After Your Study Has Been Approved

Adult Protocols at Froedtert Hospital

The next step in getting your study started after you have received approval to conduct your trial on the GCRC is to review GCRC policies and let us know if you have any questions. Beyond that you'll want to:

Step 1 - Meet with the Nursing Supervisor

Linda Templin, R.N.  

805-7301

ltemplin@fmlh.edu

Discuss:

   1. The specifics of the services you will need

   2. Any specialized supplies or nursing procedures you will need

   3. How to draft your study orders

   4. Any other issues related to your protocol

Step 2 - Provide final copies of the following documents to the administrator:

1. Documentation of IRB approval, including a copy of the current approved IRB application and the final, stamped consent form
2. Draft of study orders
3. For industry (D) studies, you must provide a finalized contract prior to seeing subjects in the GCRC 

Once the above steps are completed, we can:

Step 3 - Schedule a Study/Protocol Implementation Meeting

Attendees will include the PI and/or study coordinator and other designated study staff, the GCRC Nurse Manager and/or the GCRC nurse who will be designated as the primary nurse for the study, and at least one additional GCRC nurse. A typical meeting lasts between 60 and 90 minutes.

Goals of the Implementation Meeting:    

1. Introduce the PI's study staff to their primary GCRC nurse
2. Present an overview of the study by the PI or his/her designate
3. Review forms, e.g. CRFs, eligibility checklist, orders for the study, and finalized study orders
4. Review roles and responsibilities of each team member
   1. Introduce the PI's study staff to their primary GCRC nurse
   2. Present an overview of the study by the PI or his/her designate

5. Assess any new skills needed by the GCRC nursing staff, if any, and whether training is adequate

6. Review procedures for obtaining and processing specimens

7. Evaluate equipment and supplies necessary to perform the study

8. Review the scheduling process

9. Review ongoing documentation requirements of the GCRC which include:

   1. Copies of the consent & HIPAA forms signed by the participant and PI (or  designee) prior to seeing a patient for the initial visit

   2. A copy of the signed eligibility checklist

   3. Copy of the DSMP

   4. Copies of all IRB approved documents as soon as possible after approval, including:

      1. The original application and all correspondence related to the initial approval, including the approved consent form(s).

      2. All subsequent modifications along with revised consent form(s), DSMP, and/or protocol.

      3. All subsequent renewals

      4. All Adverse Event (AE) and Serious Adverse Event (SAE) reports

10. Review approved ancillaries         
11. Review any research billing
12. Discuss any outstanding issues

A copy of the minutes from the implementation meeting will be provided to you for your regulatory file.

For more specific information, please look over the following information:

GCRC Adult Unit Facilities and Patient Care

The Adult Unit of the General Clinical Research Center (GCRC) is located in the lower level of the Pavilion Building of Froedtert Hospital (FH). Froedtert Hospital was successfully accredited, most recently in Spring, 2004 by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). The hospital was recognized in January of 2005 by JD Powers and Associates as "An Outstanding Patient Experience", the only hospital in Wisconsin to hold that distinction. The hospital attained Magnet status in 2006. Further, the GCRC has consistently received excellent customer service scores from our research patients, as measured by the FH patient satisfaction survey, Press Ganey.

The Adult Unit occupies a total of 3758 sq. ft. The secured facility includes 6 beds in 3 day study suites, and an additional 6 examination rooms for outpatient visits. When overnight monitoring and/or sample collections are required, inpatients are housed on an inpatient unit located on the 4th floor of the Pavilion Building, directly above the GCRC facility. The facility also includes a nursing planning station, reception area, metabolic kitchen, consultation room, soiled hold and cleaning rooms, a supply room, and a small laboratory for sample processing. GCRC Administration, located down the hall from the Adult Unit, has office space for the Program Director, Administrative Director, and Senior Administrative Assistant, as well as the Nursing Director, Nursing Supervisor, and Research Dietitian. The Research Pavilion also houses GCRC Informatics Core and the Biostatistician's office, along with the GCRC Imaging Core, which includes a patient prep area. The Adult Unit is also in close proximity to the Emergency Trauma Center. Nearby parking is available for all research subjects.

