SARASOTA MEMORIAL HOSPITAL CANCER RESEARCH PROGRAM POLICY

Transcription

1 PS1006 SARASOTA MEMORIAL HOSPITAL CANCER RESEARCH PROGRAM POLICY TITLE: Satellite Site Management Plan Job Title of Reviewer: POLICY #: EFFECTIVE DATE: REVISED DATE: POLICY TYPE: Elizabeth Carr, R.N., CCRP April 28, 2010 June 19, 2017 DEPARTMENTAL INTERDEPARTMENTAL DEPARTMENTS PROVIDING NURSING CARE 1 of 8 PURPOSE: To explain the processes involved in Satellite Site Management pertaining to the Cancer Research Program. POLICY STATEMENT: Sarasota Memorial Health Care System uses First Physician Group and Florida Cancer Specialist offices as satellite sites to conduct clinical research. The Principal Investigator will be assigned from one of the research sites and will be noted on the FDA 1572 form for each study and will be responsible for operational oversight of these satellite sites, specifically with regards to the following: a general communication plan and schedule; monitoring and collection of CRF data; test drug accountability; study document management; expedited safety reporting; and staff training. Refer to delegation log for each study to see the current list of coordinators and investigators involved in specific trials. Refer to the FDA Form 1572 for a list of investigators participating in individual clinical trials. Preferably, the local Sarasota Memorial Hospital IRB will be used. A local Sarasota Memorial Hospital IRB roster will be maintained on the local IRB website and will be provided upon request. If a sponsor specifically requests that a central IRB be used then the local Sarasota Memorial Hospital IRB will still oversee the initial submission and receive annual updates regarding the status of that particular study. DEFINITIONS: Standard Operating Procedures (SOP), Investigational new drug (IND), Principle Investigator (PI), Sub-Investigator (Sub-I), Food and Drug Administration (FDA), Institution Review Board (IRB), Standard of Procedures (SOP), Adverse Events (AE), Serious Adverse Events (SAE) PROCEDURE: 1.) Communication Plan and Schedule Describes procedures for PI communication with satellite sites may include but are not limited to As needed conference calls/ s with sub-i regarding study subjects (medical issues), enrollment, inclusion criteria, protocol amendments, INDSRs, AEs/SAEs, deviations and waivers etc. Method of documenting the communication/decisions (via telephone,

2 2 of 8 contact memos, meeting minutes, s, note to file, etc.) Staff Meetings: Meetings or teleconferences are held with coordinators on an as-needed basis. Minutes are kept on file in the Site Project Manager s office. Oncology Operation Meetings: Meetings are held monthly. Agenda may items include studies closing, new studies opening, potential studies being considered, current study status, general research issues, and enrollment statistics. Oncology enrollment report is reviewed. Minutes are kept on file in the Site Project Manager s office. PI Oversight: will be provided as FDA 1572 form. Procedures include but are not limited to: On an as needed basis, coordinators print sub-investigator progress notes, labs, radiology scans, etc. from visits at Florida Cancer Specialist, First Physician Group Offices, or Sarasota Memorial Health Care System. These are forwarded to the main research office at Sarasota Memorial Health Care System and distributed to the PI for review by the Cancer Research Staff. These are then filed in the study subject s research chart or are filed in the regulatory binder. PI is notified of all SAE s immediately by phone or in person. SAE reports are summarized in an by the coordinator and forwarded to the PI and the Sub-I s within 24 hours of sponsor submission of the SAE. The PI is responsible for signing all SAE reports within 24 hours of being made aware of the event. PI reviews all sponsor interim monitor visit letters which include summaries of any protocol deviations/violations. Coordinators report significant protocol violations to the Site Project Manager, Sub-investigator and/or PI. Corrective actions are discussed and implemented as directed by the PI, Research Project Manager, Director of Cancer Research Program. and Sarasota Memorial Health Care System. Protocol deviations are reported to the Sarasota Memorial Hospital IRB by the Cancer Research staff at Sarasota Memorial Health Care System Monitoring visits preferably take place at Sarasota Memorial Health Care System. All regulatory binders, subject shadow charts, and research documentation is made available to the monitors per request for their assigned study. Monitors must make visit arrangements with a preferred 3 week advance notice. Monitors can coordinate their visit arrangements with the study staff at the main research office at Sarasota Memorial Health Care System by calling Monitors may visit satellite sites when accompanied by Sarasota Memorial Health Care System research staff for the purposes of pre-study visits, site initiation, close out, drug inventory etc. Monitors should call or prior to their visit

