Florence eBinders: Subject Folder UW User Guide

Study-specific binders in Florence eBinders™ contain subject folders. This document sets subject folder/document best practices and workflows, and supplements existing eBinder SOPs and related resources. The overall template folder structures can be found in the _Central Documents binder > Admin folder > eBinders Essential Documents Locations folder. Throughout this document, folders within the template structure are bold and italicized, while placeholders are denoted in parentheses.

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Who is impacted by Subject Folders in Florence?

UW Carbone Cancer Center staff, UW Clinical Trials Institute, FDA Regulated Research Oversight Program, Surgery, and other UW departments that will be utilizing Florence for clinical research. Note: When referring to the electronic medical record (EMR), it is assumed that access can be granted to auditors, monitors, etc. If that is not the case, then EMR documents must be uploaded to eBinders for auditor, monitor, etc. access. 

Best Practices and Workflows:

General Naming Convention Notes:

  1. The information contained within [brackets] in this document is to be modified to correctly represent the applicable information, the brackets should NOT be kept.
  2. Upon downloading documents from eBinders, it is best practice to update the file name with the study number and subject ID
  3. Dates: YYYY.MM.DD
    1. Example: 2022.08.18
    2. The above ensures folders and/or files beginning with dates are organized chronologically.
  4. Visits
    1. Visits may be in the format of:
      1. Cycles (e.g., Cycle 2, C3)
      2. Cycles/days (e.g., C2D1)
      3. Weeks (e.g., Week 38)
      4. Visit count (e.g., Visit 1, Visit 2)
      5. Term (e.g., Baseline, Follow Up or FU, End of Treatment)
    2. When the term visit is used in the naming conventions throughout this document, apply the appropriate format from above

General Reminders and Best Practices:

  1. Mark subject documents as containing PHI - marking documents as containing PHI blocks users without PHI viewing and/or downloading permissions (e.g., external monitors, UW collaborators) from viewing and/or downloading these documents. UW collaborators have general view-only non-PHI access to all study-specific eBinders to ensure access to needed non-subject documents such as IRB approvals, imaging manuals, lab manuals, etc.
    1. Mark subject documents as containing PHI - Florence help desk article (sign-in required)
    2. If you prefer to watch a video, here is a 2-minute training video on marking documents as containing PHI
  2. Do NOT file W9s or W8-BENs in eBinders, as they are not essential study records (per ICH GCP) and they contain social security numbers
    1. Refer to Payments: Storing W9s for information about how to properly store these documents
  3. Upload documents in real time whenever possible
    1. How to print to Florence
  4. Placeholders are designed to be filled by ONE document
  5. Folders are designed to hold multiple documents and/or additional folders
  6. If modifications to the study folder structure are made, they should be consistent throughout the study and cannot be specific to one staff member’s preference.
    1. For example, consistently delete unused folders/placeholders or modify them to state not used
    2. For example, consistently add new placeholders within a study if applicable
  7. If relevant EMR documents are not located in an expected or intuitive place within the EMR, upload them to eBinders
    1. Example: Information in Care Everywhere, Media tab, or Outside Docs tab 
  8. Florence eBinders: How to Sign a Document UW User Guide provides eSignature instructions

Certified Copies:

  • For a video on how to certify a copy using eBinders, refer to this training video
  • For general information, refer to Electronic Certified Copies
  • More information from the UW-Madison School of Medicine and Public Health (SMPH) is pending
  • For Oncology studies, refer to the Certified Copy SOP on the CRCO KB (restricted access site)

Creating Subject-Specific Folders:

  1. Pathway: [Study-specific binder] > Subjects folder > Subject Folders
  2. Copy the subject template folder, rename the copy using the convention below, and save it in the Subject Folders folder noted above.
    1.  [Last Name], [First Initial] (Subject ID/Sequence#)
      1. A risk assessment of the inclusion of PHI/identifiers in the above was performed and was found to be acceptable. Do NOT include subject first names.