Procedures for the Initiation and Conduct of Protocols

After the Nursing Supervisor is informed by the GCRC Administrative Director that a protocol has been approved by the GCRC Research Review Committee and the Institutional Review Board (IRB), she and the nurse assigned to the protocol (Primary Protocol RN) schedule a protocol initiation meeting with the investigator, along with the research team, and the Research Subject Advocate (RSA), to ensure that the study is conducted safely, ethically, and according to protocol. Representatives from GCRC Cores are invited to attend these initiation meetings, when appropriate. Following the initiation meetings, investigators are required to provide in-service training to the GCRC nurses prior to enrolling the first subject. Research A studies are given highest priority with regard to patient scheduling, followed by research B and D studies. If space is available in the Adult Unit, category C patients may be seen. 

All studies are performed utilizing the protocol-specific standing MD order/study procedure flow sheet to ensure congruity of the procedures approved by the GCRC Research Review Committee and the IRB with those implemented on the GCRC. These forms are developed based upon the approved protocol and in collaboration with the investigators at the protocol initiation meetings. Based upon criteria which take into account their level of medical risk, some studies require a history and physical (H&P) by the investigator or authorized designee. The nurses complete a GCRC Assessment form for each research subject. Medications, allergies, medical/surgical history, teaching needs, and learning preference are assessed. For each follow up visit, the patients are asked if there are any changes in medications, allergies, and medical surgical history, and changes are documented in the patient record.  

The staff work closely with the hospital's Quality Management Department to ensure that all documentation is compliant with JCAHO requirements. Outpatient subject charts contain the completed GCRC Admission Assessment form, a copy of the signed informed consent, and the standing orders, in addition to H&P as required, fMRI safety screening forms, MD progress notes, and other forms specific to the protocol. The GCRC, with GAC approval, has developed criteria for requiring a physical exam before initiating a protocol. HIPAA requires that all original research records be maintained at the highest level of confidentiality. These records are kept on the GCRC in a locked file cabinet. Studies involving medical treatment are maintained in the FH Medical Record department after each subject visit. Copies of these treatment-related records are maintained in the GCRC locked file cabinet. Some Investigators also choose to keep copies of patient records, with assurances of patient privacy. All subjects are provided a copy of the institution's Joint Notice of Privacy Practices in compliance with HIPAA. 

Informed consent is obtained from all subjects by either the principal investigator or his/her designee(s). The staff who may obtain consent are listed in the DSMP, Section 10, and in the registration form required for protocol IRB submission. The original goes to the principal investigator, one copy to the participant, and another copy is maintained in the subject's research record. If the study is treatment-related in that patients are being seen in the MCW clinics, an additional copy is entered into the patient's medical record. If requested by either the IRB or the principal investigator, the consent forms is signed in the presence of either the GCRC nurses or other designated health care personnel.

Inpatient Studies

GCRC inpatients are housed on an inpatient unit in the Pavilion Building on the 4th floor (4P), directly above the GCRC. Occasionally, if beds are not available on this unit, GCRC inpatients may be assigned to another inpatient unit in Froedtert Hospital. After the research procedures are completed in the outpatient adult unit of the GCRC, the subjects are transported to the inpatient unit for an overnight stay, and return to the GCRC for additional procedures as required. While the nursing staff of the inpatient unit provides routine patient care, the GCRC nurses are responsible for setting up all research procedures performed overnight. Overnight nurses on the inpatient unit receive in-services for the research aspects of the care of these patients, and are given verbal and written reports from the GCRC Nurse for each patient admitted. Each subject admitted to the inpatient scatter beds at Froedtert Hospital is seen by the investigator or co-investigator. The principal investigator, or a co-invesigator, is responsible for the physical examination performed at admission, admission orders, and daily progress notes. This responsibility may be assigned to a fellow or resident working with the investigator. However, the investigator or a co-investigator has supervisory function, reviewing and signing all medical chart notes. The investigator's team is responsible for night and weekend coverage of their GCRC scatter bed inpatients. The medical team on call will respond to any medical emergencies until the investigator arrives at the hospital. Inpatient subject charts contain the required JCAHO chart documents which includes: a copy of the consent form, MD orders, H&P, progress notes, nursing notes, discharge orders, discharge patient education, and other documents as necessary for the specific protocol.