3 3 of 8 to confirm they still plan to come monitor at their scheduled time. Monitors are expected to send a follow up letter within 1 week after the visit. Communication of Protocol News: Study-specific information is disseminated to study coordinators, Sub-I s, applicable First Physician staff, and applicable Florida Cancer Specialist staff members from the main research office at Sarasota Memorial Health Care System. Time sensitive information is disseminated immediately by correspondence or by phone. IND Safety reports are reviewed by the PI and if he feels the Sub-I s should be made aware of a specific that is communicated via or telephone call. Original communication is filed in the regulatory binder for the specified study and kept in the Research Office at Sarasota Memorial Health Care System. 2.) Monitoring and Collection of Satellite Site Data Describes how data monitoring is conducted. Procedures may include but are not be limited to: Central vs. satellite site monitoring activities Main site review of the satellite site data vs. first review by Sponsor CRF maintenance and collection at the main and satellite sites Management of discrepancies, data correction and queries PI sign-off for satellite site CRF data Monitoring and collection of data is conducted at the satellite site with the coordinator or by designated data specialist. Electronic medical records are accessed at any Florida Cancer Specialist office and any original paper source documents are available for review at the satellite site or transported to a centralized location as needed. Regulatory documents are stored in the Cancer Research Program s office at Sarasota Memorial Health Care System, and are available there for review. The site coordinator or data specialist from Sarasota Memorial Health Care System will coordinate and manage the data correction and query process. Data corrections and queries will be resolved by the appropriate study staff (PI or designee) following the guidelines and timelines as outlined by the study sponsor. The sponsor must send queries to the Cancer Research Program s office at Sarasota Memorial Health Care System by mail or . The queries are then distributed to the appropriate research staff member to be resolved. When the PI is required to sign paper CRF data, either the binder is sent to the PI or the PI travels to the Cancer Research Program s office at Sarasota Memorial Health Care System, whichever is most appropriate.

4 4 of 8 CRF binders and printed medical records are kept at the main research office at Sarasota Memorial Health Care System. At the final close of the study or as needed due to limited storage, CRFs and other study related information are forwarded to the main research office and are inventoried and packed and sent to an off-site storage facility. The off-site storage facility is LeeSar Record Retention and Management Facility, located at 401 Leonard Blvd., North; Lehigh Acres, FL ) Test Drug Accountability PI ensures test drug chain of custody. Procedures outlined in site SOP include: Centralized drug shipment to Florida Cancer Specialist at 1970 Golf Street, Sarasota, FL and couriered to satellite offices by designated, trained Sarasota Memorial Health Care System research staff. Maintenance of adequate records showing the shipment, receipt, transfer to satellite, and final disposition of all test drug Assurance of adequate transfer and storage conditions at satellite sites (temp control and monitoring, secure and limited access, etc.) Monitoring and drug accountability activities at satellites (who does it, where and how often) Drug destruction and/or drug return activities at main and satellite sites Expiration management Refer to written SOP on file in the Sarasota Memorial Health Care System, Cancer Research Program s main office. 4.) Study Document Management Describes Investigator and satellite site documents. Procedures may include but are not limited to: Quality Control practices (e.g., who checks the satellite site binders for INDSRs, etc.) All regulatory documents, original study documents, enrollment/screening/monitoring logs and any study correspondence is located in the Cancer Research Program s office at Sarasota Memorial Health Care System... A file of CVs, laboratory certifications, and normal ranges is kept at the main research office at Sarasota Memorial Health Care System and is available to study monitors for review. Investigators at all satellite sites have access to the following documents, such as protocol, current IRB approved ICF, IB, Protocol summary, and study tools. Requests are made by the investigator to the main research office at Sarasota Memorial Health Care System via or phone and then requested documents will be delivered to the Investigator via in

