Clinical Research Center

Clinical Research Centers (CRCs) provide research infrastructure for investigators who conduct research with human subjects.

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

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

Clinical Research Centers are located at Penn State Health Milton S. Hershey Medical Center in Hershey and the Elmore Wing of the Clinical Research Center in University Park.

A Clinical Research Center Advisory Committee provides oversight and all protocols are approved by this committee before work begins. Institutional Review Board approval is also required.

For details about the Clinical Research Center in Hershey, email head nurse Shirlynn Motilla at smotilla@pennstatehealth.psu.edu or Charity Sauder, CTSI Administrative Director, at csauder@pennstatehealth.psu.edu.

For details about the Clinical Research Center in University Park, email nurse manager Cyndi Flanagan at chf117@psu.edu or Dee Bagshaw, Clinical and Translational Science Institute program director, at ddm108@psu.edu.


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Meet the Clinical Research Center Team in Hershey

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

Application Process: Clinical Research Center in Hershey

Clinical Research Center and Scientific Review Applications Expand answer

To apply to use the Clinical Research Center, please complete the application forms here.

For details, 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

Clinical Research Center Advisory Committee Meeting Dates Expand answer

The Clinical Research Center Advisory Committee meets regularly.

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

Clinical Research Center Services in Hershey

Nursing Expand answer

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

Clinical Research Center nursing staff members are available 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. Clinical Research Center personnel 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 College of Medicine’s Clinical Research Center is the primary responsibility of the physician investigator. Since the Clinical Research Center provides services new to many investigators, the following investigator expectations may be beneficial.

After a Clinical Research Center protocol is approved, the principal investigator is responsible for several tasks, all listed in this section. Click each header for details.

Scheduling Initiation Meeting Expand answer

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 principal investigator is responsible for obtaining consent directly.

If this responsibility is delegated to study personnel, the principal investigator 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 is the responsibility of the investigator; this may include obtaining permission of other physicians to contact their patients.

Clinical Research Center personnel may be able to help with initial telephone screening, utilizing a question form developed by the investigator. The Clinical Research Center 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 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 Expand answer

The Clinical Research Center 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 principal investigator as needed. The investigator is responsible for the accuracy of reported data.

Data Management and Analysis Expand answer

The principal investigator is responsible for data management and analysis. The Clinical Research Center provides consultation from its 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 principal investigators and 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 contractually.

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

Actual analysis is the responsibility of the investigator. The principal investigator 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.

Communication 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 Clinical Research Center is part of Penn State Clinical and Translational Science Institute. All publications from research supported in any way by the Clinical Research Center must cite Institute support.

Learn about citing the CTSI grant

Completing Required Training Expand answer

All staff providing support to a protocol in the Clinical Research Center 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 Clinical Research Center with documentation that the human subjects protection training and the safety training have been successfully completed before a staff member works in the center.

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

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

Clinical Research Center Scheduling in Hershey

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 Clinical Research Center staff.

The CLinical Research Center 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, center staff will call the investigator and/or staff.

The maximum delay that the Clinical Research Center can accept to start an appointment is 30 minutes.

If an investigator and/or staff are not in the center 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 Clinical Research Center for that protocol.

Unscheduled Visits Policy Expand answer

In the event a patient/volunteer arrives at the Clinical Research Center 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 center 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 Clinical Research Center 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 center’s 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 Clinical Research Center’s research subject advocate.

Second Instance

  • The coordinator will be notified by the Clinical Research Center 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 research subject advocate will notify the principal investigator 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 Clinical Research Center 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 research subject advocate will notify the principal investigator’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 principal investigator, Clinical Research Center clinical head nurse, study coordinator and Clinical Research Center program director will be copied on the correspondence.

Fourth Instance

  • The coordinator will be notified by the Clinical Research Center 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 research subject advocate will notify the principal investigator’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 principal investigator and coordinator(s) combination for a period of three months. Copies of the notification will be sent to the principal investigator, the study coordinator, the Clinical Research Center research subject advocate, the Vice Dean for Research and Graduate Studies and the Clinical Research Center clinical head nurse.

Fifth instance during or after the suspension

  • The coordinator will be notified by the Clinical Research Center 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 Clinical Research Center program director will notify the principal investigator’s department chair that a fifth instance of an unscheduled visit has occurred. This notification will include the termination of use of Clinical Research Center resources for this principal investigator and coordinator(s) combination. No future protocols will be accepted for this investigator and coordinator(s) combination. Copies of the notification will be sent to the principal investigator, the study coordinator, the Clinical Research Center research subject advocate, the Vice Dean for Research and Graduate Studies and the Clinical Research Center clinical head nurse.

Future unscheduled visits will not be accommodated. If a patient arrives for an unscheduled visit, the principal investigator 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 Clinical Research Center is guided by several agencies and regulations. These include: