Cearing the Fog NCI Site Codes Andrea Denicoff, MS, RN, ANP Head, NCTN Cinica Trias Operations Cancer Therapy Evauation Program, NCI Aiance Spring Group Meeting, May 13, 2016 1
Presentation Objectives Provide a brief overview of NCTN/NCORP grants and how they reate to NCI site codes Review sections in the NCTN/NCORP guideines that describes, What is an Enroing Site? Discuss exampes and different scenarios to better understand NCI site codes Discussion and Questions 2
NCTN/NCORP Grants & NCI Site Codes (1) Within NCI s NCTN and NCORP cooperative research grants, they incude research programs that may have mutipe participating institutions and practice sites and coud be referred to as a package. They are inked together across NCI, NCTN Group, and NCORP Research Base systems according to their funding mechanism (NCTN Main Members/NCORP/LAPS grants). Reationships between sites under the grant are captured by the assigned institution site code and member roe. 3
NCTN/NCORP Grants & NCI Site Codes (2) A singe institution/practice site cannot be in more than one grant (or visuaized on next side s diagram as a swim ane ). Peope (physicians and research staff) must be rostered at a site within a research program or package to be abe to consent, enro, and treat patients and to coect, review, and submit patient data. 4
NCTN Organization Chart Main Member Main Member Main Member Main Member Swim Lane exampe 5
Definition of Engaged in Research Required to provide documentation of where research activities are being conducted Engaged in research (consenting, enroing, and treating) [45 CFR part 46] In genera, an institution is considered engaged in a particuar non-exempt human subjects research project when its empoyees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiabe private information about the subjects of the research; or (3) the informed consent of human subjects for the research. 6
NCTN/NCORP Guideines Sites engaged in research: Must have a CTEP Site Code; Must be covered under an FWA (must be abe to confirm coverage on the OHRP website); Must be caimed on an NCTN/NCORP roster; and Associated accrua must be credited to the CTEP Site Code, not to a parent institution at a geographicay distinct ocation. 7
Institutions Requiring a Site Code Institutions meeting the federa reguations/guideines of engaged in research. Institutions hoding a federa grant. Unique geographic ocation that requires drug shipment even if that site is egay part of another entity and conducts research under the parent entity s FWA 8
CTEP Site Codes: Genera Principes Exampe: Two sites (e.g., university hospita and cancer center OR community hospita and outpatient cinic) Same campus, same ega entity, same FWA >>> one CTEP Site Code. Same campus, different ega entities, different FWAs >>> two CTEP Site Codes. Different ocations (i.e., not on the same campus ), same ega entity, same FWA >>> two CTEP Site Codes. Different ocations (i.e., not on the same campus ), different ega entities, different FWAs >>> two CTEP Site Codes. 9
Discaimer The exampes in this side set are meant to provide guidance. Questions pertaining to individua scenarios shoud be directed to CTEP or DCP as appropriate. Pease don t shoot the messenger. 10
Who needs a site code? (1) Big Heath System University Hospita Meets federa and NCI requirements for hoding a site code. Community Hospita 1 across town or across the river in a different state Though egay part of the heath system and functioning under its FWA, the separate geographic ocation requires a site code. Radiation Faciity on University Hospita Campus Location is part of the main campus and part of the heath system. 11
Who needs a site code? (2) Affiiate Hospita 1 The Cancer Center at the hospita functions in partnership with the University Hospita, but has its own FWA and is egay separate. Affiiate Cancer Cinic 1 Located on the hospita campus and the cinic is owned and operated by the hospita. Affiiate Cancer Cinic 2 Cinic is owned and operated by the hospita; but, is ocated on the other side of town. Dr. Sam s Office Located in rented space on hospita property Functions as own ega entity and hods its own FWA. 12
Enroing Site Definition Enroing site Refers to the site where the patient/participant is consented, receives treatment, and wi have study-reated exams/visits (medica home). It is not the ocation where the web or phone registration to a study is competed, e.g., via a computer or phone at the research office. 13
Enroing Site Criteria Patient s primary care site (their medica home ). Where the patient s primary physician is based. Site primariy responsibe for the cinica care and monitoring of the patient. Must be covered by an IRB. Must be covered by an FWA. 14
Drug Shipment and Site Codes The NCI-registered investigator must indicate: The shipping address for their PMB-distributed agents (at this time one drug shipment address aowed per investigator). The shipping designee who wi be responsibe for receiving, propery recording, and storing the agent. The ordering designee(s) who may order agent from PMB on behaf of the investigator. Note: The investigator (not the site ) is utimatey responsibe for a investigationa agent ordered in their name. 15
Enroing Site Exampes Exampe 1: Hospita A is an NCORP component. They consented and wi treat the subject; however, the NCORP is responsibe for the enroment and enters data on their behaf. Hospita A shoud be the enroing site in OPEN. Exampe 2: Hospita B enros a patient and is responsibe for the patient s care and monitoring but sends the patient to an outside faciity for their routine RT. Hospita B is the enroing site in OPEN but shoud ensure the RT faciity can submit data to TRIAD on behaf of Hospita B. 16
Take Home Message The enroing site code (aso caed registering site code) used shoud be the cinica site that is primariy responsibe for the cinica care and monitoring of the patient for the majority of tria events (e.g. assessment of investigationa agent/treatment toxicity, dose modification determinations, assessment of disease and response status to therapy, etc.). 17
Types of Scenarios Change in Primary Site Changing Swim Lanes Site Cosures Muti-Modaity Studies 18
Scenario 1 Change in Primary Site What if a patient has protoco exams/tests and is consented at one site but woud ike to be treated at a site coser to home? Patient transfer woud need to occur if the patient is transitioning to a new medica home; however, no transfer is necessary if a patient is visiting a component site under their medica home for part of their care or receiving routine care at an outside faciity. Reference OHRP Guidance, Engagement of Institutions in Human Subjects Research (2008). 19
Scenario 2 Changing Swim Lanes What happens if my site switches its grant funding? The change wi need to be communicated to CTEP for LAPS changes, to DCP for NCORP changes, the NCTN Groups for main member changes; however, the site code wi remain the same for the site. NCORP/LAPS need to aso communicate changes with their Grants Speciaist Site must ensure ongoing IRB coverage for previousy enroed patients under the new network s IRB or through their existing IRB. Site remains responsibe for foow up of previousy enroed patients. If that is not possibe, the patient shoud be transferred or, as a ast resort, removed from study. 20
Scenario 3 Site Cosures What shoud I do when a patient is enroed to a site that has cosed after their enroment? If the patient has competed treatment and foow-up prior to site cosure, no further action is needed. If treatment or foow-up are ongoing, the patient shoud be transferred to another institution or, as a ast resort, removed from study. Remember to notify your LAPS/NCORP grant hoder (if appicabe) and your NCTN affiiated group of any site cosures. Contact the LPO for any studies with enroments at the site to verify data coection is compete. Notify ECU Hep Desk and PMB. Copy CTSU on your correspondence. 21
Scenario 4 Muti-Modaity Studies Patient is enroed to a combined modaity tria (e.g., chemotherapy foowed by RT). If the patient receives chemotherapy at one site code and radiation at another site code, to which site code shoud the patient be enroed? Specia Note: RT faciity is required to be credentiaed for the radiation portion of tria. The site code used shoud be the code of the site that is responsibe for overa care and foow-up of the patient. The patient does not need to be transferred in between sites. 22
Questions? Contact information for questions: CTSU: ctsucontact@westat.com or 1-888-823-5923 ECU Hep Desk: ecuhepdesk@mai.nih.gov For questions about site codes PMB: pmbafterhours@mai.nih.gov LAPS emai box: NCTNProgram@mai.nih.gov NCORP questions: Cynthia Whitman (whitmanc@mai.nih.gov) Marge Good (goodmj@mai.nih.gov) Or your DCP Program Director 23