INTEROFFICE MEMORANDUM - Dana–Farber/Harvard Cancer Center



DF/HCC New Researcher ChecklistInstructions: New DF/HCC Investigators and research personnel may use this as guidance to ensure they have completed the necessary training and compliance requirements prior to conducting research at DF/HCC. Requirements may vary depending on role and type of research, and additional institution-specific requirements may apply.DF/HCC training requirements are outlined in Policy EDU-100 Training Requirements for Research Personnel. Additional information may be found on the DF/HCC website. ActionDetails/ResourcesContactDoneDF/HCC Policy Training and DocumentationTraining should cover the minimum DF/HCC Policies applicable to your role and scope of research. Documentation of training is maintained by individuals, unless otherwise indicated by your supervisor. Resource: DFHCC Training and Signature RecordBIDMC: All new Investigators and staff working on DF/HCC trials must first register with the CCTO Quality Management group.Your manager/supervisor will help you determine which Policies you need to review.For additional questions, contact:ODQeducation@dfci.harvard.edu BIDMC contact: Quality Management, CCTO HYPERLINK "mailto:BIDMCCCTOQualityManagement@bidmc.harvard.edu" BIDMCCCTOQualityManagement@bidmc.harvard.edu FORMCHECKBOX Complete HSP and GCP Training (through the CITI website)Per EDU-100, Human Subject Protection (HSP) and Good Clinical Practice (GCP) training are required of all research personnel working on DF/HCC research. Resource: Step by Step Instructions to Complete HSP/GCP Training Please Note: If you completed these trainings prior to obtaining an OnCore profile, you must notify ODQ once the profile is created.ODQeducation@dfci.harvard.eduBIDMC contact: Quality Management, CCTO HYPERLINK "mailto:BIDMCCCTOQualityManagement@bidmc.harvard.edu" BIDMCCCTOQualityManagement@bidmc.harvard.edu FORMCHECKBOX Obtain OnCore Staff Profile (Note: This should be requested prior or parallel to new staff completing HSP/GCP training to ensure timely update of their training records. Staff must have an OnCore profile and up to date HSP and GCP prior to being added to a protocol.)DFCI and affiliates, MGH, NWH, MEEI, BIDMC, BCH, Broad Institute: Contact your institution’s designated contact and provide the information below. They will submit an IS Service Hub ticket.BWH: Contact your PI, Research Manager or Enhanced Coordinator. Please request that they submit an IS Service Hub ticket with the information below.Application In Use: Oncore - DFCIRequest for new OnCore staff profilePrimary Institution:First Name: Middle Name/Initial:Last Name: User Work Email:Title:Earned Degrees(Credentials):Disease Program(Department):Office Location:User Work Phone:MGB User ID: (for DFCI and MGB users only):?Has the staff member ever worked for another MGB or DF/HCC site before? If so, has the staff member ever used a different name while employed at another MGB or DF/HCC site?DFCI, MGH, BIDMC, BCH, Broad Institute contacts for OnCore profiles:DFCI and affiliates: Meaghan Manganelli, CTO MeaghanE_Manganelli@dfci.harvard.eduMGH, NWH, MEEI: Shannon Himber, CCPOshimber@mgh.harvard.eduBIDMC: Quality Management, CCTO HYPERLINK "mailto:BIDMCCCTOQualityManagement@bidmc.harvard.edu" BIDMCCCTOQualityManagement@bidmc.harvard.eduBCH: Ana Souza, Program Manager, Pediatric OncologyAna_Souza@dfci.harvard.eduBroad Institute: Susie Weisenburger, Office of Research and Sponsored Programs sweisenb@ BWH: PI, Research Manager or Enhanced Coordinator will submit an IS Service Hub ticket with the staff profile information. Indicate “Fix an Issue”. FORMCHECKBOX Obtain OnCore AccessIf, in addition to an OnCore profile, OnCore access is required, follow your site’s process.OnCore Access is necessary only for logging into OnCore to view data, register subjects, update study staff. To be added to a protocol, an OnCore profile is sufficient and access is not required.DFCI, MGH, BCH: Contact your institution’s designated contact for additional information and training requirements. BWH - Please review the OnCore information on the BWH Research Billing and Compliance Website. Click and scroll to: OnCore Information - Dana-Farber/Harvard Cancer CenterBIDMC: Access will be granted as part of the New Investigator or Study Team member process.Training is required: Discuss with QM to determine what training you should complete based on your role.Please allow at least 5 business days for access to be granted once training has been completed.DFCI, MGH, BIDMC, BCH contacts for OnCore access and training:DFCI and affiliates: Meaghan Manganelli, CTO MeaghanE_Manganelli@dfci.harvard.eduMGH, NWH, MEEI: Shannon Himber, CCPOshimber@mgh.harvard.eduBIDMC: Quality Management, CCTO HYPERLINK "mailto:BIDMCCCTOQualityManagement@bidmc.harvard.edu" BIDMCCCTOQualityManagement@bidmc.harvard.eduBCH: Ana Souza, Program Manager, Pediatric OncologyAna_Souza@dfci.harvard.eduBWH: The PI completes and submits DF-HCC OnCore Access Request Form for BWH Users FORMCHECKBOX Obtain access to OncPro Please refer to the OHRS System Access Request web page for site specific directions on requesting access to OncPro.Resource: OHRS System Access RequestBIDMC: Access will be granted as part of the New Investigator or Study Team member process.Please allow at least 2 business days for access to be granted.For system access questions, contact: ohrs_systems@dfci.harvard.edu BIDMC: Quality Management, CCTO HYPERLINK "mailto:BIDMCCCTOQualityManagement@bidmc.harvard.edu" BIDMCCCTOQualityManagement@bidmc.harvard.edu FORMCHECKBOX Obtain access to iRIS iRIS access (continued)Staff with MGB IDs (DFCI, MGH, BWH, BCH and Broad staff with dual appointments) can request iRIS access for themselves.Consult your manager and refer to the Training Matrix to determine what training and access are required. Complete the training.Open an IS Service Hub ticket with the information below. Indicate “Fix an Issue”.Application In Use: IRIS - DFHCCRequest for iRIS AccessMGB User ID:Last Name:First Name:Work email address: Phone number:Department:Study Team(s) – See list:?iRIS study teamsResearch role:If you will be doing reviews in iRIS, what committee are you joining? See list: iRIS CommitteesBIDMC: Access will be granted as part of the New Investigator or Study Team member process.Training is required: Discuss with QM to determine what training you should complete and the specific access you should request. (See the Training Matrix) Please allow at least 2 business days for access to be granted once ALL of the required information has been provided.For questions, please contact the iRIS super user for your institution / department:iRIS Contact List Please see the iRIS Training Materials for additional information.Broad Institute: If you do not have an MGB ID, contact sweisenb@BCH: If you do not have an MGB ID, contact Ana Souza, Program Manager, Pediatric OncologyAna_Souza@dfci.harvard.eduBIDMC: Quality Management, CCTO HYPERLINK "mailto:BIDMCCCTOQualityManagement@bidmc.harvard.edu" BIDMCCCTOQualityManagement@bidmc.harvard.edu FORMCHECKBOX Obtain access to InForm - Electronic Data Capture (EDC) system Note: InForm is used only for Dana - Farber / Harvard Cancer Center (DF/HCC) sponsored oncology studies.Staff who will be entering research data into InForm must complete DF/HCC’s MGBE InForm EDC DFHCC v6.2 for Site Users eLearning (2.5 hours). Training is not required for “View Only” access. DFCI, MGH, BWH and affiliates – Staff self-enroll to complete training via HealthStream.Research Manager or Lead CRC will ensure that the staff member has successfully completed HealthStream training and then email dfciinform@dfci.harvard.eduwith the information below. Request for InForm – DFCI AccessMGB User ID (if applicable):Institution:Last Name:First Name:Work email address: Phone number:Protocols to which access is required: Will the user enter data? Y / NBIDMC, BCH and staff from non-DF/HCC institutions – Research Manager or Lead CRC will email the above information to dfciinform@dfci.harvard.edu. The RIO-EDC support team will assign training that is accessible from outside the MGB firewall and grant access upon successful completion.Your manager/supervisor will help you determine your training and access requirements. Please contact InForm support at dfciinform@dfci.harvard.edu with any questions.Also refer to: FORMCHECKBOX NCI Investigator Registration*All individuals participating in NCI sponsored or funded research as an Investigator (IVR) or Non-Physician Investigator (NPIVR) are required to register and renew their registration annually. Resource: DF/HCC NCI Investigator RegistrationLenette Ranger: lenette_ranger@dfci.harvard.edu (Physician Investigators (IVR) only)Shannon Himber: SHIMBER@mgh.harvard.edu (MGH Investigators only) FORMCHECKBOX Complete New DF/HCC Principal Investigator Training*Principal Investigators must complete this training prior to serving as a PI at any DF/HCC site (including satellite sites). Training may be completed online: ODQ Education Page (under the New Investigator Training tab)ODQeducation@dfci.harvard.edu FORMCHECKBOX *Investigators only ................
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