Consented, Not Enrolled:

  1. If a potential subject has consented to a study and does not enroll on the study due to ineligibility, withdrawal of consent, etc., take the following steps:
    1. Update the subject-specific folder by adding "_Consented, not enrolled" after the standard folder naming format.
    2. Ensure existing documentation is filed per the Within Subject-Specific folders instructions below. This may include the following as applicable:
      1. Informed consent documents
      2. Documentation of why the potential subject was not enrolled (e.g., eligibility checklist showing how/why not eligible, research note stating not eligible, research note stating withdrew consent prior to enrollment)
      3. Eligibility supporting documents NOT available in the EMR that were obtained prior to decision to not enroll
      4. Sample shipping documents
      5. Serious adverse event collection/reporting documents (if collection/reporting started at time of consent)
    3. Do NOT delete existing documentation and do NOT delete/re-label existing folders/placeholders that are not in use

 Filing Subject-Related Essential Documents in eBinders

Within the general Subjects folder:

  • Requisition and Shipping Records (e.g., research samples to outside labs)
    • If samples are batched for shipping, file requisition forms and shipping records, including those pertaining to follow-up here. For individual subject samples (i.e., not batched) refer to Within Subject-Specific folders > Treatment and Data Info Per Cycle and Follow-up for more information. 
    • For Oncology studies, these are typically managed by the Cancer Pharmacology (CP) Lab and may be filed as certified copies in eBinders if requested by the sponsor/CRO. Originals are to be kept in the research records.
    • File naming convention for batched samples:
      • Batched samples_[Date shipped]
        • Example: Batched samples_2022.08.27
    • If documentation is transported between locations (e.g., University Hospital and Eastpark Medical Center) and a manifest is used, file it here.
      • File naming convention for document transport manifests:
        • [protocol number]_Doc transport manifest_[Date of finalization/receipt in YYYY.MM.DD format]
        • Example: UW23456_Doc transport manifest_2024.11.15

Within Subject-Specific folders:

The folders below are ordered according to how they appear within eBinders (i.e., alphabetically).

Informed Consent Documents

  • File all versions of signed consent documents (e.g., informed consent forms, HIPAA forms), including all documents in a multi-step consent process and re-consents
    • Originals with wet-ink signatures must be kept
    • If there is a standalone Information Sheet, scan it with the informed consent form
  • File all consent process notes, including those for re-consents (even if located within HealthLink)
  • File naming convention:
    • Informed Consent Document (with or without embedded HIPAA/Info Sheet): ICF_[Subject signature date] 
      • Example: ICF_2021.05.13
    • HIPAA (if separate): HIPAA_[Subject signature date]
      • Example: HIPAA_2021.05.13
    • Informed Consent Notes: [Initial Consent OR Reconsent] Note_[Date] 
      • Example: Initial Consent Note_2022.07.05
      • Example: Reconsent Note_2022.07.29
  • When moving consent documents to the Archived Informed Consent Documents folder, it is best practice to create consent event-specific folders for each consenting event to file the applicable documents (e.g., consent process note, signed consent form, signed HIPAA form) 

Registration and Eligibility

  • File all registrations from external sponsor systems and/or UW systems (e.g., OnCore registration, interactive web response system registrations, paper envelopes)
  • File completed eligibility checklist(s)
    • The annotations feature in eBinders can be used to add notations to documents and need to be signed. (Italics indicate sample notation)  
      • Example: Eligibility Criterion: Patient must have metastatic breast cancer that is ER+/PR+ and HER2 - metastatic liver lesion, ER+/PR+, HER2 negative per path report 1/5/2022
      • Example: Eligibility Criterion: Cannot currently be receiving any known strong inducers or inhibitors of CYP3A4/5 - None per 2022.08.04 PRC review of meds email
      • Example: Eligibility Criterion: Patient must have a life expectancy of at least 12 weeks - Yes, per discussion with MD
      • Example: Eligibility Criterion: Patient must not have active HIV or hepatitis - No to both, per review of EMR
    • To use the eligibility checklist as source, it must be signed and dated prior to enrollment on the study. This can be done:
      • By applying eSignature(s) after uploading and completing the document using annotations in eBinders
      • By applying wet-ink signature(s) to a paper document, scanning it into a PDF, and filing a certified copy in eBinders
    • File naming convention: [Study #]_[Subject ID]_Eligibility Checklist_[Final, typically investigator, signature date]
  • Source Documents used to Determine Eligibility
    • File relevant correspondence (e.g., from the sponsor, provider, Pharmaceutical Research Center (PRC))
    • File source documentation that is not available in HealthLink (e.g., creatinine clearance calculation using Cockcroft-Gault formula, EKG QTCF calculation)
    • File source documentation from HealthLink if it is not in an expected or intuitive place within HealthLink (e.g., menopausal status progress note from 6 years prior to study enrollment, documentation found in Care Everywhere, Media tab, or Outside Docs tab)
      • For Oncology studies, include all documentation from HealthLink for National Clinical Trials Network and Experimental Therapeutic Clinical Trials Network studies, as this is required for audits by the National Cancer Institute (NCI) Clinical Trials Monitoring Branch (CTMB)
    • File naming convention:
      • [Type of note/scan/result/email]_[Date]
        • Examples
          • ER_PR path result_2022.04.18
          • PET scan_2022.01.13
          • PRC con med email for eligiblity_2022.04.23

