After a Protocol Has Been Approved

The purpose of the General Clinical Research Center (GCRC) is to promote and support patient-oriented research. GCRC 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 the Penn State Hershey Medical Center GCRC is the primary responsibility of the physician investigator. Since the GCRC provides services new to many investigators, it has proven useful to clarify the GCRC’s expectations of the investigator. Principal Investigator is responsible for:

1. Initiation Meeting with Clinical Head Nurse of GCRC - Shirlynn Mottilla, RN.

Please schedule or have your study coordinator schedule an initiation meeting with Shirlynn Mottilla, RN, Clinical Head Nurse for the General Clinical Research Center. Ms. Mottilla can be reached at 717-531-1642 or by email at smottilla@psu.edu. All visits are scheduled through Ms. Mottilla or her designate.

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.

2. Informed Consent of each participant.

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.

3. Recruitment/enrollment of patients.

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. GCRC personnel may be able to help with initial telephone screening, utilizing an intake question form developed by the Investigator. The GCRC 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.

4. Medication orders.

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.

5. Recording of research data in the participant’s GCRC medical record.

The GCRC 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.

6. Data management and analysis.

The Principal Investigator is responsible for data management and analysis. The GCRC provides consultation from the GCRC Informatics Core (IC) Director and the Biostatistician on methods of data management, transfer and analysis. In addition, four personal computers and a laser printer are available for the use of PI’s and/or their designated staff to use on a first come-first serve basis; training is available from the IC Director on the use of these systems. Data entry is available on a contractual basis. The IC Director is responsible for maintaining integrity, security and backups of the data with input from the PI. The IC Director is available for training and troubleshooting in the use of GCRC 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 IC Director

7. Patient Billing

The Investigator must meet before the study begins with the financial personnel in the GCRC to decide how patient billings will be handled.

8. Communication with GCRC personnel working on the protocol.

An initiation meeting is required with the Clinical head Nurse prior to 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 his/her absence; the Investigator is responsible for study-related instruction of covering physician(s).

9. Citing the GCRC Grant

All publications from research supported in any way by the GCRC must cite GCRC support. The proper citation is: This research was supported in part by a General Clinical Research Center grant from NIH (M01RR10732) and GCRC Construction Grant (C06RR016499) awarded to the Pennsylvania State University College of Medicine.

10. GCRC Policies

a. GCRC Training Policy

All staff providing support to a protocol in the GCRC must have adequate training. This includes the Human Subjects Protection Training, Institutional Safety Training and protocol specific procedural training. It is the responsibility of the investigator or his/her designate to provide the GCRC with documentation that the Human Subject Protection Training and the Safety Training have been successfully completed prior to a staff member working in the GCRC.

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 GCRC staff in these skills, the GCRC staff will provide training on a scheduled basis. 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.

Procedure Training

  1. Individual must have training credentials from a reliable source (RN license, phlebotomy certification, LPN license, etc.) or be trained by the GCRC staff.
  2. Training will occur during normal GCRC operating hours (Monday through Friday 7:30 AM through 4:30 PM).
  3. Training will not be complete until the trainee has demonstrated competency in the skill to the trainer.
  4. Completed signed checklist for training must be on file prior to a staff member working in the GCRC.
  5. All newly trained staff will have an experienced staff member from the investigator's staff available in the GCRC during their first solo performance of the task.

b. GCRC Scheduling Policy

  1. 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 his/her staff receive confirmation from the GCRC staff.
  2. The GCRC expects the investigator or his/her staff to meet the patient at the time of the appointment.
  3. In the event that an investigator or his/her staff do not meet the patient, the GCRC staff will call the investigator and/or staff.
  4. The maximum delay that the GCRC can accept to start an appointment is 30 minutes.
  5. If an investigator and/or staff are not in the GCRC within 30 minutes the GCRC staff will advise the patient that it is their own decision as to whether they stay or leave.
  6. In the event that three instances of a 30 minute or longer wait occur for a given protocol, the investigator will be informed that he/she will no longer be able to use the GCRC for that protocol.

c. GCRC Unscheduled Visits Policy

In the event a patient/volunteer arrives at the GCRC 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 GCRC 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).

  1. First Instance:
    1. The coordinator will be notified by the GCRC Clinical Head Nurse or her designate of the patient's presence.
    2. The patient/volunteer will be accommodated as promptly as possible with a room.
    3. The GCRC Clinical Head Nurse will notify the PI via e-mail of the occurrence and include a copy of the scheduling policy for unscheduled visits. The e-mail will be copied to the study coordinator and the GCRC Research Subject Advocate (RSA).
  2. Second Instance:
    1. The coordinator will be notified by the GCRC Clinical Head Nurse or her designate of the patient's presence.
    2. The patient/volunteer will be accommodated as promptly as possible with a room.
    3. 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.
  3. Third Instance:
    1. The coordinator will be notified by the GCRC Clinical Head Nurse or her designate of the patient's presence.
    2. The patient/volunteer will be accommodated as promptly as possible with a room.
    3. 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, GCRC Clinical Head Nurse, Study Coordinator and GCRC Program Director will be copied on the correspondence.
  4. Fourth Instance:
    1. The coordinator will be notified by the GCRC Clinical Head Nurse or her designate of the patient's presence.
    2. The patient/volunteer will be accommodated as promptly as possible with a room.
    3. 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 GCRC RSA, the Vice Dean for Research and the GCRC Clinical Head Nurse.
  5. Fifth instance during or after the suspension:
    1. The coordinator will be notified by the GCRC Clinical Head Nurse or her designate of the patient's presence.
    2. The patient/volunteer will be accommodated as promptly as possible with a room.
    3. The GCRC 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 GCRC 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 GCRC RSA, the Vice Dean for Research and the GCRC Clinical Head Nurse.
  6. 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 the reschedule the visit at the patient's convenience.