Park. Biostatistics, Epidemiology and Research Design (BERD) consultations are offered through Penn State Clinical and Translational Science Institute and pool Penn State resources across campuses to offer training in biostatistical and epidemiological methodologies and assistance to investigators in study design, data management and analysis.

Learn more about CTSI BERD consultations

Investigator Responsibilities

Overview Expand answer

The purpose of the Clinical Research Center is to promote and support patient-oriented research. CRC personnel are prepared to facilitate and document the collection of accurate and timely data to complete the research protocol and to administer the research support grants appropriately. The medical care of patients admitted to Penn State Health Milton S. Hershey Medical Center’s CRC is the primary responsibility of the physician investigator. Since the CRC provides services new to many investigators, it has proven useful to clarify the CRC’s expectations of the investigator.

After a CRC protocol is approved, the principal investigator is responsible for several tasks, all listed below. Please click each one for details.

Scheduling Initiation Meeting Expand answer

Please schedule or have your study coordinator schedule an initiation meeting with Shirlynn Mottilla, RN, Clinical Head Nurse for the Clinical Research Center.

She can be reached at 717-531-1642 or smottilla@psu.edu. All visits are scheduled through her or her designate.

Informed Consent of Each Participant Expand answer

Beyond the initial qualification screening of a potential participant, informed consent must be obtained before any procedures or further investigation can be done.

The PI is responsible for obtaining consent directly.

If this responsibility is delegated to study personnel, the PI ensures that they are fully qualified to explain the study, answer questions and evaluate the participant’s understanding of the study before having the participant sign the form.

Be sure the signature part of the consent form is consistent with the practice; e.g., if investigator signature is required, a named investigator takes the consent from the participant and signs it at that time.

Signature of “Person Obtaining Consent” may be used instead of “Investigator Signature”; qualification of the person obtaining consent is the responsibility of the investigator.

Recruitment and Enrollment of Patients Expand answer

Identification of pools of potential participants and development of advertising methods is the responsibility of the investigator; this may include obtaining permission of other physicians to contact their patients.

CRC personnel may be able to help with initial telephone screening, utilizing an intake question form developed by the investigator. The CRC nurse coordinating the study may be involved in further screening of participants found appropriate for consideration in initial screening.

Selection of participants for inclusion in the study is ultimately the investigator’s responsibility.

Medication Orders Expand answer

Physician orders for medications and infusions must be written for each participant and, in certain studies, prescriptions must be written for dispensing by the pharmacy. The investigator or a co-investigator must be available in the building during infusions and at any other time required for special procedures, e.g., during observation following investigative vaccinations.

Recording of Research Data in the Participant’s CRC Medical Record Expand answer

The CRC medical record serves as the primary source document for all data reporting. The investigator and nurse must agree on their respective responsibilities for collecting and recording data for each study and must develop a system to facilitate that process. The nurse will review data (laboratory reports, etc.) for safety and efficacy and refer to the PI as needed. The investigator is ultimately responsible for the accuracy of reported data.

Data Management and Analysis Expand answer

The principal investigator is responsible for data management and analysis. The CRC provides consultation from the CRC informatics core director and the biostatistician on methods of data management, transfer and analysis.

In addition, four computers and a laser printer are available for the use of PIs and/or their designated staff to use on a first-come, first-served basis; training is available from the informatics core director on the use of these systems. Data entry is available on a contractual basis.

The informatics core director is responsible for maintaining integrity, security and backups of the data with input from the PI. The informatics core director is available for training and troubleshooting in the use of CRC computer systems for data management and analysis.

Actual analysis is the responsibility of the investigator. The PI is responsible for establishing an analysis schema with assistance from the biostatistician and informatics core director.

Patient Billing Expand answer

The investigator must provide budget and fund number for billing purposes.

Communication with CRC Personnel Working on the Protocol Expand answer

In addition to the initiation meeting with the clinical head nurse that is required before starting a study, regular meetings of the study team are strongly recommended to maintain timely and complete communication and study progress.

The investigator is responsible for being available or for communicating who is providing medical coverage in their absence; the investigator is responsible for study-related instruction of covering physician(s).

Citing the Clinical and Translational Science Institute Grant Expand answer

The CRC is part of Penn State Clinical and Translational Science Institute’s clinical services function.

All publications from research supported in any way by the CRC must cite CTSI support.

Learn about citing the CTSI grant

Completing Required Training Expand answer

All staff providing support to a protocol in the CRC must have adequate training. This includes human subjects protection training, institutional safety training and protocol-specific procedural training.

It is the responsibility of the investigator or their designate to provide the CRC with documentation that the human subjects protection training and the safety training have been successfully completed before a staff member works in the CRC.