5 5 of 8 person, , or fax. Safety reports are kept on file in the Cancer Research Program s office at Sarasota Memorial Health Care System. Investigators are made aware of safety reports via . Investigators are specifically made aware of any safety reports that cause consent modification via an . The PI is responsible for signing off in acknowledgement of any safety reports. The local Sarasota Memorial Hospital IRB is notified regarding any safety reports on a monthly basis. Documentation of this can be found in the regulatory binder. Regulatory documents are not routinely kept at the satellite sites. If the study monitor requires partial or all regulatory documents to be filed at each satellite site, it will be the responsibility of the study monitor to maintain the documents (completeness and quality). 5.) Expedited Safety Reporting Describes the process for SAE reporting to the main site and to the Sponsor. Procedures include but are not limited to: Study sponsors are notified of SAEs by Sarasota Memorial Health Care System Research coordinator within 24 hours of knowledge of the event. The study specific SAE report is faxed to the sponsor and to the designated IRB by the coordinator within hours of the coordinator knowledge of the event. PI is notified of all SAE s immediately by phone or in person. SAE reports are summarized in an by the coordinator and forwarded to the subinvestigator and PI within hours of the knowledge of the event. The PI replies as oversight of the event. A copy of this correspondence is filed in the regulatory binder. The PI also is responsible for stating whether the event is related to study procedures or study drug/device and this documentation is kept on file in the regulatory binder. Safety reports are submitted to the IRB by the main research office at Sarasota Memorial Health Care System on a monthly basis. 6.) Staff Training Describes the process for staff training on institutional SOPs as well as protocol specific training; and describes the documentation of this training. An initiation meeting, as provided by the sponsor, is held before enrollment is opened. All coordinators are expected to attend. The meeting may be conducted via teleconference. An attendance roster is filed in the regulatory binder along with a copy of any handouts provided by the sponsor. Staff unable to attend is trained at a later time by sponsor representatives or by research staff that attended the initiation meeting. The PI is initiated in one or more of the following ways: attends the

6 6 of 8 investigators meeting held by the sponsor, attends the initiation meeting, meets separately with the sponsor s representative. Sub-investigators are provided study specific training via , telephone from PI and/or study manager, coordinators and/or the site designated research staff or in person. Staff training may be provided during staff meetings/teleconferences. Minutes are kept on file in the SMH Cancer Research Program s office. New research staff is oriented to new positions based on prior experiences and include extensive one on one training with experienced staff members. All staff involved in a research study will need to sign the delegation of authority. By signing this delegation log they are signing that they have been trained regarding the protocol procedures and understand their role as determined by the PI. The PI is responsible for overseeing all study staff listed on the delegation log. A delegation log can be found for each study and can be found in the Cancer Research Program s office at Sarasota Memorial Health Care System... If a deficiency in research staff job performance is identified, it is the responsibility of the site project manager to address deficiencies as well as any need for additional training. If necessary, disciplinary action as outlined in Sarasota Memorial Health Care System employment policies will be utilized. All research staff and Investigators complete a GCP/Human Protections training course as arranged by the research manger or designee. Documentation of attendance/completion are kept on file in the research Manager s office at Sarasota Memorial Health Care System. 7.) Subject Recruitment Describes the process for identifying potential patients for enrollment on clinical trials. Procedures include but are not limited to: All Investigators and study staff are provided tools which provide general eligibility information for all accruing trials. These tools are ed to all investigators at the start of any study and at any time per request. Research Coordinators may screen all new patients for basic eligibility and discuss potential cases with investigators prior to the patient s scheduled appointment. PI or research coordinators may send periodic correspondence or phone calls to staff and sub investigators to increase awareness. The Sarasota Memorial Health Care System website includes general information on clinical trial participation. Investigators attend local Tumor Boards on a weekly basis and may discuss various trials during those meeting.

7 7 of 8 RESPONSIBILITY: It will be the responsibility of the Sarasota Memorial Health Care System directors to ensure that the Cancer Research Program Staff is aware of, and adhere to, this policy. REFERENCE(S): 1. Selected Regulations and Guidance for Drug Studies (2004). Philadelphia, PA: Clinical Research Resources. 2. FCS Policy: Satellite Site Management Plan V7, (Nov, 2009). FCS: Author. REVIEWING AUTHOR(S): SMH: Elizabeth Carr, RN, CCRP, Cancer Research Team Communicator; SMH: Tamela Fonseca, MSN,,RN, CCRC, Clinical Manager; SMH: Yulonda Greene, MBA, BSN, RN, OCN,, Director ; James Fiorica, MD; Medical Director, ACMO; FCS: Katie Goodman, Research Director

8 8 of 8 APPROVALS: Signatures indicate approval of the new or reviewed/revised policy Date Committee/Sections (if applicable): Cancer Research Program Title: Elizabeth Carr, RN, CCRP, Cancer Research Team Communicator, Sarasota Memorial Health Care System Department and Site Project Manager Title: Tamela Fonseca, MSN, RN, CCRC, Clinical Manager, Sarasota Memorial Health Care System Vice President/Administrative Director (if applicable): Title: Yulonda M. Greene, MBA, BSN, RN, OCN, Director, PT. Care Services Institute for Cancer Care, Sarasota Memorial Health Care System Physician Title: James Fiorica, MD, Medical Director Women s Cancer Care Services; Associate Chief Medical Officer Sarasota Memorial Health Care System Florida Cancer Specialist Title: Katie Goodman, Research Director