Response Assessments

  • Response refers to disease response/outcome, may be specific to some Oncology studies
  • Assessment Laboratories (Note: It may be appropriate to file these assessments in the Treatment and Data Info Per Cycle and Follow-up folder)
    • Whenever possible, lab results will be in the EMR
  • Response Forms
    • Response refers to disease response/outcome, may be specific to some Oncology studies
    • File RECIST, RADIUS, and other applicable disease assessment tools
      • It is best practice to upload new versions “onto” previous versions
      • File naming convention: [Response form/report type (e.g., RECIST, RADIUS)]_[Visit, if applicable]_[Date]
        • Examples:
          • RECIST_Cycle 7_2022.06.16
          • RADIUS Report_Week 42_2021.05.31
    • If central imaging reports are provided for the study, an additional folder can be created
  • Scan Reports
    • Whenever possible, scan reports will be in the EMR
    • Outside scan reports may be filed in eBinders as needed, and must be certified as copies
      • File naming convention: [Scan type]_[Date]
        • Example: CTc.a.p_2021.11.05

Safety Assessments

  • Adverse Event Log (cumulative or per cycle)
    • File the log if it is not in HealthLink
    • File eBinders eLog for AEs if applicable
    • File non-log documentation in the Treatment and Data Info Per Cycle and Follow-up folder as needed
  • Concomitant Medications Log (PRC emails) 
    • File the log if it is not in HealthLink
    • File eBinders eLog for concomitant medications if applicable
    • File pertinent correspondence about con meds with PRC, sponsor, investigator, etc. that occurs after registration/randomization
      • File naming convention: [Note Type]_[Date]
        • Example: PRC con med email_2022.06.25
  • Medical History and Baseline Symptoms Form (placeholder)
    • File the form if it is not in Healthlink

Subject Snapshot

  • Continuous Progress Notes
    • File general notes not also found in the EMR, as applicable
    • File naming convention: [Note type]_[Date]
      • Example: Vacation Dose Hold Note_2021.08.04
  • Subject Summary Form (placeholder)
    • File document that summarizes the subject’s experience on the study (e.g., flowsheet, roadmap)
    • File naming convention: Study Subject Summary Form_[Date of upload]
      • Example: Subject Summary Form_2021.07.29
  • Dose Modification Log (placeholder)
    • Typically, individual dose modifications notes are found in the EMR; however, a log shows all dose modifications over time.
    • This can be a separate log or incorporated into the Subject Summary Form.
    • File naming convention: Dose Modification Log_[Date of upload]
      • Example: Dose Modification Log_2022.08.04

Treatment and Data Info Per Cycle and Follow-up

  • File SAE/AESI documentation within the above folder, but do not file it within a visit-specific folder (Note: SAE refers to Serious Adverse Events and AESI refers to Adverse Events of Special Interest)
    • Create event-specific folders as needed
      • Folder naming convention: [SAE or AESI]_[Date]_[event term, optional]
      • Examples:
        • SAE_2022.07.28_fatigue
        • AESI_2022.10.01_ALT increase
        • SAE_2022.09.30
    • File SAE reports, including initial, follow-up, and final reports
      • Include supporting documents that are not in the EMR
    • File OnCore SAE documentation from the UW instance only if the study is an investigator-initiated study that only uses OnCore for SAE reporting
    • File the documentation created to evaluate the need to report to the IRB
      • Example: Decision tree outlining the reason why and timeline for reporting
    • File naming conventions:
      • SAE Report: SAE [Date]_[Initial OR Initial.Final OR Follow-up OR Final] Report
        • Example: SAE 2022.03.17_Initial Report
      • Sponsor Correspondence/Query Notes: SAE #[Date]_[Note Type]
        • Example: SAE 2022.03.26_Sponsor Query
  • Rename and duplicate the Visit folders as needed
    • Folder naming convention for treatment cycles: [cycle #], [Date]
    • Folder naming convention for visit weeks: [week #], [Date]
    • Folder naming convention for visits assigned numbers based on order: Visit [#], [Date]
    • Examples:
      • Cycle 3, 2022.07.15
      • Week 42, 2021.08.09
      • Visit 2, 2021.11.29
  • Quality of Life Questionnaires (QOLs)/Surveys
    • File certified copies in eBinders, either by visit or in one folder named QOL/Survey
    • Originals must be kept in the research office.
    • File naming convention: Survey_[Visit]_[Date QOL/survey was completed]
      • Example: Survey_Baseline_2021.05.16
  • Central Lab Results
    • File central lab results in eBinders, either by visit or in one folder named Central Labs
    • File naming convention: Central Labs_[Visit]_[Date]
      • Example: Central Labs_C2D15_2021.05.16
  • Requisition and Shipping Records (e.g., research samples to outside labs)
    • File requisition and shipping records for individual subjects in eBinders, either by visit or in one folder named Requisition and Shipping Records
    • For Oncology studies, these are typically managed by the Cancer Pharmacology (CP) Lab and may be filed as certified copies in eBinders if requested by the sponsor/CRO. Originals are to be kept in the research records.
    • File naming convention: [Specimen type]_[Visit]_[Date collected]
      • Example: Blood Biomarker_Baseline_2021.06.25
  • Treatment Administration Records
    • File treatment related certified copies of interactive web or voice response system (collectively abbreviated as IXRS) confirmation emails in eBinders, either by visit or in one folder named IXRS Confirmations.
      • Originals are to be kept
      • File naming convention: IXRS_[Visit]_[Drug name, if applicable_[Date]
        • Example: IXRS_C1D8_paclitaxel_2020.05.26
    • If available in the EMR, the following do not need to be filed in eBinders
      • IV drug administration
      • Radiotherapy records
    • For studies with subject self-administered drugs (e.g., oral drugs, subcutaneous injection):
      • File certified copies of self-administration/pill diaries, corresponding dose reconciliation forms/documentation/pill counts, either by visit or in one folder named Pill Diary_Dose Reconciliation
        • Originals must be kept
      • File naming convention:
        • Pill Diary_[Visit]
          • Example: Pill Diary_Cycle 2
        • Dose Rec_[Visit]
          • Example: Dose Rec_Cycle 2
      • If a cumulative (i.e., not visit-specific) log is used, it may be filed outside of a given visit folder
  • As needed, create other folders, such as:
    • Specialty Test Results (e.g., cardiac, ophthalmology, pulmonary, cognitive tests)
      • File in eBinders if not easily located in the EMR, either by visit or in one folder named based on the type of specialty test (e.g., Cardiac Tests)
      • File naming convention: [Test name]_[Visit]_[Date]
        • Example: Sponsor ECG_C3D1_2021.04.30
    • Research-Only Scan Results
      • File research-only scan results in eBinders, either by visit or in one folder named Research-Only Scan Results
  • Off Treatment/Study Documentation
    • Create an Off Treatment folder (Note: Create a separate Off Study folder if the Off Treatment and Off Study occur at different times/visits)
    • File a copy of the off treatment/study note(s) in eBinders (Note: This may include study coordinator and provider notes)
    • File naming convention: Off Tx [Note type] Note_[Date]
      • Examples:
        • Off Tx CRC Note_2022.07.08
        • UW12345_6789_Off Tx MD Note_ 2022.07.08
        • UW12345_6789_Off Tx NP Note_2021.10.31
  • Follow-up Visits (e.g., Long-Term Follow-Up or LTFU)
    • Create a Follow-up folder
    • If follow-up notes, tests, procedures, etc. are from an outside institution or are not easily located in the EMR, file certified copies in eBinders
    • File naming convention: [Visit]_[Date]
      • Example: 6 month FU_2021.02.14

 


Keywords:
subject, folder, UW, user, guide, Florence, ebinders, 
Doc ID:
122270
Owned by:
Jill K. in SMPH Research Informatics
Created:
2022-11-03
Updated:
2024-12-13
Sites:
SMPH Research Informatics