Individuals working in the CRC must have training credentials from a reliable source (RN license, phlebotomy certification, LPN license, etc.) or be trained by the CRC staff.

Recognizing the need of the investigator’s staff to assist with procedures of blood drawing, phlebotomy, IV care, sample processing and collection of vital signs, and the expertise of the CRC staff in these skills, the CRC staff will provide training as follows:

  • Training is available on a quarterly basis and scheduled during the first full week of each quarter (January, April, July and October). Training must be scheduled a minimum of one week prior to the first week of the quarter.
  • Training will occur during normal CRC operating hours (7:30 a.m. to 4:30 p.m. weekdays).
  • Training will not be complete until the trainee has demonstrated competency in the skill to the trainer.

A completed, signed checklist for training must be on file before a staff member works in the CRC.

All newly trained staff will have an experienced staff member from the investigator’s staff available in the CRC during their first solo performance of the task.

CRC Scheduling

Scheduling Policy Expand answer

Patients must be scheduled at least one day in advance. Although email or fax requests are preferred, verbal requests may also be made. In any event, it is essential that the clinical investigator or their staff receive confirmation from the CRC staff.

The CRC expects the investigator or their staff to meet the patient at the time of the appointment.

In the event that an investigator or their staff do not meet the patient, the CRC staff will call the investigator and/or staff.

The maximum delay that the CRC can accept to start an appointment is 30 minutes.

If an investigator and/or staff are not in the CRC within 30 minutes, the CRC staff will advise the patient that it is their own decision as to whether they stay or leave.

In the event that three instances of a 30-minute or longer wait occur for a given protocol, the investigator will be informed that they will no longer be able to use the CRC for that protocol.

Unscheduled Visits Policy Expand answer

In the event a patient/volunteer arrives at the CRC for an unscheduled visit and the protocol and coordinator can be determined, the following process will occur. (Of necessity, when a patient/volunteer arrives at the CRC for an unscheduled visit and none of the pertinent information – protocol, coordinator or principal investigator – can be determined, the patient/volunteer will be turned away).

First Instance

  • The coordinator will be notified by the CRC clinical head nurse or their designate of the patient’s presence.
  • The patient/volunteer will be accommodated as promptly as possible with a room.
  • The CRC clinical head nurse will notify the PI via email of the occurrence and include a copy of the scheduling policy for unscheduled visits. The email will be copied to the study coordinator and the CRC Research Subject Advocate (RSA).

Second Instance

  • The coordinator will be notified by the CRC clinical head nurse or their designate of the patient’s presence.
  • The patient/volunteer will be accommodated as promptly as possible with a room.
  • The RSA will notify the PI and copy the clinical head nurse and study coordinator of the repeat offense. A copy of the scheduling policy and the policy for unscheduled visits will be included.

Third Instance

  • The coordinator will be notified by the CRC clinical head nurse or their designate of the patient’s presence.
  • The patient/volunteer will be accommodated as promptly as possible with a room.
  • The RSA will notify the PI’s department chair of the incident including the fact that this is a repeated action. The chair will receive a copy of the scheduling policy and the policy for unscheduled visits. The PI, CRC clinical head nurse, study coordinator and CRC program director will be copied on the correspondence.

Fourth Instance

  • The coordinator will be notified by the CRC clinical head nurse or their designate of the patient’s presence.
  • The patient/volunteer will be accommodated as promptly as possible with a room.
  • The RSA will notify the PI’s department chair that a fourth instance of an unscheduled visit has occurred. This notification will include the suspension of all scheduling privileges for this PI and coordinator(s) combination for a period of three months. Copies of the notification will be sent to the PI, the study coordinator, the CRC Research Subject Advocate, the Vice Dean for Research and the CRC clinical head nurse.

Fifth instance during or after the suspension

  • The coordinator will be notified by the CRC clinical head nurse or their designate of the patient’s presence.
  • The patient/volunteer will be accommodated as promptly as possible with a room.
  • The CRC program director will notify the PI’s department chair that a fifth instance of an unscheduled visit has occurred. This notification will include the termination of use of CRC resources for this PI and coordinator(s) combination. No future protocols will be accepted for this PI and coordinator(s) combination. Copies of the notification will be sent to the PI, the study coordinator, the CRC Research Subject Advocate, the Vice Dean for Research and the CRC clinical head nurse.

Future unscheduled visits will not be accommodated. If a patient arrives for an unscheduled visit, the PI will be paged and expected to meet the patient and escort them to an appropriate place for the visit to take place, or to reschedule the visit at the patient’s convenience.

Resources

Regulatory Information Expand answer

The work in the CRC is guided by several agencies and regulations. These include: