ACTRI BMI - Florence Service Request Form

ACTRI Biomedical Informatics (BMI) - Florence Service Request Form
Florence eRegulatory
Please choose your Florence service:

Create StudyUpdate StudyGrant/Update Department User AccessGrant/Update External Monitor User AccessGrant/Update Study-Specific User AccessRemove User Access
Florence service:
What is your Role?*

User's ManagerPMRegulatory AdminPI
Florence Role:
User Access-related services can only be requested by Users' Manager!
- Create Study
- Please indicate the department that will manage this study:*
- Will either ACTRI or MCC manage this study?*
  
  YesNo
- Currently only ACTRI or MCC managed studies will be built. Please contact actri-florence@health.ucsd.edu if you have any questions.
- Study Name (Florence, calc)*
  Format: PI Last Name, PI First Name - IRB Number
- Study Sponsor*
- Sponsor Protocol ID*
- Is the study Sponsor Initiated?*
  
  YesNo
- Note: There will be a one-time charge of $575 if the study becomes active. Please provide the necessary chartstring information further below.
- Is this an eISF or eTMF study?*
  
  eISFeTMF
- Note: Setting up the eTMF study in Florence will incur a cost of $256, which covers 2 hours of recharge time. Please provide the appropriate recharge account information so we can proceed with the setup.
- For eISF, please select Study Type(s):
  
  FeasibilityInvestigator held FDA Application TrialNCI Trial CIRB as IRB RecordNonTherapeutic Trial OIA as IRB of RecordSingle Patient Investigator held FDA Application TrialTherapeutic Trial External IRB as IRB of RecordTherapeutic Trial OIA as IRB of Record
- Update Study
- Study Name (in Florence):*
  Format: PI Last Name, PI First Name - IRB Number
- Which study parameters need to be updated?*
- Grant/Update Department User Access
- Grant/Update External Monitor User Access
- Grant/Update Study-Specific User Access
- Note: This section MUST be filled out by the users' manager!
- Did the user(s) in question complete both the Florence User Role Training and the E-Course in UCLC for certified copies? (For PI and External Monitor roles, only Florence training satisfies both requirements)*
  
  YesNo
- Cannot proceed until training has been completed.
- Please download the User Access Excel spreadsheet here, fill in the required information for each user, and upload the completed file below.
- Please upload completed User Access Excel file:*
  
  Browse Files
  
  Cancelof
- Please upload completed UCLC training certificates for all users:*
  
  Browse Files
  Combine multiple files into one .zip or .pdf file if necessary! Cancelof
- Remove User Access
  
  Note: This section MUST be filled out by the users' manager!
- Please download the appropriate User Access Excel spreadsheet here, fill in the required information for each user, and upload the completed file below.
- Please upload completed User Access Excel file:*
  
  Browse Files
  
  Cancelof
- Study Information
- Study Title*
- Do you have an IRB# or ACQUIRE# ?*
  
  IRB #ACQUIRE#
- IRB Number*
  6-digit numerical value.
- Study Type
- ACQUIRE Number*
  3-4 digit numerical value.
- Do you have a HIPAA Waiver?*
  
  Yes, issued by UCSDYes, issued outside of UCSDNot yetNot applicable
- Please attach HIPAA waiver documentation.*
  
  Browse Files
  Combine multiple files into one .zip file if necessary! Cancelof
- PI Information
- PI First Name*
- PI Last Name*
- PI Full Name
- PI Email*
  example@example.com
- PI Department (= Kuali Lead Department)*
  For all Florence requests, must match Kuali lead department name!
- Please indicate PI's ACTRI membership level*
  
  General (existing or pending)Associate (existing or pending)Affiliate (existing or pending)No membership / Don't know
- If you are not an ACTRI member yet, please click here to review membership eligibility criteria and submit your application. Once submitted, please select the applicable membership level from the above options to proceed.
- Contact Person/Submitter Information
- Contact Person/Submitter same as PI?
  
  Yes
- Contact/Submitter Name*
  
  FirstLast
- Contact/Submitter Email*
  example@example.com
- Contact/Submitter Department*
  For all Florence requests, must match Kuali lead department name!
- Recharge Information
  
  Please provide valid fund manager and OFC chartstring information for recharge purposes.
  
  Click here to review current ACTRI recharge rates.
- Fund Manager Name
  
  First NameLast Name
- Fund Manager Email
  example@example.com
- OFC Project:
  Always required! (7 digit numerical value)
- OFC Task:
  Always required! (1-3 digit numerical value)
- Funding Source
  Required for sponsored projects only! (5-7 character alphanumerical value)
- Providing incorrect or incomplete OFC chartstring information will require further clarification and delay the process! Contact your fund manager or use the chartstring verification tool (requires VPN connection) to ensure chartstring accuracy prior to submission.
- Additional Information
- Funding Agency*
  
  NIH or other federal support with study section reviewIndustry Sponsored StudyCTRI Pilot Project AwardCTRI KL2 AwardCTRI TL1 AwardFoundation SupportInvestigator-initiated without NIH or other federal study section reviewOther
- Industry-sponsored studies are not eligible to receive voucher support. To proceed with your service request, please scroll up to the ACTRI Voucher Program section and unselect 'Yes'.
- Organizational Affiliation*
  
  University of California, San Diego (UCSD)J. Craig Venter InstituteSalk Institute for Biological SciencesLa Jolla Institute for Allergy and Immunology (LIAI)San Diego Veteran Affairs Medical CenterPalomar Pomerado HealthSanford/Burnham Institute for Medical ResearchRady's Children's Hospital San DiegoSanford SymposiumEisenhower HealthOther
- Any further information or comments you would like to submit with this request:
- Additional Request Documents:
  
  Browse Files
  Combine multiple files into one .zip or .pdf file if necessary! Cancelof
- BMI Service
- Stop submission active?
- Request Date
  
  YearMonthDay
  DateHourMinutesAM/PM Option
- Should be Empty:

ACTRI Biomedical Informatics (BMI) - Florence Service Request Form

Recharge Information